# SUMMARY OF SAFETY AND EFFECTIVENESS DATA

I. [GENERAL INFORMATION]{.underline}

> Device Generic Names: paflufocon B and paflufocon D rigid gas
> permeable contact lenses

Device Trade Names: Paragon CRT (paflufocon B) and CRT 100 (paflufocon
D), Paragon Quadra RG (paflufocon B) and Quadra RG 100 (paflufocon D)
Rigid Gas Permeable Contact Lenses for Corneal Refractive Therapy

##  Applicant\'s Name and Address: Paragon Vision Sciences

947 East Impala

##  Mesa, AZ 85204-6619

Date of Panel Recommendation: January 18, 2002

Premarket Approval Application (PMA) Supplement Number: P870024/S43

Date of Notice of Approval to Applicant:

II\. [INDICATIONS FOR USE]{.underline}

> The Paragon CRT™ (paflufocon B) and Paragon CRT™ 100 (paflufocon D)
> rigid gas permeable Contact Lenses for Corneal Refractive Therapy are
> indicated for use in the reduction of myopic refractive error in
> non-diseased eyes. The lenses are indicated for overnight wear in a
> Contact Lens Corneal Refractive Therapy fitting program for the
> temporary reduction of myopia up to 6.00 diopters in eyes with
> astigmatism up to 1.75 diopters. The lenses may be disinfected using
> only a chemical disinfection system.
>
> The Paragon Quadra RG (paflufocon B) and Paragon Quadra RG 100
> (paflufocon D) Rigid Gas Permeable Contact Lenses for Corneal
> Refractive Therapy are indicated for the reduction of myopic
> refractive error in non-diseased eyes. The lenses are indicated for
> overnight wear in a Contact Lens Corneal Refractive Therapy fitting
> program for the temporary reduction of myopia up to 3.00 diopters in
> eyes with astigmatism up to 1.50 diopters. The lenses may be
> disinfected using only a chemical disinfection system.
>
> Note: To maintain the Contact Lens Corneal Refractive Therapy effect
> of myopia reduction overnight lens wear must be continued on a
> prescribed schedule. Failure to do so can affect daily activities
> (e.g., night driving), visual fluctuations and changes in intended
> correction.

III\. [CONTRAINDICATIONS]{.underline}

> PARAGON CRT and PARAGON Quadra contact lenses for Corneal Refractive
> Therapy should not be used when any of the following conditions exist:
>
> • Acute and subacute inflammations or infection of the anterior
> segment of the eye.
>
> • Any eye disease, injury, or abnormality that affects the cornea,
> conjunctiva or eyelids.
>
> • Severe insufficiency of tears (dry eyes).
>
> • Corneal hypoesthesia (reduced corneal sensitivity).
>
> • Any systemic disease that may affect the eye or be exacerbated by
> wearing contact lenses.

-   Allergic reactions of ocular surfaces or adnexa which may be induced
    or exaggerated by wearing contact lenses or use of contact lens
    solutions.

> • Allergy to any ingredient, such as mercury or thimerosal, in a
> solution which is to be used to care for contact lenses.
>
> • Any active corneal infection (bacterial, fungal or viral).
>
> • If eyes become red or irritated.

IV\. [WARNINGS AND PRECAUTIONS]{.underline}

> The warnings and precautions can be found in the device labeling
> (Attached).

V. [DEVICE DESCRIPTION]{.underline}

> [Paragon CRT and Paragon CRT 100 (Sigmoid Proximity Control
> Design)]{.underline}

Paragon CRT design contact lenses are manufactured from Paragon HDS
(paflufocon B) and Paragon CRT 100 design contact lenses are
manufactured from Paragon HDS 100 (paflufocon D). The lenses are
designed to have congruent anterior and posterior surfaces each
consisting of three zones:

![](media/image1.wmf)

1.  The central spherical zone (OZ).

2.  A mathematically designed sigmoid corneal proximity" Return Zone"
    (W).

3.  A non-curving "Landing Zone" (LZW).

> The lens design also includes a convex elliptical edge terminus
> smoothly joining the anterior and posterior surfaces.

Paragon CRT and Paragon CRT 100 designs for contact lens corneal
refractive therapy are to be worn overnight with removal during all or
part of each following day. Both materials are thermoset fluorosilicone
acrylate polymer with a water content of less than 1%. The lens designs
for corneal refractive therapy are available as lathe cut firm contact
lenses with blue and green tints. The blue tinted lens contains D&C
Green No. 6. The green lens contains D&C Green No. 6 and Perox Yellow
No. 9.

Paragon Quadra RG and Paragon Quadra RG 100 (Reverse geometry
Proximity Control Design)

Paragon Quadra RG and Paragon Quadra RG 100 four zone reverse geometry
design is manufactured in Paragon HDS and Paragon HDS 100 (paflufocon
B and D) rigid gas permeable contact lens materials. The designs have
posterior surfaces consisting of four zones:

![](media/image2.wmf){width="5.344444444444444in" height="2.75in"}

1.  The central spherical or aspheric zone (OZ).

2.  An annular "Reverse Zone(s)" (R) surrounding the central zone with a
    curvature steeper (shorter radius) than the central zone .

3.  An "alignment zone(s)" (A) generally paralleling the underlying
    corneal surface.

4.  A peripheral curve(s) (P) with a radius selected to create "edge
    lift" to promote tear flow under the lens and avoid impingement of
    the peripheral curve on the cornea.

> The lens design also includes a "rounded" edge terminus extending from
> the anterior to the posterior surfaces to promote comfort.

The Paragon Quadra RG and Paragon Quadra RG 100 designs for corneal
refractive therapy are to be worn overnight with removal during all or
part of each following day. Both materials are thermoset fluorosilicone
acrylate copolymer with a water content of less than 1%. Paragon Quadra
RG and Paragon Quadra RG 100 are available with a handling aid for
locating the lens. The tinted lens materials, paflufocon B and D,
contain D&C Green No. 6, Perox Yellow No. 9, D&C Violet No. 2, and/or
D&C Red No. 17 as color additives.

VI\. [ALTERNATIVE PRACTICES OR PROCEDURES]{.underline}

The alternative practices and procedures to correcting myopia by wearing
these lenses include wearing daily wear RGP lenses in a reverse geometry
design, daily and extended wear RGP or soft (hydrophilic) contact
lenses, spectacles, and refractive surgeries such as LASIK.

VII. [MARKETING HISTORY]{.underline}

> On December 31, 1987, the applicant received approval of a PMA for the
> paflufocon A contact lens material for daily wear lenses. In November
> 1988 a PMA supplement was approved for the paflufocon B material (a
> modification of the paflufocon A material) for daily wear and in 1989
> another supplement approval for extended wear. The applicant, again,
> modified the material and received approval for a PMA supplement for
> daily and extended wear of the paflufocon D material in November 1993.
> In each if these submissions the devices were demonstrated to be safe
> and effective for the intended uses for both daily wear and for
> extended wear from 1-7 days.
>
> For the same lens materials, paflufocon B and paflufocon D, the
> applicant submitted premarket notification applications (K000224 and
> K010109) for the Paragon HDS-OK reverse geometry design for daily
> wear corneal refractive therapy (orthokeratology). The HDS-OK
> manufactured in paflufocon B was cleared for daily wear on April 17,
> 2000 while the lens manufactured in paflufocon D was cleared for
> marketing on February 28, 2001. The peripheral curve geometries for
> the HDS-OK orthokeratology lens design are the same as those for
> Quadra RG lens design.

Paragon has recently launched a market trial of its lens in Toronto,
Canada using only trained and certified fitters, but too few patients
have been fit to draw any conclusions other than to state that there
have been no reports to date of any complications. Furthermore, no
literature reports of complications in Europe or Australia are known to
Paragon.

VIII\. [POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH]{.underline}

Potential adverse effects on health associated with overnight wear
contact lenses include eye problems such as corneal ulcers, epithelial
microcysts, infiltrates and endothelial polymegathism. The risk of
corneal ulcer has been shown to be greater among users of overnight wear
contact lenses than among users of daily wear contact lenses. The risk
among overnight wear users increases with wear time. In addition,
smoking increases the risk of corneal ulcers for contact lens users,
especially when lenses are worn overnight or while sleeping. Strict
compliance with the proper lens care regimen and wearing schedule is
essential in minimizing risk.

IX\. [SUMMARY OF PRECLINICAL STUDIES]{.underline}

The application includes by reference the preclinical tests and results
in the approved original PMA (P870024), all related supplements and
substantially equivalent premarket notification applications 510(k)'s
K000224 and K010109.

X. [SUMMARY OF CLINICAL STUDIES - Paragon Quadra RG and Quadra RG
100]{.underline}

The Paragon Quadra RG lens designs was studied in a 3 month daily wear
clinical study as the HDS-OK lens made with the paflufocon B lens
material. That clinical study also served as the basis for clinical
performance data to determine the substantial equivalency of the HDS-OK
lens made with paflufocon D. The Summary of Safety and Effectiveness for
the daily wear clinical study is attached.

XI\. [SUMMARY OF CLINICAL STUDIES - Paragon CRT and Paragon CRT
100]{.underline}

**Objectives**

> The objective of the clinical study was to assess the safety and
> effectiveness of the Paflufocon B and D corneal refractive therapy
> lenses contact lens devices worn overnight to treat myopia and myopia
> with astigmatism.

A.  Study Design

> This was a controlled prospective, material randomized double masked
> study involving eleven clinical centers. Subjects were screened for
> eligibility criteria and participation interest only. The first eye
> was treated on June 16, 2000. The last eye treatment of the 18 and
> over cohort occurred on February 7, 2001 when enrollment was suspended
> pending approval to expand enrollment to subjects that are 12 years of
> age or older.
>
> A three month interim report was submitted to FDA for the purpose of
> demonstrating sufficient safety and effectiveness to allow the
> inclusion criteria to be amended from age 18 to age 12. Approval to
> lower the inclusion criteria to age 12 was granted on March 26, 2001
> and the maximum enrollment was increased from 200 to 225 subjects.
>
> A total of 218 subjects received baseline evaluation and 205 were
> dispensed lenses and treated in the study through August 23, 2001. The
> database was frozen for the purpose of this report on April 8, 2002.
> At that time, one hundred twenty two subjects, (240 eyes) completed a
> minimum of nine months of treatment. One subject remains active
> awaiting the nine month visit.
>
> **Eligibility Criteria**
>
> **a) Inclusion Criteria**

1.  Male or female subjects, of any race, and at least 18 years old
    (amended to 12 years) at the time of the pre-treatment examination.

2.  The prospective eye(s) must have naturally occurring refractive
    myopia from -0.5 to -6.0 diopters sphere (spectacle plane), with up
    to --1.75 diopters of refractive astigmatism (spectacle plane), as
    determined by manifest refraction (phoropter or trial frame with a
    12.5 mm vertex distance). Patients must have best spectacle
    corrected visual acuity of at least 0.04 logMAR in each eye.

3.  The prospective eye(s) must demonstrate refractive stability,
    confirmed by clinical records. Neither the spherical nor the
    cylindrical portion of the manifest refraction may have changed more
    than 0.5 D during the 12-month period immediately preceding the
    baseline examination. The astigmatic axis may not vary by more than
    15 degrees.

4.  If the subject wore rigid contact lenses in the prospective eye(s),
    lens use must cease at least four (4) weeks prior to the
    pre-treatment examination. The subject must have two central
    keratometry readings taken that are at least one week apart. The two
    readings shall not differ by more than 0.50 diopter in either
    meridian. The mires should be regular.

5.  Subjects must be willing and capable to return for all scheduled
    follow-up visits for a period of at least 12 months.

> **b) Exclusion Criteria**

1.  Female subjects who were pregnant, breast-feeding or intended to
    become pregnant over the course of the study.

2.  Subjects with a history of any of the following medical conditions:
    collagen vascular disease, autoimmune disease, immunodeficiency
    diseases, ocular herpes zoster or simplex, endocrine disorders
    (including, but not limited to active thyroid disorders and
    diabetes), lupus, and rheumatoid arthritis.

> **NOTE:** The presence of diabetes (either type 1 or 2), regardless of
> disease duration, severity or control, specifically excluded subjects
> from eligibility.

3.  Subjects with a history of intraocular or corneal surgery (including
    cataract extraction), active ophthalmic disease or abnormality
    (including, but not limited to, blepharitis, recurrent corneal
    erosion, dry eye syndrome, neovascularization \> 1mm from limbus),
    clinically significant lens opacity, clinical evidence of trauma
    (including scarring), or with evidence of glaucoma or propensity for
    narrow angle glaucoma as determined by gonioscopic examination in
    either eye.

> **NOTE:** This included any subject with open angle glaucoma,
> regardless of medication regimen or control. Additionally, any subject
> with an IOP greater than 21 mm Hg at baseline was specifically
> excluded from eligibility.

4.  Subjects with evidence of keratoconus, corneal irregularity, or
    abnormal videokeratography in either eye.

5.  Subjects with pupil size greater than 5.5 mm in photopic
    illumination as measured with infrared pupilometry, pupil detection
    component of computer assisted video keratography, or slit lamp
    reticule.

6.  Subjects who are participating in any other clinical trial (FDA or
    other).

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1.  **Safety Endpoints**

> The primary endpoints used to evaluate the safety of the treatment
> are:

a)  The proportion of eyes with a loss of two or more lines of BSCVA.

b)  The proportion of eyes with a post-treatment BSCVA of worse than
    20/40.

c)  The proportion of eyes with adverse events.

d)  The proportion of eyes with slit lamp findings greater than level 2
    at any follow-up visit.

e)  The proportion of eyes with symptoms, problems and complaints at
    each follow-up visit.

# 

2.  **Effectiveness Endpoints**

> The effectiveness endpoints from the FDA Guidance Document, "Guidance
> for Premarket Submissions of Orthokeratology Rigid Gas Permeable
> Contact lenses", are used to profile the overall effectiveness of the
> treatment of myopia and myopia with astigmatism with the proximity
> control lenses in Paflufocon B and D.
>
> []{.mark}
>
> The primary effectiveness endpoints are:

a)  The proportion of eyes that achieve an UCVA of 20/20 or better and
    20/40 or better.

b)  The proportion of eyes that have a reduction in manifest refraction
    spherical equivalent (MRSE) at nine months of treatment.

c)  The proportion of eyes that achieve predictability (attempted versus
    achieved) of the manifest refraction spherical equivalent of within
    ± 0.50 D and ± 1.00 D.

d)  The proportion of eyes that achieve stability of manifest refraction
    spherical equivalent as defined by a change of no more than 0.50 D
    and no more than 1.00 D manifest refraction spherical equivalent
    between the subjective refraction measures of two consecutive
    visits.

e)  The proportion of eyes that have a reduction of corneal curvature
    and absolute corneal astigmatism at nine months of treatment.

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3.  **Patient Assessments**

> The clinical trial was protocol controlled. The protocol detailed the
> procedures and methods for the initial examination, dispensing and all
> scheduled and non-scheduled follow up visits.
>
> The protocol stipulated uniform testing procedures for logMAR acuity
> measures. Bailey Lovie Charts were employed with a total correct
> letter count and test distance recorded on the case report form. The
> resultant logMAR acuity was calculated. The boundary for a line of
> vision was set at 0.04 logMAR below the threshold. For example, the
> 20/20 boundary was set at 0.04, equivalent to 20/20 ^--2^. The
> boundary for the category of eyes targeted for emmetropia was set from
> --0.25 to +0.50 D. Exact dioptric values and results were used to
> determine the boundaries for accuracy, stability and change in the
> MRSE
>
> The investigators were responsible for the final lens parameters. All
> lenses used in treatment have a proximity control zone (return zone)
> that joins the optic zone that is flatter in radius than the cornea to
> the peripheral landing zone. The proximity control zone returns the
> lens to the cornea to achieve centration and precise clearance to
> allow the corneal apex to retreat during treatment. The following
> methods were followed to determine the lens design:
>
> A diagnostic lens is selected having a radius of curvature
> corresponding to the intended keratometric correction. The return zone
> depth was determined using diagnostic lenses having 50 micron steps of
> return zone depth. This was followed by fluorescein pattern
> observations of landing zone angle in 2 degree increments to determine
> the landing zone that was tangent to the cornea midway between the
> midpoint of the landing zone and the edge. The investigator determined
> the final lens prescription based on the apparent fluorescein pattern
> as indicated in the diagnostic lens set fitting guide.

4.  **Demographic Data**

> A total of 218 subjects received baseline evaluation and 205 were
> dispensed lenses and treated in the study through August 23, 2001. The
> database was frozen for the purpose of this report on September 25,
> 2001. At that time, ninety-five subjects, (188 eyes) completed a
> minimum of nine months of treatment. Clinical investigators and sites
> were selected in an effort to provide sufficient diversity in
> geographic access, climate and elevation, urban and rural living, and
> racial mix for a resultant study population that represents the
> intended population to be treated.
>
> As of the cut-off date for the amended clinical report, the data for
> 121 subjects (240 eyes) were analyzed following 9 months of treatment.
> The mean age of these subjects was 34.98 years (ranging from 12 to 56
> years). There were 73 female and 48 male subjects. The completed
> subjects included adolescents and adults. There were 12 adolescent
> subjects (24 eyes) that completed 9 months of treatment. There were
> 188 Caucasians, 1 African American, 13 Asian/Pacific Islanders, and 3
> Hispanics.
>
> Table 1 (attached) presents demographic information for all patients
> analyzed for safety. The ratio of women to men enrolled was consistent
> with the contact lens wearing population. The pre-treatment refractive
> characteristics of the study population are represented in Table 2
> (attached).

5.  **Accountability**

> Two hundred eighteen subjects underwent baseline evaluation in the
> study. Of these, 205 subjects (408 eyes) had lenses dispensed and wore
> them for at least one night of treatment. The safety analysis was
> conducted on all 408 treated eyes of the 205 subjects. Of the 205
> subjects, 121 subjects (240 eyes) completed nine months of treatment
> and 1 subject remained active awaiting the 9-month visit.
>
> The efficacy analysis was conducted on 110 subjects (220 eyes) of the
> 121 that completed nine months of treatment. Twenty eyes of 11
> subjects were not included due to intermittent or interrupted wear
> during the last month of treatment preceding the nine-month visit. The
> lowest safety accountability at a single visit was 93% (238/256 eyes)
> with an average accountability of 96.8%. The lowest efficacy
> accountability at a single visit was 92.5% (222/240 eyes) with an
> average accountability of 96%.
>
> Of the 205 subjects, 83 were discontinued prior to the nine month
> visit and 1 subject (2 eyes) was not due for their nine month visit.
> Of these 83 subjects, 44 discontinued for reason of unacceptable
> vision and 8 discontinued for reason of comfort. The remainder was
> loss of interest, lost to follow up and missed visits, other and one
> subject that was reported to discontinue due to a protocol violation
> was because of pregnancy and the desire to discontinue at the 6 month
> follow up visit. Table 3 (attached) reports the tabulation of subjects
> that were discontinued prior to the nine-month visit and the reason
> for discontinuation.

B.  Effectiveness Data Analysis and Results

Analysis of effectiveness outcomes was performed on the cohort of eyes
that completed a minimum of 9 months of post dispensing follow up, and
had consistent wear prior to the nine-month visit. In this trial, 220
eyes fit this criterion. [The treatment is temporary and regression
occurs within 72 hours.]{.underline} A period of intermittent or
interrupted lens wear creates difficulty evaluating treatment
effectiveness. Several subjects experienced the loss or damage to one of
their lenses or elected to vary from the established wearing schedule
for the investigation. As a result, the respective eyes were
disqualified from the efficacy analysis.

1.  Analysis of manifest refraction spherical equivalent (MRSE)

> Table 4 (attached) presents the uncorrected visual acuity (UCVA) of
> all eyes available for efficacy analysis following 9 months of
> treatment. The UCVA results are stratified by pretreatment MRSE. The
> analysis of all eyes targeted for emmetropia is valuable for profiling
> the number of eyes that achieved 20/40 or better. [In this trial,
> 90.2% of eyes (185/205) achieved 20/40 or better at nine months of
> treatment.]{.underline}
>
> The analysis of UCVA of 20/20 or better as a measure of effectiveness
> is most meaningful for eyes with the ability to achieve a best
> spectacle corrected visual acuity (BSCVA) of at least 20/20
> pre-treatment. These eyes have the capacity to achieve an uncorrected
> visual acuity of 20/20 post-treatment, unlike those eyes that cannot
> be corrected to 20/20 pre-treatment. Of the 205 of the 220 completed
> eyes targeted for emmetropia, 159 demonstrated 20/20 BSCVA at the
> baseline evaluation.
>
> [Of the 159 eyes targeted for emmetropia with pretreatment BSCVA of
> 20/20 or better, 59.1% obtained 20/20 or better uncorrected visual
> acuity and 91.8% obtained 20/40 or better visual acuity at 9
> months.]{.underline}
>
> The analysis was conducted for the adolescent subset to profile the
> efficacy of the treatment for that group. The UCVA of the adolescent
> 22 eyes was 20/20 or better for 10 eyes (45.5%) and 20/40 or better
> for 20 eyes (90.91%).

2.  Analysis of manifest refraction spherical equivalent (MRSE)

> The analysis of the reduction in manifest refraction spherical
> equivalent at the nine-month visit provides an endpoint to assist in
> profiling the effectiveness of the treatment. Tables 5 and 6
> (attached) report the change in diopters of the manifest refraction
> spherical equivalent (MRSE) from the baseline to the nine-month post
> dispensing follow-up visits stratified by pretreatment MRSE for
> nine-month efficacy qualified eyes.
>
> At the nine-month visit for all eyes, 98.7% of eyes (217/220)
> demonstrated a reduction in the MRSE of pretreatment myopia. The trend
> is present for a corresponding increase in the refractive error
> reduction with greater pretreatment MRSE. Twenty-four eyes, 10.9%
> (24/220) demonstrated a reduction in MRSE of greater than 4.00 D.
>
> At 6 months post-treatment, 54.92% of subjects were within ±0.50 D of
> intended MRSE; 91.9% were within ±1.0 D and 96.89% were within ±2.0 D
> for all eyes treated. When analyzed by dioptric categories, 84.9% of
> eyes that attained post-treatment MRSE within ±0.50D had pretreatment
> refractive errors of 4.0D or less; 82.95% were within ±1.0D; and
> 83.42% were within ±2.0D. The greatest accuracy of this treatment
> modality is for those refractive errors that are 4.0D MRSE and less.
> Table 7 (attached) shows that these results were consistent for the
> 9-month analysis.
>
> No adolescent eyes demonstrated an increase in MRSE from baseline to
> the 9-month visit. Two eyes of the same subject with a pretreatment
> MRSE of -1.00 D demonstrated no change from baseline. The subject
> reported wearing the lenses only 4 nights per week since the 6-month
> visit.

3.  Analysis of Predictability (attempted vs. achieved)

> Table 7 (attached) provides the accuracy of treatment of the 9 month
> efficacy qualified eyes at the one, two, three, six and nine month
> follow up visits.
>
> For the 9 month efficacy qualified eyes, more than 50% demonstrate
> post treatment MRSE within [\<]{.underline} 0.50 D of the attempted
> target for post treatment follow up from the 3 through 9 month visits.
> More than 85% demonstrate accuracy within [\<]{.underline}1.00 D
> through the same post treatment interval.

4.  Analysis of Stability (Attached Tables 8 and 9)

> The analysis of the stability of the MRSE is presented as the number
> of eyes that manifest less than or equal to 0.50, 0.75, 1.00 and
> \>1.00 diopter of difference in MRSE measured in two consecutive
> visits measured at the three month to six month and six month to nine
> month visits. Stability of outcome is evaluated for qualified eyes
> with subjective refraction at all three visits. This cohort is
> comprised of 202 eyes.
>
> The attached Table 8 shows that from three to six months, 75.7% of
> eyes (179/202) demonstrated less than or equal to 0.50 D of difference
> in the MRSE while 95.1% of eyes (192/202) demonstrated less than or
> equal to 1.00 D of difference in the MRSE. The mean of the differences
> for all eyes was a decrease (toward target) in MRSE of -- 0.078 D.
> This indicates a rate of continued reduction in the MRSE between the 3
> and 6 month visits that would approach 0.25 D per year.
>
> The attached Table 9 shows for the adolescent subset from six to nine
> months 81.8% of eyes (18/22) demonstrated ≤0.50 D of difference in the
> MRSE while 90.9 % of eyes (20/22) demonstrated ≤1.00 D of difference
> in the MRSE.
>
> The mean of the difference for all eyes was an increase in MRSE of
> 0.028 D. This indicates a rate of regression in the MRSE between the
> 6-month and 9-month visits that would approach 0.12 D per year if
> sustained.

5.  Change in Corneal Curvature and Refractive Cylinder

> The reduction in refractive error and improvement in unaided visual
> acuity is the result in part of a change in the corneal radius as
> measured by keratometry. The keratometer measures the corneal
> curvature in the two principal meridians at a chord diameter slightly
> less than 3 millimeters. The keratometer does not provide data of the
> local curvature inside or outside of the location of its measurement.
> While video-keratographers were used in this trial, their methods of
> measurement and calculation of corneal eccentricity varied widely. The
> accuracy and repeatability of the simulated keratometer readings are
> not established and varied across instruments.
>
> For the purpose of this trial, the change in the absolute corneal
> cylinder and the change in curvature in the flat meridian at nine
> months of treatment are analyzed as endpoints to profile the
> effectiveness of the treatment.
>
> Nine eyes, 4.1% (9/220) manifested more than one diopter of increase
> in corneal cylinder from baseline to the nine month visit. Four of
> these were equal to or less than 1.25 D and three were greater than
> 1.50 D. Only one eye, 0.5% (1/220) demonstrated an increase of greater
> than 2.00 D. The increase in absolute corneal cylinder of that eye was
> measured to be 2.25 D.
>
> One adolescent eye, 4.2% (1/24) manifested more than one diopter of
> increase in corneal cylinder from baseline to the nine month visit.
> The increase in absolute corneal cylinder in this eye was 1.25 D.

6.  Change in MRSE as a function of the change in the Flat Meridian

> Most importantly is the analysis of the change in MRSE as a function
> of the change in the flat meridian from pretreatment levels. Table 10
> (attached) reports the change in the flat meridian at 9 months of
> treatment for all efficacy qualified eyes targeted for emmetropia,
> stratified by the pretreatment MRSE.
>
> Analysis of Keratometry Change in the Flat Meridian at 9 months
> post-treatment shows that all eyes experienced some degree of change
> in the flat k meridian. Overall, there is a flattening of the flat k
> meridian with this treatment modality.

7.  Analysis of Refractive and Keratometric Stability

> An analysis of the mean of the differences of the post treatment
> measures as compared with the baseline and serial measures provides
> value in studying the change over time as well as the stability of the
> treatment.
>
> The mean of the differences of the MRSE and mean keratometry from
> baseline to one month, one to two months, two to three months, three
> to six months and six to nine months for the efficacy qualified eyes
> targeted for emmetropia were provided.
>
> The analysis indicates that the major portion of the treatment occurs
> in the first month with continued reduction of the MRSE thereafter.
> The rate of change in the mean of the differences supports stability
> before 3 months post treatment.
>
> This analysis also indicates that the major portion of the treatment
> occurs in the first month with continued minor reduction of the mean
> keratometry thereafter.
>
> The mean of the differences for the adolescent subset targeted for
> emmetropia that completed nine months of treatment reflects the lower
> baseline MRSE mean for the adolescent subset. The combined mean of the
> differences from 3 to 6 to 9 months is useful to project the annual
> rate of change to approximately 0.12 D.

8.  Analysis of Wearing Time

> The subjects were instructed to apply their lenses within 30 minutes
> of going to sleep and to remove them within 30 minutes of awakening.
> The wearing time generally corresponds to the expected distribution of
> sleep time per night. The average wear time during this study was 6.1
> to 8 hours per night. There does not appear to be a relationship
> between length of wear and unaided visual acuity.

9.  Analysis of Post lens removal UCVA Regression

> An analysis of the rate of regression of MRSE and UCVA over time was
> conducted to provide information regarding the change over time
> following lens removal. Per
>
> the protocol, subjects were evaluated at 8, 24, 48, and 72 hours after
> removal of the lenses following either the six or nine month scheduled
> visit.
>
> The original premise was that regression post lens removal was related
> to the magnitude of treatment applied such that the larger the
> correction achieved, the greater the regression rate. This was
> analyzed by conducting regression analyses in dioptric treatment
> ranges stratified by achieved correction of: 0.12 to 1.50D; 1.62 to
> 3.00D; 3.12 to 4.50D; and \> 4.50D. Each of the corneas within these
> stratifications would likely have experienced similar reshaping and
> would likely respond with similar rates of return to pretreatment
> conditions.
>
> The established nine month refraction as well as the refraction at
> each of the evaluation time points post lens removal were plotted
> against the actual time at which the regression measurement was made.
> The trend varied from eyes having low achieved treatment to eyes with
> higher achieved treatment. These results are consistent with the
> original premise that greater amounts of corrections regress at
> greater rates. Data are reported in Table 14 (attached).

C.  Safety Data Analysis and Results

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1.  Change in BSCVA from Baseline

> Table 11 (attached) provides the change in lines of BSCVA at the
> 9-month post-treatment interval for all completed eyes in the study.
> The majority of eyes, 69.17% had no change in BSCVA from baseline.
> Thirty-three (33) eyes had a gain of 1 line, no eyes had a gain of 2
> lines, and 4 eyes had a gain of \>2 lines in BSCVA as compared to
> baseline. Concurrently, 28 eyes (11.67%) had a loss of 1 line, 2 eyes
> (0.83%) lost 2 lines; and 5 eyes (2.08%) had BSCVA losses of \>2 lines
> as compared to baseline.
>
> An important note is that there were no losses of \>2 lines in
> refractive errors up to --3.0D as compared to refractive errors above
> --3.0D. Also, the losses of \>2 lines were low even for those
> refractive errors above --3.0D.
>
> For the 24 adolescent subjects, the change in lines of BSCVA at the
> 9-month post-treatment interval 18 eyes (75.0%) had no change in BSCVA
> from baseline, 5 eyes (20.83%) gained 1 line, and 1 eye (4.17%) gained
> 2 lines. There were no eyes with loss of BSCVA.
>
> There were no losses worse than 20/40 at the nine-month visit. At
> prior visits eyes measured worse than 20/40 BSCVA were re-tested when
> possible with a contact lens in place. Three eyes found to have worse
> than 20/40 BSCVA did not have a contact lens applied because of the
> grade of staining. In the remaining cases the acuity improved to
> within one line of vision indicating that the loss was due to
> wavefront aberration in the anterior corneal plane.
>
> There were no measures of permanent or persistent loss of 2 or more
> lines of vision. All eyes with BSCVA losses of 2 or more lines were
> re-examined at a subsequent visit and found to be within one line of
> the baseline measure.

2.  Adverse Reactions

> There were no persistent losses or reductions of sight or deaths
> attributable to treatment during the course of this trial. There were
> 4 events reported on Adverse Event Forms. Each of the events were, by
> definition, study related complications and not adverse events.
>
> One subject scratched the eye with a lens plunger and/or lens, one
> subject had a red and slightly irritated eye presumed to be bacterial
> conjunctivitis, one subject had tearing and discomfort, and one
> subject had diffuse subepithelial infiltrative keratitis. In each case
> the condition resolved.

3.  Slit Lamp Findings

> Slit lamp findings greater than grade 2 were reported as grade 3 for
> edema (18 incidents); staining (9 incidents); and injection (1
> incident). All findings greater than grade 2 resolved without further
> complications. There were no positive slit lamp findings greater than
> grade 2 for any adolescent subjects at any time during the study.

4.  Symptoms, Problems and Complaints

> Subjects were asked to report symptoms and complaints as part of the
> dispensing visit and each follow up visit. These complaints are
> tabulated as follows for 2,197 eye exams:
>
> Discomfort 770 Itching/Burning 99
>
> Blurred Vision 408 Photophobia 59
>
> Variable Vision 358 Halos 109
>
> Dryness/Scratching 264 Lens needs Cleaning 17
>
> Other 113
>
> The symptom of discomfort is prevalent at dispensing and improves
> through the treatment. Blur and variable vision were reported at every
> visit. The report of symptoms, problems and complaints does not
> differentiate whether the blur is with or without the lenses.

5.  Intraocular Pressure

> Table 12 (attached) reports the change in intraocular pressure from
> baseline to each follow up visit for all the 408 eyes enrolled. Of the
> 240 completed eyes at nine months, 92.3% (203 eyes) showed no change
> or a variation between +/- 5mmHG.

6.  Device Failures and Replacements

> The modality is designed as a single lens treatment. Investigators
> were permitted one retreatment lens per eye and were allowed to
> reorder lenses in the event of loss or damage. If additional
> retreatment lenses were required, the investigators were instructed to
> request authorization from the study monitor. There were 82 lenses
> reordered for 240 eyes. Of these, 10 were reordered to replace lost or
> damaged lenses. There were 2 reordered due to deposits and 70 were
> used for purpose of re-treatment. Table 13 reports the number of lens
> reorders for the completed eyes after the original dispensing.

7.  Persistent Corneal Change

> The protocol stipulated that all discontinued eyes must be followed at
> one month intervals until the keratometry measures were equal to or
> less than 0.50 diopter of difference from the baseline value in each
> meridian. At the same follow up visits the manifest refraction and
> best spectacle corrected visual acuity was reported and inspected for
> return to the baseline measure. Persistent corneal change can be
> profiled by analysis of the return to baseline keratometry, refraction
> and best spectacle corrected visual acuity. An analysis was performed
> on all eyes having 3 or more weeks of treatment. The length of
> treatment and time to return to baseline was tabulated as a function
> of the pre treatment manifest refraction spherical equivalent.
>
> Of the 83 discontinued subjects (166 eyes), 44 eyes of 22 subjects
> discontinued with two weeks or less treatment and were found to be at
> baseline upon dispensing or upon the first follow up visit. Four
> subjects, (8 eyes) discontinued without returning for a final visit
> and were lost to follow up. Fourteen subjects (28 eyes) miss serial
> post discontinuation visits or reported for scheduled post treatment
> visits having discontinued wear between visits without notification to
> the investigator and were found to be at baseline at the
> discontinuation visit. These subjects were excluded from the analysis
> since the time to baseline is unknown and would have to be estimated.

D.  Additional Data Analysis and Results

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1.  Analysis of lens material

> Statistical testing for evaluating the clinical effects of the
> material used to manufacture the lenses was performed after the
> database was locked for the initial PMA submission. Analysis by
> material was conducted on the subset that had completed nine months of
> treatment at that time. The efficacy points analyzed were:

-   Uncorrected visual acuity of 20/40 or better and 20/20 or better for
    eyes targeted for emmetropia with pretreatment best corrected acuity
    of 20/20 or better

-   Accuracy of the attempted vs. achieved of [+]{.underline} 0.50 D and
    [+]{.underline}1.00 D of the 9 month MRSE

-   Stability of [+]{.underline} 0.50 D and [+]{.underline}1.00 D
    between the three and six month and six and 9 month measured MRSE.

> There was not a statistically significant difference between materials
> for the three efficacy outcomes analyzed.
>
> Analysis by material was also conducted for the safety variables of
> Slit Lamp Findings by visit and the incidence of symptoms, problems
> and complaints by visit.
>
> Of the six slit lamp variables reported at eight intervals (48
> statistical tests in all), the finding of edema at unscheduled visits
> was the only p-value that approached the predetermined level of
> statistical significance between the two materials.
>
> While the difference lacked statistical significance, the proportion
> was greater for paflufocon B than for D. It is expected that the use
> of the moderate Dk material could result in edema in persons having
> higher corneal oxygen requirements, even though both paflufocon B and
> D are approved for 7 days of extended wear in conventional designs.
>
> Analysis by material of the reported symptoms, problems and complaints
> was conducted on nine variables reported at eight intervals (72
> statistical tests in all). The complaint of halos at the two month
> visit was the only p-value that resulted in statistical significance.
> For the reports of halos, the proportion was greater at both intervals
> for paflufocon B than for D. It is possible that the halos reported in
> greater proportion with the moderate Dk material may be related to
> hypoxia and corneal edema.
>
> Overall both materials performed well as evaluated in this study and
> are equivalent in performance.

2.  Comparative Analysis of lens designs

> As reported in the device description section of this summary, the CRT
> lens design used in the overnight study had specific features that
> represented some difference from generic 4 curve Quadra RG design. In
> order to address effectiveness concerns of the Quadra RG design used
> overnight, a further analysis of existing data was provided.
>
> The data from the daily wear submission cleared for marketing by FDA
> cleared for the open eye treatment of up to 3.00 D of myopia with up
> to 1.50 D of astigmatism included four generic reverse geometry
> designs. The prior generic data from the 3 month open eye trial was
> re-analyzed to demonstrate the efficacy of the generic design in
> comparison to the proximity control design used in the overnight
> clinical trial.
>
> This efficacy comparison used subsets of the data from each of the two
> clinical trials derived from all eyes with up to --3.00 D of
> pretreatment MRSE for all subjects 12 years of age and older that
> reported at the three month visits. There were 78 eyes in the generic
> design open eye study subset and 72 eyes in the specific design
> overnight study subset with up to --3.00 D of pretreatment MRSE.
>
> The efficacy endpoints of uncorrectred visual acuity, reduction in
> pretreatment MRSE, accuray of attempted vs. achieved reducrion in
> MRSE, stability and keratometry change in the flat meridian were
> compared. There were not statistically significan differences found
> for the parameters evaluated, with the exception of a statistically
> significant difference in the change in keratometry in the flat
> meridian (p=0.1). The analysis showed that a greater proportion of
> eyes experienced an increased flattening of the flat keratometry
> meridian in the eyes with higher myopia treated in the overnight study
> as compared to the open eye study.
>
> Selected outcomes of the measures analyzed are reported below:

-   Uncorrected visual acuity

> The proportion of eyes that achieve an UCVA of 20/20 or better and
> 20/40 or better. Both clinical trials utilized the same logMAR charts
> under the same conditions. In each case the protocol stipulated
> reporting the letter count and test distance for all measures. The
> logMAR and corresponding Snellen values were calculated from the
> letter count and test distances reported. UCVA for eyes targeted for
> emmetropia with a pretreatment BSCVA of 20/20 or better was selected
> from the two databases. From the open eye dataset, 56 eyes met the
> comparison criteria. 52.7% achieved post treatment UCVA of 20/20 and
> 94.6% achieved 20/40. From the overnight dataset, 61 eyes met the
> comparison criteria. 57.4% achieved post treatment UCVA of 20/20 and
> 88.5% achieved 20/40.

-   Change in MRSE

> From the 78 eyes analyzed from the open eye dataset 70.6% were within
>
> +/- .50D and 98.5% within +/- 1.00D. From the 72 eyes in the overnight
> dataset, 73.6% % were within +/- .50D and 97.2% within +/- 1.00D.

XI\. [CONCLUSIONS DRAWN FROM THE STUDIES]{.underline}

The results of the preclinical studies and clinical studies provide
reasonable assurance of the safety and effectiveness of the devices for
the subject population, refractive conditions and specified wearing
modality. Although the potential exists for minor differences in
physiological response by gender for the target population, minimal
number of clinically significant findings does not indicate that gender
differences are of clinical importance for these devices.

XII\. [PANEL RECOMMENDATION]{.underline}

> At an advisory meeting held on January 18, 2002, the Ophthalmic
> Devices Panel recommended that Paragon Vision Sciences' PMA for the
> Paragon CRT™, CRT™100, Quadra RB, and Quadra RG100 rigid gas permeable
> contact lenses for overnight orthokeratology be approved subject to
> submission to, and approval by, the Center for Devices and
> Radiological Health (CDRH) of the following:
>
> **[CRT Lenses]{.underline}**

1.  Revise indications to include \"in ages 18 years and older\"

2.  Revise labeling to include

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a.  Information noting that the study population was mostly Caucasian
    women.

b.  A statement that the discontinuation rate of use was 34.6% with the
    reasonsfor discontinuation included.

c.  Statement that no data is known on those excluded from the study.

d.  Include data on patients who are post treatment uncorrected visual
    acuity (UCVA) targeted for emmetropia, stratified by mean refractive
    spherical equivalent (MRSE).

e.  Include statement that orthokeratology does not affect the magnitude
    of pretreatment astigmatism.

f.  Include data on the post lens removal decrease in treatment affect
    with time stratified by refractive error.

g.  List transient changes in post treatment best corrected visual
    acuity (BSCVA).

h.  Emphasize that lenses need to be worn each night overnight. Failure
    to do so can affect activities of daily living, e.g., night driving,
    visual fluctuations, changes in intended correction. Some wearers
    may need corrective lenses during the day.

i.  State that 10-15% of the study patients did not achieve 20/40 UCVA
    with the trend worsening for higher myopic patients.

j.  Caution Statement that corneal edema is more prevalent with the use
    of the lens in high altitudes.

k.  Inclusion of refraction data on the time from removal of the lens to
    recovery to baseline visual acuity and MRSE, stratified by
    preoperative MRSE.

l.  Side effect data to include discomfort rates, punctate epithelial
    keratopathy, and other clinical findings.

m.  Alternative therapies delineated in the patient information booklet,
    e.g., spectacles, contact lenses, refractive surgery alternatives.

n.  Statement on satisfaction rates.

o.  Transmissibility data showing the Dk/L values of the two contact
    lens materials to be placed in the physicians' information.

p.  Physician and patient informational materials should be clarified
    for the target audience.

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3.  Physician certification or training should be required prior to the
    use of the lens

> **[Quadra Lenses]{.underline}**
>
> In addition to numbers 1, 2, and 3 above, the sponsor should submit
> further analysis of existing data to address effectiveness concerns.

XIII\. [CDRH DECISION]{.underline}

CDRH concurred with the Ophthalmic Devices Panel's recommendation of
January 18, 2002, and issued a letter to Paragon Vision Sciences on
February 27, 2002, advising that its PMA was approvable subject to their
submission of an amendment adequately addressing the conditions listed
above as recommended by the Panel. In amendments received by FDA on
April 23, May 7 and June 3, 2002, Paragon Vision Sciences adequately
addressed conditions 2 and 3 of the Panel's conditions for the CRT™ and
CRT™ 100 lenses and all the conditions for the Quadra RG™ and Quadra RG™
100 lenses.

In regards to condition 1 (above) of the Panel's recommendation, there
are several considerations for not concurring with the recommendation
and thereby not limiting the age of treatment in the indication for use.
Although there were limited data reported, those data reported on
adolescents did comprise 11% of the completed dataset. FDA notes that
adolescent subjects in this clinical study had fewer positive slit lamp
findings (none greater than grade 2) and no reports of adverse
reactions.

> Adolescent patients wearing rigid contact lenses, both gas permeable
> (RGP) and polymethylmethacrylate (PMMA) has been an accepted practice
> since their initial availability. Adolescent subjects have worn both
> daily wear and extended wear RGP lenses up to 7 days and beyond and
> have been included in clinical studies of these lenses.
>
> Although there are no reports in the orthokeratology literature
> specific to adolescent subjects, the primary effectiveness concern in
> this age group is their expected progression of myopic refractive
> error as they grow. However, the contact lens base curve can be
> adjusted to correct for any refractive error progression over time. In
> addition, the long safety term effects of rigid gas permeable lens use
> for reshaping the cornea has not been established for any specific age
> population.
>
> CDRH does not believe that the approval of these devices for overnight
> corneal refractive therapy without an age restriction would pose any
> additional compromise of safety or effectiveness for adolescent
> patients when used in accordance with the approved labeling.

FDA issued an approval order on .

XIV\. [APPROVAL SPECIFICATIONS]{.underline}

Directions for use: See the labeling.

Hazards to Health from Use of the Device: See Indications,
Contraindications, Warnings, precautions and Adverse Events in the
labeling.

Postapproval Requirements and Restrictions: See approval order.

+-----------------+---------------------------+-----------+-----------+
| **Table 1**     |                           |           |           |
|                 |                           |           |           |
| **Demographic   |                           |           |           |
| Information of  |                           |           |           |
| All Enrolled    |                           |           |           |
| and Treated     |                           |           |           |
| Subjects**      |                           |           |           |
|                 |                           |           |           |
| **N=205, (408   |                           |           |           |
| Eyes Treated)** |                           |           |           |
+-----------------+---------------------------+-----------+-----------+
| **Category**    | **Classification**        | **n**     | **%       |
|                 |                           |           | Eyes**    |
+-----------------+---------------------------+-----------+-----------+
| **Gender**      | **Male**                  | **80**    | **39.0**  |
+-----------------+---------------------------+-----------+-----------+
|                 | **Female**                | **125**   | **61.0**  |
+-----------------+---------------------------+-----------+-----------+
| **Eyes**        | **Right**                 | **205**   | **50.2**  |
+-----------------+---------------------------+-----------+-----------+
|                 | **Left**                  | **203**   | **49.8**  |
+-----------------+---------------------------+-----------+-----------+
| **Race**        | **Caucasian**             | **188**   | **91.7**  |
|                 |                           |           |           |
|                 | **African American**      |           |           |
|                 |                           |           |           |
|                 | **Asian / Pacific         |           |           |
|                 | Islander**                |           |           |
|                 |                           |           |           |
|                 | **American Indian / Aleut |           |           |
|                 | Eskimo**                  |           |           |
|                 |                           |           |           |
|                 | **Hispanic**              |           |           |
|                 |                           |           |           |
|                 | **Latino**                |           |           |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **1**     | **0.5**   |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **13**    | **6.3**   |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **0**     | **0.0**   |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **3**     | **1.5**   |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **0**     | **0.0**   |
+-----------------+---------------------------+-----------+-----------+
| **Current CL    | **None**                  | **37**    | **18.1**  |
| History**       |                           |           |           |
|                 | **Hydrogel**              |           |           |
|                 |                           |           |           |
|                 | **Rigid**                 |           |           |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **154**   | **75.1**  |
+-----------------+---------------------------+-----------+-----------+
|                 |                           | **14**    | **6.8**   |
+-----------------+---------------------------+-----------+-----------+
| **Age (in       | **Average**               | **33.66** |           |
| Years)**        |                           |           |           |
|                 | **Standard Deviation**    | **±       |           |
|                 |                           | 12.4**    |           |
|                 | **Minimum**               |           |           |
|                 |                           | **12**    |           |
|                 | **Maximum**               |           |           |
|                 |                           | **58**    |           |
+-----------------+---------------------------+-----------+-----------+

+-----------+------+------+------+------+------+------+------+------+
| **Table   |      |      |      |      |      |      |      |      |
| 2**       |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **Pre     |      |      |      |      |      |      |      |      |
| treatment |      |      |      |      |      |      |      |      |
| R         |      |      |      |      |      |      |      |      |
| efractive |      |      |      |      |      |      |      |      |
| C         |      |      |      |      |      |      |      |      |
| ylinder** |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **S       |      |      |      |      |      |      |      |      |
| tratified |      |      |      |      |      |      |      |      |
| by        |      |      |      |      |      |      |      |      |
| Pre       |      |      |      |      |      |      |      |      |
| treatment |      |      |      |      |      |      |      |      |
| Sphere**  |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **All     |      |      |      |      |      |      |      |      |
| Efficacy  |      |      |      |      |      |      |      |      |
| Qualified |      |      |      |      |      |      |      |      |
| Eyes      |      |      |      |      |      |      |      |      |
| (N=220)** |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | **   |      |      |      |      |      |      |      |
|           | Pret |      |      |      |      |      |      |      |
|           | reat |      |      |      |      |      |      |      |
|           | ment |      |      |      |      |      |      |      |
|           | Sp   |      |      |      |      |      |      |      |
|           | here |      |      |      |      |      |      |      |
|           | (D   |      |      |      |      |      |      |      |
|           | S)** |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **Pretr   | **≤  | **   | **   | **   | **   | **   | **   | *    |
| eatment** | 1.   | 1.25 | 2.25 | 3.25 | 4.25 | 5.25 | 6.25 | *Tot |
|           | 0D** | to** | to** | to** | to** | to** | to** | al** |
| **R       |      |      |      |      |      |      |      |      |
| efractive |      |      |      |      |      |      |      |      |
| C         |      |      |      |      |      |      |      |      |
| ylinder** |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **(DC)**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           |      | *    | *    | *    | *    | *    | *    |      |
|           |      | *2.0 | *3.0 | *4.0 | *5.0 | *6.0 | *7.0 |      |
|           |      | 0D** | 0D** | 0D** | 0D** | 0D** | 0D** |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | *    | *    | *    | *    | *    | *    | *    |
|           | *n** | *n** | *n** | *n** | *n** | *n** | *n** | *n** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | *    | *    | *    | *    | *    | *    | *    |
|           | *%** | *%** | *%** | *%** | *%** | *%** | *%** | *%** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | *    | *    | *    | *    | *    | *    | *    |
|           | *Col | *Col | *Col | *Col | *Col | *Col | *Col | *Col |
|           | %**  | %**  | %**  | %**  | %**  | %**  | %**  | %**  |
+-----------+------+------+------+------+------+------+------+------+
|           |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **0.00**  | *    | **   | **   | *    | *    | *    | *    | **   |
|           | *7** | 24** | 22** | *7** | *6** | *0** | *0** | 66** |
+-----------+------+------+------+------+------+------+------+------+
|           | **3. | *    | **   | **3. | **2. | *    | *    | **3  |
|           | 18** | *10. | 10** | 18** | 73** | *0** | *0** | 0%** |
|           |      | 91** |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | *    | *    | *    | *    | *    |      |
|           | *41. | 30** | *32. | *21. | *37. | *0** | *0** |      |
|           | 18** |      | 35** | 88** | 50** |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **0.12 to | *    | **   | **   | **   | *    | *    | *    | **   |
| 0.50**    | *6** | 33** | 23** | 18** | *5** | *2** | *0** | 87** |
+-----------+------+------+------+------+------+------+------+------+
|           | **2. | *    | *    | **8. | **2. | **0. | *    | **   |
|           | 73** | *15. | *10. | 18** | 27** | 91** | *0** | 39.5 |
|           |      | 00** | 45** |      |      |      |      | 5%** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | *    | *    | *    | *    | *    | *    |      |
|           | *35. | *41. | *33. | *56. | *31. | *28. | *0** |      |
|           | 29** | 25** | 82** | 25** | 25** | 57** |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **0.62 to | *    | **   | **   | *    | *    | *    | *    | **   |
| 1.00**    | *2** | 17** | 16** | *4** | *2** | *3** | *0** | 44** |
+-----------+------+------+------+------+------+------+------+------+
|           | **0. | **7. | **7. | **1. | **0. | **1. | *    | **2  |
|           | 91** | 73** | 27** | 82** | 91** | 36** | *0** | 0%** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | *    | *    | *    | *    | *    | *    |      |
|           | *11. | *21. | *23. | *12. | *12. | *42. | *0** |      |
|           | 76** | 25** | 53** | 50** | 50** | 86** |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **1.12 to | *    | *    | *    | *    | *    | *    | *    | **   |
| 1.50**    | *2** | *5** | *3** | *1** | *3** | *2** | *0** | 16** |
+-----------+------+------+------+------+------+------+------+------+
|           | **0. | **2. | **1. | **0. | **1. | **0. | *    | *    |
|           | 91** | 27** | 36** | 45** | 36** | 91** | *0** | *7.2 |
|           |      |      |      |      |      |      |      | 7%** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **6. | **4. | **3. | *    | *    | *    |      |
|           | *11. | 25** | 41** | 13** | *18. | *28. | *0** |      |
|           | 76** |      |      |      | 75** | 57** |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **1.62 to | *    | *    | *    | *    | *    | *    | *    | *    |
| 2.00**    | *0** | *1** | *4** | *2** | *0** | *0** | *0** | *7** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **0. | **1. | **0. | *    | *    | *    | *    |
|           | *0** | 45** | 82** | 91** | *0** | *0** | *0** | *3.1 |
|           |      |      |      |      |      |      |      | 8%** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **1. | **5. | **6. | *    | *    | *    |      |
|           | *0** | 25** | 88** | 25** | *0** | *0** | *0** |      |
+-----------+------+------+------+------+------+------+------+------+
|           |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **Total** | **   | **   | **   | **   | **   | *    | *    | **2  |
|           | 17** | 80** | 68** | 32** | 16** | *7** | *0** | 20** |
+-----------+------+------+------+------+------+------+------+------+
|           | **7. | *    | *    | *    | **7. | **3. | *    | **10 |
|           | 73** | *36. | *30. | *14. | 27** | 18** | *0** | 0%** |
|           |      | 36** | 91** | 55** |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+

+-------------------------------------------+--------------------------+
| **Table 3**                               |                          |
|                                           |                          |
| **Reason for Discontinuation**            |                          |
|                                           |                          |
| **(N=83 Subjects, 166 Eyes)**             |                          |
+-------------------------------------------+--------------------------+
| **Reason for Discontinuation**            | **Number of Patients**   |
+-------------------------------------------+--------------------------+
| **Unacceptable Vision**                   | **44**                   |
+-------------------------------------------+--------------------------+
| **Lack of Interest**                      | **12**                   |
+-------------------------------------------+--------------------------+
| **Lost to follow-up**                     | **9**                    |
+-------------------------------------------+--------------------------+
| **Lack of Comfort**                       | **8**                    |
+-------------------------------------------+--------------------------+
| **Other**                                 | **6**                    |
+-------------------------------------------+--------------------------+
| **Missed Visits**                         | **3**                    |
+-------------------------------------------+--------------------------+
| **Protocol Violation**                    | **1**                    |
+-------------------------------------------+--------------------------+
|                                           |                          |
+-------------------------------------------+--------------------------+

+-----------+------+------+------+------+------+------+------+------+
| **Table   |      |      |      |      |      |      |      |      |
| 4**       |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **Un      |      |      |      |      |      |      |      |      |
| corrected |      |      |      |      |      |      |      |      |
| Visual    |      |      |      |      |      |      |      |      |
| Acuity    |      |      |      |      |      |      |      |      |
| (UCVA) at |      |      |      |      |      |      |      |      |
| the 9     |      |      |      |      |      |      |      |      |
| Month     |      |      |      |      |      |      |      |      |
| Visit     |      |      |      |      |      |      |      |      |
| S         |      |      |      |      |      |      |      |      |
| tratified |      |      |      |      |      |      |      |      |
| by        |      |      |      |      |      |      |      |      |
| Pre-      |      |      |      |      |      |      |      |      |
| treatment |      |      |      |      |      |      |      |      |
| M         |      |      |      |      |      |      |      |      |
| anifest** |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **R       |      |      |      |      |      |      |      |      |
| efraction |      |      |      |      |      |      |      |      |
| Spherical |      |      |      |      |      |      |      |      |
| Equi      |      |      |      |      |      |      |      |      |
| valent.** |      |      |      |      |      |      |      |      |
|           |      |      |      |      |      |      |      |      |
| **All     |      |      |      |      |      |      |      |      |
| Efficacy  |      |      |      |      |      |      |      |      |
| Qualified |      |      |      |      |      |      |      |      |
| Eyes      |      |      |      |      |      |      |      |      |
| (N=220)** |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **Post    | *    |      |      |      |      |      |      |      |
| treatment | *Pre |      |      |      |      |      |      |      |
| UCVA)**   | T    |      |      |      |      |      |      |      |
|           | reat |      |      |      |      |      |      |      |
|           | ment |      |      |      |      |      |      |      |
|           | My   |      |      |      |      |      |      |      |
|           | opia |      |      |      |      |      |      |      |
|           | (MRS |      |      |      |      |      |      |      |
|           | E)** |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | **≤  | **   | **   | **   | **   | **   | **   | *    |
|           | 1.   | 1.25 | 2.25 | 3.25 | 4.25 | 5.25 | 6.25 | *Tot |
|           | 0D** | to** | to** | to** | to** | to** | to** | al** |
|           |      |      |      |      |      |      |      |      |
|           |      | *    | *    | *    | *    | *    | *    | *    |
|           |      | *2.0 | *3.0 | *4.0 | *5.0 | *6.0 | *7.0 | *N** |
|           |      | 0D** | 0D** | 0D** | 0D** | 0D** | 0D** |      |
|           |      |      |      |      |      |      |      | *    |
|           |      |      |      |      |      |      |      | *%** |
+-----------+------+------+------+------+------+------+------+------+
| **20/20   | *    | **   | **   | **   | *    | *    | *    | **1  |
| or        | *5** | 40** | 32** | 18** | *7** | *1** | *0** | 03** |
| better**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | *    | *    | *    | **   | **   |
|           | *2.2 | 18.1 | 14.5 | *8.1 | *3.1 | *0.4 | 0%** | 46.8 |
|           | 7%** | 8%** | 5%** | 8%** | 8%** | 5%** |      | 2%** |
+-----------+------+------+------+------+------+------+------+------+
|           | **   | **   | **   | **   | **   | **   | **   |      |
|           | 62.5 | 67.8 | 40.5 | 42.8 | 31.8 | 12.5 | 0%** |      |
|           | 0%** | 0%** | 1%** | 6%** | 2%** | 0%** |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **20/32   | *    | **   | **   | **   | **   | *    | *    | **1  |
| or        | *6** | 58** | 67** | 36** | 14** | *5** | *0** | 86** |
| better**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | **   | *    | *    | **   | **   |
|           | *2.7 | 26.3 | 30.4 | 16.3 | *6.3 | *2.2 | 0%** | 84.5 |
|           | 3%** | 6%** | 5%** | 6%** | 6%** | 7%** |      | 5%** |
+-----------+------+------+------+------+------+------+------+------+
|           | **7  | **   | **   | **   | **   | **   | **   |      |
|           | 5%** | 98.3 | 84.8 | 85.7 | 63.6 | 62.5 | 0%** |      |
|           |      | 1%** | 1%** | 1%** | 4%** | 0%** |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **20/40   | *    | **   | **   | **   | **   | *    | *    | **1  |
| or        | *6** | 58** | 69** | 37** | 17** | *6** | *0** | 93** |
| better**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | **   | *    | *    | **   | **   |
|           | *2.7 | 26.3 | 31.3 | 16.8 | *7.7 | *2.7 | 0%** | 87.7 |
|           | 3%** | 6%** | 6%** | 2%** | 3%** | 3%** |      | 3%** |
+-----------+------+------+------+------+------+------+------+------+
|           | **7  | **   | **   | **   | **   | **   | **   |      |
|           | 5%** | 98.3 | 87.3 | 88.1 | 77.2 | 75.0 | 0%** |      |
|           |      | 1%** | 4%** | 0%** | 7%** | 0%** |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **20/64   | *    | **   | **   | **   | **   | *    | *    | **2  |
| or        | *8** | 59** | 78** | 39** | 20** | *7** | *2** | 13** |
| better**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | **   | *    | *    | *    | **   |
|           | *3.6 | 26.8 | 35.4 | 17.7 | *9.0 | *3.1 | *0.9 | 96.8 |
|           | 4%** | 2%** | 5%** | 3%** | 9%** | 8%** | 1%** | 2%** |
+-----------+------+------+------+------+------+------+------+------+
|           | **10 | **10 | **   | **   | **   | **   | **10 |      |
|           | 0%** | 0%** | 98.7 | 92.8 | 90.9 | 87.5 | 0%** |      |
|           |      |      | 3%** | 6%** | 1%** | 0%** |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **20/80   | *    | **   | **   | **   | **   | *    | *    | **2  |
| or        | *8** | 59** | 78** | 40** | 21** | *8** | *2** | 16** |
| better**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | **   | *    | *    | *    | **   |
|           | *3.6 | 26.8 | 35.4 | 18.1 | *9.5 | *3.6 | *0.9 | 98.1 |
|           | 4%** | 2%** | 5%** | 8%** | 5%** | 4%** | 1%** | 8%** |
+-----------+------+------+------+------+------+------+------+------+
|           | **10 | **10 | **   | **   | **   | **10 | **10 |      |
|           | 0%** | 0%** | 98.7 | 95.2 | 95.4 | 0%** | 0%** |      |
|           |      |      | 3%** | 4%** | 5%** |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **20/200  | *    | **   | **   | **   | **   | *    | *    | **2  |
| or        | *8** | 59** | 79** | 42** | 22** | *8** | *2** | 20** |
| better**  |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | **   | **1  | *    | *    | **10 |
|           | *3.6 | 26.8 | 35.9 | 19.0 | 0%** | *3.6 | *0.9 | 0%** |
|           | 4%** | 2%** | 1%** | 9%** |      | 4%** | 1%** |      |
+-----------+------+------+------+------+------+------+------+------+
|           | **10 | **10 | **10 | **10 | **10 | **10 | **10 |      |
|           | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |      |
+-----------+------+------+------+------+------+------+------+------+
| **Su      | *    | **   | **   | **   | **   | *    | *    | **2  |
| b-Total** | *8** | 59** | 79** | 42** | 22** | *8** | *2** | 20** |
+-----------+------+------+------+------+------+------+------+------+
|           | *    | **   | **   | **   | **   | *    | *    | **10 |
|           | *3.6 | 26.8 | 35.9 | 19.0 | 10.0 | *3.6 | *0.9 | 0%** |
|           | 4%** | 2%** | 1%** | 9%** | 0%** | 4%** | 1%** |      |
+-----------+------+------+------+------+------+------+------+------+
| **Not     | *    | *    | *    | *    | *    | *    | *    | *    |
| R         | *0** | *0** | *0** | *0** | *0** | *0** | *0** | *0** |
| eported** |      |      |      |      |      |      |      |      |
+-----------+------+------+------+------+------+------+------+------+
| **Total** | *    | **   | **   | **   | **   | *    | *    | **2  |
|           | *8** | 59** | 79** | 42** | 22** | *8** | *2** | 20** |
+-----------+------+------+------+------+------+------+------+------+

+---------+------+------+------+------+------+------+------+-------+
| **Table |      |      |      |      |      |      |      |       |
| 5**     |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| **Ref   |      |      |      |      |      |      |      |       |
| ractive |      |      |      |      |      |      |      |       |
| Change  |      |      |      |      |      |      |      |       |
| in      |      |      |      |      |      |      |      |       |
| D       |      |      |      |      |      |      |      |       |
| iopters |      |      |      |      |      |      |      |       |
| from    |      |      |      |      |      |      |      |       |
| B       |      |      |      |      |      |      |      |       |
| aseline |      |      |      |      |      |      |      |       |
| to      |      |      |      |      |      |      |      |       |
| Month   |      |      |      |      |      |      |      |       |
| 9**     |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| **Str   |      |      |      |      |      |      |      |       |
| atified |      |      |      |      |      |      |      |       |
| by      |      |      |      |      |      |      |      |       |
| Pretr   |      |      |      |      |      |      |      |       |
| eatment |      |      |      |      |      |      |      |       |
| MRSE**  |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| **All 9 |      |      |      |      |      |      |      |       |
| Month   |      |      |      |      |      |      |      |       |
| E       |      |      |      |      |      |      |      |       |
| fficacy |      |      |      |      |      |      |      |       |
| Qu      |      |      |      |      |      |      |      |       |
| alified |      |      |      |      |      |      |      |       |
| Eyes (N |      |      |      |      |      |      |      |       |
| =       |      |      |      |      |      |      |      |       |
| 220)**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| *       | **   |      |      |      |      |      |      |       |
| *Change | Pret |      |      |      |      |      |      |       |
| at**    | reat |      |      |      |      |      |      |       |
|         | ment |      |      |      |      |      |      |       |
| **9     | My   |      |      |      |      |      |      |       |
| M       | opia |      |      |      |      |      |      |       |
| onths** | (MRS |      |      |      |      |      |      |       |
|         | E)** |      |      |      |      |      |      |       |
| **      |      |      |      |      |      |      |      |       |
| (DSE)** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **≤  | **   | **   | **   | **   | **   | **   | **To  |
|         | 1.   | 1.12 | 2.12 | 3.12 | 4.12 | 5.12 | 6.12 | tal** |
|         | 0D** | to** | to** | to** | to** | to** | to** |       |
+---------+------+------+------+------+------+------+------+-------+
|         |      | *    | *    | *    | *    | *    | *    |       |
|         |      | *2.0 | *3.0 | *4.0 | *5.0 | *6.0 | *7.0 |       |
|         |      | 0D** | 0D** | 0D** | 0D** | 0D** | 0D** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | *    | *    | *    | *    | *    | *    | **n** |
|         | *n** | *n** | *n** | *n** | *n** | *n** | *n** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | *    | *    | *    | *    | *    | *    | **%** |
|         | *%** | *%** | *%** | *%** | *%** | *%** | *%** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | *    | *    | *    | *    | *    | *    | **Col |
|         | *Col | *Col | *Col | *Col | *Col | *Col | *Col | %**   |
|         | %**  | %**  | %**  | %**  | %**  | %**  | %**  |       |
+---------+------+------+------+------+------+------+------+-------+
| **No    | *    | *    | *    | *    | *    | *    | *    | **2** |
| C       | *2** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| hange** |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| *       |      |      |      |      |      |      |      |       |
| *0.00** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| #       | **0. | **   | **   | **   | **   | **   | **   | **0   |
| #### [] | 9%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | .9%** |
| {.mark} |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| #       | *    | **   | **   | **   | **   | **   | **   |       |
| #### [] | *25. | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
| {.mark} | 0%** |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **Dec   |      |      |      |      |      |      |      |       |
| rease** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **0.12  | *    | *    | *    | *    | *    | *    | *    | **5** |
| to      | *2** | *2** | *1** | *0** | *0** | *0** | *0** |       |
| 0.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **0. | **0. | **0. | **   | **   | **   | **   | **2   |
|         | 9%** | 9%** | 5%** | 0%** | 0%** | 0%** | 0%** | .3%** |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | **3. | **1. | **   | **   | **   | **   |       |
|         | *25. | 4%** | 3%** | 0%** | 0%** | 0%** | 0%** |       |
|         | 0%** |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **0.62  | *    | **   | *    | *    | *    | *    | *    | *     |
| to      | *4** | 12** | *4** | *0** | *0** | *0** | *0** | *20** |
| 1.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **1. | **5. | **1. | **   | **   | **   | **   | **9   |
|         | 8%** | 5%** | 8%** | 0%** | 0%** | 0%** | 0%** | .1%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **5  | *    | **5. | **   | **   | **   | **   |       |
|         | 0%** | *20. | 1%** | 0%** | 0%** | 0%** | 0%** |       |
|         |      | 3%** |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **1.12  | *    | **   | **   | *    | *    | *    | *    | *     |
| to      | *0** | 23** | 11** | *1** | *0** | *0** | *0** | *35** |
| 1.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | *    | **5. | **0. | **   | **   | **   | **15  |
|         | 0%** | *10. | 0%** | 5%** | 0%** | 0%** | 0%** | .9%** |
|         |      | 5%** |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | *    | *    | **2. | **   | **   | **   |       |
|         | 0%** | *39. | *13. | 4%** | 0%** | 0%** | 0%** |       |
|         |      | 0%** | 9%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **1.62  | *    | **   | **   | *    | *    | *    | *    | *     |
| to      | *0** | 20** | 27** | *1** | *0** | *0** | *0** | *48** |
| 2.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **9. | *    | **0. | **   | **   | **   | **21  |
|         | 0%** | 1%** | *12. | 5%** | 0%** | 0%** | 0%** | .8%** |
|         |      |      | 3%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | *    | *    | **2. | **   | **   | **   |       |
|         | 0%** | *33. | *34. | 4%** | 0%** | 0%** | 0%** |       |
|         |      | 9%** | 2%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **2.12  | *    | *    | **   | *    | *    | *    | *    | *     |
| to      | *0** | *2** | 19** | *5** | *1** | *0** | *0** | *27** |
| 2.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **0. | **8. | **2. | **0. | **   | **   | **12  |
|         | 0%** | 9%** | 6%** | 3%** | 5%** | 0%** | 0%** | .3%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **3. | *    | *    | **4. | **   | **   |       |
|         | 0%** | 4%** | *24. | *11. | 5%** | 0%** | 0%** |       |
|         |      |      | 1%** | 9%** |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **2.62  | *    | *    | **   | **   | *    | *    | *    | *     |
| to      | *0** | *0** | 13** | 12** | *2** | *0** | *0** | *27** |
| 3.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **5. | **5. | **0. | **   | **   | **12  |
|         | 0%** | 0%** | 9%** | 5%** | 9%** | 0%** | 0%** | .3%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | *    | *    | **9. | **   | **   |       |
|         | 0%** | 0%** | *16. | *28. | 1%** | 0%** | 0%** |       |
|         |      |      | 5%** | 6%** |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **3.12  | *    | *    | *    | **   | *    | *    | *    | *     |
| to      | *0** | *0** | *2** | 12** | *3** | *0** | *0** | *17** |
| 3.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **0. | **5. | **1. | **   | **   | **7   |
|         | 0%** | 0%** | 9%** | 5%** | 4%** | 0%** | 0%** | .7%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **2. | *    | *    | **   | **   |       |
|         | 0%** | 0%** | 5%** | *28. | *13. | 0%** | 0%** |       |
|         |      |      |      | 6%** | 6%** |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **3.62  | *    | *    | *    | *    | *    | *    | *    | *     |
| to      | *0** | *0** | *1** | *8** | *3** | *1** | *1** | *14** |
| 4.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **0. | **3. | **1. | **0. | **0. | **6   |
|         | 0%** | 0%** | 5%** | 6%** | 4%** | 5%** | 5%** | .4%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **1. | *    | *    | *    | **5  |       |
|         | 0%** | 0%** | 3%** | *19. | *13. | *12. | 0%** |       |
|         |      |      |      | 0%** | 6%** | 5%** |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **\     | *    | *    | *    | *    | **   | *    | *    | *     |
| >4.00** | *0** | *0** | *0** | *3** | 13** | *7** | *1** | *24** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **1. | **5. | **3. | **0. | **10  |
|         | 0%** | 0%** | 0%** | 4%** | 9%** | 2%** | 5%** | .9%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **7. | *    | *    | **5  |       |
|         | 0%** | 0%** | 0%** | 1%** | *59. | *87. | 0%** |       |
|         |      |      |      |      | 1%** | 5%** |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **Inc   |      |      |      |      |      |      |      |       |
| rease** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **0.12  | *    | *    | *    | *    | *    | *    | *    | **1** |
| to      | *0** | *0** | *1** | *0** | *0** | *0** | *0** |       |
| 0.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **0. | **   | **   | **   | **   | **0   |
|         | 0%** | 0%** | 5%** | 0%** | 0%** | 0%** | 0%** | .5%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **1. | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 3%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **      | *    | **   | **   | **   | **   | *    | *    | **    |
| Total** | *8** | 59** | 79** | 42** | 22** | *8** | *2** | 220** |
+---------+------+------+------+------+------+------+------+-------+
|         | **10 | **10 | **10 | **10 | **10 | **10 | **10 | **1   |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 00%** |
+---------+------+------+------+------+------+------+------+-------+

+---------+------+------+------+------+------+------+------+-------+
| **Table |      |      |      |      |      |      |      |       |
| 6**     |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| **Ado   |      |      |      |      |      |      |      |       |
| lescent |      |      |      |      |      |      |      |       |
| Ref     |      |      |      |      |      |      |      |       |
| ractive |      |      |      |      |      |      |      |       |
| Change  |      |      |      |      |      |      |      |       |
| in      |      |      |      |      |      |      |      |       |
| D       |      |      |      |      |      |      |      |       |
| iopters |      |      |      |      |      |      |      |       |
| from    |      |      |      |      |      |      |      |       |
| B       |      |      |      |      |      |      |      |       |
| aseline |      |      |      |      |      |      |      |       |
| to      |      |      |      |      |      |      |      |       |
| Month   |      |      |      |      |      |      |      |       |
| 9**     |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| **Str   |      |      |      |      |      |      |      |       |
| atified |      |      |      |      |      |      |      |       |
| by      |      |      |      |      |      |      |      |       |
| Pretr   |      |      |      |      |      |      |      |       |
| eatment |      |      |      |      |      |      |      |       |
| MRSE**  |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| **All 9 |      |      |      |      |      |      |      |       |
| Month   |      |      |      |      |      |      |      |       |
| E       |      |      |      |      |      |      |      |       |
| fficacy |      |      |      |      |      |      |      |       |
| Qu      |      |      |      |      |      |      |      |       |
| alified |      |      |      |      |      |      |      |       |
| Eyes (N |      |      |      |      |      |      |      |       |
| = 24)** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| *       | **   |      |      |      |      |      |      |       |
| *Change | Pret |      |      |      |      |      |      |       |
| at**    | reat |      |      |      |      |      |      |       |
|         | ment |      |      |      |      |      |      |       |
| **9     | My   |      |      |      |      |      |      |       |
| M       | opia |      |      |      |      |      |      |       |
| onths** | (MRS |      |      |      |      |      |      |       |
|         | E)** |      |      |      |      |      |      |       |
| **      |      |      |      |      |      |      |      |       |
| (DSE)** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **≤  | **   | **   | **   | **   | **   | **   | **To  |
|         | 1.   | 1.12 | 2.12 | 3.12 | 4.12 | 5.12 | 6.12 | tal** |
|         | 0D** | to** | to** | to** | to** | to** | to** |       |
+---------+------+------+------+------+------+------+------+-------+
|         |      | *    | *    | *    | *    | *    | *    |       |
|         |      | *2.0 | *3.0 | *4.0 | *5.0 | *6.0 | *7.0 |       |
|         |      | 0D** | 0D** | 0D** | 0D** | 0D** | 0D** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | *    | *    | *    | *    | *    | *    | **n** |
|         | *n** | *n** | *n** | *n** | *n** | *n** | *n** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | *    | *    | *    | *    | *    | *    | **%** |
|         | *%** | *%** | *%** | *%** | *%** | *%** | *%** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | *    | *    | *    | *    | *    | *    | *    | **Col |
|         | *Col | *Col | *Col | *Col | *Col | *Col | *Col | %**   |
|         | %**  | %**  | %**  | %**  | %**  | %**  | %**  |       |
+---------+------+------+------+------+------+------+------+-------+
| **No    | *    | *    | *    | *    | *    | *    | *    | **2** |
| C       | *2** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| hange** |      |      |      |      |      |      |      |       |
|         |      |      |      |      |      |      |      |       |
| *       |      |      |      |      |      |      |      |       |
| *0.00** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| #####   | **8. | **   | **   | **   | **   | **   | **   | **8   |
|         | 3%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | .3%** |
+---------+------+------+------+------+------+------+------+-------+
| #####   | **10 | **   | **   | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **Dec   |      |      |      |      |      |      |      |       |
| rease** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **0.12  | *    | *    | *    | *    | *    | *    | *    | **0** |
| to      | *0** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| 0.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   | *     |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | *0%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **0.62  | *    | *    | *    | *    | *    | *    | *    | **4** |
| to      | *0** | *4** | *0** | *0** | *0** | *0** | *0** |       |
| 1.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | *    | **   | **   | **   | **   | **   | **16  |
|         | 0%** | *16. | 0%** | 0%** | 0%** | 0%** | 0%** | .7%** |
|         |      | 7%** |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **4  | **   | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **1.12  | *    | *    | *    | *    | *    | *    | *    | **5** |
| to      | *0** | *4** | *1** | *0** | *0** | *0** | *0** |       |
| 1.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | *    | **4. | **   | **   | **   | **   | **20  |
|         | 0%** | *16. | 2%** | 0%** | 0%** | 0%** | 0%** | .8%** |
|         |      | 7%** |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **4  | *    | **   | **   | **   | **   |       |
|         | 0%** | 0%** | *12. | 0%** | 0%** | 0%** | 0%** |       |
|         |      |      | 5%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **1.62  | *    | *    | *    | *    | *    | *    | *    | **4** |
| to      | *0** | *2** | *2** | *0** | *0** | *0** | *0** |       |
| 2.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **8. | **8. | **   | **   | **   | **   | **16  |
|         | 0%** | 3%** | 3%** | 0%** | 0%** | 0%** | 0%** | .7%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **2  | *    | **   | **   | **   | **   |       |
|         | 0%** | 0%** | *25. | 0%** | 0%** | 0%** | 0%** |       |
|         |      |      | 0%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **2.12  | *    | *    | *    | *    | *    | *    | *    | **4** |
| to      | *0** | *0** | *4** | *0** | *0** | *0** | *0** |       |
| 2.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | *    | **   | **   | **   | **   | **16  |
|         | 0%** | 0%** | *16. | 0%** | 0%** | 0%** | 0%** | .7%** |
|         |      |      | 7%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **5  | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **2.62  | *    | *    | *    | *    | *    | *    | *    | **3** |
| to      | *0** | *0** | *1** | *2** | *0** | *0** | *0** |       |
| 3.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **4. | **8. | **   | **   | **   | **12  |
|         | 0%** | 0%** | 2%** | 3%** | 0%** | 0%** | 0%** | .5%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | *    | **10 | **   | **   | **   |       |
|         | 0%** | 0%** | *12. | 0%** | 0%** | 0%** | 0%** |       |
|         |      |      | 5%** |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **3.12  | *    | *    | *    | *    | *    | *    | *    | **0** |
| to      | *0** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| 3.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   | *     |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | *0%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **3.62  | *    | *    | *    | *    | *    | *    | *    | **0** |
| to      | *0** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| 4.00**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   | *     |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | *0%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **\     | *    | *    | *    | *    | *    | *    | *    | **2** |
| >4.00** | *0** | *0** | *0** | *0** | *0** | *1** | *1** |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **4. | **4. | **8   |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 2%** | 2%** | .3%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **10 | **10 |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **Inc   |      |      |      |      |      |      |      |       |
| rease** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **0.12  | *    | *    | *    | *    | *    | *    | *    | **0** |
| to      | *0** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| 0.50**  |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   | *     |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | *0%** |
+---------+------+------+------+------+------+------+------+-------+
|         | **   | **   | **   | **   | **   | **   | **   |       |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** |       |
+---------+------+------+------+------+------+------+------+-------+
| **Not   | *    | *    | *    | *    | *    | *    | *    | **0** |
| Rep     | *0** | *0** | *0** | *0** | *0** | *0** | *0** |       |
| orted** |      |      |      |      |      |      |      |       |
+---------+------+------+------+------+------+------+------+-------+
| **      | *    | **   | *    | *    | *    | *    | *    | *     |
| Total** | *2** | 10** | *8** | *2** | *0** | *1** | *1** | *24** |
+---------+------+------+------+------+------+------+------+-------+
|         | **10 | **10 | **10 | **10 | **   | **10 | **10 | **1   |
|         | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 0%** | 00%** |
+---------+------+------+------+------+------+------+------+-------+

+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Table 7**    |     |     |     |     |     |     |     |       |
|                |     |     |     |     |     |     |     |       |
| **Accuracy of  |     |     |     |     |     |     |     |       |
| Targeted Vs.   |     |     |     |     |     |     |     |       |
| Achieved       |     |     |     |     |     |     |     |       |
| Correction at  |     |     |     |     |     |     |     |       |
| 9 Month        |     |     |     |     |     |     |     |       |
| Visit**        |     |     |     |     |     |     |     |       |
|                |     |     |     |     |     |     |     |       |
| **Stratified   |     |     |     |     |     |     |     |       |
| by             |     |     |     |     |     |     |     |       |
| Pretreatment   |     |     |     |     |     |     |     |       |
| Myopia**       |     |     |     |     |     |     |     |       |
|                |     |     |     |     |     |     |     |       |
| **All 9 Month  |     |     |     |     |     |     |     |       |
| Efficacy       |     |     |     |     |     |     |     |       |
| Qualified Eyes |     |     |     |     |     |     |     |       |
| (N=220)**      |     |     |     |     |     |     |     |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Int. Vs.     | **  |     |     |     |     |     |     |       |
| Ach**          | Pre |     |     |     |     |     |     |       |
|                | Tre |     |     |     |     |     |     |       |
| **(DSE)**      | atm |     |     |     |     |     |     |       |
|                | ent |     |     |     |     |     |     |       |
|                | Myo |     |     |     |     |     |     |       |
|                | pia |     |     |     |     |     |     |       |
|                | (M  |     |     |     |     |     |     |       |
|                | RSE |     |     |     |     |     |     |       |
|                | )** |     |     |     |     |     |     |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | *   | **1 | **2 | **3 | **4 | **5 | **6 | **To  |
|                | *\< | .12 | .12 | .12 | .12 | .12 | .12 | tal** |
|                | 1.0 | t   | t   | t   | t   | t   | t   |       |
|                | D** | o** | o** | o** | o** | o** | o** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                |     | **2 | **3 | **4 | **5 | **6 | **7 |       |
|                |     | .00 | .00 | .00 | .00 | .00 | .00 |       |
|                |     | D** | D** | D** | D** | D** | D** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **  | **  | **  | **  | **  | **  | **n** |
|                | n** | n** | n** | n** | n** | n** | n** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **  | **  | **  | **  | **  | **  | **%** |
|                | %** | %** | %** | %** | %** | %** | %** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **  | **  | **  | **  | **  | **  | **Col |
|                | Col | Col | Col | Col | Col | Col | Col | %**   |
|                | %** | %** | %** | %** | %** | %** | %** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **±0.50 D**    | **  | **4 | **3 | **2 | **1 | **  | **  | **    |
|                | 5** | 1** | 3** | 3** | 4** | 2** | 1** | 119** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **1 | **1 | **1 | **  | **  | **  | **54. |
|                | 2.2 | 8.6 | 5.0 | 0.4 | 6.3 | 0.9 | 0.4 | 09%** |
|                | 7** | 4** | 0** | 5** | 6** | 1** | 5** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **6 | **6 | **4 | **5 | **6 | **2 | *   |       |
|                | 2.5 | 9.4 | 1.7 | 4.7 | 3.6 | 5.0 | *50 |       |
|                | 0** | 9** | 7** | 6** | 4** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **±1.00 D**    | **  | **5 | **7 | **3 | **2 | **  | **  | **    |
|                | 8** | 9** | 1** | 7** | 0** | 6** | 1** | 202** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **2 | **3 | **1 | **  | **  | **  | **91. |
|                | 3.6 | 6.8 | 2.2 | 6.8 | 9.0 | 2.7 | 0.4 | 82%** |
|                | 4** | 2** | 7** | 2** | 9** | 3** | 5** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | *   | *   | **8 | **8 | **9 | **7 | *   |       |
|                | *10 | *10 | 9.8 | 8.1 | 0.9 | 5.0 | *50 |       |
|                | 0** | 0** | 7** | 0** | 1** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **±2.00 D**    | **  | **5 | **7 | **4 | **2 | **  | **  | **    |
|                | 8** | 9** | 9** | 2** | 1** | 8** | 1** | 218** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **2 | **3 | **1 | **  | **  | **  | **99. |
|                | 3.6 | 6.8 | 5.9 | 9.0 | 9.5 | 3.6 | 0.4 | 09%** |
|                | 4** | 2** | 1** | 9** | 5** | 4** | 5** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | *   | *   | *   | *   | **9 | *   | *   |       |
|                | *10 | *10 | *10 | *10 | 5.4 | *10 | *50 |       |
|                | 0** | 0** | 0** | 0** | 5** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **±3.00 D**    | **  | **5 | **7 | **4 | **2 | **  | **  | **    |
|                | 8** | 9** | 9** | 2** | 2** | 8** | 2** | 220** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **2 | **3 | **1 | *   | **  | **  | **1   |
|                | 3.6 | 6.8 | 5.9 | 9.0 | *10 | 3.6 | 0.9 | 00%** |
|                | 4** | 2** | 1** | 9** | 0** | 4** | 1** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | *   | *   | *   | *   | *   | *   | *   |       |
|                | *10 | *10 | *10 | *10 | *10 | *10 | *10 |       |
|                | 0** | 0** | 0** | 0** | 0** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **\> 4.00 D**  | **  | **5 | **7 | **4 | **2 | **  | **  | **    |
|                | 8** | 9** | 9** | 2** | 2** | 8** | 2** | 220** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **2 | **3 | **1 | *   | **  | **  | **1   |
|                | 3.6 | 6.8 | 5.9 | 9.0 | *10 | 3.6 | 0.9 | 00%** |
|                | 4** | 2** | 1** | 9** | 0** | 4** | 1** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | *   | *   | *   | *   | *   | *   | *   |       |
|                | *10 | *10 | *10 | *10 | *10 | *10 | *10 |       |
|                | 0** | 0** | 0** | 0** | 0** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Sub-Total**  | **  | **5 | **7 | **4 | **2 | **  | **  | **    |
|                | 8** | 9** | 9** | 2** | 2** | 8** | 2** | 220** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **2 | **3 | **1 | *   | **  | **  | **1   |
|                | 3.6 | 6.8 | 5.9 | 9.0 | *10 | 3.6 | 0.9 | 00%** |
|                | 4** | 2** | 1** | 9** | 0** | 4** | 1** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Not          | **  | **  | **  | **  | **  | **  | **  | **0** |
| Reported**     | 0** | 0** | 0** | 0** | 0** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Total**      | **  | **5 | **7 | **4 | **2 | **  | **  | **    |
|                | 8** | 9** | 9** | 2** | 2** | 8** | 2** | 220** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                | **  | **2 | **3 | **1 | *   | **  | **  | **1   |
|                | 3.6 | 6.8 | 5.9 | 9.0 | *10 | 3.6 | 0.9 | 00%** |
|                | 4** | 2** | 1** | 9** | 0** | 4** | 1** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
|                |     |     |     |     |     |     |     |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Undercorr.\> | **  | **  | **  | **  | **  | **  | **  | *     |
| 1**            | 0** | 0** | 8** | 5** | 2** | 2** | 1** | *18** |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Undercorr.\> | **  | **  | **  | **  | **  | **  | **  | **2** |
| 2**            | 0** | 0** | 0** | 0** | 1** | 0** | 1** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+
| **Undercorr.\> | **  | **  | **  | **  | **  | **  | **  | **0** |
| 3**            | 0** | 0** | 0** | 0** | 0** | 0** | 0** |       |
+----------------+-----+-----+-----+-----+-----+-----+-----+-------+

+-----------+------+------+------+------+------+------+------+-------+
| **Table   |      |      |      |      |      |      |      |       |
| 8**       |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **        |      |      |      |      |      |      |      |       |
| Stability |      |      |      |      |      |      |      |       |
| of        |      |      |      |      |      |      |      |       |
| Manifest  |      |      |      |      |      |      |      |       |
| R         |      |      |      |      |      |      |      |       |
| efraction |      |      |      |      |      |      |      |       |
| Spherical |      |      |      |      |      |      |      |       |
| E         |      |      |      |      |      |      |      |       |
| quivalent |      |      |      |      |      |      |      |       |
| from 3    |      |      |      |      |      |      |      |       |
| Month to  |      |      |      |      |      |      |      |       |
| 6 Month   |      |      |      |      |      |      |      |       |
| Visit**   |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **S       |      |      |      |      |      |      |      |       |
| tratified |      |      |      |      |      |      |      |       |
| by        |      |      |      |      |      |      |      |       |
| Pre       |      |      |      |      |      |      |      |       |
| treatment |      |      |      |      |      |      |      |       |
| Dioptic   |      |      |      |      |      |      |      |       |
| Group**   |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **All     |      |      |      |      |      |      |      |       |
| Efficacy  |      |      |      |      |      |      |      |       |
| Qualified |      |      |      |      |      |      |      |       |
| Eyes with |      |      |      |      |      |      |      |       |
| 3, 6, and |      |      |      |      |      |      |      |       |
| 9 month   |      |      |      |      |      |      |      |       |
| visits    |      |      |      |      |      |      |      |       |
| (N=202)** |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Change  | *    |      |      |      |      |      |      |       |
| in MRSE** | *Pre |      |      |      |      |      |      |       |
|           | T    |      |      |      |      |      |      |       |
| **(DSE)** | reat |      |      |      |      |      |      |       |
|           | ment |      |      |      |      |      |      |       |
|           | My   |      |      |      |      |      |      |       |
|           | opia |      |      |      |      |      |      |       |
|           | (MRS |      |      |      |      |      |      |       |
|           | E)** |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **≤  | **   | **   | **   | **   | **   | **   | **To  |
|           | 1.   | 1.12 | 2.12 | 3.12 | 4.12 | 5.12 | 6.12 | tal** |
|           | 0D** | to** | to** | to** | to** | to** | to** |       |
|           |      |      |      |      |      |      |      | **n** |
|           | *    | *    | *    | *    | *    | *    | *    |       |
|           | *n** | *2.0 | *3.0 | *4.0 | *5.0 | *6.0 | *7.0 | **%** |
|           |      | 0D** | 0D** | 0D** | 0D** | 0D** | 0D** |       |
|           | *    |      |      |      |      |      |      | **Col |
|           | *%** | *    | *    | *    | *    | *    | *    | %**   |
|           |      | *n** | *n** | *n** | *n** | *n** | *n** |       |
|           | *    |      |      |      |      |      |      |       |
|           | *Col | *    | *    | *    | *    | *    | *    |       |
|           | %**  | *%** | *%** | *%** | *%** | *%** | *%** |       |
|           |      |      |      |      |      |      |      |       |
|           |      | *    | *    | *    | *    | *    | *    |       |
|           |      | *Col | *Col | *Col | *Col | *Col | *Col |       |
|           |      | %**  | %**  | %**  | %**  | %**  | %**  |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **[\<]{.u | *    | **   | **   | **   | **   | *    | *    | **    |
| nderline} | *8** | 45** | 49** | 33** | 14** | *3** | *1** | 153** |
| 0.50 D**  |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **3. | *    | *    | *    | **6. | **1. | **0. | **75. |
|           | 96** | *22. | *24. | *16. | 93** | 49** | 50** | 74%** |
|           |      | 28** | 26** | 34** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **1  | *    | *    | *    | **7  | *    | **5  |       |
|           | 00** | *84. | *71. | *78. | 00** | *37. | 00** |       |
|           |      | 91** | 01** | 57** |      | 50** |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **≤ 0.75  | *    | **   | **   | **   | **   | *    | *    | **    |
| D**       | *8** | 50** | 62** | 37** | 16** | *5** | *1** | 179** |
+-----------+------+------+------+------+------+------+------+-------+
|           | **3. | *    | *    | *    | **7. | **2. | **0. | **88. |
|           | 96** | *24. | *30. | *18. | 92** | 48** | 50** | 61%** |
|           |      | 75** | 69** | 32** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **1  | *    | *    | *    | **8  | *    | **5  |       |
|           | 00** | *94. | *89. | *88. | 00** | *62. | 00** |       |
|           |      | 34** | 86** | 10** |      | 50** |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **≤ 1.00  | *    | **   | **   | **   | **   | *    | *    | **    |
| D**       | *8** | 53** | 64** | 41** | 19** | *6** | *1** | 192** |
+-----------+------+------+------+------+------+------+------+-------+
|           | **3. | *    | *    | *    | **9. | **2. | **0. | **95. |
|           | 96** | *26. | *31. | *20. | 41** | 97** | 50** | 05%** |
|           |      | 24** | 68** | 30** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **1  | **1  | *    | *    | *    | *    | **5  |       |
|           | 00** | 00** | *92. | *97. | *95. | *75. | 00** |       |
|           |      |      | 75** | 62** | 00** | 00** |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **\> 1.00 | *    | *    | *    | *    | *    | *    | *    | *     |
| D**       | *0** | *0** | *5** | *1** | *1** | *2** | *1** | *10** |
+-----------+------+------+------+------+------+------+------+-------+
|           | *    | *    | **2. | **0. | **0. | **0. | **0. | **4.  |
|           | *0** | *0** | 48** | 50** | 50** | 99** | 50** | 95%** |
+-----------+------+------+------+------+------+------+------+-------+
|           | *    | *    | **7. | **2. | **5. | *    | **5  |       |
|           | *0** | *0** | 25** | 38** | 00** | *25. | 00** |       |
|           |      |      |      |      |      | 00** |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Total** | *    | **   | **   | **   | **   | *    | *    | **    |
|           | *8** | 53** | 69** | 42** | 20** | *8** | *2** | 202** |
+-----------+------+------+------+------+------+------+------+-------+
|           | **3. | *    | *    | *    | **9. | **3. | **0. | **1   |
|           | 96** | *26. | *34. | *20. | 90** | 96** | 99** | 00%** |
|           |      | 24** | 16** | 79** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Mean**  | *    | **-0 | **   | **-0 | **   | **   | *    | **-   |
|           | *0.1 | 09** | -0.1 | 80** | -0.2 | -0.2 | *0.6 | 078** |
|           | 88** |      | 00** |      | 94** | 35** | 25** |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Stdev** | *    | *    | *    | *    | *    | *    | *    | **0.  |
|           | *0.1 | *0.3 | *0.5 | *0.5 | *0.6 | *1.2 | *0.7 | 569** |
|           | 89** | 86** | 65** | 78** | 14** | 54** | 07** |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Lower C | **0  | **   | **   | **   | **   | **   | **   | **-0. |
| L**       | 30** | -0.1 | -0.2 | -0.2 | -0.5 | -1.2 | -5.7 | 157** |
|           |      | 16** | 35** | 60** | 81** | 84** | 28** |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Upper C | *    | **0  | **0  | *    | **-0 | *    | *    | **    |
| L**       | *0.3 | 97** | 36** | *0.1 | 06** | *0.8 | *6.9 | 001** |
|           | 45** |      |      | 00** |      | 14** | 78** |       |
+-----------+------+------+------+------+------+------+------+-------+

+-----------+------+------+------+------+------+------+------+-------+
| **Table   |      |      |      |      |      |      |      |       |
| 9**       |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **A       |      |      |      |      |      |      |      |       |
| dolescent |      |      |      |      |      |      |      |       |
| Stability |      |      |      |      |      |      |      |       |
| of        |      |      |      |      |      |      |      |       |
| Manifest  |      |      |      |      |      |      |      |       |
| R         |      |      |      |      |      |      |      |       |
| efraction |      |      |      |      |      |      |      |       |
| Spherical |      |      |      |      |      |      |      |       |
| Equ       |      |      |      |      |      |      |      |       |
| ivalent** |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **from 6  |      |      |      |      |      |      |      |       |
| Month to  |      |      |      |      |      |      |      |       |
| 9 Month   |      |      |      |      |      |      |      |       |
| Visit**   |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **S       |      |      |      |      |      |      |      |       |
| tratified |      |      |      |      |      |      |      |       |
| by        |      |      |      |      |      |      |      |       |
| Pre       |      |      |      |      |      |      |      |       |
| treatment |      |      |      |      |      |      |      |       |
| Dioptic   |      |      |      |      |      |      |      |       |
| Group**   |      |      |      |      |      |      |      |       |
|           |      |      |      |      |      |      |      |       |
| **All     |      |      |      |      |      |      |      |       |
| A         |      |      |      |      |      |      |      |       |
| dolescent |      |      |      |      |      |      |      |       |
| Eyes with |      |      |      |      |      |      |      |       |
| 3, 6, and |      |      |      |      |      |      |      |       |
| 9 month   |      |      |      |      |      |      |      |       |
| visits    |      |      |      |      |      |      |      |       |
| (N=22)**  |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Change  | *    |      |      |      |      |      |      |       |
| in MRSE** | *Pre |      |      |      |      |      |      |       |
|           | T    |      |      |      |      |      |      |       |
| **(DSE)** | reat |      |      |      |      |      |      |       |
|           | ment |      |      |      |      |      |      |       |
|           | My   |      |      |      |      |      |      |       |
|           | opia |      |      |      |      |      |      |       |
|           | (MRS |      |      |      |      |      |      |       |
|           | E)** |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **≤  | **   | **   | **   | **   | **   | **   | **To  |
|           | 1.   | 1.12 | 2.12 | 3.12 | 4.12 | 5.12 | 6.12 | tal** |
|           | 0D** | to** | to** | to** | to** | to** | to** |       |
|           |      |      |      |      |      |      |      | **n** |
|           | *    | *    | *    | *    | *    | *    | *    |       |
|           | *n** | *2.0 | *3.0 | *4.0 | *5.0 | *6.0 | *7.0 | **%** |
|           |      | 0D** | 0D** | 0D** | 0D** | 0D** | 0D** |       |
|           | *    |      |      |      |      |      |      | **Col |
|           | *%** | *    | *    | *    | *    | *    | *    | %**   |
|           |      | *n** | *n** | *n** | *n** | *n** | *n** |       |
|           | *    |      |      |      |      |      |      |       |
|           | *Col | *    | *    | *    | *    | *    | *    |       |
|           | %**  | *%** | *%** | *%** | *%** | *%** | *%** |       |
|           |      |      |      |      |      |      |      |       |
|           |      | *    | *    | *    | *    | *    | *    |       |
|           |      | *Col | *Col | *Col | *Col | *Col | *Col |       |
|           |      | %**  | %**  | %**  | %**  | %**  | %**  |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **[\<]{.u | *    | *    | *    | *    | *    | *    | *    | *     |
| nderline} | *2** | *8** | *4** | *2** | *0** | *1** | *1** | *18** |
| 0.50 D**  |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **9. | *    | *    | **9. | *    | **4. | **4. | **81. |
|           | 09** | *36. | *18. | 09** | *0** | 55** | 55** | 82%** |
|           |      | 36** | 18** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **10 | **8  | **   | **10 | *    | **10 | **10 |       |
|           | 0%** | 0%** | 66.6 | 0%** | *0** | 0%** | 0%** |       |
|           |      |      | 7%** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **≤ 0.75  | *    | *    | *    | *    | *    | *    | *    | *     |
| D**       | *2** | *9** | *5** | *2** | *0** | *1** | *1** | *20** |
+-----------+------+------+------+------+------+------+------+-------+
|           | **9. | *    | *    | **9. | *    | **4. | **4. | **90. |
|           | 09** | *40. | *22. | 09** | *0** | 55** | 55** | 91%** |
|           |      | 91** | 73** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **10 | **9  | **   | **10 | *    | **10 | **10 |       |
|           | 0%** | 0%** | 83.3 | 0%** | *0** | 0%** | 0%** |       |
|           |      |      | 3%** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **≤ 1.00  | *    | *    | *    | *    | *    | *    | *    | *     |
| D**       | *2** | *9** | *5** | *2** | *0** | *1** | *1** | *20** |
+-----------+------+------+------+------+------+------+------+-------+
|           | **9. | *    | *    | **9. | *    | **4. | **4. | **90. |
|           | 09** | *40. | *22. | 09** | *0** | 55** | 55** | 91%** |
|           |      | 91** | 73** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | **10 | **9  | **   | **10 | *    | **10 | **10 |       |
|           | 0%** | 0%** | 83.3 | 0%** | *0** | 0%** | 0%** |       |
|           |      |      | 3%** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **\> 1.00 | *    | *    | *    | *    | *    | *    | *    | **2** |
| D**       | *0** | *1** | *1** | *0** | *0** | *0** | *0** |       |
+-----------+------+------+------+------+------+------+------+-------+
|           | *    | **4. | **4. | *    | *    | *    | *    | **9.  |
|           | *0** | 55** | 55** | *0** | *0** | *0** | *0** | 09%** |
+-----------+------+------+------+------+------+------+------+-------+
|           | *    | **   | **   | *    | *    | *    | *    |       |
|           | *0** | 10** | 16.6 | *0** | *0** | *0** | *0** |       |
|           |      |      | 7%** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Total** | *    | **   | *    | *    | *    | *    | *    | *     |
|           | *2** | 10** | *6** | *2** | *0** | *1** | *1** | *22** |
+-----------+------+------+------+------+------+------+------+-------+
|           | **9. | *    | *    | **9. | *    | **4. | **4. | **1   |
|           | 09** | *45. | *27. | 09** | *0** | 55** | 55** | 00%** |
|           |      | 45** | 27** |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
|           |      |      |      |      |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Mean**  | **   | *    | **-0 | **   | *    | *    | *    | **    |
|           | 00** | *0.1 | 21** | -0.3 | *.** | *0.1 | *0.1 | 028** |
|           |      | 13** |      | 13** |      | 25** | 25** |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Stdev** | **   | *    | *    | *    | *    | *    | *    | **0.  |
|           | 00** | *0.5 | *0.8 | *0.2 | *.** | *.** | *.** | 569** |
|           |      | 38** | 71** | 65** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Lower C | *    | **   | **   | **   | *    | *    | *    | **-0. |
| L**       | *.** | -0.2 | -0.9 | -2.6 | *.** | *.** | *.** | 224** |
|           |      | 73** | 35** | 95** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+
| **Upper C | *    | *    | *    | *    | *    | *    | *    | **0.  |
| L**       | *.** | *0.4 | *0.8 | *2.0 | *.** | *.** | *.** | 281** |
|           |      | 98** | 93** | 70** |      |      |      |       |
+-----------+------+------+------+------+------+------+------+-------+

+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Table 10**    |     |     |     |     |     |     |     |     |
|                 |     |     |     |     |     |     |     |     |
| **Keratometry   |     |     |     |     |     |     |     |     |
| Change in the   |     |     |     |     |     |     |     |     |
| Flat Meridian   |     |     |     |     |     |     |     |     |
| at 9 Months**   |     |     |     |     |     |     |     |     |
|                 |     |     |     |     |     |     |     |     |
| **Stratified by |     |     |     |     |     |     |     |     |
| Pretreatment    |     |     |     |     |     |     |     |     |
| Dioptic Group** |     |     |     |     |     |     |     |     |
|                 |     |     |     |     |     |     |     |     |
| **All 9 Month   |     |     |     |     |     |     |     |     |
| Efficacy        |     |     |     |     |     |     |     |     |
| Qualified Eyes  |     |     |     |     |     |     |     |     |
| Targeted for    |     |     |     |     |     |     |     |     |
| Emmetropia      |     |     |     |     |     |     |     |     |
| (N=205)**       |     |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Keratometry   | **  |     |     |     |     |     |     |     |
| Change in Flat  | Pre |     |     |     |     |     |     |     |
| Meridian**      | Tre |     |     |     |     |     |     |     |
|                 | atm |     |     |     |     |     |     |     |
| **(D)**         | ent |     |     |     |     |     |     |     |
|                 | Myo |     |     |     |     |     |     |     |
|                 | pia |     |     |     |     |     |     |     |
|                 | (M  |     |     |     |     |     |     |     |
|                 | RSE |     |     |     |     |     |     |     |
|                 | )** |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **≤ | **1 | **2 | **3 | **4 | **5 | **6 | **T |
|                 | 1.0 | .12 | .12 | .12 | .12 | .12 | .12 | ota |
|                 | D** | t   | t   | t   | t   | t   | t   | l** |
|                 |     | o** | o** | o** | o** | o** | o** |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 |     | **2 | **3 | **4 | **5 | **6 | **7 |     |
|                 |     | .00 | .00 | .00 | .00 | .00 | .00 |     |
|                 |     | D** | D** | D** | D** | D** | D** |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **  |
|                 | n** | n** | n** | n** | n** | n** | n** | N** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **  |
|                 | %** | %** | %** | %** | %** | %** | %** | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **  |
|                 | Col | Col | Col | Col | Col | Col | Col | Col |
|                 | %** | %** | %** | %** | %** | %** | %** | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Flatter**     |     |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **4.62 to       | **  | **  | **  | **  | **  | **  | **  | **  |
| 5.00**          | 0** | 0** | 2** | 0** | 0** | 0** | 0** | 2** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **0 |
|                 | 0** | 0** | 0.9 | 0** | 0** | 0** | 0** | .99 |
|                 |     |     | 9** |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  |     |
|                 | 0** | 0** | 2.7 | 0** | 0** | 0** | 0** |     |
|                 |     |     | 8** |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **4.12 to       | **  | **  | **  | **  | **  | **  | **  | **  |
| 4.50**          | 0** | 0** | 0** | 0** | 0** | 0** | 0** | 0** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **  |
|                 | 0** | 0** | 0** | 0** | 0** | 0** | 0** | 0** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  |     |
|                 | 0** | 0** | 0** | 0** | 0** | 0** | 0** |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **3.62 to       | **  | **  | **  | **  | **  | **  | **  | **  |
| 4.00**          | 0** | 0** | 0** | 0** | 0** | 3** | 0** | 3** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **1 |
|                 | 0** | 0** | 0** | 0** | 0** | 1.4 | 0** | .48 |
|                 |     |     |     |     |     | 8** |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **5 | **  |     |
|                 | 0** | 0** | 0** | 0** | 0** | 0** | 0** |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **3.12 to       | **  | **  | **  | **  | **  | **  | **  | **  |
| 3.50**          | 0** | 0** | 0** | 1** | 3** | 1** | 0** | 5** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **2 |
|                 | 0** | 0** | 0** | 0.4 | 1.4 | 0.4 | 0** | .46 |
|                 |     |     |     | 9** | 8** | 9** |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **1 | **1 | **  |     |
|                 | 0** | 0** | 0** | 2.6 | 5.0 | 6.6 | 0** |     |
|                 |     |     |     | 3** | 0** | 7** |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **2.62 to       | **  | **  | **  | **  | **  | **  | **  | **1 |
| 3.00**          | 0** | 0** | 2** | 3** | 7** | 1** | 0** | 3** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **6 |
|                 | 0** | 0** | 0.9 | 1.4 | 3.4 | 0.4 | 0** | .40 |
|                 |     |     | 9** | 8** | 5** | 9** |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **3 | **1 | **  |     |
|                 | 0** | 0** | 2.7 | 7.8 | 5.0 | 6.6 | 0** |     |
|                 |     |     | 8** | 9** | 0** | 7** |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **2.12 to       | **  | **  | **  | **1 | **  | **  | **  | **3 |
| 2.50**          | 0** | 3** | 8** | 6** | 3** | 0** | 1** | 1** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | *   |
|                 | 0** | 1.4 | 3.9 | 7.8 | 1.4 | 0** | 0.4 | *15 |
|                 |     | 8** | 4** | 8** | 8** |     | 9** | .27 |
|                 |     |     |     |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **1 | **4 | **1 | **  | *   |     |
|                 | 0** | 5.1 | 1.1 | 2.1 | 5.0 | 0** | *10 |     |
|                 |     | 7** | 1** | 1** | 0** |     | 0** |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **1.62 to       | **  | **  | **1 | **1 | **  | **  | **  | **3 |
| 2.00**          | 0** | 3** | 6** | 0** | 3** | 1** | 0** | 3** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | *   |
|                 | 0** | 1.4 | 7.8 | 4.9 | 1.4 | 0.4 | 0** | *16 |
|                 |     | 8** | 8** | 3** | 8** | 9** |     | .26 |
|                 |     |     |     |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **2 | **2 | **1 | **1 | **  |     |
|                 | 0** | 5.1 | 2.2 | 6.3 | 5.0 | 6.6 | 0** |     |
|                 |     | 7** | 2** | 2** | 0** | 7** |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **1.12 to       | **  | **1 | **2 | **  | **  | **  | **  | **4 |
| 1.50**          | 0** | 7** | 0** | 6** | 4** | 0** | 0** | 7** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | *   |
|                 | 0** | 8.3 | 9.8 | 2.9 | 1.9 | 0** | 0** | *23 |
|                 |     | 7** | 5** | 6** | 7** |     |     | .15 |
|                 |     |     |     |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **2 | **2 | **1 | **2 | **  | **  |     |
|                 | 0** | 9.3 | 7.7 | 5.7 | 0** | 0** | 0** |     |
|                 |     | 1** | 8** | 9** |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **0.62 to       | **  | **2 | **1 | **  | **  | **  | **  | **3 |
| 1.00**          | 1** | 3** | 3** | 1** | 0** | 0** | 0** | 8** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **1 | **  | **  | **  | **  | **  | *   |
|                 | 0.4 | 1.3 | 6.4 | 0.4 | 0** | 0** | 0** | *18 |
|                 | 9** | 3** | 0** | 9** |     |     |     | .72 |
|                 |     |     |     |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **1 | **3 | **1 | **  | **  | **  | **  |     |
|                 | 2.5 | 9.6 | 8.0 | 2.6 | 0** | 0** | 0** |     |
|                 | 0** | 6** | 6** | 3** |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **0.12 to       | **  | **1 | **  | **  | **  | **  | **  | **2 |
| 0.50**          | 5** | 0** | 9** | 1** | 0** | 0** | 0** | 5** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | *   |
|                 | 2.4 | 4.9 | 4.4 | 0.4 | 0** | 0** | 0** | *12 |
|                 | 6** | 3** | 3** | 9** |     |     |     | .32 |
|                 |     |     |     |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **6 | **1 | **1 | **  | **  | **  | **  |     |
|                 | 2.5 | 7.2 | 2.5 | 2.6 | 0** | 0** | 0** |     |
|                 | 0** | 4** | 0** | 3** |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 |     |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **No Change     | **  | **  | **  | **  | **  | **  | **  | **  |
| 00**            | 0** | 0** | 0** | 0** | 0** | 0** | 0** | 0** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 |     |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Steeper**     |     |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **0.12 to       | **  | **  | **  | **  | **  | **  | **  | **  |
| 0.50**          | 0** | 2** | 2** | 0** | 0** | 0** | 0** | 4** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **1 |
|                 | 0** | 0.9 | 0.9 | 0** | 0** | 0** | 0** | .97 |
|                 |     | 9** | 9** |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  |     |
|                 | 0** | 3.4 | 2.7 | 0** | 0** | 0** | 0** |     |
|                 |     | 5** | 8** |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **0.62 to       | **  | **  | **  | **  | **  | **  | **  | **  |
| 1.00**          | 2** | 0** | 0** | 0** | 0** | 0** | 0** | 2** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **  | **  | **  | **  | **  | **  | **  | **0 |
|                 | 0.9 | 0** | 0** | 0** | 0** | 0** | 0** | .99 |
|                 | 9** |     |     |     |     |     |     | %** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **2 | **  | **  | **  | **  | **  | **  |     |
|                 | 5.0 | 0** | 0** | 0** | 0** | 0** | 0** |     |
|                 | 0** |     |     |     |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Subtotal**    | **  | **5 | **7 | **3 | **2 | **  | **  | *   |
|                 | 8** | 8** | 2** | 8** | 0** | 6** | 1** | *20 |
|                 |     |     |     |     |     |     |     | 3** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
|                 | **3 | *   | *   | *   | **9 | **2 | **0 | **  |
|                 | .94 | *28 | *35 | *18 | .85 | .96 | .49 | 100 |
|                 | %** | .57 | .47 | .72 | %** | %** | %** | %** |
|                 |     | %** | %** | %** |     |     |     |     |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Not           | **  | **  | **  | **  | **  | **  | **  | **  |
| Reported**      | 0** | 0** | 2** | 0** | 0** | 0** | 0** | 2** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+
| **Total**       | **  | **5 | **7 | **3 | **2 | **  | **  | *   |
|                 | 8** | 8** | 4** | 8** | 0** | 6** | 1** | *20 |
|                 |     |     |     |     |     |     |     | 5** |
+-----------------+-----+-----+-----+-----+-----+-----+-----+-----+

+-----------------+---------+---------+---------+---------+---------+
| **Table 11**    |         |         |         |         |         |
|                 |         |         |         |         |         |
| **Change in     |         |         |         |         |         |
| BSCVA Over      |         |         |         |         |         |
| Time**          |         |         |         |         |         |
|                 |         |         |         |         |         |
| **(All Eyes,    |         |         |         |         |         |
| N=408)**        |         |         |         |         |         |
+-----------------+---------+---------+---------+---------+---------+
| #               | **1     | **2     | **3     | **6     | **9     |
|                 | Month** | M       | M       | M       | M       |
|                 |         | onths** | onths** | onths** | onths** |
|                 | **(n    |         |         |         |         |
|                 | =330)** | **(n    | **(n    | **(n    | **(n    |
|                 |         | =292)** | =286)** | =238)** | =240)** |
+-----------------+---------+---------+---------+---------+---------+
| #               | **n %** | **n %** | **n %** | **n %** | **n %** |
|                 |         |         |         |         |         |
|                 | **(95%  | **(95%  | **(95%  | **(95%  | **(95%  |
|                 | CI)**   | CI)**   | CI)**   | CI)**   | CI)**   |
+-----------------+---------+---------+---------+---------+---------+
| **Increase \> 2 | **2     | **2     | **1     | **6     | **4     |
| Lines**         | 0.6**   | 0.7**   | 0.4**   | 2.5**   | 1.7**   |
+-----------------+---------+---------+---------+---------+---------+
|                 | **(0.1, | **(0.1, | **(0,   | **(0.9, | **(0.5, |
|                 | 2.3)**  | 2.6)**  | 2.0)**  | 5.5)**  | 4.2)**  |
+-----------------+---------+---------+---------+---------+---------+
| **Increase 2    | **2     | **2     | **3     | **4     | **0 0** |
| Lines**         | 0.6**   | 0.7**   | 1.1**   | 1.7**   |         |
+-----------------+---------+---------+---------+---------+---------+
|                 | **(0.1, | **(0.1, | **(0.2, | **(0.5, | **(0,   |
|                 | 2.3)**  | 2.6)**  | 3.2)**  | 4.3)**  | 1.3)**  |
+-----------------+---------+---------+---------+---------+---------+
| **Increase 1    | **34    | **44    | **39    | **31    | **33    |
| Line**          | 10.9**  | 15.9**  | 14.2**  | 13.1**  | 13.9**  |
+-----------------+---------+---------+---------+---------+---------+
|                 | **(7.7, | *       | *       | **(9.1, | **(9.7, |
|                 | 14.9)** | *(11.8, | *(10.3, | 18.1)** | 18.9)** |
|                 |         | 20.8)** | 18.9)** |         |         |
+-----------------+---------+---------+---------+---------+---------+
| **No Change**   | **196   | **166   | **184   | **159   | **166   |
|                 | 63.0**  | 60.1**  | 67.2**  | 67.4**  | 69.7**  |
+-----------------+---------+---------+---------+---------+---------+
|                 | *       | *       | *       | *       | *       |
|                 | *(57.4, | *(54.1, | *(61.2, | *(61.0, | *(63.5, |
|                 | 68.4)** | 66.0)** | 72.7)** | 73.3)** | 75.5)** |
+-----------------+---------+---------+---------+---------+---------+
| **Decrease 1    | **50    | **43    | **36    | **28    | **28    |
| Line**          | 16.1**  | 15.6**  | 13.1**  | 11.9**  | 11.8**  |
+-----------------+---------+---------+---------+---------+---------+
|                 | *       | *       | **(9.4, | **(8.0, | **(8.0, |
|                 | *(12.2, | *(11.5, | 17.7)** | 16.7)** | 16.6)** |
|                 | 20.6)** | 20.4)** |         |         |         |
+-----------------+---------+---------+---------+---------+---------+
| **Decrease 2    | **10    | **6     | **2     | **1     | **2     |
| lines**         | 3.2**   | 2.2**   | 0.7**   | 0.4**   | 0.8**   |
+-----------------+---------+---------+---------+---------+---------+
|                 | **(1.6, | **(0.8, | **(0.1, | **(0,   | **(0.1, |
|                 | 5.8)**  | 4.7)**  | 2.6)**  | 2.3)**  | 3.0)**  |
+-----------------+---------+---------+---------+---------+---------+
| **Decrease \> 2 | **17    | **13    | **9     | **7     | **5     |
| Lines**         | 5.5**   | 4.7**   | 3.3**   | 3.0**   | 2.1**   |
+-----------------+---------+---------+---------+---------+---------+
|                 | **(3.2, | **(2.5, | **(1.5, | **(1.2, | **(0.7, |
|                 | 8.6)**  | 7.9)**  | 6.1)**  | 6.0)**  | 4.8)**  |
+-----------------+---------+---------+---------+---------+---------+
| **Not           | **19**  | **16**  | **12**  | **2**   | **2**   |
| Reported**      |         |         |         |         |         |
+-----------------+---------+---------+---------+---------+---------+
| **Total**       | **330** | **292** | **286** | **238** | **240** |
+-----------------+---------+---------+---------+---------+---------+

+-----------------+----------+--------+---------+---------+---------+
| **Table 12**    |          |        |         |         |         |
|                 |          |        |         |         |         |
| **Change in     |          |        |         |         |         |
| Intraocular     |          |        |         |         |         |
| Pressure Over   |          |        |         |         |         |
| Time**          |          |        |         |         |         |
|                 |          |        |         |         |         |
| **(All Eyes,    |          |        |         |         |         |
| N=408)**        |          |        |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| #               | **1      | **2    | **3     | **6     | **9     |
|                 | Month**  | Mo     | M       | M       | M       |
|                 |          | nths** | onths** | onths** | onths** |
|                 | **(      |        |         |         |         |
|                 | n=330)** | **(n=  | **(n    | **(n    | **(n    |
|                 |          | 292)** | =286)** | =238)** | =240)** |
+-----------------+----------+--------+---------+---------+---------+
| #               | **n %**  | **n    | **n %** | **n %** | **n %** |
|                 |          | %**    |         |         |         |
|                 | **(95%   |        | **(95%  | **(95%  | **(95%  |
|                 | CI)**    | **(95% | CI)**   | CI)**   | CI)**   |
|                 |          | CI)**  |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **Decrease \>   | **1      | **0    | **0 0** | **0 0** | **0 0** |
| 10**            | 0.3**    | 0**    |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(0,    | **(0,  | **(0,   | **(0,   | **(0,   |
|                 | 1.9)**   | 1.1)** | 1.1)**  | 1.3)**  | 1.3)**  |
+-----------------+----------+--------+---------+---------+---------+
| **Decrease 6 to | **10     | **14   | **18    | **13    | **13    |
| 10**            | 3.4**    | 5.2**  | 6.7**   | 5.7**   | 5.5**   |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(1.6,  | *      | **(4.0, | **(3.0, | **(3.0, |
|                 | 6.2)**   | *(2.9, | 10.4)** | 9.5)**  | 9.2)**  |
|                 |          | 8.5)** |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **Decrease 1 to | **136    | **131  | **130   | **111   | **122   |
| 5**             | 46.3**   | 48.3** | 48.7**  | 48.3**  | 51.7**  |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(40.5, | **     | *       | *       | *       |
|                 | 52.1)**  | (42.3, | *(42.6, | *(41.6, | *(45.1, |
|                 |          | 5      | 54.9)** | 54.9)** | 58.2)** |
|                 |          | 4.5)** |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **No Change**   | **50     | **40   | **38    | **36    | **34    |
|                 | 17.0**   | 14.8** | 14.2**  | 15.7**  | 14.4**  |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(12.9, | **     | *       | *       | *       |
|                 | 21.8)**  | (10.8, | *(10.3, | *(11.2, | *(10.2, |
|                 |          | 1      | 19.0)** | 21.0)** | 19.5)** |
|                 |          | 9.6)** |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **Increase 1 to | **92     | **80   | **79    | **68    | **63    |
| 5**             | 31.3**   | 29.5** | 29.6**  | 29.6**  | 26.7**  |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(26.0, | **     | *       | *       | *       |
|                 | 36.9)**  | (24.2, | *(24.2, | *(23.7, | *(21.2, |
|                 |          | 3      | 35.5)** | 35.9)** | 32.8)** |
|                 |          | 5.3)** |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **Increase 6 to | **5      | **6    | **2     | **2     | **4     |
| 10**            | 1.7**    | 2.2**  | 0.7**   | 0.9**   | 1.7**   |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(0.6,  | *      | **(0.1, | **(0.1, | **(0.5, |
|                 | 3.9)**   | *(0.8, | 2.7)**  | 3.1)**  | 4.3)**  |
|                 |          | 4.8)** |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **Increase \>   | **0 0**  | **0    | **0 0** | **0 0** | **0 0** |
| 10**            |          | 0**    |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
|                 | **(0,    | **(0,  | **(0,   | **(0,   | **(0,   |
|                 | 1.0)**   | 1.1)** | 1.1)**  | 1.3)**  | 1.3)**  |
+-----------------+----------+--------+---------+---------+---------+
| **Not           | **36**   | **21** | **19**  | **8**   | **4**   |
| Reported**      |          |        |         |         |         |
+-----------------+----------+--------+---------+---------+---------+
| **Total**       | **330**  | *      | **286** | **238** | **240** |
|                 |          | *292** |         |         |         |
+-----------------+----------+--------+---------+---------+---------+

+---------------------------------------------------+------------------+
| **Table 13**                                      |                  |
|                                                   |                  |
| **Description and Number of Lens Reorders         |                  |
| Completed Eyes**                                  |                  |
|                                                   |                  |
| **(N=240)**                                       |                  |
+---------------------------------------------------+------------------+
| **Reason for Replacement**                        | **Number of      |
|                                                   | Lenses           |
|                                                   | Replaced**       |
+---------------------------------------------------+------------------+
| **Poor Centration**                               | **31**           |
+---------------------------------------------------+------------------+
| **Under Treatment**                               | **19**           |
+---------------------------------------------------+------------------+
| **Lost Lens**                                     | **7**            |
+---------------------------------------------------+------------------+
| **Excessive Landing Zone Clearance**              | **6**            |
+---------------------------------------------------+------------------+
| **Reverse Zone Bridging**                         | **5**            |
+---------------------------------------------------+------------------+
| **Excessive Reverse Zone Junction Clearance**     | **3**            |
+---------------------------------------------------+------------------+
| **Damaged Lens**                                  | **3**            |
+---------------------------------------------------+------------------+
| **Over Treatment**                                | **2**            |
+---------------------------------------------------+------------------+
| **Power Change**                                  | **2**            |
+---------------------------------------------------+------------------+
| **Landing Zone Bridging**                         | **2**            |
+---------------------------------------------------+------------------+
| **Lens Deposits**                                 | **2**            |
+---------------------------------------------------+------------------+
| **Pathology**                                     | **0**            |
+---------------------------------------------------+------------------+
| **TOTAL**                                         | **82**           |
+---------------------------------------------------+------------------+

+---+---+---+-----------+------------+------------+------------+----------+
| * |   |   |           |            |            |            |          |
| * |   |   |           |            |            |            |          |
| T |   |   |           |            |            |            |          |
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| T |   |   |           |            |            |            |          |
| o |   |   |           |            |            |            |          |
| - |   |   |           |            |            |            |          |
| - |   |   |           |            |            |            |          |
| 1 |   |   |           |            |            |            |          |
| . |   |   |           |            |            |            |          |
| 0 |   |   |           |            |            |            |          |
| 0 |   |   |           |            |            |            |          |
| D |   |   |           |            |            |            |          |
| i |   |   |           |            |            |            |          |
| o |   |   |           |            |            |            |          |
| p |   |   |           |            |            |            |          |
| t |   |   |           |            |            |            |          |
| e |   |   |           |            |            |            |          |
| r |   |   |           |            |            |            |          |
| ( |   |   |           |            |            |            |          |
| \ |   |   |           |            |            |            |          |
| ~ |   |   |           |            |            |            |          |
| 2 |   |   |           |            |            |            |          |
| 0 |   |   |           |            |            |            |          |
| / |   |   |           |            |            |            |          |
| 4 |   |   |           |            |            |            |          |
| 0 |   |   |           |            |            |            |          |
| ) |   |   |           |            |            |            |          |
| * |   |   |           |            |            |            |          |
| * |   |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   |   | * |           |            |            |            |          |
|   |   | * |           |            |            |            |          |
|   |   | P |           |            |            |            |          |
|   |   | r |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | t |           |            |            |            |          |
|   |   | r |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | a |           |            |            |            |          |
|   |   | t |           |            |            |            |          |
|   |   | m |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | n |           |            |            |            |          |
|   |   | t |           |            |            |            |          |
|   |   | M |           |            |            |            |          |
|   |   | a |           |            |            |            |          |
|   |   | n |           |            |            |            |          |
|   |   | i |           |            |            |            |          |
|   |   | f |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | s |           |            |            |            |          |
|   |   | t |           |            |            |            |          |
|   |   | R |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | f |           |            |            |            |          |
|   |   | r |           |            |            |            |          |
|   |   | a |           |            |            |            |          |
|   |   | c |           |            |            |            |          |
|   |   | t |           |            |            |            |          |
|   |   | i |           |            |            |            |          |
|   |   | v |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | S |           |            |            |            |          |
|   |   | p |           |            |            |            |          |
|   |   | h |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | r |           |            |            |            |          |
|   |   | i |           |            |            |            |          |
|   |   | c |           |            |            |            |          |
|   |   | a |           |            |            |            |          |
|   |   | l |           |            |            |            |          |
|   |   | E |           |            |            |            |          |
|   |   | q |           |            |            |            |          |
|   |   | u |           |            |            |            |          |
|   |   | i |           |            |            |            |          |
|   |   | v |           |            |            |            |          |
|   |   | a |           |            |            |            |          |
|   |   | l |           |            |            |            |          |
|   |   | e |           |            |            |            |          |
|   |   | n |           |            |            |            |          |
|   |   | t |           |            |            |            |          |
|   |   | * |           |            |            |            |          |
|   |   | * |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
| * |   |   | **-1.25   | **-2.25 to | **-3.25 to | **-4.25 to | **-5.25  |
| * |   |   | to -2.00  | -3.00      | -4.00      | -5.00      | to -6.00 |
| R |   |   | (D)**     | (D)**      | (D)**      | (D)**      | (D)**    |
| e |   |   |           |            |            |            |          |
| f |   |   |           |            |            |            |          |
| r |   |   |           |            |            |            |          |
| a |   |   |           |            |            |            |          |
| c |   |   |           |            |            |            |          |
| t |   |   |           |            |            |            |          |
| i |   |   |           |            |            |            |          |
| o |   |   |           |            |            |            |          |
| n |   |   |           |            |            |            |          |
| a |   |   |           |            |            |            |          |
| t |   |   |           |            |            |            |          |
| L |   |   |           |            |            |            |          |
| e |   |   |           |            |            |            |          |
| n |   |   |           |            |            |            |          |
| s |   |   |           |            |            |            |          |
| R |   |   |           |            |            |            |          |
| e |   |   |           |            |            |            |          |
| m |   |   |           |            |            |            |          |
| o |   |   |           |            |            |            |          |
| v |   |   |           |            |            |            |          |
| a |   |   |           |            |            |            |          |
| l |   |   |           |            |            |            |          |
| * |   |   |           |            |            |            |          |
| * |   |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   | * |   | 40 to 80+ | 24 to 40   | 18 to 24   | 13 to 15   | 11 to 13 |
|   | * |   | Hrs       | Hrs        | Hrs        | Hrs        | Hrs      |
|   | + |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | . |   |           |            |            |            |          |
|   | 5 |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   | * |   | 30 to 80+ | 21 to 30   | 16 to 21   | 11 to 16   | 10 to 11 |
|   | * |   | Hrs       | Hrs        | Hrs        | Hrs        | Hrs      |
|   | + |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | . |   |           |            |            |            |          |
|   | 2 |   |           |            |            |            |          |
|   | 5 |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   | * |   | 22 to 44  | 16 to 22   | 13 to 18   | 9 to 13    | 7 to 8   |
|   | * |   | Hrs       | Hrs        | Hrs        | Hrs        | Hrs      |
|   | P |   |           |            |            |            |          |
|   | l |   |           |            |            |            |          |
|   | a |   |           |            |            |            |          |
|   | n |   |           |            |            |            |          |
|   | o |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   | * |   | 22 to 29  | 16 to 20   | 11 to 16   | 7 to 11    | 5 to 7   |
|   | * |   | Hrs       | Hrs        | Hrs        | Hrs        | Hrs      |
|   | - |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | . |   |           |            |            |            |          |
|   | 2 |   |           |            |            |            |          |
|   | 5 |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   | * |   | 18 to 24  | 10 to 18   | 7 to 10    | 6 to 7 Hrs | 3 to 5   |
|   | * |   | Hrs       | Hrs        | Hrs        |            | Hrs      |
|   | - |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | . |   |           |            |            |            |          |
|   | 5 |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+
|   | * |   | 8 to 18   | 5 to 8 Hrs | 4 to 5 Hrs | 3 to 4 Hrs | 2 to 3   |
|   | * |   | Hrs       |            |            |            | Hrs      |
|   | - |   |           |            |            |            |          |
|   | 0 |   |           |            |            |            |          |
|   | . |   |           |            |            |            |          |
|   | 7 |   |           |            |            |            |          |
|   | 5 |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
|   | * |   |           |            |            |            |          |
+---+---+---+-----------+------------+------------+------------+----------+

+-------------------------------+------+-----+---+----+-----+---+----+-----+
| **Table 15**                  |      |     |   |    |     |   |    |     |
|                               |      |     |   |    |     |   |    |     |
| **Summary of Key Safety and   |      |     |   |    |     |   |    |     |
| Effectiveness Variables**     |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| **Criteria**                  | **9  |     | * |    |     | * |    |     |
|                               | Mont |     | * |    |     | * |    |     |
|                               | hs** |     | 9 |    |     | 9 |    |     |
|                               |      |     | M |    |     | M |    |     |
|                               | **Co |     | o |    |     | o |    |     |
|                               | mbin |     | n |    |     | n |    |     |
|                               | ed** |     | t |    |     | t |    |     |
|                               |      |     | h |    |     | h |    |     |
|                               | **n  |     | s |    |     | s |    |     |
|                               | %**  |     | * |    |     | * |    |     |
|                               |      |     | * |    |     | * |    |     |
|                               |      |     |   |    |     |   |    |     |
|                               |      |     | * |    |     | * |    |     |
|                               |      |     | * |    |     | * |    |     |
|                               |      |     | A |    |     | A |    |     |
|                               |      |     | d |    |     | d |    |     |
|                               |      |     | u |    |     | o |    |     |
|                               |      |     | l |    |     | l |    |     |
|                               |      |     | t |    |     | e |    |     |
|                               |      |     | s |    |     | s |    |     |
|                               |      |     | * |    |     | c |    |     |
|                               |      |     | * |    |     | e |    |     |
|                               |      |     |   |    |     | n |    |     |
|                               |      |     | * |    |     | t |    |     |
|                               |      |     | * |    |     | s |    |     |
|                               |      |     | n |    |     | * |    |     |
|                               |      |     | % |    |     | * |    |     |
|                               |      |     | * |    |     |   |    |     |
|                               |      |     | * |    |     | * |    |     |
|                               |      |     |   |    |     | * |    |     |
|                               |      |     |   |    |     | n |    |     |
|                               |      |     |   |    |     | % |    |     |
|                               |      |     |   |    |     | * |    |     |
|                               |      |     |   |    |     | * |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| n                             | **1  |     | * |    |     | * |    |     |
|                               | 59** |     | * |    |     | * |    |     |
|                               |      |     | 1 |    |     | 1 |    |     |
|                               |      |     | 4 |    |     | 5 |    |     |
|                               |      |     | 4 |    |     | * |    |     |
|                               |      |     | * |    |     | * |    |     |
|                               |      |     | * |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| UCVA 20/20 or better \*       | 94   | 5   |   | 84 | 5   |   | 10 | 6   |
| \*\*\*                        |      | 9.1 |   |    | 8.3 |   |    | 6.7 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| n                             | **2  |     |   | *  |     |   | ** |     |
|                               | 05** |     |   | *1 |     |   | 22 |     |
|                               |      |     |   | 83 |     |   | ** |     |
|                               |      |     |   | ** |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| UCVA 20/20 or better\* \*\*   | 103  | 5   |   | 93 | 5   |   | 10 | 4   |
|                               |      | 0.2 |   |    | 0.8 |   |    | 5.5 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| UCVA 20/40 or better\* \*\*   | 185  | 9   |   | 1  | 9   |   | 20 | 9   |
|                               |      | 0.2 |   | 65 | 0.2 |   |    | 0.9 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| n                             | **2  |     |   | *  |     |   | ** |     |
|                               | 20** |     |   | *1 |     |   | 24 |     |
|                               |      |     |   | 96 |     |   | ** |     |
|                               |      |     |   | ** |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| MRSE Change of 0.12 to 1.00 D | 26   | 1   |   | 22 | 1   |   | 4  | 1   |
|                               |      | 1.8 |   |    | 1.3 |   |    | 6.7 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| MRSE Change of 1.12 to 2.00 D | 83   | 3   |   | 74 | 3   |   | 9  | 3   |
|                               |      | 7.7 |   |    | 7.7 |   |    | 7.7 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| MRSE Change of 2.12 to 3.00 D | 54   | 2   |   | 47 | 2   |   | 12 | 2   |
|                               |      | 4.6 |   |    | 3.9 |   |    | 9.2 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| MRSE Change of 3.12 to 4.00 D | 31   | 1   |   | 31 | 1   |   | 0  | 0   |
|                               |      | 4.1 |   |    | 5.8 |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| MRSE Change of 4.12 to 5.00 D | 19   | 8.6 |   | 17 | 8.7 |   | 2  | 8.3 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| MRSE Change of ≥ 5.00 D       | 5    | 2.3 |   | 5  | 2.6 |   | 0  | 0   |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
|                               | **2  |     |   | *  |     |   | ** |     |
|                               | 20** |     |   | *1 |     |   | 24 |     |
|                               |      |     |   | 96 |     |   | ** |     |
|                               |      |     |   | ** |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Accuracy MRSE ± 0.50 D        | 119  | 5   |   | 1  | 5   |   | 15 | 6   |
|                               |      | 4.1 |   | 04 | 3.1 |   |    | 2.5 |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Accuracy MRSE ± 1.00 D        | 202  | 9   |   | 1  | 9   |   | 24 | 100 |
|                               |      | 1.8 |   | 78 | 0.8 |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Accuracy MRSE ± 2.00 D        | 218  | 9   |   | 1  | 9   |   | 24 | 100 |
|                               |      | 9.1 |   | 94 | 9.0 |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| n                             | **2  |     |   | *  |     |   | ** |     |
|                               | 02** |     |   | *1 |     |   | 22 |     |
|                               |      |     |   | 80 |     |   | ** |     |
|                               |      |     |   | ** |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Stability; MRSE               | 153  | 7   |   | 1  | 7   |   | 18 | 8   |
| [\<]{.underline}0.50 Change 3 |      | 5.7 |   | 35 | 5.0 |   |    | 1.8 |
| to 6 months                   |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Stability; MRSE               | 179  | 8   |   | 1  | 8   |   | 19 | 8   |
| [\<]{.underline}0.75 Change 3 |      | 8.6 |   | 60 | 8.9 |   |    | 6.4 |
| to 6 months                   |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Stability; MRSE               | 192  | 9   |   | 1  | 9   |   | 21 | 9   |
| [\<]{.underline}1.00 Change 3 |      | 5.0 |   | 71 | 5.0 |   |    | 5.5 |
| to 6 months                   |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Stability; MRSE               | 163  | 8   |   | 1  | 8   |   | 18 | 8   |
| [\<]{.underline}0.50 Change 6 |      | 0.7 |   | 45 | 0.6 |   |    | 1.8 |
| to 9 months                   |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Stability; MRSE               | 176  | 8   |   | 1  | 8   |   | 20 | 9   |
| [\<]{.underline}0.75 Change 6 |      | 7.1 |   | 56 | 6.7 |   |    | 0.9 |
| to 9 months                   |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Stability; MRSE               | 183  | 9   |   | 1  | 9   |   | 20 | 9   |
| [\<]{.underline}1.00 Change 6 |      | 0.6 |   | 63 | 0.6 |   |    | 0.9 |
| to 9 months                   |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| n                             | **2  |     |   | *  |     |   | ** |     |
|                               | 40** |     |   | *2 |     |   | 24 |     |
|                               |      |     |   | 16 |     |   | ** |     |
|                               |      |     |   | ** |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Serious Adverse Events        | 0    | 0   |   | 0  | 0   |   | 0  | 0   |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
|                               |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Loss of ≥ 2 lines BSCVA       | 7    | 2.9 |   | 7  | 3.2 |   | 0  | 0   |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| BSCVA worse than 20/40        | 0    | 0   |   | 0  | 0   |   | 0  | 0   |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Increase of \> 1 D Refractive | 2    | 0.9 |   | 2  | 1.0 |   | 0  | 0   |
| Cyl                           |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Increase of \> 2 D Refractive | 0    | 0   |   | 0  | 0   |   | 0  | 0   |
| Cyl                           |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+
| Increase of \> 1 D Corneal    | 9    | 4.1 |   | 8  | 4.1 |   | 2  | 9.5 |
| Cyl                           |      |     |   |    |     |   |    |     |
+-------------------------------+------+-----+---+----+-----+---+----+-----+

\*Excluding eyes intentionally under-corrected

\*\*Includes eyes with a pre-treatment BSCVA worse than 20/20.

\*\*\*BSCVA 20/20 or better pre-treatment.