Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study
Phase: NA
Conditions: Intraocular Pressure and PROSE Lens
Sponsor: Boston Sight

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study 
 
SPONSOR: 
 
  
N/A 
 
PRINCIPAL INVESTIGATOR: 
Daniel Brocks, MD 
464 Hillside Avenue, Suite 205 
Needham, MA 02494 
(781) 726-7337  
dbrocks@bostonsight.org 
 
 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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Table of Contents 
1.0 
Objectives ............................................................................................................................ 3 
2.0 
Background .......................................................................................................................... 3 
3.0 
Inclusion and Exclusion Criteria .......................................................................................... 4 
4.0 
Vulnerable Populations ........................................................................................................ 5 
5.0 
Number of Subjects.............................................................................................................. 5 
6.0 
Recruitment Methods ........................................................................................................... 5 
7.0 
Multi-Site Research Communication – N/A ........................................................................ 5 
8.0 
Study Timelines ................................................................................................................... 6 
9.0 
Study Endpoints ................................................................................................................... 6 
10.0 Procedures Involved............................................................................................................. 7 
11.0 Setting .................................................................................................................................. 9 
12.0 Drugs or Devices.................................................................................................................. 9 
13.0 Risks to Subjects .................................................................................................................. 9 
14.0 Potential Benefits to Subjects .............................................................................................. 9 
15.0 Withdrawal of Subjects ........................................................................................................ 9 
16.0 Costs/Payments to Subjects ............................................................................................... 10 
17.0 Compensation for Research-Related Injury ....................................................................... 10 
18.0 Confidentiality ................................................................................................................... 10 
19.0 Provisions to Protect the Privacy Interests of Subjects ...................................................... 10 
20.0 Informed Consent Process ................................................................................................. 11 
21.0 Process to Document Consent in Writing .......................................................................... 11 
22.0 HIPAA ............................................................................................................................... 11 
23.0 Data Management .............................................................................................................. 11 
24.0 Specimen Use and Banking – N/A .................................................................................... 11 
25.0 Sharing of Results with Subjects ....................................................................................... 12 
26.0 Resources ........................................................................................................................... 12 
27.0    Citations…………………………………………………………………………………..12 
 
 
 
 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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1.0 
Objectives 
The goal of this pilot study is to determine the precision and accuracy of measurements of 
intraocular pressure (IOP) when a PROSE (Prosthetic Replacement of the Ocular Surface 
Ecosystem) scleral lens is on the eye.  
 
The PROSE device (PD) is a specialized scleral lens that is filled with preservative-free saline 
and then applied to the eye in order to treat a variety of ocular conditions. The PROSE device 
vaults the cornea without touch and lands gently on the conjunctival tissue overlying the sclera. 
Because scleral lenses vault and therefore cover the cornea, measuring IOP during lens wear is 
challenging as traditional techniques rely on corneal contact. Measuring IOP before insertion and 
after removal of the PROSE device likely does not correspond to the IOP when the lens is 
actively on the eye. 
 
This is a prospective study of the precision and accuracy of tonometry measurements with scleral 
lens wear. Three non-traditional means of IOP measurements will be used: scleral TonoPen, 
scleral pneumatonometry, and transpalpebral Diaton tonometer. Data on precision and accuracy 
of these instruments in this pilot study aims to guide decision making in a full study on the 
effects of scleral lenses on IOP. 
 
2.0 
Background 
The PROSE device is a refractive treatment for individuals with pathologies that require a rigid 
lens to mask irregularities on the front refracting surface of their eye (the cornea). PROSE is also 
used in cases of ocular surface disease to protect and support the ocular surface in an effort to 
reduce dryness, prevent ocular surface breakdown, ulceration, and perforation. The PROSE 
device is similar to a scleral lens in theory though it allows for unique customizations that are 
unavailable in currently marketed scleral lens designs, including fenestrations and channels (air 
and fluid ventilation, respectively). 
 
Recent literature has suggested that intraocular pressure may rise during scleral lens wear, 
although variability exists in methods and results within the literature.1-3 Possible causes include 
negative pressure and suction created underneath the lens during settling or due to the pressure 
applied by the lens on the structures involved in aqueous outflow, namely the trabecular 
meshwork and the episcleral veins.1-3 The challenge in elucidating this concept is that the scleral 
lens and its relationship to the cornea is a closed environment that is difficult to study.  
 
Traditional measurements of intraocular pressure rely on corneal contact. Methods of IOP 
measurement that do not rely on corneal contact  instead use either scleral contact (i.e. scleral 
pneumatonometry and scleral TonoPen) or contact with the eye through the eyelid 
(transpalpebral Diaton). This study will use these three methods due to the fact that they are the 
only options currently available to measure IOP without corneal contact, which is a requirement 
for  IOP measurement during scleral lens wear.  
 
An important consideration when using these instruments is that measurements taken over the 
extraocular muscles may give inaccurate results. Literature suggests that superotemporal and 
inferotemporal measurements using the pneumatonometer provide the most accurate and 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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comparable results to a direct corneal measurement perhaps due to the avoidance of 
measurement over the extraocular muscles. 4 Scleral pneumatonometry IOP measurements can 
potentially be used to estimate corneal IOP using a published equation posited by Kuo et al.5 
 
3.0 
Inclusion and Exclusion Criteria 
The participant will be eligible to participate if the following criteria apply:  
1. Written Informed Consent has been obtained prior to any study-related procedures 
taking place 
2. Written documentation has been obtained in accordance with the relevant county and 
local privacy requirements, where applicable  
3. Male or female, 18 years of age and older prior to the initial visit  
4. Has a current diagnosis of corneal ectasia, i.e. keratoconus, pellucid margin 
degeneration 
5. Is an established wearer of PROSE in both eyes; without fenestrations or channels; with 
diameter equal to or greater than 18.0 mm 
6. Upon examination by the investigator, there is adequate exposure of the sclera as 
required for IOP measurements with the planned device 
7. In the opinion of the investigator, the subject has the ability to follow study instructions  
8. In the opinion of the investigator, the subject has the ability to complete all study 
procedures and visits  
 
The participant would not be eligible to participate if at least one of the following criteria is met: 
1. Is aphakic (i.e., missing their natural lens inside the eye)  
2. Is currently participating in any other type of eye-related clinical or research study  
3. Is pregnant or nursing as reported by the subject 
4. Less than 18 years of age 
5. Has a condition or is in a situation which, in the investigator’s opinion, may put the 
subject at significant risk, may confound study outcomes, or may significantly interfere 
with the subject’s participation in the study 
6. Has had previous ocular surgery within the past 12 weeks 
7. Has a diagnosis of glaucoma, glaucoma suspect, ocular hypertension or prior glaucoma 
surgery 
 
 
The following special populations will be excluded from this study: 
• 
Adults unable to consent (including adults unable to read and 
understand English) 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women  
• 
Prisoners 
• 
Employees of BostonSight 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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4.0 
Vulnerable Populations 
The following special populations will be excluded from this study: 
• 
Adults unable to consent (including adults unable to read and 
understand English) 
• 
Individuals who are not yet adults (infants, children, teenagers) 
• 
Pregnant women  
• 
Prisoners 
• 
Employees of BostonSight 
5.0 
Number of Subjects 
A minimum of 30 subjects will be enrolled in this study with 10 subjects in each of the three 
cohorts. This is a low risk study. We can expect an approximate 10% drop-out rate, so we will 
expect to recruit approximately 33 subjects; and the first 30 to be eligible and complete the study 
will be used for data analysis.  
 
The first 10 subjects that are eligible to proceed and consented will be consecutively enrolled in 
the  first cohort (scleral TonoPen). The second 10 subjects  that are eligible to proceed and 
consented will be consecutively enrolled in the second cohort (scleral pneumatonometry). The 
third 10 subjects  that are eligible to proceed and consented will be consecutively enrolled in the 
third cohort (Diaton). Sequential assignment allows for focus on one instrument and one 
technique at a time by one investigator. 
 
6.0 
Recruitment Methods 
Recruitment will begin once IRB approval has been received and will occur through 
BostonSight. The subject pool will consist of patients who are actively coming through the 
clinic. We anticipate that all our subjects will be from the current patient population at 
BostonSight. Patients will be recruited via mailing and/or email and at office visits. If a patient is 
interested in participating in the study, they will be directed to the principal investigator or the 
study coordinator who will go over the study and ask the screening questions. If they are eligible 
based on the screening criteria, they will be invited for participation in the study. If the person 
calls to learn about the study, the investigator or coordinator will use the outline to determine 
initial eligibility. Current patients of BostonSight may also be recruited as a result of a search of 
the patient database. A partial HIPAA waiver is requested to permit the investigators to use the 
database to identify prospective patients. 
 
7.0 
Multi-Site Research Communication – N/A  
 
8.0 
Study Timelines 
The total duration of the subjects’ participation in the study will be approximately 1 visit.  
It is anticipated that to enroll all study subjects, it will take approximately 6 months.  

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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The estimated date for completion of this study is 12 months after the start of recruitment.  
 
The study visit will contain: 
a. Completion of informed consent 
b. Collection of baseline data of the eye 
i. Corneal and conjunctival staining, Oxford grading 
ii. Corneal IOP measurement via TonoPen 
c. Collection of baseline data on the PROSE device fit 
d. IOP measurement with lenses in place via one of three methods: 
i. Scleral TonoPen 
ii. Scleral pneumatonometry 
iii. Diaton 
 
The study visit will take approximately 65 minutes in total. All assessment performed will 
be for research purposes and not part of the subjects standard clinical care. 
 
9.0 
Study Endpoints 
The study design allows for the subjects to serve as their own control. The subjects’ 
baseline IOP will be measured with the standard clinical approach via corneal TonoPen. 
Corneal TonoPen was chosen as the control method for intraocular pressure 
measurements as it is a standard of care method and process used every day in clinical 
practice by ophthalmologists and optometrists. This will be compared to the IOP 
measurement obtained in the same subject with lenses in place. 
 
The primary endpoints in this study are as follows: 
1. Intraocular pressure  
a. TonoPen, corneal without lens 
i. Baseline, one measurement 
b. TonoPen, scleral with lens 
i. IOP and confidence level will be recorded 
ii. Attempt 5 measurements maximum  
• Goal of achieving 3 measurements in total with confidence level of 
90% of higher  
iii. One measurement defined as a completed result or attempting to 
measure until the machine times out 
c. Pneumatonometer, scleral with lens 
i. Measurement in “manual IOP mode” 
ii. IOP and standard deviation (SD) will be recorded for each measurement 
iii. Attempt 10 measurements maximum 
• Goal of achieving 3 measurements in total with a SD of 2 mmHg or 
less 
iv. One measurement defined as a completed result or attempting to 
measure until the machines times out 
d. Diaton, transpalpebral with lens  

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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i. Up to 6 individual attempts are included in each complete measurement, 
with the instrument averaging the measurements for a result  
ii. Reliable average is confirmed:  
 
• When the instrument shows symbol <<A>> and the mean IOP value 
is non-flickering 
• When the instrument shows symbol <<A>> and the mean IOP value 
is flickering with a result of equal or less than 19 mmHg 
iii. Attempt 5 complete measurements maximum  
• Goal of achieving 3 reliable measurements 
• Reliability defined (per manufacturer Diaton, Ryazan State 
Instrument-Making Enterprise, www.diaton-tonometer.com) as: 
a. +/- 2mmHg error in range 5-20mmHg 
b. +/- 10% error in range 20-60mmHg 
 
Correct calibration of each instrument will be ensured prior to the study per individual 
manufacturer’s standards. The first measurement of every subject will not be included but 
will serve as one practice measurement to familiarize the subject with the measurement 
process. 
 
10.0 Procedures Involved 
Once a subject has been identified, the initial visit will be scheduled.  
 
During the visit: 
1. Informed consent will be completed  
2. Record the patient’s general medical history and habitual contact lens information, 
including lens design, power, and diameter. 
3. An investigator will conduct visual acuity assessments of both eyes (Snellen).  
4. Assess the fit of the PROSE device via slit lamp assessment of both eyes. 
5. Assess the cornea and conjunctiva of both eyes with the PROSE device on and off. 
6. Measure corneal intraocular pressure of both eyes after PROSE device removal  
7. The investigator will instill one drop of topical anesthetic in both eyes followed by a 
lubricating preservative-free artificial tear drop, such as Refresh Plus, prior to IOP 
measurements. 
8. Measure intraocular pressure of both eyes with the PD on via (method depends on which 
cohort the subject is in): 
a. Scleral TonoPen 
b. Scleral pneumatonometry  
c. Transpalpebral Diaton 
9. Reassess the ocular surface of both eyes after intraocular pressure measurement at the 
slit lamp biomicroscope with and without fluorescein staining in order to rule out 
adverse events, such as conjunctival abrasion or erosion or other irritations. 
 
Procedure 
Length of Time 
Required for 
Frequency of Repetition 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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Informed consent & HIPAA 
20 minutes 
Once 
General History and 
Medications 
10 minutes 
Once  
Visual Acuity 
2 minutes 
Once  
Slit-lamp Examination 
(with PD) 
4 minutes 
Once  
Corneal IOP Measurement 
(TonoPen) 
5 minutes 
Once 
IOP Measurement 
(One of the below 
will be completed) 
 
 
COHORT 1: 
Scleral TonoPen 
 
 
 
20 minutes 
5 
(maximum) 
COHORT 2:  
Scleral Pneumatonometer 
10  
(maximum) 
COHORT 3:  
Transpalpebral Diaton  
5  
(maximum) 
Slit-lamp Examination after 
measurement 
4 minutes 
Once 
TOTAL TIME 
65 minutes 
 
The testing descriptions are summarized in the table below: 
 
Test 
Description 
General History 
and Medications 
Participants will be asked questions about their general, ocular and 
medication use histories along with contact lens use history if 
applicable.  
Lens Evaluation 
The PROSE device fit and vision will be evaluated.  
Visual Acuity 
The participant’s vision in each eye while wearing lenses will be 
measured with a high contrast visual acuity chart. The participant will 
be asked to cover one eye and read the chart, and this procedure will 
be repeated for the other eye.   
Slit-lamp 
Examination 
The participant’s front portion of each eye and contact lenses will be 
examined with a lighted microscope. The participant will be asked to 
place his/her chin on the chinrest and place his/her forehead against 
the bar and look straight ahead. The instrument’s light will be shined 
onto the eye to visualize the ocular surface for approximately 4 
minutes per eye. Photographs will be taken at the discretion of the 
investigator.  

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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Sodium Fluorescein 
Sodium fluorescein staining will be used to evaluate ocular surface 
damage indicated by cell damage or death. Corneal and conjunctival 
staining will be scored using the Oxford grading scale. 
Diaton tonometry 
The Diaton device will be placed on the superior lid as the participant 
looks down to measure the intraocular pressure transpalpebrally. 
Pneumatonometry 
One drop of topical anesthetic (Proparacaine) will be instilled into 
each eye. The pneumatonometer will be placed on the superotemporal 
sclera and overlying conjunctival tissue as the participant looks down 
and in to measure the intraocular pressure. 
Scleral TonoPen 
One drop of topical anesthetic (Proparacaine) will be instilled into 
each eye. The participant will look down and in as the TonoPen probe 
lightly contacts the superior temporal sclera and overlying 
conjunctival tissue. 
Corneal TonoPen 
One drop of topical anesthetic (Proparacaine) will be instilled into 
each eye. The participant will look straight ahead and a probe will 
lightly contact the cornea to measure the intraocular pressure. 
      Table 3. Descriptions of tests 
 
 
The following data will be collected in this study: 
• 
Intraocular pressure via several different methods 
o Corneal TonoPen 
o Scleral TonoPen 
o Scleral pneumatonometry 
o Transpalpebral Diaton 
11.0 Setting 
Subjects will be asked to complete the study visits, which will be conducted in clinical facilities 
at BostonSight. 
 
12.0 Drugs or Devices 
The PROSE device is considered a class II medical device by the FDA. All rigid lens materials 
are FDA approved for use in a rigid contact lens, and they are not investigative devices.  
 
All devices included in the study are standard of care, are intended to be used to measure 
intraocular pressure in clinical practice, and are FDA approved to do so. The Diaton was created 
to allow IOP measurement without contact with the ocular structures as the instrument touches 
only the outer part of the upper eyelid. The TonoPen and the pneumatonometer are typically used 
on the cornea but include an option of scleral measurement when corneal pathology or post-
surgical conditions contraindicate corneal contact. There is literature supporting use of the 
pneumatonometer on the sclera for IOP measurement.4-8 Literature supporting use of the 
TonoPen on the sclera for IOP measurement is also available.4,9 
 
13.0 Risks to Subjects 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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This study presents a minimal risk to subjects. Risk with PROSE devices are those that are 
already associated with wearing any form of contact lens. All contact lens wearers are at risk for 
developing an abrasion (‘cut’ on the eye) during lens application or removal as well as 
inflammatory and/or infectious complications during lens wear, but there is no added risk by 
participating in this study. Measurement of IOP via conjunctival/scleral contact does introduce 
the risk of conjunctival abrasions, irritation, redness, or discomfort.  
 
If a subject experiences an adverse event during the duration of the study, they will be instructed 
to call the study coordinator who will communicate with the investigators to determine the best 
course of action. If the subject needs to be seen due to an adverse event, a study investigator will 
examine them and the customary procedure for management will be followed.  
 
If an adverse event such as an abrasion occurs during a study visit, the condition will be treated 
as it is customarily, and the fees associated with treatment will be covered by the study. 
Additionally the subjects are encouraged to call immediately if experiencing any pain or other 
discomfort  after the exam, which may be an indicator of irritation following intraocular pressure 
measurements. 
 
In a review of current literature, no reported adverse events or serious adverse events were found 
ifor each specific manner of IOP measurement with the instruments to be used in this study 
(scleral TonoPen, scleral pneumatonometry, Diaton). No documented adverse events for these 
instruments were found in literature at the time of submission.  
 
If, in the unlikely event, during the study a patient experiences any serious adverse event, they 
will be removed from the study and the IRB will be notified.  
 
14.0 Potential Benefits to Subjects 
There may be no benefit to the subject for participation in this study.  
 
15.0 Withdrawal of Subjects 
Subjects will be withdrawn from the study if they are unable to complete the tasks in the study 
protocol. In addition, if they experience an adverse event in which the investigator does not feel 
that the subjects should continue, they will be withdrawn.  
 
The data from a subject that withdraws or is terminated from the study will not be included in the 
analysis.  
 
16.0 Costs/Payments to Subjects 
The only cost that the subjects may be responsible for in this study is the cost of transportation to 
and from the appointments.  
 
Compensation will be given in $20 gift card. 
 
17.0 Compensation for Research-Related Injury  

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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If there is an ocular injury in this study directly related to the use of the lenses or during IOP 
measurement, treatment for the injury and any subsequent referrals will be covered by the study. 
The subject will not receive any direct compensation. If there is an unrelated or non-ocular injury 
during a subject’s enrollment in the study, it will not be covered by the study.  
 
18.0 Confidentiality 
The subject ID worksheet, informed consent, subject surveys, and examiner worksheets will all 
be kept in a single binder, locked in the office of the principal investigator. The informed consent 
forms and the subject ID worksheet will be kept in a separate binder from the study data.   
At the start of participation in the study, the subject will be assigned a non-identifiable subject ID 
that will be used for identification on all other documents used in the study. This identification 
document, which will be the only document that decodes the subject, will be kept in a locked 
filing bin in a locked room within BostonSight, separate from the informed consent and other 
study documents. Names, email addresses, and telephone numbers will be recorded in this 
subject ID worksheet, which will be a paper file kept in the locked office of the principal 
investigator.  
 
All other exam findings will be recorded on the paper forms and stored in a binder. This binder 
will be kept locked in the principal investigator's office when not being used to add or remove 
data collection worksheets. 
 
Only the investigators will have access to the paper and electronic records kept in this study. 
 
All study data will be stored for a minimum of 3 years following study completion. The link will 
be maintained to allow pertinent regulatory or government agencies to inspect the data and 
ensure that subjects participated in the study. The principal investigator will be responsible for 
maintaining study data security and subject confidentiality. 
 
19.0 Provisions to Protect the Privacy Interests of Subjects 
We will ensure that all data is maintained with confidentiality and will assure subjects of this 
when they begin the study. If subjects are not comfortable with disclosing any of the information 
that is asked in the study, they will not be pressured to disclose, but they may not be able to 
participate if the withholding prevents us from screening or determining eligibility in the study. 
All PHI (DOB, name, health information) will be stored in the locked office of the Principal 
Investigator.  
 
Subjects will only be asked questions that are relevant to the study and their ocular health.  The 
investigators, who are all optometrists that regularly see patients and communicate about 
potentially sensitive information, have been trained to develop proper rapport with patients and 
study subjects. All investigators will make every effort to avoid seeming intrusive when asking 
the subjects questions.  
 
20.0 Informed Consent Process 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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Informed consent will be obtained before any testing is done. The subject will be provided an 
informed consent document written in non-technical language. The study staff will review the 
document with the subject and will give the subject adequate time to review the form and ask 
any questions before deciding whether to participate. After answering any questions, if the study 
staff believes the subject comprehends the elements of the informed consent document, the study 
staff will invite the subject to participate in the study and will have the subject sign the consent 
form. The investigators and key personnel associated with the informed consent process are 
trained to not influence the participant in their decision to participate in the research or not. The 
individual may choose not to sign the consent form without any coercion from the study 
personnel. Non-participation in the study from patients will not impact future care. Informed 
consent is estimated to take approximately 20 minutes for this study. 
 
21.0 Process to Document Consent in Writing 
Participants will complete the Informed Consent document.  
 
22.0 HIPAA 
Study will be performed in compliance with HIPAA regulations. A partial waiver is requested 
for study recruitment. Subjects will be asked to sign a HIPAA authorization to allow access to 
their private information. 
 
23.0 Data Management 
Data will be stored in a study paper file at BostonSight. Electronic data will be stored on a 
password-protected computer in a locked office. All study data will remain at BostonSight for a 
minimum of 3 years following study completion. The principal investigator will be responsible 
for maintaining study data security and subject confidentiality, and the PI and the study 
coordinator will be responsible for receipt and transmission of the data. The investigative team 
and inspectors from regulatory agencies such as the US Food and Drug Administration will have 
access to the data if requested for study monitoring or an audit.  
All collected data will be documented on study documents and analyzed for differences 
between baseline and test data. Hypothesis testing will be performed using statistical 
analyses including parametric or nonparametric comparisons (i.e., t-tests, signed-rank 
tests), analysis of variance, general linear models, correlation, or regression techniques. 
 
24.0 Specimen Use and Banking – N/A 
 
25.0 Sharing of Results with Subjects 
Study results will not be shared with subjects, unless the investigator feels that the subject should 
know something about the ocular health of their eye as a result of the study.  
 
26.0 Resources  
All investigators in this study are optometrists and are qualified to examine subjects and evaluate 
the performance of the PROSE devices. The investigators all have experience working within 

TITLE: Tonometry Precision and Accuracy in PROSE Scleral Lens Wear: A Pilot Study 
PROTOCOL NUMBER: BFS-KR-IOP-02 DATE: 04/14/2020 
 
 
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BostonSight, and with all the exam rooms, equipment, and data storage rooms. All investigators 
have completed the necessary training for good clinical practices and are specialists in lens 
fitting and management.  The study coordinator is an experienced coordinator who is also trained 
on IRB practices and is experienced with informed consent processes and confidentiality.   
We do not expect to have difficulty recruiting subjects in this study. All subjects will come from 
current patients of BostonSight. 
 
27.0 Citations 
 
1. McMonnies CW. A hypothesis that scleral contact lenses could elevate intraocular 
pressure. Clin Exp Optom 2016; 99: 594-596. 
 
2. Michaud L, et al. Intra-ocular pressure variation associated with the wear of scleral lenses 
of different diameters. Contact Lens and Anterior Eye 2019; 42: 104-110. 
 
3. Nau, et al. Intraocular Pressure After 2 Hours of Small-Diameter Scleral Lens Wear. Eye 
Contact Lens 2016; 42(6): 350-353. 
 
4. Tai et al. Correlation of Tono-Pen and Pneumatonometer Measurements from Four Scleral 
Quadrants with Intraocular Pressure Measurements from the Cornea. J Clin Exp 
Ophthalmol 2015; 6(6): 504. 
 
5. Kuo et al. Correlation of Serial Scleral and Corneal Pneumatonometry. Ophthalmology 
2015; 122: 1771-1776. 
 
6. Lee JH, Sanchez LR, Porco T, et al. Correlation of corneal and scleral pneumatonometry 
in pediatric patients. Ophthalmology 2018; 125 :1209-1214. 
 
7. Kapamajian M, et al. Correlation of corneal and scleral pneumatonometry: An Alternative 
Method for Intraocular Pressure Measurement. American Journal of Ophthalmology Nov 
2013; 156(5) : 902-906. 
 
8. Magalhaes OA, Aldave AJ. Scleral Pneumatonometry in Penetrating Keratoplasty: A 
Clinic Study. Cornea Oct 2017; 36(10): 1200-1205. 
 
9. Kolin T, Wedemeyer LL, Kolin E, Braun Y. Comparison of scleral and corneal Tono-Pen 
readings. Journal of AAPOS Aug 2003; 7(4): 291-292.