Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus
Phase: NA
Conditions: Keratoconus, Glaucoma
Sponsor: NYU Langone Health

Official Title: 
Optic Nerve Head Structural Response to IOP Elevation in Patients 
With Keratoconus  
NCT Number:
NCT03560609
Study Number:
17-01360 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
July 13, 2023 

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Optic Nerve Head Structural Response to IOP Elevation in Patients with Keratoconus
Principal Investigator:  
Chaim Gadi Wollstein, MD
Department of Ophthalmology 
 
462 First Ave., NBV 5N1 
New York, NY 10016 
 
Tel: (646) 501 8741 
 
Gadi.Wollstein@nyumc.org  
Funding Support:
National Eye Institute R01-EY013178
Study Intervention:
In-vivo investigation of ocular structure under elevated intraocular           
pressure using OCT in keratoconus 
 
IRB Number:  
17-01360 
 

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List of Abbreviations 
AMD – Age related macular degeneration
FDA – Food and drug administration
IOP – Intraocular Pressure
NYU – New York University
OCT – Optical coherence tomography 
ODM- Ophthalmodynamometer  
ONH – Optic Nerve Head 
ORA – Ocular Response Analyzer 
UPMC – University of Pittsburgh medical center
VF – Visual field 
 

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Study Summary
Title
Optic Nerve Head Structural Response to IOP Elevation in Patients 
with Keratoconus
Short Title
Keratoconus and IOP elevation Study 
IRB Number
17-01360
Study Type
Human study
Study Design
Prospective experimental study
Study Intervention
In-vivo investigation of ocular structure in eyes with keratoconus 
under elevated intraocular pressure
Study Duration
Indefinite
Study Location(s)
NYU Department of Ophthalmology: Faculty Group Practice
Primary Objective
To examine in-vivo how lamina cribrosa in subjects with keratoconus 
respond to increasing intraocular pressure
Sample Size 
230 subjects
Diagnosis and Main 
Inclusion Criteria
Subjects diagnosed with keratoconus or glaucoma
Control / 
Comparison
None
Statistical 
Methodology 
Mixed effect models for the comparison between keratoconus and 
glaucomatous eyes 

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1. Introduction
This study will be conducted in compliance with the protocol approved by the IRB, GCP 
guidelines, and applicable NYUMC and federal regulatory requirements.
Background
Glaucoma is a leading cause of blindness worldwide and its prevalence tends to increase (1). 
Intraocular pressure (IOP) is the primary risk factor for the development and progression of 
glaucoma, however the mechanisms of damage on tissues of the eye remain unclear (2). The 
optic nerve head (ONH) was proposed to be a biomechanical structure where the influence of 
IOP-related connective tissue stress and strain plays a central role in the pathophysiology of 
glaucoma acting on the ONH connective tissues including the lamina cribrosa (LC), on its axons 
and on its cellular components (3). Some eyes have characteristics that may render them 
sensitive to IOP and more likely to develop glaucoma and other eyes present more resilient to 
IOP and more prone to present with hypertension only (4).  
 
Keratoconus is a frequently occurring asymmetric non-inflammatory disease of the cornea 
characterized by thinning and ectasia. Its etiology is unknown and it affects mainly the central 
cornea (5). Histopathological findings of keratoconus explants may explain biomechanical 
abnormalities such as decreased elastic strength and abnormal shear behavior (6-8).  The 
biomechanical properties of the cornea are currently accessed with the ocular response 
analyzer (ORA) that is based on a dynamic bidirectional applanation process. This device 
measures the corneal hysteresis (CH) and the corneal resistance factor (CRF). Studies show that 
keratoconus has decreased CH and CRF (5, 9).  
Optical coherence tomography (OCT) enables tissue pathology to be imaged in situ and in real 
time with a resolution approaching that of conventional histopathology, but without the need 
for excising and processing specimens. Over the course of the years, we and other groups have 
demonstrated the excellent diagnostic ability of OCT, and the technology has become the 
cornerstone of clinical management in ophthalmology worldwide and the number of 
publications using this technology has soared exponentially in recent years (10, 11). OCT has 
been approved by the Food and Drug Administration for use in ophthalmology.  The device 
provides accurate and reproducible measurements of tissues of interest in the eye (12). These 
properties enable improved diagnosis and longitudinal assessment for ocular disease such as 
glaucoma, age related macular degeneration (AMD), diabetic retinopathy (DR) and macular 
edema (13-16). Extensive studies have been performed with OCT examining both cross-
sectional as well as longitudinal patient populations (17). Our group has published more than 
100 peer-reviewed manuscripts focusing on the use of this technology in ocular diseases (18,
19). 
 
Considering that the cornea and the LC are predominantly composed by collagen and elastin 
fibers, the defective corneal properties might also affect the LC reflected by abnormal response 
to biomechanical modulation. In the present project, our objective is to evaluate with OCT of 
the optic nerve head the response to IOP elevation in eyes with keratoconus, with glaucoma 
and in controls using commercial and prototype ophthalmic OCT imaging instruments in order 

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to assess the biomechanical properties of the ONH structures including the LC. This project 
complements our ongoing research on the LC response to pressure modulation in healthy and 
glaucoma (IRB protocol under review) and in animal models.
 
Study Rationale 
The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that 
increased IOP is a major risk factor. It is also thought that the LC is a site of primary damage 
during the pathogenesis of the disease. We would like to determine the in-vivo mechanical 
response to IOP modulation at the level of the ONH and LC. Subjects with keratoconus exhibit 
abnormal collagen properties that can impair their LC behavior. By evaluating their lamina 
biomechanical response we can advance our understanding on the role of the lamina in 
glaucoma pathogenesis. A better understanding of the process will ultimately lead to improved 
detection and management of glaucoma. 
 
The study design involves a short increase in IOP and imaging with prototype OCT devices to 
examine the response of the LC to elevated pressure. These devices adhere to all American 
National Standards Institute safety requirements and do not pose any risk to the participants. 
The length and magnitude of the pressure elevation in our study design has been previously 
used, and did not cause any short or long- term damage. 
 
2. Study Objectives 
To study the differences in optic nerve microstructure and biomechanical features between 
keratoconus and glaucomatous eyes. We hypothesize that subjects with keratoconus have an 
abnormal biomechanical response of the lamina cribrosa in response to IOP modulation. 
 
3. Study Design  
This is a prospective, non-randomized, consecutive, experimental study. 
 
4. Participant Selection, Enrollment, and Withdrawal 
Study Population 
We aim to enroll 230 subjects including subjects diagnosed with keratoconus or glaucoma (115 
in each cohort). There will be no enrollment restrictions based on gender, ethnic origin or HIV 
status and the study population will reflect the demographics of NYU Department of 
Ophthalmology.  
 
Inclusion Criteria 
Candidates must meet the following inclusion criteria in order to participate in the study. 
– 
Ages 18 and older 
– 
Ability to provide informed consent and to understand the study procedures 
And have a diagnosis of either: 
Keratoconus:  
– 
Clinical diagnosis of keratoconus 
– 
Central thinning of the cornea  
– 
Abnormal posterior ectasia. 

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Or:
Glaucoma:
– 
Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or 
diffuse or localized RNFL defects that are characteristic of glaucoma.
–
Two consecutive abnormal SITA standard perimetry tests with GHT outside normal 
limits.
Exclusion Criteria  
Candidates that meet any of the exclusion criteria at baseline will be excluded from study 
participation.
– 
Media opacity (e.g. lens, vitreous, cornea). 
– 
Strabismus, nystagmus or a condition that would prevent fixation. 
–
Diabetes with evidence of retinopathy.
–
Previous intraocular surgery or ocular trauma. 
–
Neurological and non-glaucomatous causes for visual field damage.
– 
Any intraocular non-glaucomatous ocular disorders. 
Participant Recruitment, Screening and Enrollment
Subjects will be enrolled consecutively from NYU Department of Ophthalmology from the 
investigator’s and the research team’s clinics. Eligibility will be determined based on the results 
of a patient’s eye examination, and all qualified subjects will be offered to participate in the 
study. Study team members will approach participants during their routine examinations at 
NYU Department of Ophthalmology. To maximize recruitment, eligible subjects may also be 
contacted via IRB-approved messaging through the NYULH MyChart portal in Epic.  
 
The consent will be obtained after thorough explanation of the study to the participant by the 
clinician and/or study team member. The participant will be encouraged to ask questions and 
offered to spend as much time as needed to review the consent with the guidance of the study 
team member. We will emphasize that participation is voluntary. Documentation of the 
informed consent process will be used to ensure that the appropriate questions have been 
asked to the perspective participant. Only study personnel will conduct the consenting process. 
For candidates who are not fluent in English, NYU translation service will be used to ensure that 
the candidate fully understands the study and the consent. While the short form will be used 
with an interpreter, if we encounter a subject who meets inclusion criteria and speaks a 
language other than English, we will ensure that if more than 10% of prospective subjects per 
language speak a language other than English, we will amend the submission to include a 
consent form translated to that particular language. 
 
The site will enroll NYU employees, including those working within the Department of 
Ophthalmology. Employees listed on the delegation log as study team members will not be 
enrolled into the research study. 
 
The study assessments/procedures will take place at the NYU Langone Eye Center. 
 

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To minimize undue inducement, IRB approved advertisements will be distributed and displayed 
at IRB approved locations.  Interested employees will approach the study team to discuss the 
study and if they are interested, the informed consent process will take place prior to any study 
related procedures.  The study team member will emphasize that participation is voluntary. The 
person obtaining consent will also emphasize that the volunteer’s decision will not affect their 
employment within NYU Langone Health and/or NYU School of Medicine. 
Participation in the study and data collection will be possible only after subjects have signed 
consent.
Early Withdrawal of Participants 
There are no anticipated circumstances that would lead to discontinuing a subject’s 
participation in this research study. 
 
Subjects may withdraw their consent for participation in this research study at any time. Any 
identifiable research or medical information recorded for, or resulting from, subject 
participation in this research study prior to the date that subject formally withdrew consent 
may continue to be used and disclosed by the investigators for the purposes described above.
 
5. Study Intervention 
Participants will be examined by an ophthalmologist using conventional techniques. The eye 
examination (which is standard of care) includes recording medical and family history, visual 
acuity testing, axial length, intraocular pressure and central corneal thickness measurements, 
slit lamp examination, dilated slit lamp examination with stereo biomicroscopy of the optic 
nerve head and nerve fiber layer, indirect ophthalmoscopy, and visual field testing. This is 
followed by imaging of the cornea with Pentacam, hysteresis evaluation with ORA, 
stereophotography of the optic nerve head, macula and nerve fiber layer optical coherence 
tomography (OCT) and anterior segment OCT (ASOCT) imaging with FDA approved and non-FDA 
approved devices (see below). The estimated time for this step is approximately two hours and 
will occur during a single visit. 
 
The Department of Ophthalmology at NYU includes Pentacam and OCT as part of standard 
ophthalmic work-up. Every subject with keratoconus routinely undergoes scanning with 
Pentacam, and they will also have the hysteresis accessed with ORA, both are FDA approved 
and used as per their approved indication. Subjects with glaucoma routinely undergo imaging 
with OCT. OCT images will be acquired using commercial OCT instruments (FDA approved 
devices), and non-commercial instruments that have not been approved by the FDA. More 
information on the later devices are provided in the appendixes. 
 
These devices are designed using all safety requirements as defined by American National 
Standards Institute’s regulations. The non-FDA approved devices will be used to obtain 
physiological data, and are non-investigational in the context of this study. 
 

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As part of the routine examination, pupils will be dilated using dilating drops (tropicamide
and/or phenylephrine hyrdrochloride). As part of routine clinical IOP measurement, numbing 
drops (proparacaine) will be used. In cases where the clinical evaluation did not include pupil 
dilation and pupil size prevents ocular imaging, dilating drops might be used for the purpose of 
imaging in the study. 
All procedures will be performed by clinical or research staff. 
Experimental procedure: The IOP will be measured with the Goldman applanation tonometer, 
and then the IOP will be increased using an ODM. Proparacaine drops, which are widely used 
during routine eye examinations, will be used during this procedure to numb the eye while the 
IOP is measured. ODM is an FDA approved device that allows an increase of force on the eye in 
a controlled fashion and is routinely used as part of neurophthalmic evaluation. Forces will be 
imposed on the eye while Goldman tonometry is used to measure the IOP to reach the target 
IOP between 20-35 mmHg. The procedure will take five minutes. 
 
OCT scanning will be obtained at baseline and with increased IOP. The IOP elevation will last no 
longer than two minutes, during which scans will be acquired by the imaging device. This stage 
will take 10 minutes. 
 
The subject will be tested by clinical or research staff under the direct supervision and direction 
of the principal investigator or co-investigators. All devices in this study are FDA-approved with 
the exception of the investigational OCT devices and multi-modal adaptive optics system; see 
Appendix). None of the systems in this study are considered investigational, nor do any of the 
devices produce harmful radiation. 
 
Devices  
 
1. Ophthalmodynamometer 
The ODM (Baillart ophthlmodynamometer, W. Koch Optik, Zurich, Switzerland) is a disc 
attached to a piston that induces a controlled force on a fixed area. The device will be used to 
apply a pressure within the range of 20 mmHg - 35 mmHg 4 times to each eye. Each increase of 
pressure will last approximately 30 seconds. The device is FDA approved and will be used as 
routinely used in clinical practice. 
 
2. Goldmann Applanation Tonometer 
The Goldmann applanation tonometer (Haag-Streit, Basel, Switzerland) measures the IOP after 
the eye is numbed with a drop of anesthetic (proparacaine), which is approved by the FDA. 
Proparacaine is part of routine patient care using a tonometer regardless of participation in this 
study. The instrument’s tip lightly touches the surface of the cornea and the IOP is measured. 
The device is FDA approved is routinely used in clinical practice. 
 
3. Pentacam 

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This device (Pentacam HR; Oculus Optikgerate GmbH, Wetzlar, Germany) maps the cornea and 
provides pachymetry, topography and corneal aberration maps. The device is FDA approved 
and routinely used in clinical practice. 
 
4. ORA  
ORA (Reichert Corp, Buffalo NY) is an air puff tonometer that applies controlled force to flattens 
the cornea and provides the corneal hysteresis and corneal resistance factor. The device is FDA 
approved and routinely used in clinical practice.  
 
5. Optical Coherence Tomography (OCT) 
OCT is a non-contact, real-time, high resolution, and reproducible imaging modality that 
provides in-vivo optical cross-sectional scanning of the retina, the ONH and of the anterior 
segment structures including the cornea. Some are FDA approved and used for their approved 
indications. The other OCT systems and the multi-modal adaptive optics system used in this 
study have not been approved by the FDA, but are not being used in a way that would cause 
significant risk to subjects.  Their use is for obtaining physiologic data, not for clinical 
investigation.  Clinical staff will perform subject testing, not research coordinators. Information 
about these non-FDA approved OCTs and the multi-modal adaptive optics system can be found 
in appendices. With all devices, the participant sits in a slit lamp like frame. A low power laser 
light is projected toward the back of their eyes while the subject fixates on a target. None of the 
systems produce harmful radioactive radiation. 
 
 
6. Statistical Plan 
The data will be divided into two groups according to the clinical diagnosis: subjects with 
keratoconus and with glaucoma. Baseline ONH location and shape will be compared to IOP 
stressed location and shape by mixed effect models. 
 
Based on unpublished pilot data, an increase in cup depth of approximately 13µm in response 
to acute IOP elevation is anticipated. To detect a difference of 13µm in cup depth with an 
experimental error of 0.07µm, a sample of 230 subjects with keratoconus and glaucoma has a 
power of 80% (5% level of significance). 
 
Analysis Methods 
The ONH and peripapillary region scans by OCT will be evaluated for tissue deformation, 
decrease in the rim area, increase in cup depth and changes in the lamina cribrosa structure. . 
Outcome measures will evaluate the aforementioned expected deformations of the LC in 
microns. These micron measurements will be obtained from in vivio OCT images. 
Cornea will be evaluated for anterior and posterior curvatures, aberrations, pachymetry and 
hysteresis.  
 
Mixed effect models will be used for longitudinal analysis accounting for the use of information 
from both eyes for some subjects. Custom analysis techniques will be utilized to measure 
differences in ocular structures, especially the LC, under different pressure conditions. 

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7. Safety and Adverse Events
Risks and Discomforts
There is a risk of blurred vision and difficulty in near vision operation (e.g., reading and writing), 
which is common, due to the use of dilating drops (tropicamide and/or phenylephrine 
hyrdrochloride). The effects of these drops will disappear within 3-4 hours after instillation. The 
participant may be asked to remain in the clinic in the event that they experience blurred vision 
and do not have an accompanying person. 
 
Pupil dilation may cause an increase in eye pressure or the possibility of an angle-closure event, 
which happens in a rare configuration of eyes. All subjects will be examined clinically before 
dilating drops are instilled to identify eyes at risk, in which case no dilation drops will be used. If 
either of these risks should occur, the subject will be treated immediately with eye drops at no 
cost. There is a rare risk of an allergic reaction to the drops, as with any drug or medication. 
 
Ophthalmologic OCT imaging is performed in a non-contact fashion, so there is minimal risk of 
infection to the participant. To reduce the possibility of eye infection, all exposed surfaces near 
the eye, as well as the chin rest and forehead rest of the instrument, will be cleaned with 
alcohol before participants are examined. The risk of infection is low. 
Imaging will be performed using commercial (FDA approved) and non-commercial (non-FDA 
approved) imaging instruments. All devices are subject to standard medical regulatory and 
safety requirements and adhere to the American National Standards Institute safety standards 
for the use and exposure to lasers. There is no known cumulative risk for repeating OCT scans 
multiple times on the same day or on different days. 
 
Infrequent risks from the IOP elevation using the ODM include corneal abrasion. However, the 
ODM is designed with a smooth surface to minimize this risk. While increasing IOP causes 
neural loss, the length and magnitude of the pressure elevation in our study design was 
previously used and have been shown to not cause any short or long-term damage.
Adverse Event 
The IRB and participants will be notified immediately of any new information learned in regards 
to this study. Expected and serious adverse events that occur will be reported to the
IRB. Fatal or life threatening adverse events with research intervention will be reported to the 
IRB within 24 hours of notice. If there is a major unresolved dispute between the research 
investigator and a research subject or between research investigators, a letter will be submitted 
to the IRB describing the dispute and identifying the parties involved. 
 
All adverse events occurring during the study period will be recorded. At each contact with the 
participant, the research team members will seek information on adverse events by specific 
questioning and examination. Information on all adverse events will be recorded in the patient 
file immediately. The clinical course of each event will be followed by the PI and research team 
members until resolution, stabilization or until it has been determined that participation in the 

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study is not the cause. Serious adverse events that are still ongoing at the end of the study 
period will be followed to determine the final outcome.  
A review of the outcome and adverse event data will be monitored by the PI and clinical 
coordinators to determine whether the study should be continued, changed or terminated. A 
copy of the review will be submitted to the DSMB and to the IRB at the time of renewal. 
 
The PI will ultimately be responsible for the data safety monitoring of the overall study. The 
DSMB will include the PI and clinical coordinators, who will meet every other week to monitor 
data, recruitment, retention, confidentiality and adherence to the study protocol. At the time of 
obtaining renewal approval from the IRB, a report indicating the PI’s evaluation of whether 
there is any change in the risk benefit considerations of the study will be submitted. A licensed 
medically qualified sub-investigator will be responsible for reviewing and assessing adverse 
events. There are no predetermined stopping criteria. 
 
Adverse events will be reported immediately to the DSMB for further evaluation. Annual 
reports will be provided regularly to the DSMB by each of the sub-sites. If the DSMB or IRB 
conclude that changes should be made to the study protocol, all sites will be informed in 
writing by the PI. There are no direct benefits to subjects who participate in this study. 
 
 
8. Data Management and Record Keeping 
Information about study participants will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  In 
accordance with these regulations, participants will sign authorization of the following:  
– 
The protected health information (PHI) that will be collected
– 
Who will have access to that information and why 
– 
Who will use or disclose that information 
– 
The rights of a research participant to revoke their authorization for use of their PHI 
In the event that a participant revokes authorization to collect or use PHI, the investigator
retains the ability to use all information collected prior to the revocation of authorization.  
Data will be collected after the participant has signed an informed consent form and completed 
their visit. The collected data will include demographics, clinical information and testing results. 
Data management will include steps that will ensure confidentiality and security of the data. 
Data will be collected only by members of the research team and stored in accordance with 
Federal and University regulations. The data will be de-identified prior to any analysis and the 
key will be accessible only by study personnel. Research related materials will be retained and 
stored following NYU policy (a minimum of seven years following study completion). ICF's will 
also be retained for seven years. Paper-based records and external hard drives containing data 
will be kept in a secure location within a double locked room and only be accessible to 
personnel involved in the study. Computer-based files will only be made available to personnel 
involved in the study through the use of access privileges and passwords, granted prior to 

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access to any study-related information residing within NYU firewall. Identifiable health 
information will not be reused or disclosed to any other person or entity, except as required by 
law or for authorized oversight of the research study. Records will only be destroyed after 
confirmation from sponsor and IRB.
The project is funded by the NIH, who may have access to de-identified data. Our research 
results are published in scientific journals and deposited in PubMed in a timely manner, as 
required. We willingly distribute the reprints of our publications to those who are interested 
but do not have access to these journals. Additionally, our group has a long history of successful 
collaborations with interested investigators. We share de-identified data and our analytical 
tools with collaborators in accord with New York University and NIH policies. Although this 
study is not designed for data collection of genome wide association study (GWAS), we would 
contribute data from some of our well-characterized participants to multi-center GWAS studies.
 
 
Study Monitoring, Auditing, and Inspecting  
Study Monitoring Plan 
The study will be routinely monitored by the PI and the coordinator during their regular DSMB 
meetings. The following aspects will be specifically monitored: enrollment and retention, data 
collection, confidentiality, breaches from the study protocol or any adverse event. The 
Investigator will also ensure that the monitor or other compliance or quality assurance reviewer 
is given access to all the above noted study-related documents and study related facilities (e.g. 
diagnostic tests), and has adequate space to conduct the monitoring visit. 
 
The investigator(s) and study team will meet bi-weekly to discuss recruitment, retention and 
breaches in confidentiality and any adverse events that may have occurred. A summary report 
of the DSMB and multi-centered DSMB will be submitted with annual review. All adverse events 
that occur including expected and serious will be reported to the IRB as outlined in Chapters 3 
of the IRB Reference Manual. 
 
Both the IRB and the participants will be notified immediately of any new information that is 
learned in regards to this study. Any adverse event that occurs during this research study will 
be reported to the IRB, as reported in the adverse events section of this protocol. 
 
Auditing and Inspecting 
The investigator will permit study-related monitoring, audits, and inspections by the IRB/EC, the 
funding sponsor, and University compliance and quality assurance groups of all study related 
documents. The investigator will also ensure the capability for inspections of applicable study-
related facilities. Participation as an investigator in this study implies acceptance of potential 
inspection by government regulatory authorities and applicable University compliance and 
quality assurance offices. 
 
10. Ethical Considerations 

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This study will be conducted in compliance with the protocol approved by the IRB, GCP 
guidelines, and applicable NYU Langone Health and federal regulatory requirements. No 
deviation from the protocol will be implemented without prior review and approval of the IRB, 
except where it may be necessary to eliminate an immediate risk to a participant. In such case, 
the deviation will be reported to the IRB according to its policies and procedures.  
This protocol and any amendments will be submitted to an IRB in agreement with local legal 
prescriptions, for formal approval of study conduct.  The decision of the IRB concerning the 
conduct of the study will be made in writing to the investigator. 
All participants will be provided with a consent form describing the study and providing 
sufficient information for them to make an informed decision about their participation. See 
attachment for a copy of the Participant Informed Consent Form.  This consent form will be 
submitted with the protocol for review and approval by the IRB for the study. The formal 
consent of a participant, using the IRB-approved consent form, will be obtained before that 
participant undergoes any study procedure. The participant must sign the consent form, and 
only the investigator-designated research personnel may obtain the consent. 
 
11. Study Finances 
Funding Source 
Charges will be billed only for procedures performed as part of the subject's routine clinical 
care. All other costs will be charged to the grant funded by the NIH R01-EY013178. 
 
Conflict of Interest 
The PI Chaim Gadi Wollstein and three of the co-investigators, Dr. Sperber, Dr. Schuman, and 
Dr. Ishikawa, have a potential conflict of interest with this project. The NYU COI committee has 
established a management plan that will be implemented for this project. 
 
Participant Stipends or Payments 
 Subjects will receive $30 at the completion of study procedures to compensate them for their 
participation in this research study. 
 
12. Publication Plan 
All publications resulting from this project will cite funding from NIH R01-EY013178.
 
The results of the study, complete or partial, carried out under this protocol will not be 
published or passed on to any third party without the consent of the PI or primary responsible 
party. Any investigators involved with this study will be obligated to provide the PI or primary 
responsible party with complete test results and all data derived from the study. 
13. References  
 
 

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1. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma 
and projections of glaucoma burden through 2040: a systematic review and meta-
analysis. Ophthalmology. 2014; 121(11):2081-90. 
 
2. Sigal IA, Bilonick RA, Kagemann L, Wollstein G, Ishikawa H, Schuman JS, et al. The optic 
nerve head as a robust biomechanical system. Invest Ophthal Vis Sci. 2012; 53(6):2658-
67.
3. Burgoyne CF, Downs JC, Bellezza AJ, Suh JK, Hart RT. The optic nerve head as a 
biomechanical structure: a new paradigm for understanding the role of IOP-related 
stress and strain in the pathophysiology of glaucomatous optic nerve head damage. 
Prog Retin Eye Res. 2005; 24(1):39-73. 
 
4. Voorhees AP, Grimm JL, Bilonick RA, Kagemann L, Ishikawa H, Schuman JS, et al. What is 
a typical optic nerve head? Exp Eye Res. 2016; 149:40-7. 
5. Wolffsohn JS, Safeen S, Shah S, Laiquzzaman M. Changes of corneal biomechanics with 
keratoconus. Cornea. 2012; 31(8):849-54.
6. Meek KM, Tuft SJ, Huang Y, Gill PS, Hayes S, Newton RH, et al. Changes in collagen 
orientation and distribution in keratoconus corneas. Invest Ophthalmol Vis Sci. 2005;
46(6):1948-56. 
 
7. Andreassen TT, Simonsen AH, Oxlund H. Biomechanical properties of keratoconus and 
normal corneas. Exp Eye Res. 1980; 31(4):435-41.  
 
8. Girard MJ, Dupps WJ, Baskaran M, Scarcelli G, Yun SH, Quigley HA, et al. Translating 
ocular biomechanics into clinical practice: current state and future prospects. Curr Eye 
Res. 2015; 40(1):1-18.  
 
9. Luce DA. Determining in vivo biomechanical properties of the cornea with an ocular 
response analyzer. J Cataract Refract Surg. 2005; 31(1):156-62. 
 
10.  Huang D, Swanson EA, Lin CP, et al. Optical coherence tomography. Science 1991; 
254(5035):1178-81. 
 
11.  Fujimoto J, Huang D. Foreword: 25 Years of Optical Coherence Tomography. Invest 
Ophthalmol Vis Sci. 2016; 57(9):OCTi-OCTii. 
 
12. Gabriele ML, Wollstein G, Ishikawa H, Kagemann L, Xu J, Folio LS, et al. Optical 
coherence tomography: history, current status, and laboratory work. Invest Ophthalmol
Vis Sci. 2011; 52(5):2425-36. 
 

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