P010018

SUMMARY OF SAFETY AND EFFECTIVENESS DATA

ViewPoint CK System

TABLE OF CONTENTS

Page

[I. GENERAL INFORMATION 3](#general-information)

[II. INDICATIONS FOR USE 3](#indications-for-use)

[III. CONTRAINDICATIONS 3](#contraindications)

[IV. WARNINGS AND PRECAUTIONS 4](#warnings-and-precautions)

[V. DEVICE DESCRIPTION 4](#device-description)

[VI. ALTERNATIVE PRACTICES OR PROCEDURES
6](#alternative-practices-or-procedures)

[VII. MARKETING HISTORY 6](#marketing-history)

[VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH
7](#potential-adverse-effects-of-the-device-on-health)

[IX. SUMMARY OF PRECLINICAL STUDIES 7](#summary-of-preclinical-studies)

[A. Objectives 7](#objectives)

[B. Design Verification 7](#design-verification)

[C. Electrical Safety Tests 7](#electrical-safety-tests)

[D. EMC Compliance 7](#emc-compliance)

[E. Physical Tests 8](#physical-tests)

[F. Physical Safety Tests 8](#physical-safety-tests)

[G. Biocompatibility 8](#biocompatibility)

[H. Performance Testing 8](#performance-testing)

[I. Electrical and Thermal Simulation
9](#electrical-and-thermal-simulation)

[J. Histopathology 9](#histopathology)

[K. Conclusions 10](#conclusions)

[X. SUMMARY OF CLINICAL STUDIES 10](#summary-of-clinical-studies)

[A. Objectives 10](#objectives-1)

[B. Study Design 11](#study-design)

[C. Study Plan and Subject Assessments
14](#study-plan-and-subject-assessments)

[D. Study Period and Investigational Sites
14](#study-period-and-investigational-sites)

[E. Demographic Data 15](#demographic-data)

[F. Data Analysis and Results 16](#data-analysis-and-results)

[XI. CONCLUSIONS DRAWN FROM THE STUDIES
29](#conclusions-drawn-from-the-studies)

[XII. PANEL RECOMMENDATION 29](#panel-recommendation)

[XIII. CDRH DECISION 30](#cdrh-decision)

[XIV. APPROVAL SPECIFICATIONS 30](#approval-specifications)

# GENERAL INFORMATION

Device Generic Name: RF Electrosurgical Device

Device Trade Name: ViewPoint CK System

Applicant's Name and Address: Refractec, Inc.

5 Jenner, Suite 150

Irvine, California 92618 U.S.

\(949\) 784-2600

\(949\) 784-2601 (fax)

Date of Panel Recommendation: 11/30/2001

PMA Number: P010018

Date of GMP Inspection: July 25, 2001

Date of Notice of Approval to Applicant: April 11, 2002

# INDICATIONS FOR USE

The ViewPoint™ CK System / Conductive Keratoplasty^SM^ (CK^SM^)
Procedure is indicated for the temporary reduction of spherical
hyperopia in patients who have 0.75 D to 3.25 D of cycloplegic spherical
hyperopia, less than or equal to 0.75 D of refractive astigmatism (minus
cylinder format), a cycloplegic spherical equivalent of 0.75 D to 3.00
D, and are 40 years of age or greater with a documented stability of
refraction for the prior 12 months, as demonstrated by a change of less
than\
0.50 D in spherical and cylindrical components of the manifest
refraction. The magnitude of correction with this treatment diminishes
over time, with some patients retaining some or all of their intended
refractive correction.

# CONTRAINDICATIONS

Conductive Keratoplasty^SM^ treatment with the ViewPoint CK System is
contraindicated in:

-   Patients with a peripheral pachymetry reading, measured at the 6 mm
    optical zone, of less than 560 microns.

-   Patients who have had previous strabismus surgery or are likely to
    develop strabismus following the CK^SM^ procedure.

-   Patients with a history of Herpes zoster or Herpes simplex
    keratitis.

-   Patients who have diabetes, diagnosed autoimmune disease, connective
    tissue disease, or clinically significant atopic syndrome.

-   Patients who are being treated with chronic systemic corticosteroid
    or other immunosuppressive therapy that may affect wound healing,
    and any immunocompromised patients.

-   Patients who are pregnant or lactating.

-   Patients with keratoconus.

-   Patients with a history of keloid formation.

-   Patients with intractable keratoconjunctivitis sicca.

-   Patients with implantable electrical devices (pacemakers,
    defibrillators, cochlear implants, etc.).

-   Patients with narrow angles.

# WARNINGS AND PRECAUTIONS

The warnings and precautions can be found in the device labeling.

# DEVICE DESCRIPTION

The ViewPoint™ CK System is designed to treat spherical, previously
untreated hyperopia of 0.75 to 3.25 D through a procedure known as
Conductive Keratoplasty^SM^ (CK^SM^).

Conductive Keratoplasty^SM^ utilizes low energy, delivered directly into
the corneal stroma through a handpiece and Keratoplast™ Tip, to effect
refractive change in the cornea. As a result of conducting a controlled
amount of radiofrequency energy into the corneal stroma, the desired
collagen shrinkage temperature is achieved. The peripheral application
of this treatment in a predetermined pattern creates a band of
tightening and results in a steepening of the central cornea. This
steepening results in the desired refractive effect.

***Overview of the ViewPoint™ CK System***

The ViewPoint™ CK System used to perform the CK^SM^ procedure consists
of the following components:

-   Radiofrequency energy-generating console

-   Reusable corneal marker

-   Reusable lid speculum with cable and connector

-   Reusable hand-held, pen-shaped handpiece with cable and connector

-   Footpedal

-   Disposable Keratoplast™ Tip

-   Patient treatment card

Refractec submitted declarations that the ViewPoint™ CK System conforms
to the following standards:

-   ISO/EN 60601-1 Electrical Safety

-   ISO/EN 60601-1-2 EMC

-   ISO/EN 60601-2-2 Electrical Safety For RF

-   ISO/EN 60601-1-4 Programmable Electrical Medical Systems

-   ISO 10993 Biocompatibility

-   ISO 10993-7 ETO Residuals

-   ISO 11135 ETO Sterilization

***ViewPoint™ CK System Console***

A patient treatment card is inserted into the console to activate the
system. The energy level is set at 60% power (0.6W) with a treatment
time of 0.6 seconds. Selection of parameters outside the default
settings is not allowed in the U.S. market version. An AC powered,
portable, low power, energy source provides regulated radiofrequency
energy through the handpiece to the Keratoplast™ Tip.

***Handpiece***

The handpiece is a hand-held, reusable, pen-shaped instrument attached
by a removable cable and connector to the console. The radiofrequency
energy is delivered by means of the Keratoplast™ Tip, which attaches to
the handpiece.

***Keratoplast™ Tip***

A sterile, disposable, stainless steel, Keratoplast™ Tip, 90 µm in
diameter and 450 µm long, that delivers radiofrequency energy directly
to the corneal stroma, is attached to the handpiece. The Keratoplast™
Tip has a proximal bend of 45° and a distal bend of 90° to allow access
to the cornea over the patient's brow and nasal regions. A Teflon^®^
stop at the very distal portion of the stainless steel tip assures
correct depth of penetration. The Keratoplast™ Tip must not be used on
fellow eyes or subsequent patients.

***Lid Speculum***

The lid speculum serves as the return (dispersive) electrode for the
radiofrequency energy being delivered through the Keratoplast™ Tip. Two
types of specula are offered: Barraquer type and Lancaster type. The
Barraquer type is a small, malleable wire-speculum and the Lancaster is
a locking speculum. The Lancaster lid speculum was not used in the
clinical investigation of the device, but is considered equivalent for
the purpose of a return electrode.

***Footpedal***

The footpedal attaches to the console and controls the release of
radiofrequency energy.

***Patient Treatment Card***

A patient treatment card is inserted into the console to activate the
system.

***Safety Features***

The ViewPoint™ CK System has numerous features to assure proper
operation. The ViewPoint™ CK System includes safety checks at start-up
and monitors output during treatment.

***Software***

The ViewPoint™ CK System software controls the user interface, and
provides the user with system diagnostics and error messages in the
event of a device anomaly. Additionally, the software saves all error
messages to the patient treatment card to assist in the diagnosis of
technical issues.

# ALTERNATIVE PRACTICES OR PROCEDURES

Alternative methods of correcting farsightedness (hyperopia) include:
spectacles, contact lenses, laser *in situ* keratomileusis (LASIK),
photorefractive keratectomy (PRK), and laser thermal keratoplasty (LTK).

# MARKETING HISTORY

The ViewPoint CK System has not been marketed in the United States. The
ViewPoint CK System was first marketed outside the United States in
March 2001. Refractec, Inc. has 27 ViewPoint™ CK Systems located in 15
countries (Australia, Brazil, Argentina, Mexico, Canada, United Kingdom,
France, Finland, Spain, Italy, Germany, Greece, Saudi Arabia, South
Africa, and Paraguay). The ViewPoint CK System has not been withdrawn
from any country or market for reasons of safety and effectiveness.

# POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH

Potential adverse events associated with the CK^SM^ procedure include:
decrease in BSCVA of \> 10 letters not due to irregular astigmatism as
shown by hard contact lens refraction at 6 months or later, IOP \> 25 mm
Hg, secondary surgical intervention other than CK treatment, late onset
of haze beyond 6 months with loss of 2 lines (10 letters) or more BSCVA,
a corneal epithelial defect involving the treatment site, corneal edema,
corneal microbial infection, corneal decompensation, corneal scar in the
visual axis, intraocular infection, hypopyon, hyphema, onset of cataract
unrelated to age/systemic disease/ trauma, retinal detachment, retinal
vascular accidents.

Please refer to the complete listings of adverse events and
complications observed during the clinical study, which are presented on
pages 22 and 23 in the Summary of Clinical Studies section.

# SUMMARY OF PRECLINICAL STUDIES 

## Objectives

Preclinical studies were conducted to establish the safety and
performance of the ViewPoint CK System.

## Design Verification

Upon completion of the assembly and testing of prototype units, the
output of the device was evaluated to assess the waveform and to verify
that the output met the original design intent. This report concluded
that the waveform generated by the prototype device meets the design
intent.

## Electrical Safety Tests

The device has been designed to comply with electrical standards that
are recognized domestically and internationally. EN 60601-1 and EN
60601-2-2 Test Reports completed by Intertek Testing Service concluded
that the device meets all of the applicable elements of these standards.

## EMC Compliance

The device has been designed and tested to assure that the unit meets
the applicable elements on EN 60601-1-2. The test report completed by
Intertek Testing Service concluded that the device meets this standard
for EMC compliance.

## Physical Tests

1\. Treatment probe dimensional/physical properties testing:

> Qualification of the manufacturing and assembly process was conducted
> to verify that dimensional specifications were met and that process
> variability was within acceptable limits. Testing included dimensional
> analysis, visual inspection of the tip after repeated insertions and
> activation of radiofrequency energy, and evaluation of the glue bond
> between the Teflon® stop and the tip. The test report shows that the
> tip dimensions fall within an acceptable tolerance range, the glue
> bond is sufficient to withstand forces encountered during the
> procedure, and that repeated insertion and conductance of
> radiofrequency energy does not adversely affect the tip.

2\. Return Electrode Heat Transfer Study:

> A study was conducted to confirm that there are no adverse heating
> effects at the return electrode (the lid speculum). This study
> confirmed that the radiofrequency energy applied to the treatment
> probe caused localized heating at the treatment site and that there
> was no evidence of heating at the return electrode.

## Physical Safety Tests

Sterility Validation and Expiration Dating: The device is terminally
sterilized in its package utilizing a 100% ETO cycle that has been
validated. The sterilization cycle provides a 10^-6^ Sterility Assurance
Level (SAL). Accelerated and Real Time aging studies confirm the labeled
expiration date.

## Biocompatibility

The contact material of the tip is a medical grade 420 series Stainless
Steel. This material is of known biocompatibility.

## Performance Testing

Each device is evaluated against a Final Test Procedure as part of the
manufacturing/assembly process. This Test Procedure includes calibration
and verification of the critical waveform parameters as well as other
performance criteria. The Test Procedure has been completed as part of
the manufacturing process validation on five prototype units. The
results of these tests are on file with the contract manufacturer and as
part of the Design History File at Refractec. The results of the
validation were found to be acceptable.

## Electrical and Thermal Simulation

Computer simulation of the ViewPoint™ CK System was performed in order
to analyze the power deposition pattern and thermal profile surrounding
the needle tip. This simulation consisted of two steps. First, the
needle tip was assigned a voltage with respect to the return electrode;
other boundary conditions were defined on the surface of a rectangular
volume as required. This information was analyzed by using a computer
program to solve the Laplace equation to calculate the potential
distribution within the volume. The electric field, power density, and
circuit impedance were then calculated. Once power density was
identified, this value was used as the heating source input into a
program that solved a bioheat equation, calculating the temperature
distribution within the volume as a function of time. The applied power
was then modified to simulate the effect of tissue coagulation or
desiccation that occurs over time.

Temperature distributions were computed throughout the entire simulation
volume. Based on the power deposition patterns computed from the
electric field modeling program, the highest temperatures were predicted
to be achieved along the axis of the needle and near the needle tip. At
a distance from the needle, where power deposition was insignificant,
increase in temperature was due to thermal conduction effects. While
initially, maximum heating occurred near the needle tip, with increasing
temperature, heating extended along the needle shaft, and ultimately
spread at later points to tissue elements located further away from the
tip. The extent of the thermal lesion produced was shown to be a
function of both time and temperature.

## Histopathology

As part of the clinical evaluation of the ViewPoint CK System, six
subjects scheduled for penetrating keratoplasty underwent the CK^SM^
procedure 24 to 48 hours prior to penetrating keratoplasty (PK).
Histology was performed on the corneal tissue obtained from these
subjects.

Initially, the corneal tissue was examined to determine the exact
location of the radiofrequency applications, and to ensure that the
section selected for histopathologic processing did not have any
evidence of the underlying pathology that necessitated penetrating
keratoplasty. The selected specimen was then processed and stained, and
evaluated under high-powered light microscopy.

Histopathologic examination revealed a V-shaped or U-shaped stromal
thermal footprint at the site of the radiofrequency application that
clearly demarcated the shrunken collagen from the surrounding preserved
lamellae. A bullous-like separation of epithelium from the underlying
Bowman's layer, or a total absence of epithelium at the site of the
CK^SM^ application was observed. Epithelial cells at the site of the
CK^SM^ application were abnormal, with necrotic, shrunken nuclei.
Bowman's layer remained intact in all of the sections examined. The
keratocyte population was decreased or shrunken, with edema between the
stromal lamellae, and collagen disorganization. The surrounding stroma
maintained its normal staining properties, with preservation of collagen
structure and keratocyte nuclei. No inflammatory cells were observed
within the area of the CK^SM^ application. Descemet's membrane was
continuous, with no folds.

Based on this histological study of human corneas, it can be concluded
that Conductive Keratoplasty^SM^ was not associated with an inflammatory
response, and no damage to either Bowman's layer or Descemet's membrane
in the areas of application was observed.

## Conclusions

The preclinical testing provided evidence to support the conclusion that
the device did not present an unreasonable risk to subjects and could
proceed to clinical trials under an approved investigational device
exemption (IDE).

# SUMMARY OF CLINICAL STUDIES

Refractec, Inc. conducted a clinical study of the ViewPoint CK System
in the U.S. under IDE #G980224. The data from this study served as the
basis for the approval decision. Safety and effectiveness outcomes
through 12 months post-treatment were evaluated for confirmation.

## Objectives 

> The objective of the clinical study was to evaluate the safety and
> effectiveness of the ViewPoint™ CK System in the correction of low to
> moderate spherical hyperopia.

## Study Design

This study was a prospective, multi-center clinical study where the
primary control was the preoperative status of the treated eye.

> **1. Inclusion and Exclusion Criteria**
>
> Enrollment in the Refractec clinical study was limited to patients
> who:

-   Had 0.75 to 3.25 D of manifest spherical hyperopia, ≤ 0.75 D of
    refractive astigmatism, and 0.75 to 3.00 D of spherical equivalent
    by cycloplegic refraction in the eye to be treated.

-   Had spherical equivalent manifest refraction and spherical
    equivalent cycloplegic refraction that did not differ by more than
    0.50 D.

-   Discontinued using hard or rigid gas permeable contact lenses for at
    least 3 weeks and discontinued using soft contact lenses for at
    least 2 weeks prior to the preoperative evaluation in the eye to be
    treated.

-   For hard contact lens wearers -- had 2 central keratometry readings
    and 2 manifest refractions taken at least one week apart, the last
    of which did not differ from the previous values by more than 0.50 D
    in either meridian; mires were regular in the eye to be treated.

-   Had visual acuity correctable to at least 20/40 in both eyes.

-   Were at least 21 years of age.

-   Were willing and able to return for scheduled follow‑up examinations
    for 24 months after surgery.

-   Provided written informed consent.

-   Were able to tolerate their full cycloplegic correction while not
    under cycloplegia.

> Patients with the following conditions were excluded from the study:

-   Previous strabismus surgery, or who would have been likely to
    develop strabismus following the CK^SM^ procedure.

-   Anterior segment pathology, including cataracts (in the operative
    eye).

-   Any corneal abnormality (in the operative eye).

-   Progressive or unstable hyperopia (in the operative eye).

-   Latent hyperopia.

-   Distorted or unclear corneal mires.

-   Blind in the fellow eye.

-   Previous intraocular or corneal surgery.

-   History of Herpes zoster or Herpes simplex keratitis.

-   History of steroid-responsive rise in IOP, glaucoma, or preoperative
    IOP \> 21 mm Hg.

-   At risk for angle closure or with a potentially occludable angle.

-   Diabetes, diagnosed autoimmune disease, connective tissue disease,
    or clinically significant atopic syndrome.

-   Chronic systemic corticosteroid or other immunosuppressive therapy,
    and any immunocompromised patients.

-   Using ophthalmic medication(s) other than artificial tears for
    treatment of any ocular pathology.

-   Using systemic medications with significant ocular side effects.

-   History of keloid formation.

-   Intractable keratoconjunctivitis sicca.

-   Pregnant, planning to be pregnant, or lactating during the course of
    the study.

-   Known sensitivity to planned study concomitant medications.

-   Participating in any other ophthalmic drug or device clinical trial
    during the time of this clinical investigation.

-   Peripheral pachymetry reading of less than 560 microns.

-   Distance UCVA better than 20/32.

> **2. Study Endpoints**
>
> The following primary study parameters were evaluated in the
> determination of safety and effectiveness of the Refractec ViewPoint
> CK System.
>
> [Primary Safety Parameter:]{.underline}

-   Preservation of best corrected visual acuity: less than 5% of eyes
    should lose more than two lines of best corrected visual acuity at
    the postoperative interval at which stability has been established.

> Primary Effectiveness Parameter:

-   Predictability: 75% of eyes should have a manifest refraction
    spherical equivalent within [+]{.underline}1.00 D of the attempted
    correction at the postoperative interval at which stability has been
    established.

> The following secondary study parameters were evaluated in the
> determination of safety and effectiveness of the Refractec ViewPoint
> CK System.
>
> [Secondary Safety Parameters:]{.underline}

-   Preservation of best corrected visual acuity: less than 1% of eyes
    with preoperative BSCVA of 20/20 should have a visual acuity outcome
    worse than 20/40 BSCVA at the postoperative interval at which
    stability has been established.

-   Mean extent of induced manifest refractive astigmatism: less than 5%
    of eyes should have a postoperative manifest refractive astigmatism
    that varies from target amount by greater than 2.00 D at the
    postoperative interval at which stability has been established.

-   Results of slit lamp examination: less than 1% of eyes should have
    clinically significant haze, defined as a decrease in BSCVA of \>2
    lines not due to irregular astigmatism, at the postoperative
    interval at which stability has been established.

-   Central endothelial cell loss: mean endothelial cell loss should be
    no more than 10% at the postoperative interval at which stability
    has been established.

-   Cumulative incidence of adverse events. Adverse events should occur
    in less than 5% of eyes and any single adverse event should occur in
    less than 1% of eyes.

> [Secondary Effectiveness Parameters:]{.underline}

-   Predictability: 50% of eyes should have a manifest refraction
    spherical equivalent within [+]{.underline} 0.50 D of attempted
    correction at the postoperative interval at which stability has been
    established.

-   Stability (absence of change in refractive outcome over time): 95%
    of eyes should have a change of [\<]{.underline} 1.00 D in manifest
    refraction spherical equivalent between two refractions performed at
    least three months apart.

-   Improvement in uncorrected visual acuity: 85% of eyes who had 20/20
    or better spectacle-corrected visual acuity preoperatively, and for
    whom the intended target correction was emmetropia should have an
    uncorrected visual acuity of 20/40 or better at the postoperative
    interval at which stability has been established. For those eyes
    which had spectacle-corrected visual acuity of worse than 20/20 but
    at least 20/40 preoperatively, and for which the intended target
    correction was emmetropia, 75% should have an uncorrected visual
    acuity of 20/40 or better at the postoperative interval at which
    stability has been established.

-   Decrease in manifest refraction spherical equivalent and
    astigmatism: 75% of eyes should be within [+]{.underline} 1.00 D of
    attempted spherical and astigmatism correction at the postoperative
    interval at which stability has been established.

-   Subject satisfaction as measured by subjective questionnaire.

## Study Plan and Subject Assessments

> **1. Study Plan**

All subjects were expected to return for follow-up examinations at one
day, one week, and 1, 3, 6, 9, 12, and 24 months post-treatment. After
the first 50 eyes were evaluated, the option to perform simultaneous
bilateral surgery was left to the discretion of the investigator.
Retreatments were not attempted in this study.

**2. Subject Assessments and Efficacy Criteria**

-   Distance visual acuity, uncorrected and best spectacle-corrected,
    using ETDRS charts

-   Manifest refraction (no auto-refraction)

-   Cycloplegic refraction

-   Pachymetry

-   Intraocular pressure (applanation)

-   Slit lamp examination

-   Fundus examination (dilated)

-   Specular microscopy of the central and peripheral corneal
    endothelium (in a subgroup of 100 subjects)

-   Mesopic contrast sensitivity, with and without glare (subgroup)

-   Computerized corneal topography (postoperatively in eyes with
    anomalous refractive outcomes)

-   Central keratometry

-   Subject self-evaluation/questionnaire

## Study Period and Investigational Sites

Subjects were treated between 2/10/1999 and 12/01/2000 at 12
investigational sites. The database for this PMA cohort reflected data
collected through 10/01/2001 and included 401 eyes: 233 primary eyes and
168 fellow eyes.

## Demographic Data

Of the 233 subjects, 58% were female and 42% were male. The mean age for
all enrolled subjects was 55.3 years, with a range from 40 to 73 years.
The study population consisted primarily of Caucasians (81%). Mean
hyperopia (CRSE) prior to surgery was 1.86 diopters.

Table 1

Demographics

All Eyes Enrolled

  ------------------------ ----------------------------- ------------ -------
  **401 Eyes of 233                                                   
  Enrolled Subjects**                                                 

                                                                      

  **Gender**               Male                          42%          

                           Female                        58%          

                                                                      

  **Race**                 Caucasian                     81%          

                           Black                         9%           

                           Asian                         2%           

                           Other                         9%           

                                                                      

  **Eye**                  Left                          49%          

                           Right                         51%          

                                                                      

  **Age (yrs)**            N                             233          

                           Mean                          55.3         

                           95% Confidence Interval       54.5,56.1    

                           Standard Deviation            6.36         

                           Median                        55.6         

                           Range                         40.2,73.9    

                                                                      

  **Range of Treatment -   N                             401          
  CRSE**                                                              

                           Mean                          1.86         

                           95% Confidence Interval       1.80,1.92    

                           Standard Deviation            0.628        

                           Median                        1.75         

                           Range                         0.75,4.00    

                                                                      

  **Range of Treatment -   N                             401          
  MRSE**                                                              

                           Mean                          1.80         

                           95% Confidence Interval       1.74,1.86    

                           Standard Deviation            0.637        

                           Median                        1.75         

                           Range\*                       -0.38,3.75   
  ------------------------ ----------------------------- ------------ -------

## Data Analysis and Results

> The protocol was amended after enrollment of the initial cohort of 54
> eyes to reflect a decrease in the maximum spherical hyperopia to be
> corrected by CK^SM^. A modified nomogram that shifted the treatment
> ranges and number of spots also reduced the maximum CK^SM^ treatment
> from 4.00 D to 3.25 D spherical hyperopia (CRSE ≤3.00 D). Thus the
> nomogram identified as \"current nomogram\" specifies a treatment
> range of 0.75 D to 3.25 D spherical hyperopia, a spherical equivalent
> of 0.75 D to 3.00 D, and no more than 0.75 D absolute cylinder.
>
> Of the 54 eyes that underwent CK^SM^ during the first phase of study,
> only 25 eyes fit into the modified CK^SM^ nomogram. The remaining 29
> eyes fell outside of the treatment ranges defined in the modified
> nomogram, identified throughout this report as the \"current
> nomogram,\" which was used for the remainder of the study. Since these
> 29 eyes were not treated with the current nomogram, their refractive
> outcomes do not reflect the effectiveness of the current nomogram, and
> on this basis, they have been excluded from the effectiveness
> outcomes, i.e., uncorrected visual acuity, accuracy of intended
> (target) to achieved refraction, expressed as spherical equivalent
> manifest refraction or MRSE, and mean postoperative refraction, also
> expressed as MRSE. An additional 9 eyes were treated outside the
> current nomogram as a result of protocol deviations or surgeon error,
> and have also been excluded from analyses of effectiveness. All eyes
> have been included in analyses of the stability and safety parameters.
>
> **1. Pre-Treatment Characteristics**

Table 2 presents a summary of the pre-treatment visual acuity and
refraction. The treatment goal for all eyes was emmetropia.

Table 2

Preoperative Refractive Parameters

Eyes Treated with Current Nomogram

  ------------------------ ---------- ----------- -------- ----- ---------- -------- ----- -------- --------
                                      **Primary                  **Fellow                  **All    
                                      Eyes**                     Eyes**                    Eyes**   

                                                                                                    

  **Spherical Equivalent   0.0-0.99 D 11              6%         11             7%         22           6%
  (MRSE) \***                                                                                       

                           1.0-1.99 D 121           61%          84           52%          205        57%

                           2.0-2.99 D 62            31%          63           39%          125        35%

                           3.0-4.00 D 5               3%         4              2%         9            2%

                           Total      199         100%           162        100%           361      100%

                                                                                                    

  **Cylinder (manifest)    0.00 D     69            35%          57           35%          126        35%
  \*\***                                                                                            

                           0.25 D     41            21%          38           23%          79         22%

                           0.50 D     59            30%          49           30%          108        30%

                           0.75 D     28            14%          18           11%          46         13%

                           1.00 D     3               2%         1              1%         4            1%

                           1.25 D     0               0%         0              0%         0            0%

                           Total      200         100%           163        100%           363      100%

                                                                                                    

  **Spherical Equivalent   0.0-0.99 D 8               4%   9                    6%   17                 5%
  (CRSE) \*\***                                                                                     

                           1.0-1.99 D 117           59%    85                 52%    202              56%

                           2.0-2.99 D 65            33%    60                 37%    125              34%

                           3.0-4.00 D 10              5%   9                    6%   19                 5%

                           Total      200         100%     163              100%     363            100%

                                                                                                    

  **Cylinder (cycloplegic) 0.00 D     69            35%    67                 41%    136              37%
  \*\***                                                                                            

                           0.25 D     29            15%    36                 22%    65               18%

                           0.50 D     75            38%    39                 24%    114              31%

                           0.75 D     26            13%    21                 13%    47               13%

                           1.00 D     1               1%   0                    0%   1                \<1%

                           1.25 D     0               0%   0                    0%   0                  0%

                           Total      200         100%     163              100%     363            100%
  ------------------------ ---------- ----------- -------- ----- ---------- -------- ----- -------- --------

  -----------------------------------------------------------------------
  \* Excludes two ineligible eyes with minus MRSE; these eyes are
  included in the cylinder analysis.

  \*\* Includes one ineligible eye with \>0.75 D cycloplegic cylinder.
  -----------------------------------------------------------------------

#### 2. Subject Accountability {#subject-accountability .unnumbered}

Of the 401 eyes enrolled in the study, follow-up data through 12 months
postoperative are available for 344 eyes (95%). Of the remaining eyes,
one (\<1%) was discontinued from the study, 4 eyes (1%) were lost to
follow-up, and 14 eyes (4%) were not yet eligible for the visit.

**Table 3**

**Accountability**

**Eyes Treated with Current Nomogram**

  ----------------- --------- -------- --------- -------- --------- -------- --------- -------- --------- --------
                    Month 1            Month 3            Month 6            Month 9            **Month   
                                                                                                12**      

  Available for     354/363     98%    358/363     99%    352/363     97%    350/363     96%    344/363     95%
  Analysis                                                                                                

  Discontinued      1/363       \<1%   1/363       \<1%   1/363       \<1%   1/363       \<1%   1/363       \<1%

  Missed Visit      8/363         2%   4/363         1%   10/363        3%   10/363        3%   0/363         0%

  Not yet eligible  0/363         0%   0/363         0%   0/363         0%   0/363         0%   14/363       4%
  for interval                                                                                            

  Lost to Follow-up 0/363         0%   0/363         0%   0/363         0%   2/363         1%   4/363         1%

  Accountability    354/363     98%    358/363     99%    352/363     97%    350/363     96%    344/349     99%
  ----------------- --------- -------- --------- -------- --------- -------- --------- -------- --------- --------

> **3. Summary of Key Effectiveness Variables**

Table 4 demonstrates that the key effectiveness outcomes at 6 months
postoperative meet or exceed the outcomes recommended in the October 10,
1996 *FDA Guidance for Refractive Surgery Lasers*.

Table 4

Summary of Key Efficacy Variables

Eyes Treated with Current Nomogram

+------------------+--------+---------+---------+---------+----------+
|                  | *      | **Month | **Month | **Month | **Month  |
|                  | *Month | 3\***   | 6**     | 9**     | 12**     |
|                  | 1**    |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| **Efficacy       |        |         |         |         |          |
| Variables**      |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| UCVA 20/20 or    | 29%    | 40%     | 45%     | 49%     | 56%      |
| better           |        |         |         |         |          |
|                  | 51%    | 63%     | 64%     | 73%     | 75%      |
|                  |        |         |         |         |          |
|                  | 79%    | 86%     | 90%     | 93%     | 92%      |
|                  |        |         |         |         |          |
|                  | 47%    | 56%     | 61%     | 63%     | 62%      |
|                  |        |         |         |         |          |
|                  | 75%    | 83%     | 88%     | 87%     | 89%      |
|                  |        |         |         |         |          |
|                  | 94%    | 97%     | 99%     | 99%     | 99%      |
+------------------+--------+---------+---------+---------+----------+
| UCVA 20/25 or    |        |         |         |         |          |
| better           |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| UCVA 20/40 or    |        |         |         |         |          |
| better           |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| MRSE ≤ 0.50 D    |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| MRSE ≤ 1.00 D    |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| MRSE ≤ 2.00 D    |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+
| \* Two eyes were |        |         |         |         |          |
| excluded from    |        |         |         |         |          |
| the 3 Month MRSE |        |         |         |         |          |
| efficacy         |        |         |         |         |          |
| variables due to |        |         |         |         |          |
| manifest         |        |         |         |         |          |
| refraction and   |        |         |         |         |          |
| BSCVA not        |        |         |         |         |          |
| performed.       |        |         |         |         |          |
+------------------+--------+---------+---------+---------+----------+

Table 5

Summary of Key Efficacy Variables at 12 Months

Preoperative MRSE Stratified by Dioptric Group

Eyes Treated with Current Nomogram

+----------------------------+----------+---+----------+---+----------+---+
|                            | **0.00   |   | **1.00   |   | **2.00   |   |
|                            | to 0.99  |   | to 1.99  |   | to 3.25  |   |
|                            | D**      |   | D**      |   | D**      |   |
+----------------------------+----------+---+----------+---+----------+---+
| **Efficacy Variables**     |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+
| UCVA 20/20 or better       | 64%      |   | 59%      |   | 48%      |   |
|                            |          |   |          |   |          |   |
|                            | 73%      |   | 77%      |   | 72%      |   |
|                            |          |   |          |   |          |   |
|                            | 91%      |   | 94%      |   | 90%      |   |
|                            |          |   |          |   |          |   |
|                            | 82%      |   | 68%      |   | 50%      |   |
|                            |          |   |          |   |          |   |
|                            | 100%     |   | 94%      |   | 78%      |   |
|                            |          |   |          |   |          |   |
|                            | 100%     |   | 100%     |   | 98%      |   |
+----------------------------+----------+---+----------+---+----------+---+
| UCVA 20/25 or better       |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+
| UCVA 20/40 or better       |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+
| MRSE ≤ 0.50 D              |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+
| MRSE ≤ 1.00 D              |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+
| MRSE ≤ 2.00 D              |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+
|                            |          |   |          |   |          |   |
+----------------------------+----------+---+----------+---+----------+---+

Table 6

Summary of Key Efficacy Variables at 12 Months

Stratified by Treatment Spots Applied

Eyes Treated with Current Nomogram

+---------------------+-----------+-----------+-----------+-----------+
|                     | **8       | **16      | **24      | **32      |
|                     | Spots\*** | Spots\*** | Spots\*** | Spots\*** |
+---------------------+-----------+-----------+-----------+-----------+
| **Efficacy          |           |           |           |           |
| Variables**         |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| UCVA 20/20 or       | 67%       | 63%       | 49%       | 49%       |
| better              |           |           |           |           |
|                     | 80%       | 77%       | 73%       | 71%       |
|                     |           |           |           |           |
|                     | 93%       | 96%       | 92%       | 87%       |
|                     |           |           |           |           |
|                     | 100%      | 70%       | 60%       | 41%       |
|                     |           |           |           |           |
|                     | 100%      | 96%       | 92%       | 67%       |
|                     |           |           |           |           |
|                     | 100%      | 100%      | 100%      | 97%       |
+---------------------+-----------+-----------+-----------+-----------+
| UCVA 20/25 or       |           |           |           |           |
| better              |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| UCVA 20/40 or       |           |           |           |           |
| better              |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| MRSE ≤ 0.50 D       |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| MRSE ≤ 1.00 D       |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| MRSE ≤ 2.00 D       |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+
| \* 8 spots = CRSE   |           |           |           |           |
| 0.75 to 0.875 D     |           |           |           |           |
|                     |           |           |           |           |
| 16 spots = CRSE     |           |           |           |           |
| 1.00 to 1.625 D     |           |           |           |           |
|                     |           |           |           |           |
| 24 spots = CRSE     |           |           |           |           |
| 1.75 to 2.25 D      |           |           |           |           |
|                     |           |           |           |           |
| 32 spots = CRSE     |           |           |           |           |
| 2.375 to 3.00 D     |           |           |           |           |
+---------------------+-----------+-----------+-----------+-----------+

> **4. Change in Manifest Refraction Over Time**

**Table 7**

**Stability of Manifest Refraction through 12 Months**

Patients with Consecutive visits

**All Eyes Treated**

+-----------------------+-------------+---------------+---------------+
|                       | **Between 3 | **Between 6   | **Between 9   |
|                       | and 6       | and 9         | and 12**      |
|                       | Months**    | Months**      |               |
|                       |             |               | **Months**    |
+-----------------------+-------------+---------------+---------------+
|                       |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Change in MRSE        | 74%         | 89%           | 88%           |
| [\<]{.underline} 0.50 |             |               |               |
| D                     | 87%         | 95%           | 96%           |
|                       |             |               |               |
|                       | 93%         | 98%           | 97%           |
|                       |             |               |               |
|                       | 0.26        | 0.10          | 0.14          |
|                       |             |               |               |
|                       | 0.20,0.32   | 0.06,0.14     | 0.10,0.18     |
|                       |             |               |               |
|                       | 0.493       | 0.372         | 0.362         |
|                       |             |               |               |
|                       | 0.09        | 0.03          | 0.05          |
|                       |             |               |               |
|                       | 0.07,0.11   | 0.01,0.05     | 0.03,0.07     |
|                       |             |               |               |
|                       | 0.164       | 0.124         | 0.121         |
+-----------------------+-------------+---------------+---------------+
| Change in MRSE        |             |               |               |
| [\<]{.underline} 0.75 |             |               |               |
| D                     |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Change in MRSE        |             |               |               |
| [\<]{.underline} 1.00 |             |               |               |
| D                     |             |               |               |
+-----------------------+-------------+---------------+---------------+
|                       |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Change in MRSE        |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Mean                  |             |               |               |
+-----------------------+-------------+---------------+---------------+
| 95% Confidence        |             |               |               |
| Interval              |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Standard Deviation    |             |               |               |
+-----------------------+-------------+---------------+---------------+
|                       |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Change in MRSE per    |             |               |               |
| Month                 |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Mean                  |             |               |               |
+-----------------------+-------------+---------------+---------------+
| 95% Confidence        |             |               |               |
| Interval              |             |               |               |
+-----------------------+-------------+---------------+---------------+
| Standard Deviation    |             |               |               |
+-----------------------+-------------+---------------+---------------+

**Table 8**

Mean MRSE by Visit

**12 Month Cohort**

**Eyes Treated with Current Nomogram**

  ---------------- -------------- ------------- ------------- ------------ ------------ -----------
                   **Baseline**   **1 Month**   **3 Months**  **6 Months** **9 Months** **12
                                                                                        Months**

                                                                                        

  N                325            325           323           325          325          325

  Mean             1.77           -0.56         -0.29         -0.04        0.05         0.19

  95% Confidence   1.71,1.83      -0.66,-0.46   -0.37,-0.21   -0.12,0.04   -0.03,0.13   0.11,0.27
  Interval                                                                              

  Standard         0.587          0.889         0.781         0.727        0.692        0.662
  Deviation                                                                             
  ---------------- -------------- ------------- ------------- ------------ ------------ -----------

#### a. Factors Associated with Outcomes {#a.-factors-associated-with-outcomes .unnumbered}

[]{.mark}

> Statistical modeling performed on the data generated in the CK^SM^
> clinical study found no effect of age, race, sex or clinical site on
> outcomes.

#### b. Subject Satisfaction  {#b.-subject-satisfaction .unnumbered}

> Subjects were asked to rate their quality of vision compared to before
> the Conductive Keratoplasty^SM^ (CK^SM^) procedure. Table 9 shows the
> percentage of subjects that rated each condition as improvement that
> was "extreme," "marked," "moderate," "slight," or "no improvement".

Table 9

Quality of Vision

  -------------- --------- -------- --------- -------- --------- -------- --------- -------- --------- --------
                 **Month            **Month            **Month            **Month            **Month   
                 1**                3**                6**                9**                12**      

  Extreme        83/353      24%    87/361      24%    109/370     29%    115/366     31%    112/369     30%
  Improvement                                                                                          

  Marked         149/353     42%    159/361     44%    164/370     44%    144/366     39%    160/369     43%
  Improvement                                                                                          

  Moderate       68/353      19%    78/361      22%    57/370      15%    67/366      18%    61/369      17%
  Improvement                                                                                          

  Slight         37/353      10%    22/361        6%   28/370        8%   28/366        8%   26/369        7%
  Improvement                                                                                          

  No Improvement 16/353        5%   15/361        4%   12/370        3%   12/366        3%   10/369        3%
  -------------- --------- -------- --------- -------- --------- -------- --------- -------- --------- --------

Overall subject satisfaction was assessed on a subject survey at 1, 3,
6, 9, and 12 months post-treatment using a 5-point grading scale from
"very satisfied" to "very dissatisfied".

Table 10

Subject Satisfaction

  -------------- --------- -------- --------- -------- --------- -------- --------- -------- --------- --------
                 **Month            **Month            **Month            **Month            **Month   
                 1**                3**                6**                9**                12**      

  Very Satisfied 161/356     45%    168/362     46%    172/371     46%    181/366     49%    185/369     50%

  Satisfied      112/356     31%    118/362     33%    134/371     36%    110/366     30%    115/369     31%

  Neutral        57/356      16%    55/362      15%    34/371        9%   42/366      11%    34/369       9%

  Dissatisfied   16/356        4%   12/362        3%   20/371        5%   21/366        6%   27/369        7%

  Very           10/356        3%   9/362         2%   11/371        3%   12/366        3%   8/369         2%
  Dissatisfied                                                                                         
  -------------- --------- -------- --------- -------- --------- -------- --------- -------- --------- --------

Table 11

**Need for Distance Correction**

  -------- --------- ---- --------- ----- --------- ----- --------- ---- ---------
           **Month        **Month         **Month         **Month        **Month
           1**            3**             6**             9**            12**

  No       84%            89%             87%             82%            82%

  Yes      16%            11%             13%             18%            18%
  -------- --------- ---- --------- ----- --------- ----- --------- ---- ---------

> **5. Summary of Key Safety Variables**

The following table demonstrates that the key safety outcomes meet or
exceed the outcomes recommended in the October 10, 1996 *FDA Guidance
for Refractive Surgery Lasers*.

Table 12

Summary of Key Safety Variables

All Eyes Treated

+---------------------+-------+---------+---------+---------+-----+---+
|                     | Month | **Month | **Month | **Month | *   |   |
|                     | 1     | 3**     | 6**     | 9**     | *Mo |   |
|                     |       |         |         |         | nth |   |
|                     |       |         |         |         | 1   |   |
|                     |       |         |         |         | 2** |   |
+---------------------+-------+---------+---------+---------+-----+---+
| **Safety            |       |         |         |         |     |   |
| Variables\***       |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+
| Loss of 2 lines     | > 6%  | 5%      | 4%      | 3%      | 2%  |   |
| BSCVA               | >     |         |         |         |     |   |
|                     | > 2%  | 1%      | 1%      | 1%      | 0%  |   |
|                     | >     |         |         |         |     |   |
|                     | > 0%  | 0%      | 0%      | 0%      | 0%  |   |
|                     | >     |         |         |         |     |   |
|                     | > 3%  | 2%      | 1%      | \<1%    | \   |   |
|                     | >     |         |         |         | <1% |   |
|                     | > 4%  | 2%      | 1%      | 1%      |     |   |
|                     |       |         |         |         | 0%  |   |
+---------------------+-------+---------+---------+---------+-----+---+
| Loss of \> 2 lines  |       |         |         |         |     |   |
| BSCVA               |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+
| BSCVA worse than    |       |         |         |         |     |   |
| 20/40               |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+
| Increase \> 2.00 D  |       |         |         |         |     |   |
| cylinder            |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+
| BSCVA worse than    |       |         |         |         |     |   |
| 20/25               |       |         |         |         |     |   |
|                     |       |         |         |         |     |   |
| if 20/20 or better  |       |         |         |         |     |   |
| preoperatively      |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+
|                     |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+
| \* Two eyes were    |       |         |         |         |     |   |
| excluded from all   |       |         |         |         |     |   |
| safety variables    |       |         |         |         |     |   |
| due to manifest     |       |         |         |         |     |   |
| refraction and      |       |         |         |         |     |   |
| BSCVA not           |       |         |         |         |     |   |
| performed.          |       |         |         |         |     |   |
+---------------------+-------+---------+---------+---------+-----+---+

Table 13

Summary of Key Safety Variables at 12 Months

Preoperative MRSE Stratified by Dioptric Group

All Eyes Treated

+--------------------------+-----------+---+---+----------+---+---+---------+---+
|                          | **0.00 to | * |   |          | * |   |         |   |
|                          | 0.99 D**  | * |   |          | * |   |         |   |
|                          |           | 1 |   |          | 2 |   |         |   |
|                          |           | . |   |          | . |   |         |   |
|                          |           | 0 |   |          | 0 |   |         |   |
|                          |           | 0 |   |          | 0 |   |         |   |
|                          |           | t |   |          | t |   |         |   |
|                          |           | o |   |          | o |   |         |   |
|                          |           | 1 |   |          | 3 |   |         |   |
|                          |           | . |   |          | . |   |         |   |
|                          |           | 9 |   |          | 2 |   |         |   |
|                          |           | 9 |   |          | 5 |   |         |   |
|                          |           | D |   |          | D |   |         |   |
|                          |           | * |   |          | \ |   |         |   |
|                          |           | * |   |          | * |   |         |   |
|                          |           |   |   |          | * |   |         |   |
|                          |           |   |   |          | * |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
|                          |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| **Safety Variables**     |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| Loss of 2 lines BSCVA    | 0%        | 3 |   |          | 1 |   |         |   |
|                          |           | % |   |          | % |   |         |   |
|                          | 0%        |   |   |          |   |   |         |   |
|                          |           | 0 |   |          | 0 |   |         |   |
|                          | 0%        | % |   |          | % |   |         |   |
|                          |           |   |   |          |   |   |         |   |
|                          | 0%        | 0 |   |          | 0 |   |         |   |
|                          |           | % |   |          | % |   |         |   |
|                          | 0%        |   |   |          |   |   |         |   |
|                          |           | \ |   |          | 0 |   |         |   |
|                          |           | < |   |          | % |   |         |   |
|                          |           | 1 |   |          |   |   |         |   |
|                          |           | % |   |          | 0 |   |         |   |
|                          |           |   |   |          | % |   |         |   |
|                          |           | 0 |   |          |   |   |         |   |
|                          |           | % |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| Loss of \> 2 lines BSCVA |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| BSCVA worse than 20/40   |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| Increase \> 2.00 D       |           |   |   |          |   |   |         |   |
| cylinder                 |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| BSCVA worse than 20/25   |           |   |   |          |   |   |         |   |
|                          |           |   |   |          |   |   |         |   |
| if 20/20 or better       |           |   |   |          |   |   |         |   |
| preoperatively           |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
|                          |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+
| \* Safety variables      |           |   |   |          |   |   |         |   |
| shown for all treated    |           |   |   |          |   |   |         |   |
| eyes; includes 2 eyes    |           |   |   |          |   |   |         |   |
| with preoperative MRSE   |           |   |   |          |   |   |         |   |
| \> 3.25.                 |           |   |   |          |   |   |         |   |
|                          |           |   |   |          |   |   |         |   |
| Neither of these eyes    |           |   |   |          |   |   |         |   |
| lost ≥ 2 lines BSCVA,    |           |   |   |          |   |   |         |   |
| had BSCVA worse than     |           |   |   |          |   |   |         |   |
| 20/40, or increased \>   |           |   |   |          |   |   |         |   |
| 2.00 D                   |           |   |   |          |   |   |         |   |
|                          |           |   |   |          |   |   |         |   |
| cylinder.                |           |   |   |          |   |   |         |   |
+--------------------------+-----------+---+---+----------+---+---+---------+---+

Table 14

Summary of Key Safety Variables at 12 Months

Stratified by Treatment Spots Applied

All Eyes Treated

+------------------------+-----------+---------+----------+---+----------+---+
|                        | **8       | **16    | **24     | * |          |   |
|                        | Spots\*** | Sp      | S        | * |          |   |
|                        |           | ots\*** | pots\*** | 3 |          |   |
|                        |           |         |          | 2 |          |   |
|                        |           |         |          | S |          |   |
|                        |           |         |          | p |          |   |
|                        |           |         |          | o |          |   |
|                        |           |         |          | t |          |   |
|                        |           |         |          | s |          |   |
|                        |           |         |          | \ |          |   |
|                        |           |         |          | * |          |   |
|                        |           |         |          | * |          |   |
|                        |           |         |          | * |          |   |
+------------------------+-----------+---------+----------+---+----------+---+
| **Safety Variables**   |           |         |          |   |          |   |
+------------------------+-----------+---------+----------+---+----------+---+
| Loss of 2 lines BSCVA  | 0%        | 3%      | 3%       |   | 0%       |   |
|                        |           |         |          |   |          |   |
|                        | 0%        | 0%      | 0%       |   | 0%       |   |
|                        |           |         |          |   |          |   |
|                        | 0%        | 0%      | 0%       |   | 0%       |   |
|                        |           |         |          |   |          |   |
|                        | 0%        | 1%      | 0%       |   | 0%       |   |
|                        |           |         |          |   |          |   |
|                        | 0%        | 0%      | 0%       |   | 0%       |   |
+------------------------+-----------+---------+----------+---+----------+---+
| Loss of \> 2 lines     |           |         |          |   |          |   |
| BSCVA                  |           |         |          |   |          |   |
+------------------------+-----------+---------+----------+---+----------+---+
| BSCVA worse than 20/40 |           |         |          |   |          |   |
+------------------------+-----------+---------+----------+---+----------+---+
| Increase \> 2.00 D     |           |         |          |   |          |   |
| cylinder               |           |         |          |   |          |   |
+------------------------+-----------+---------+----------+---+----------+---+
| BSCVA worse than 20/25 |           |         |          |   |          |   |
|                        |           |         |          |   |          |   |
| if 20/20 or better     |           |         |          |   |          |   |
| preoperatively         |           |         |          |   |          |   |
+------------------------+-----------+---------+----------+---+----------+---+

+-----------------------------------------------------------------------+
| \* 8 spots = CRSE 0.75 to 0.875 D                                     |
|                                                                       |
| 16 spots = CRSE 1.00 to 1.625 D                                       |
|                                                                       |
| 24 spots = CRSE 1.75 to 2.25 D                                        |
|                                                                       |
| 32 spots = CRSE 2.375 to 3.00 D                                       |
+-----------------------------------------------------------------------+

> The following adverse events were reported in clinical study of the
> ViewPoint CK System.

Table 15

Adverse Event Summary

<table>
<colgroup>
<col style="width: 35%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 10%" />
<col style="width: 2%" />
<col style="width: 11%" />
</colgroup>
<tbody>
<tr class="odd">
<td></td>
<td><strong>Month 1</strong></td>
<td></td>
<td><strong>Month 3</strong></td>
<td></td>
<td><strong>Month 6</strong></td>
<td></td>
<td><strong>Month 9</strong></td>
<td></td>
<td><strong>Month 12</strong></td>
</tr>
<tr class="even">
<td>Decrease in BSCVA of &gt; 10 letters not due to irregular
astigmatism as shown by hard contact lens refraction at 6 months or
later</td>
<td>0%</td>
<td></td>
<td>0%</td>
<td></td>
<td>0%</td>
<td></td>
<td>0%</td>
<td></td>
<td>&lt;1%</td>
</tr>
<tr class="odd">
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
<td></td>
</tr>
<tr class="even">
<td><p>IOP &gt;25 mm Hg</p>
<p>Secondary Surgical Intervention other than CK treatment</p></td>
<td><p>0%</p>
<p>0%</p></td>
<td></td>
<td><p>0%</p>
<p>0%</p></td>
<td></td>
<td><p>1%</p>
<p>0%</p></td>
<td></td>
<td><p>&lt;1%</p>
<p>0%</p></td>
<td></td>
<td><p>&lt;1%</p>
<p>&lt;1%</p></td>
</tr>
<tr class="odd">
<td>Other</td>
<td>1%</td>
<td></td>
<td>1%</td>
<td></td>
<td>&lt;1%</td>
<td></td>
<td>1%</td>
<td></td>
<td>1%</td>
</tr>
</tbody>
</table>

> In clinical studies of the ViewPoint CK System, the following
> complication was reported on the day of surgery with a reported rate
> of \<1%:

-   Corneal scratch

> The following adverse events were reported on the day of surgery at a
> rate of \<1%:

-   Corneal perforation

-   Procedure could not be performed and had to be rescheduled due to
    technical difficulties with the CK^SM^ device

> Each of the following complications was reported at the one week visit
> at a rate of less than 1%:

-   Blurred vision

-   Conjunctivitis

-   Double vision

-   Stye

> The following adverse reaction was reported at one week at a rate of
> less than 1%:

-   Mild iritis

> During the first week following surgery patients may experience: pain,
> discomfort, a feeling of something in the eye lasting from one up to
> three days after surgery, mild light sensitivity, and swelling of the
> cornea.
>
> Table 16 presents a summary of the complications reported in the
> clinical study.

Table 16

Complication Summary

All Eyes Treated

  ----------------- --------- ----------- ----------- ----------- -----------
                    **Month   **Month 3** **Month 6** **Month 9** **Month
                    1**                                           12**

                                                                  

  Recurrent corneal 0%        1%          0%          0%          0%
  erosion at one                                                  
  month or later                                                  

  Double/ghost      1%        1%          2%          1%          1%
  images in the                                                   
  operative eye                                                   

  Foreign body      0%        0%          0%          \<1%        0%
  sensation at one                                                
  month or later                                                  

  Pain at one month 0%        1%          0%          0%          0%
  or later                                                        

  Other             2%        3%          2%          1%          1%
  ----------------- --------- ----------- ----------- ----------- -----------

The following complications were not reported in the clinical study, but
could potentially occur following CK^SM^ procedure: peripheral corneal
epithelial defect; corneal edema.

Table 17 below shows the absolute change in refractive cylinder for all
eyes treated.

Table 17

Absolute Change in Refractive Cylinder

All Eyes Treated

  ----------------- ---------- ---------- ---------- ---------- -----------
  **Astigmatism**   **Month    **Month    **Month    **Month    **Month
                    1**        3**        6**        9**        12**

                                                                

  Increase \> 2.00  3%         2%         1%         \<1%       \<1%
  D                                                             

  Increase \> 1.00  21%        15%        14%        7%         6%
  D                                                             
  ----------------- ---------- ---------- ---------- ---------- -----------

Table 18 presents a comparison of eyes with \> 1.00 D induced cylinder
and eyes with ≤ 1.00 D induced cylinder.

Table 18

**Comparison of Eyes with \> 1.00 D Induced Cylinder**

**and Eyes with ≤ 1.00 D Induced Cylinder**

**All Eyes Treated**

  --------------------- -------------- --------- -------------- --------- -------------- --------- ------------- ---------
                        **≤ 1.00 D                                        **\> 1.00 D                            
                        Induced                                           Induced                                
                        Cylinder**                                        Cylinder**                             

                        **Month 9**              **Month 12**             **Month 9**              **Month 12**  

                                                                                                                 

  Loss of ≥ 2 lines                        4%                       3%                       4%                      0%
  BSCVA                                                                                                          

  No Change (± 1 line)                   93%                      94%                      96%                     96%

  Increase of ≥ 2 lines                    3%                       4%                       0%                      5%
  BSCVA                                                                                                          

                                                                                                                 

  UCVA 20/20 or better                   52%                      57%                        9%                    35%

  UCVA 20/25 or better                   75%                      76%                      43%                     47%

  UCVA 20/40 or better                   93%                      94%                      83%                     71%

                                                                                                                 

  UCVA                                                                                                           

  N                     327                      327                      23                       17            

  Mean                  26.22                    25.75                    40.13                    34.41         

  95% Confidence        24.81,27.63              24.30,27.20              25.23,55.03              25.83,42.99   
  Interval                                                                                                       

  Standard Deviation    13.034                   13.460                   36.462                   18.056        

  Median                20.00                    20.00                    32.00                    30.00         

  Range                 12.50,100.00             12.50,100.00             20.00,200.00             16.00,80.00   
  --------------------- -------------- --------- -------------- --------- -------------- --------- ------------- ---------

Table 19 below shows the absolute shift in cylinder axis.

Table 19

**Absolute Shift in Axis**

All Eyes Treated

  ---------------- ---------------- ------------------ -------------------
  **Induced        **Month 6**      **Month 9**        **Month 12**
  Shift**                                              

                                                       

  0° to 15°        34%              37%                39%

  16° to 30°       19%              16%                16%

  31° to 45°       11%              10%                9%

  46° to 60°       11%              12%                10%

  61° to 75°       12%              12%                15%

  76° to 90°       15%              14%                10%
  ---------------- ---------------- ------------------ -------------------

Table 20 presents change in best spectacle visual acuity for all eyes
treated.

Table 20

**Change in Best Spectacle Corrected Visual Acuity**

**All Eyes Treated**

  ------------------ ---------- ---------- ---------- ---------- ----------
                     **Month    **Month    **Month    **Month    **Month
                     1**        3**        6**        9**        12**

                                                                 

  Decrease \> 2      2%         1%         1%         1%         0%
  lines                                                          

  Decrease 2 lines   6%         5%         4%         3%         2%

  Decrease 1 line    29%        27%        27%        22%        22%

                                                                 

  No Change          48%        51%        51%        54%        54%

                                                                 

  Increase 1 line    12%        13%        16%        18%        18%

  Increase 2 lines   2%         3%         1%         2%         4%

  Increase \> 2      0%         0%         1%         0%         0%
  lines                                                          
  ------------------ ---------- ---------- ---------- ---------- ----------

NOTE: At 6 months, 5% (18/387) of eyes reported greater than or equal to
2 lines loss of BSCVA. Of these 18 eyes, 39% (7/18) reported a BSCVA of
20/20 and 78% (14/18) had a BSCVA of 20/25 or better. All but one eye
(17/18) had 20/32 or better with no eye worse than 20/40. In regards to
patient satisfaction specifically for these 18 eyes, half (9/18)
reported being "Satisfied" or "Very Satisfied" while 28% or 5 eyes
reported being "Dissatisfied" or "Very Dissatisfied".

Subjects were asked to complete a questionnaire that allowed them to
report any symptoms or complaints they had regarding their vision or
ocular comfort following the procedure. Results for the subjective
responses to these questionnaires at 6, 9, and 12 months post treatment
are provided in Table 21.

Table 21

Subject Symptoms

All Eyes Treated

+---------------+---------+---------+---------+---------+-----------+---+
|               | *       | *       | **Mod   | **M     | **Very    |   |
|               | *None** | *Mild** | erate** | arked** | Severe**  |   |
+---------------+---------+---------+---------+---------+-----------+---+
| **Light       |         |         |         |         |           |   |
| Sensitivity** |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Preop         | 69%     | 17%     | 9%      | 4%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 52%     | 33%     | 11%     | 3%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 57%     | 28%     | 12%     | 3%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 54%     | 31%     | 10%     | 3%      | 1%        |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 6       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 9       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 12      |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| **Headaches** |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Preop         | 84%     | 12%     | 2%      | 1%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 84%     | 10%     | 4%      | 1%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 84%     | 9%      | 4%      | 1%      | 2%        |   |
|               |         |         |         |         |           |   |
|               | 85%     | 10%     | 4%      | 1%      | 1%        |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 6       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 9       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 12      |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| **Pain**      |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Preop         | 95%     | 4%      | 1%      | 0%      | 0%        |   |
|               |         |         |         |         |           |   |
|               | 91%     | 7%      | 1%      | 1%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 92%     | 6%      | 1%      | 0%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 96%     | 3%      | 0%      | 1%      | 1%        |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 6       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 9       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 12      |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| **Redness**   |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Preop         | 83%     | 13%     | 3%      | \<1%    | 1%        |   |
|               |         |         |         |         |           |   |
|               | 81%     | 13%     | 4%      | 1%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 77%     | 15%     | 6%      | 2%      | 1%        |   |
|               |         |         |         |         |           |   |
|               | 83%     | 13%     | 3%      | 1%      | \<1%      |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 6       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 9       |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+
| Month 12      |         |         |         |         |           |   |
+---------------+---------+---------+---------+---------+-----------+---+

+--------------+---------+---------+---------+---------+------------+---+
| **Dryness**  |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Preop        | 77%     | 15%     | 8%      | 1%      | 0%         |   |
|              |         |         |         |         |            |   |
|              | 58%     | 28%     | 8%      | 6%      | 1%         |   |
|              |         |         |         |         |            |   |
|              | 60%     | 27%     | 8%      | 5%      | 1%         |   |
|              |         |         |         |         |            |   |
|              | 61%     | 27%     | 7%      | 4%      | 1%         |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 6      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 9      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 12     |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| **Excessive  |         |         |         |         |            |   |
| Tearing**    |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Preop        | 87%     | 6%      | 4%      | 2%      | 1%         |   |
|              |         |         |         |         |            |   |
|              | 85%     | 9%      | 3%      | 2%      | 1%         |   |
|              |         |         |         |         |            |   |
|              | 83%     | 11%     | 3%      | 1%      | 2%         |   |
|              |         |         |         |         |            |   |
|              | 89%     | 6%      | 3%      | 1%      | 1%         |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 6      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 9      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 12     |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| **Burning**  |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Preop        | 88%     | 9%      | 2%      | 1%      | \<1%       |   |
|              |         |         |         |         |            |   |
|              | 83%     | 12%     | 3%      | 2%      | \<1%       |   |
|              |         |         |         |         |            |   |
|              | 82%     | 11%     | 5%      | 2%      | \<1%       |   |
|              |         |         |         |         |            |   |
|              | 85%     | 12%     | 2%      | 1%      | 0%         |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 6      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 9      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 12     |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| **Gritty,    |         |         |         |         |            |   |
| Scratchy, or |         |         |         |         |            |   |
| Sandy        |         |         |         |         |            |   |
| Feeling**    |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Preop        | 83%     | 14%     | 2%      | 0%      | 0%         |   |
|              |         |         |         |         |            |   |
|              | 79%     | 13%     | 4%      | 3%      | 0%         |   |
|              |         |         |         |         |            |   |
|              | 82%     | 14%     | 3%      | 1%      | 1%         |   |
|              |         |         |         |         |            |   |
|              | 81%     | 14%     | 4%      | 0%      | 1%         |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 6      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 9      |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+
| Month 12     |         |         |         |         |            |   |
+--------------+---------+---------+---------+---------+------------+---+

Table 21

Subject Symptoms

All Eyes Treated

(Continued)

+--------------+---------+---------+--------+---------+------------+---+
|              | *       | *       | **Mode | **M     | **Very     |   |
|              | *None** | *Mild** | rate** | arked** | Severe**   |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Glare**    |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 74%     | 18%     | 6%     | 1%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 56%     | 28%     | 11%    | 5%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 58%     | 28%     | 8%     | 4%      | 2%         |   |
|              |         |         |        |         |            |   |
|              | 60%     | 25%     | 11%    | 2%      | 2%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Halos**    |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 90%     | 7%      | 2%     | 2%      | \<1%       |   |
|              |         |         |        |         |            |   |
|              | 63%     | 21%     | 8%     | 5%      | 2%         |   |
|              |         |         |        |         |            |   |
|              | 66%     | 21%     | 9%     | 2%      | 2%         |   |
|              |         |         |        |         |            |   |
|              | 65%     | 21%     | 8%     | 3%      | 2%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Blurred    |         |         |        |         |            |   |
| Vision**     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 67%     | 13%     | 11%    | 7%      | 2%         |   |
|              |         |         |        |         |            |   |
|              | 52%     | 28%     | 12%    | 6%      | 3%         |   |
|              |         |         |        |         |            |   |
|              | 59%     | 22%     | 12%    | 5%      | 2%         |   |
|              |         |         |        |         |            |   |
|              | 63%     | 22%     | 10%    | 4%      | 1%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Double     |         |         |        |         |            |   |
| Vision**     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 90%     | 5%      | 5%     | 1%      | 0%         |   |
|              |         |         |        |         |            |   |
|              | 67%     | 17%     | 8%     | 6%      | 3%         |   |
|              |         |         |        |         |            |   |
|              | 74%     | 13%     | 7%     | 4%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 77%     | 14%     | 5%     | 3%      | 1%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+

+--------------+---------+---------+--------+---------+------------+---+
| *            |         |         |        |         |            |   |
| *Fluctuation |         |         |        |         |            |   |
| of Vision**  |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 84%     | 12%     | 3%     | 1%      | 0%         |   |
|              |         |         |        |         |            |   |
|              | 54%     | 29%     | 8%     | 7%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 60%     | 25%     | 7%     | 5%      | 3%         |   |
|              |         |         |        |         |            |   |
|              | 60%     | 28%     | 7%     | 4%      | 1%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Variation  |         |         |        |         |            |   |
| in Vision in |         |         |        |         |            |   |
| Bright       |         |         |        |         |            |   |
| Light**      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 74%     | 16%     | 8%     | 2%      | \<1%       |   |
|              |         |         |        |         |            |   |
|              | 55%     | 30%     | 10%    | 3%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 62%     | 24%     | 8%     | 5%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 58%     | 28%     | 9%     | 4%      | 1%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Variation  |         |         |        |         |            |   |
| in Vision in |         |         |        |         |            |   |
| Normal       |         |         |        |         |            |   |
| Light**      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 85%     | 11%     | 4%     | \<1%    | \<1%       |   |
|              |         |         |        |         |            |   |
|              | 70%     | 19%     | 9%     | 1%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 71%     | 17%     | 8%     | 3%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 70%     | 22%     | 6%     | 2%      | 1%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| **Variation  |         |         |        |         |            |   |
| in Vision in |         |         |        |         |            |   |
| Dim Light**  |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Preop        | 75%     | 14%     | 8%     | 1%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 54%     | 26%     | 13%    | 5%      | 1%         |   |
|              |         |         |        |         |            |   |
|              | 60%     | 19%     | 12%    | 5%      | 3%         |   |
|              |         |         |        |         |            |   |
|              | 57%     | 25%     | 11%    | 4%      | 3%         |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 6      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 9      |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+
| Month 12     |         |         |        |         |            |   |
+--------------+---------+---------+--------+---------+------------+---+

Table 21

Subject Symptoms

All Eyes Treated

(Continued)

+--------------+---------+---------+---------+---------+------------+---+---+
|              | *       | *       | **Mod   | **M     | **Very     |   |   |
|              | *None** | *Mild** | erate** | arked** | Severe**   |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| **Night      |         |         |         |         |            |   |   |
| Driving      |         |         |         |         |            |   |   |
| Vision       |         |         |         |         |            |   |   |
| Problems**   |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Preop        | 64%     | 19%     | 12%     | 2%      | 2%         |   |   |
|              |         |         |         |         |            |   |   |
|              | 55%     | 24%     | 12%     | 6%      | 4%         |   |   |
|              |         |         |         |         |            |   |   |
|              | 59%     | 23%     | 7%      | 6%      | 4%         |   |   |
|              |         |         |         |         |            |   |   |
|              | 60%     | 24%     | 7%      | 5%      | 4%         |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Month 6      |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Month 9      |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Month 12     |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| **Other      |         |         |         |         |            |   |   |
| Symptoms**   |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Preop        | 96%     | 1%      | 2%      | 1%      | 0%         |   |   |
|              |         |         |         |         |            |   |   |
|              | 96%     | 2%      | 1%      | \<1%    | 1%         |   |   |
|              |         |         |         |         |            |   |   |
|              | 97%     | 2%      | 1%      | 0%      | \<1%       |   |   |
|              |         |         |         |         |            |   |   |
|              | 96%     | 1%      | 1%      | 1%      | \<1%       |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Month 6      |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Month 9      |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+
| Month 12     |         |         |         |         |            |   |   |
+--------------+---------+---------+---------+---------+------------+---+---+

> NOTE: At the 12 month interval, ≥ 5% of patients reported a
> postoperative increase in moderate to marked ratings for the following
> symptoms: glare, halos, fluctuation of vision, and variation in vision
> in dim light. There was no significant increase (≥ 5%) in symptoms
> with very severe rating.

# CONCLUSIONS DRAWN FROM THE STUDIES

The data in this application support reasonable assurance of the safety
and efficacy of this device when used in accordance with the indications
for use.

# PANEL RECOMMENDATION

> On November 20, 2001, the Ophthalmic Devices Advisory Panel
> recommended that the premarket approval application for the Refracec
> ViewPoint CK[^SM^]{.smallcaps} System for the treatment of hyperopia
> be considered approvable with conditions. The conditions recommended
> by the panel were to:

1.  Revise the indications for use statement as follows:

-   Conductive keratoplasty treatment is for the temporary reduction of
    spherical hyperopia in the range of:

> +0.75 to +3.25 Diopters (D) of cycloplegic spherical hyperopia
>
> -0.75 D or less of refractive astigmatism
>
> +0.75 to +3.00 D cycloplegic spherical equivalent

-   In patients with ≤ 0.50 D difference between preoperative manifest
    and cycloplegic refractions.

-   In patients 40 years of age or older.

2.  Revise the labeling.

3.  Continue the clinical study out to 24 months and submit the data to
    FDA for review as a post market study.

# CDRH DECISION

> Following the panel meeting on November 30, 2001, FDA did not issue a
> deficiency letter to Refractec, Inc., but worked interactively with
> Refractec regarding the remaining issues. Generally, FDA agreed with
> the Panel\'s recommendations, and Refractec agreed to continue
> follow-up of subjects in their clinical study per the protocol out to
> the 24-month examination. Refractec submitted responses that
> adequately addressed all of FDA\'s concerns and labeling changes.
>
> The applicant's manufacturing facilities were inspected and found to
> be in compliance with the Quality Systems Regulation (21 CFR 820).
> CDRH issued an approval order on April 11, 2002.
>
> .

# APPROVAL SPECIFICATIONS

-   Postapproval Requirements and Restrictions: see Approval Order.

-   Hazards to Health from Use of the Device: see Indications,
    Contraindications, Warnings, Precautions, and Adverse Events in the
    labeling.

-   Directions for Use: see labeling.