A Single-Center Proof Of Concept Study of a Novel Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp Configuration Devices
Phase: NA
Conditions: Age-Related Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy, Glaucoma, Glaucoma, Suspect, Eye Diseases
Sponsor: NYU Langone Health

Official Title:
A Single-Center Proof Of Concept Study of a Novel Comfortable and 
Stabilizing Chin & Forehead Rest Attachment for Slit Lamp 
Configuration Devices  
NCT Number:
NCT05686421
Study Number:
22-01420 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
April 11, 2023 

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sponsor.
A SINGLE-CENTER PROOF OF CONCEPT STUDY OF A NOVEL 
COMFORTABLE AND STABILIZING CHIN & FOREHEAD REST 
ATTACHMENT FOR SLIT LAMP CONFIGURATION DEVICES
Principal Investigator:
Chaim Gadi Wollstein, MD
Department of Ophthalmology 222 E. 41st Street
New York, NY 10017 
Phone: (929) 455-5530
Gadi.Wollstein@nyulangone.org  
Sub-Investigator:
Joel Schuman, MD
Department of Ophthalmology 222 E. 41st Street
New York, NY 10017 
Phone: (212) 263-2939
Joel.Schuman@nyulangone.org
NYULMC Study Number:
S22-01420 
Study Product:
Comfortable chin and forehead rest that can be adjusted to fit each 
individual’s size. 
Initial version:
12/20/2022
Version 2.0:
  03/09/2023  
Version 3.0: 
  03/31/2023

Study number: s22-01420
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Statement of Compliance 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with FDA and DHHS regulations. 
The Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement and documented approval from the Institutional Review Board (IRB), except where 
necessary to eliminate an immediate hazard(s) to the trial participants. All personnel involved in the conduct 
of this study have completed Human Subjects Protection Training. 
 
 

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Table of Contents 
STATEMENT OF COMPLIANCE ................................................................................................................. II
LIST OF ABBREVIATIONS......................................................................................................................... VI
PROTOCOL SUMMARY .............................................................................................................................. 1
SCHEMATIC OF STUDY DESIGN ............................................................................................................... 2
1 
KEY ROLES ......................................................................................................................................... 3
2
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE.......................4
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................ 4
2.2 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL AGENT .............................................................. 4
2.2.1
Preclinical Data........................................................................................................................ 6
2.2.2 
Clinical Data to Date ................................................................................................................ 6
2.3 
RATIONALE.................................................................................................................................... 6
2.4
POTENTIAL RISKS & BENEFITS........................................................................................................6
2.4.1 
Known Potential Risks & Benefits ........................................................................................... 6
OBJECTIVES 
AND 
PURPOSE
...................................................................................................................................................................... 7
3 .................................................................................................................................................................... 7
3.1 
PRIMARY OBJECTIVE ...................................................................................................................... 7
3.2 
SECONDARY OBJECTIVES............................................................................................................... 7
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 7
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................... 7
4.2 
STUDY ENDPOINTS......................................................................................................................... 7
4.2.1 
Primary Study Endpoints ......................................................................................................... 7
4.2.2 
Secondary Study Endpoints .................................................................................................... 8
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................... 8
5.1 
INCLUSION CRITERIA ...................................................................................................................... 8
GROUP-SPECIFIC INCLUSION CRITERIA ................................................................................................ 9
HEALTHY ..................................................................................................................................................... 9
POAG ............................................................................................................................................................ 9
– 
CLINICAL CHARACTERISTICS OF GLAUCOMA: OPTIC NERVE HEAD (ONH) ABNORMALITIES: 
GLOBAL RIM THINNING, RIM NOTCH, OR DISC HEMORRHAGE; RETINAL NERVE FIBER LAYER 
(RNFL) DEFECT. .......................................................................................................................................... 9
– 
TYPICAL GLAUCOMATOUS FIELD LOSS IN RELIABLE VF, REPRODUCIBLE GLAUCOMA 
HEMIFIELD TESTS LABELED OUTSIDE NORMAL LIMITS ON AT LEAST TWO CONSECUTIVE TESTS.
 
9 
– 
GOOD QUALITY (ADEQUATE SIGNAL STRENGTH 
 6/10, WITHOUT SEGMENTATION 
ALGORITHM FAILURE AND MOTION ARTIFACTS > 1 VESSEL DIAMETER) RNFL AND GCIPL OCT, 
LABELED OUTSIDE NORMAL LIMITS WITH TYPICAL GLAUCOMATOUS RNFL AND GCIL THINNING.
 
9 
NTG ............................................................................................................................................................... 9
– 
 . 9
5.2 
EXCLUSION CRITERIA ..................................................................................................................... 9
5.3 
STRATEGIES FOR RECRUITMENT AND RETENTION ............................................................................ 9
5.3.1 
Use of DataCore/Epic Information for Recruitment Purposes ................................................ 9

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5.4 
DURATION OF STUDY PARTICIPATION............................................................................................ 10
5.5
TOTAL NUMBER OF PARTICIPANTS AND SITES................................................................................11
5.6 
PARTICIPANT WITHDRAWAL OR TERMINATION................................................................................ 11
5.6.1 
Reasons for Withdrawal or Termination ................................................................................ 11
5.7
PREMATURE TERMINATION OR SUSPENSION OF STUDY..................................................................11
6 
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE ETC.) AND/OR PROCEDURAL 
INTERVENTION ......................................................................................................................................... 12
6.1
STUDY DEVICE DESCRIPTION .......................................................................................................12
6.1.1 
Acquisition ............................................................................................................................. 13
6.1.2 
Formulation, Appearance, Packaging, and Labeling ............................................................ 13
6.1.3
Product Storage and Stability................................................................................................13
6.1.4 
Preparation ............................................................................................................................ 13
6.1.5 
Administration ........................................................................................................................ 13
6.1.6
Duration of Therapy...............................................................................................................14
6.1.7 
Device Specific Considerations ............................................................................................. 14
7 
STUDY PROCEDURES AND SCHEDULE ....................................................................................... 15
7.1
STUDY PROCEDURES/EVALUATIONS .............................................................................................15
7.1.1
Standard of Care Study Procedures .....................................................................................15
7.2 
IMAGING PROCEDURES................................................................................................................. 15
7.2.1 
Clinical Laboratory Evaluations ............................................................................................. 15
7.3 
CONCOMITANT MEDICATIONS, TREATMENTS, AND PROCEDURES .................................................... 15
8 
ASSESSMENT OF SAFETY ............................................................................................................. 15
8.1 
SAFETY, ADVERSE EVENTS RISKS AND DISCOMFORTS ................................................................... 15
8.1.1 
Adverse Event ....................................................................................................................... 16
8.2 
TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP.................................... 16
8.2.1 
Unanticipated Problem Reporting ......................................................................................... 17
8.3 
REPORTING PROCEDURES – NOTIFYING THE STUDY SPONSOR...... ERROR! BOOKMARK NOT DEFINED.
8.4 
REPORTING PROCEDURES – NOTIFYING THE FDA......................... ERROR! BOOKMARK NOT DEFINED.
9 
CLINICAL MONITORING .................................................................................................................. 17
10
STATISTICAL CONSIDERATIONS .................................................................................................. 18
10.1 STATISTICAL HYPOTHESES ................................................................................................................ 18
10.2
SAMPLE SIZE DETERMINATION ...................................................................................................... 18
10.3
STATISTICAL METHODS ................................................................................................................ 18
10
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 18
11
QUALITY ASSURANCE AND QUALITY CONTROL ....................................................................... 19
12
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 19
12.1
ETHICAL STANDARD ..................................................................................................................... 19
12.2
INSTITUTIONAL REVIEW BOARD..................................................................................................... 19
12.3
INFORMED CONSENT PROCESS .................................................................................................... 20
12.3.1 
Consent/Assent and Other Informational Documents Provided to Participants ............... 20
12.3.2 
Consent Procedures and Documentation ......................................................................... 20
12.4
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................... 20
13
DATA HANDLING AND RECORD KEEPING ................................................................................... 21
13.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 21
13.2
STUDY RECORDS RETENTION ....................................................................................................... 21
13.3
PROTOCOL DEVIATIONS ............................................................................................................... 22
13.4
PUBLICATION AND DATA SHARING POLICY..................................................................................... 22
14
STUDY FINANCES ............................................................................................................................ 23

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14.1
FUNDING SOURCE ........................................................................................................................ 23
14.2
COSTS TO THE PARTICIPANT.........................................................................................................23
14.3
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 23
15
INTEREST POLICY ........................................................................................................................... 23
16
REFERENCES...................................................................................................................................24
17
ATTACHMENTS ................................................................................................................................ 25
18
SCHEDULE OF EVENTS .................................................................................................................. 26

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List of Abbreviations                                        
ABS 
AE 
C
Acrylonitrile butadiene styrene 
Adverse Event/Adverse Experience 
 
OCT Imaging Device C, Conventional Device 
CFR
Code of Federal Regulations
CRF
Case Report Form
CSOC
Clinical Study Oversight Committee
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
DSMB
Data and Safety Monitoring Board
FFR 
Federal Financial Report 
FWA 
Federal wide Assurance 
GCP
Good Clinical Practice
HIPAA
Health Insurance Portability and Accountability Act 
ICF
Informed Consent Form 
ICH
International Conference on Harmonization
IRB
Institutional Review Board
ISM
Independent Safety Monitor 
MOP 
Manual of Procedures
N 
OCT Imaging Device N, Novel Device  
NIH
OCT  
OD 
National Institutes of Health 
Optical Coherence Tomography 
  
Oculus Dextrus  
OHRP 
Office for Human Research Protections 
OHSR 
ONG 
OS
Office of Human Subjects Research 
Optic Nerve Head 
 
Oculus Sinister 
PI 
Principal Investigator 
QA
Quality Assurance
QC
Quality Control 
SAE
Serious Adverse Event/Serious Adverse Experience
SOP 
Standard Operating Procedure

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UP
US 
Unanticipated Problems
 
United States

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Interventional Template Version: 11 JAN 2019 
 
Protocol Summary
Title 
Comfortable and Stabilizing Chin & Forehead Rest Attachment for Slit Lamp 
Configurations
Short Title 
Invention Study  
Brief Summary
Cohort will consist of 150 subjects consisting of those that are healthy or 
have an existing eye disease. Subjects will be imaged on two OCT devices: 
device N, invention attached to the device and device C, the standard 
conventional device. The Imager will time multiple durations, one of them 
which will act to evaluate the number of motion artifacts that arise due to both 
the instability and lack of comfort the patient is experiencing in that particular 
moment. Following the imaging session, subject will be asked which device 
was more comfortable. 
Phase
NA
Objectives 
The primary objective is to ascertain that the OCT Imaging device with the 
invention attached provides a more comfortable experience for the subject. 
While the secondary objective is to reduce the time it takes for the system to 
account for the number of motion artifacts.   
Methodology 
Randomized  
Study Duration 
Until target number of subjects is reached 
Participant Duration 
One clinic visit 
Duration of IP 
administration 
One clinic visit 
Study Sites 
NYU Department of Ophthalmology  
Number of participants 
150 subjects 
Description of Study 
Agent/Procedure 
Comfortable chin and forehead rest that can be adjusted to fit each 
individual’s size.  
Statistical Analysis 
Descriptive statistics for continuous variables and categorical data, presented 
using frequency counts and percentages will be used for group and device 
comparison. Patient experience will be assessed using two-sided exact test 
of proportion. Comfort levels of each device will be compared using t test. 
Linear mixed effect models will be utilized to compare the time duration while 
accounting for inter-eyes correlations.  
 

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Schematic of Study Design
Screening Period 
 
Total n=150   
 
Obtain informed consent  
 
Screen potential subjects by inclusion and exclusion criteria  
 
Obtain history, document  
 
Day of Imaging 
1. Randomize Order of Devices  
 
Provide clinic with 150 envelopes in which they are assigned with instructions regarding which 
device and eye the Imager should begin with (C/N & OS/OD)  
 
2. Study Intervention  
 
Measure the length of the subject’s face 
 
Provide subject with questionnaire containing the following 
o 
Are you feeling well? 
o 
Are you feeling tired today? 
o 
Are you uncomfortable? 
 
Scans should be taken on device C and N on each eye 
o 
 
 
3.  End of Study Assessments  
 
Directly following the imaging session, questionnaire including the following should be provided to 
the subject: 
o 
Which device was more comfortable? 
o 
On a scale of 0-5, please rate the comfort level for each device  
 
 

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1 Key Roles
PI 
Chaim Gadi Wollstein, MD 
Department of Ophthalmology 222 E. 41st Street
New York, NY 10017  
Phone: (929) 455-5530 
Gadi.Wollstein@nyulangone.org  
Clinical Research Program Manager 
Jamika Singleton-Garvin, CCRP 
Department of Ophthalmology 222 E. 41st Street
New York, NY 10017  
Phone: 929-455-5522  
Jamika.Singleton-Garvin@nyumc.org 
 
Clinical Research Coordinator 
Meera Mathur  
Department of Ophthalmology 222 E. 41st Street 
New York, NY 10017  
Phone: 929-455-5540 
Meera.Mathur@nyulangone.org 
 
Research Ophthalmic Photographer 
Ezekiel Ede, OD 
Department of Ophthalmology 222 E. 41st Street 
New York, NY 10017  
Phone: 929-455-5023 
Ezekiel.Ede@nyulangone.org 
 
Research Ophthalmic Photographer/Research Coordinator 
Ronald Zambrano 
Department of Ophthalmology 222 E. 41st Street 
New York, NY 10017 
Phone: 929-455-5046 
Ronald.Zambrano@nyulangone.org 
 
Sub-Investigator/ Device Engineer 
Sarah Segal, BS 
Department of Ophthalmology 222 E. 41st Street 
New York, NY 10017  
Phone: 212-263-2735 
Sarah.Segal@nyulangone.org
Statistician 
TingFang Lee, PhD 
Department of Ophthalmology 222 E. 41st Street 
New York, NY 10017  
Phone: 401-644-3783 
Ting-Fang.Lee@nyulangone.org
 

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2
Introduction, Background Information and Scientific Rationale
2.1
Background Information and Relevant Literature
Currently in Ophthalmological Offices, patients that are being imaged on OCT devices often do 
not have a comfortable patient experience. They tend to move away from the device in order to 
stretch every so often and oftentimes complain about it. This adds additional time to the imaging 
process, thereby extending the wait time for the following patients. Furthermore, due to the lack 
of ability to adjust the chin and forehead rest components to each individual patient’s size, the 
patients tend to move around quite a bit which both lengthens the time, as previously mentioned, 
as well as increases the likelihood of artifacts, which lead to the misdiagnosis of Glaucoma.1This 
is a catastrophic pitfall as 3 million Americans have Glaucoma, which is the "second leading 
cause of blindness worldwide2. Additionally, there are 43 million people worldwide that suffer 
from blindness and 77% of those cases could have possibly been prevented by reducing the 
number of artifacts in their scans.3 To summarize, the purpose of this invention is to solve the 
problem in which patients are potentially being misdiagnosed or undiagnosed with ocular 
diseases as a result of patient discomfort induced movement and subsequent diagnostic testing 
artifacts which could prevent an efficient intervention to be enacted thereby reducing the 
patient's chances of suffering from a debilitating eye disease.
2.2 Name and Description of the Investigational Agent 
The extendable and comfortable chin and forehead rest is a patent pending device (Atty. Dkt. 
No.: 046434-0793). The invention consists of six components: the chin rest, mount and its 
attachment and the forehead rest, mount and its corresponding attachment.  
  
When designing this product, various constraints were considered: the need to easily and 
efficiently sterilize the components between patients, the material being biocompatible (in terms 
of it not having any adverse effects on the patient due to its properties), the materials selected 
and structure designed needed to prove to be durable enough to withstand the weight of a 
person’s head, aid in providing the patient with a comfortable resting position, and, lastly, to 
stabilize the patient’s head properly. 
 
Table 1 shown below provides the Bill of Materials for the Chin rest. It includes the material 
used, quantity along with a description of the component.  
 
Part
Qty. Description
Material 
Chin rest Base Front 1
patient rests chin on 
ABS/ Biomed Back Resin
Chin rest Base Back 1
2 threaded holes for knobs Steel
Rotary Shaft
2
extension mechanism
316 Stainless Steel
Bearing
4
reduces friction along shaft 841 Bronze
Head Thumb Screw 2
locking mechanism 
Steel low profile 

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Table 1: Chin Rest - Bill of Materials
 
The mechanism used to adjust the chin rest for each individual patient are two rotary shafts that 
the chin rest can slide along to be extended as needed and locked in place by two head thumb 
screws (this design can be upgraded to operate via a remote control). Four bearings are also 
incorporated into the design in order to reduce friction caused by the movement of the shafts 
within the extrusions.  
 
Lastly, a cushion is used for the rests, which provides the essential component of comfort 
enhancing the patient's overall experience.
 
In order to incorporate the chin rest into the existing ophthalmic devices on the market, a mount 
and attachment were designed. The mount functions as a stage for the chin rest and can be 
adjusted, by use of grippers, to fit the variable length of the chin rest for each patient’s 
appropriate dimensions. The mount is then connected to the attachment via a ball joint. This 
provides the ability to make additional adjustments per patient as it can move in the y and z 
directions as well, which will ultimately maximize the stability of the patient's head while being 
imaged, as well as provide a more comfortable and positive patient experience. Finally, in order 
to connect the chin rest and mount to the devices, a simple clamping mechanism is utilized, 
which is designed for each device.  
 
In Table 2 below, the bill of materials is provided for the mount and attachment for the chin rest.  
 
Part
Qty. Description
Material
Clamp (male) 
1
half of clamp (specific to each device) 
ABS 
Clamp (female)
1
half of clamp (specific to each device) 
ABS 
Lock - Threaded Rod
1
locking mechanism for attachment to device
Stainless Steel
Slide Lock
1
locking mechanism for extending the mount 
Stainless Steel
Threaded Pin
1
connects male and female clamp
Stainless Steel
Edge Adjuster 
4
adjusts mount size according to chin rest extension ABS 
Table 2: Mount & Attachment - Bill of Materials
The overall mass and weight of the chin rest, mount and attachment is approximately .249 kg and 
2.44 N. 
The forehead rest component of the invention was designed with similar considerations and 
constraints in mind. One additional constraint when designing the adjusting mechanism for 
different size patient heads was to ensure that while adjusting the forehead rest no part of the 
patient’s skin on their forehead would be pinched as a result of the movement of the parts 
relative to one another.

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The overall design of the forehead rest includes multiple mechanisms. Specifically, two 
mechanisms that are present to adjust for each patient include:  
1) the cylinders protruding from the side of the forehead rest 
2) the quick release strap on the buckle located on the front and center of the forehead rest.  
The cylinders are designed to fit into a slot clamped to the ophthalmic device and have a dual 
purpose in which it is used to account for adjustments needed to move the patient relative to the 
device, as well as mounting the forehead rest to the ophthalmic devices. Similarly, the quick 
release buckle is used to account for each individual patient’s head size which can be done by 
tightening or loosening the strap accordingly. As the forehead rest is composed of the male and 
female parts, the male part would have the ability to move linearly relative to the female part.  
 
The forehead rest would be made almost exclusively from ABS, not accounting for the parts 
sourced off the shelf (quick release buckle, screws, etc.) and the silicone cushion covering. 
2.2.1 Preclinical Data 
 
There is no available preclinical research data on the investigational product.  
2.2.2 Clinical Data to Date 
 
There is no available clinical research data to date on the investigational product.  
2.3 Rationale
This study primarily focuses on increasing the comfort for each patient’s experience as well as 
reducing motion artifacts by improving the former, as well as stabilizing the patient’s head, accomplished 
by adjusting the chin and forehead rest for each individual patient. The cohort will consist of a total of 90 
subjects consisting of subjects that are both healthy and have an existing eye disease, as commonly 
observed in ophthalmology outpatient offices. 
In order for certain limitations to not affect the validity of the results, various aspects of the trial will be 
randomized. This includes, but is not limited to, the order in which a patient will begin being imaged on 
either device C/N and which eye, OS/OD the Imager will scan first. This can help account for parameters 
including whether the time it takes to image the patient and/or level of comfort is affected as a result of 
their degree of alertness, energy level, how they are feeling on that particular day, etc.   
2.4 Potential Risks & Benefits 
2.4.1 Known Potential Risks and Benefits 
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 the dilating drops Phenylephrine Hydrochloride 
or Tropicamide. 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,

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which happens in a rare configuration of the 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. 
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 cleanedwith
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) OCT 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. 
 
Participants will receive no direct benefit by participating in this study. However, there may 
be societal benefit related to generalizable knowledge gained by doing this study.
3 Objectives and Purpose 
3.1 Primary Objective
To assess the level of comfort provided by the chin and forehead rest attachment invention when coupled 
with existing imaging devices, i.e. OCT and Slit Lamp.  
3.2 Secondary Objectives  
To evaluate the time duration that is needed to adjust for the number of motion artifacts present while 
using the novel chin and forehead rest attachment when coupled with existing imaging devices, i.e. OCT 
and Slit Lamp.  
4
Study Design and Endpoints
4.1 Description of Study Design
This is a randomized clinical trials study that includes two arms: experimental and control. 
The purpose of these arms is to compare the medical outcomes in terms of the subject’s level of 
comfort as well as reducing the amount of motion artifacts. Subjects that are willing to participate 
will be required to participate in both arms. 
Because the study design follows routine standard of care, there are no specific safety end
points related to this project. 
4.2 Study Endpoints 
4.2.1 Primary Study Endpoints 

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In order to achieve the primary objective, proving that the level of comfort of the chin and forehead rest 
invention attached to the existing OCT imaging devices, as opposed to the conventional existing 
headframes is of a higher caliber, the primary endpoint will be achieved by providing the subject with a 
questionnaire directly after being imaged and asking two questions: which device, C/N, provided a more 
comfortable experience, and on a scale of 0-5 to rate the level of comfort, as a result of the headframe, i.e. 
chin and forehead rest, that the subject experienced while being imaged on either device C/N.    
 
4.2.2
Secondary Study Endpoints
A secondary objective includes evaluating various time durations while a patient is being imaged to 
determine whether the amount of motion artifacts are in fact being reduced by implementing the invention 
to existing devices. In one of the standard clinical OCT imaging devices, the Cirrus OCT, there is an eye 
tracking mode that can be activated whilst imaging a patient. This feature selects a specific location within 
the eye and will constantly adjust, i.e. track, for the fine fixation adjustments that occur when a patient’s 
eye is moving very slightly. Therefore, in order to view whether there are a higher number of motion 
artifacts found in one image versus another, the Imager can time the duration it takes from the moment 
that they click “acquire”, to when the progress bar is full. This is because the more time it takes for the 
system to fully acquire an image it directly correlates to how still the subject’s eye is. Additionally, the data 
acquisition time can also be affected by whether the Imager is able to acquire a clear fundus photo, i.e. 
when there are no media opacities as well as if the Imager properly corrects for the refractive error.    
5 Study Enrollment and Withdrawal 
We aim to enroll 150 total subjects including healthy volunteers and subjects that have an existing eye 
disease including, but not limited to, glaucoma, AMD, DR, and CSCR. The site can actively enroll new 
subjects and these subjects will be are continuously followed in their institute. The total NYU cohort will 
include 150 healthy subjects as well as any eye related disease suspect subjects. 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. Subjects from clinical groups will participate in 
all applicable sub-studies of the protocol. 
Subjects will be included in both groups, labelled as either Group 1 (Novel) or Group 2 (Conventional). 
Both groups will include subjects that are identified with glaucoma, age related macular degeneration, 
diabetic retinopathy, and central serous chorioretinopathy or any other eye related disease as well as 
healthy volunteers that are recruited from the clinic that undergo the clinical examination as part of their 
routine clinical management and healthy volunteers that are invited to the clinic to undergo the clinical 
examination for the purpose of the study.  
5.1 Inclusion Criteria 
Candidates must meet the first inclusion criteria and either one of the last two criteria in order to 
participate in the study. 
– 
Ages 18 and older 
– 
Healthy volunteers 
– 
AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma 
suspects or any other suspected eye disease  
– 
Face length of less than or equal to 6.900 inches 

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Group-Specific Inclusion Criteria 
There are no group-specific inclusion criteria for subjects with AMD, diabetic retinopathy, and 
central serous chorioretinopathy. 
Healthy 
– 
A normal clinical ophthalmic examination. 
Primary Open Angle Glaucoma (POAG)  
– 
Clinical characteristics of glaucoma: optic nerve head (ONH) abnormalities: global rim thinning, 
rim notch, or disc hemorrhage; retinal nerve fiber layer (RNFL) defect. 
– 
Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled 
outside normal limits on at least two consecutive tests. 
– 
Good quality (adequate signal strength  6/10, without segmentation algorithm failure and 
motion artifacts > 1 vessel diameter) RNFL and GCIPL OCT, labeled outside normal limits with 
typical glaucomatous RNFL and GCIL thinning. 
Normal Tension Glaucoma (NTG) 
  – 
 
5.2 Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, 
canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than 
glaucoma. 
2. Face length of over 6.900 inches 
5.3 Strategies for Recruitment and Retention
Healthy volunteers, and patients with glaucoma, AMD, DR, and/or CSCR as well as any other eye 
disease will be enrolled consecutively from NYU Department of Ophthalmology from the investigators and 
the research team’s clinics, recruitment telephone script and via IRB-approved messaging through the 
MyChart portal in Epic. The study does not require a screening procedure, and all qualified subjects will 
be offered to participate in the study. Potential candidates will be informed by their clinician or a clinical 
coordinator from the research team. The participants will receive a comprehensive explanation about the 
study, risks and benefits and will be encouraged to ask questions related to the study. 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 consenting process. For candidates who are not fluent in English, NYU translation services will 
be used to ensure that the candidate fully understands the study and the consent. We anticipate on 
encountering subjects that are fluent in a language other than English. Therefore, the informed consent 
will be translated in the following languages following initial approval: Spanish and Korean. For an 
unexpected enrollment (subject doesn’t speak English, Spanish, Korean but meets all inclusion criteria), 
we will use the short form with an interpreter and then will have the ICF translated in the subject’s 
language and submitted via modification to the IRB to allow for any reconsenting in the future if necessary 
as well as to enroll other subjects who speak this particular language. 
 
 
 
 
Participation in the study and data collection will be possible only after subjects have signed consent. 
5.3.1 Use of DataCore/Epic Information for Recruitment Purposes 

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This study will utilize EPIC to identify subjects. Data and records will be sourced for EPIC. Data will be 
gathered upon request by DataCore and be used for case identification as well as collecting information. 
The data team will search EPIC weekly. Medical records will be screened by initially filtering for all 
patients that are diagnosed as healthy, primary open angel glaucoma, and normal tension glaucoma from 
2022-2026. Identified patients will then have their electronic medical records reviewed based on the 
protocol’s outlined inclusion and exclusion criteria. Protected health information that will be used during 
this study includes patient name, zip code, date of birth, and specific date of birth for patients over 90 
years in stead of recording their as “90 or older”. Patient names will temporarily be used while 
determining eligibility but will not be used for data analysis. Date of birth and specific date of birth for 
patients over 90 years instead of recording their age as “90 or older” will be used to determine eligibility 
and to group patients by age during data analysis.  Data will be collected and recorded using Microsoft 
Excel. Data will be stored within an NYULH MCIT-managed network shared drive and be subsequently 
deleted from the shared drive upon completion of the study. Data will be accessible to the principal 
investigator, sub-investigator, coordinators and study team members.  
 
Data Points and PHI used in EPIC search: 
 
Age 
 
Name 
 
Date of birth 
 
Diagnosis (Healthy, Primary Open Angel Glaucoma, Normal tension glaucoma, AMD, diabetic 
retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any 
other suspected eye disease) 
 
To minimize risks to subjects and/or potential breach of confidentiality, only information required to 
answer the previously listed research objectives will be acquired. Additionally, any potential disclosure 
outside of research would not put subjects at risk or harm. 
 
 
Any recruitment information sent by email will utilize Send Safe email.  
 
Once potential subjects have been identified, the study team will notify the treating physician (TP) by 
email that they have patients eligible to participate as one of the following:  
 
Provide TP with a list, advertisement, letters or oral script to use when contacting potential 
subjects  
 
TP and Research PI send letter to all potential subjects (letter must have both TP and Research 
PI's name) 
 
TP agrees to permit study team to directly contact potential subjects on behalf of TP.  
 
TP has been notified that the study team will contact potential subjects directly, by letter, phone, 
email, or the MyChart portal etc. 
 
The patients will be contacted either by MyChart, in-person during their clinic visit at the eye center or 
prior to their visit using a phone script (attached). 
 
Once contact is made, approved recruitment language will be used to communicate the reason they are 
being contacted and subjects will be asked if they are interested in participating in this specific study. 
Should the potential subjects agree, the study team will provide the subjects with information regarding 
the next steps for participation.  
 
If a subject requests information regarding opting out of further recruitment for all research, subjects will 
be directed to contact research-contact-optout@nyumc.org or 1-855-777-7858. 
5.4 Data Storage and Confidentiality 
Data collection is the responsibility of the study staff at the site under the supervison of the site PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. Confidentiality will be held in strict trust by the research team. Medical record review will be limited 

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to just the elements needed to complete the study. Information about individual subjects will not be shared 
with anyone outside of the study team. 
Study data will be stored in Trialmaster used in the NYU Langone Health Department of Ophthalmology. 
Subject data will be stored until the completion of data analysis and will subsequently be removed from the 
shared drive upon completion.  
5.5
Duration of Study Participation
Besides for the screening, which is discussed in the previous section, the duration of study participation is 
solely for the one-time imaging session, i.e. one day. There is also no follow-up period.  
5.6 Total Number of Participants and Sites  
Recruitment will end when approximately 150 participants are enrolled at NYUMC.  
 
 
5.7 Participant Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination 
Participants are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
participant 
 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation
 
Subjects may withdraw, at any time, their consent for participation in this research study.  
Subjects who are unduly distressed and cannot complete the research requirements will be 
withdrawn from the study. 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. 
 
5.8
Premature Termination or Suspension of Study
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to the Principal Investigator. If the study is prematurely terminated 
or suspended, the PI will promptly inform the IRB and will provide the reason(s) for the termination or 
suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Demonstration of efficacy that would warrant stopping 
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the IRB and/or FDA. 
 

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6 Study Agent (Study drug, device, biologic, vaccine etc.) and/or 
Procedural Intervention  
6.1 Study Device Description
The device, chin and forehead rest, has its provisional patent currently filed to the USPTO. 
Its constituent parts may include, but are not limited to other possible configurations as listed in the 
patent, and are described and can be seen in further details in the tables below.  
Table 1 shown below provides the Bill of Materials for the Chin rest. It includes the material used, quantity 
along with a description of the component.  
Part 
Qty. Description
Material 
Chin rest Base Front 1 
patient rests chin on 
ABS/ Biomed Back Resin
Chin rest Base Back 1 
2 threaded holes for knobs Steel 
Rotary Shaft
2 
extension mechanism
316 Stainless Steel
Bearing 
4 
reduces friction along shaft 841 Bronze 
Head Thumb Screw 2 
locking mechanism
Steel low profile
Table 1: Chin Rest - Bill of Materials   
In Table 2 below, the bill of materials is provided for the mount and attachment for the chin rest.  
Part 
Qty. Description
Material 
Clamp (male) 
1
half of clamp (specific to each device)
ABS
Clamp (female)
1
half of clamp (specific to each device)
ABS
Lock - Threaded Rod
1
locking mechanism for attachment to device 
Stainless Steel
Slide Lock
1
locking mechanism for extending the mount
Stainless Steel
Threaded Pin 
1
connects male and female clamp
Stainless Steel
Edge Adjuster
4
adjusts mount size according to chin rest extension ABS
Table 2: Mount & Attachment - Bill of Materials 
  
A further description of the device and its potential configurations can be found in section 2.2 as well as 
the provisional patent application attached.  
 
The device is not a significant risk device as it is solely being used to stabilize the subject’s head. The 
materials in contact with the patient are biocompatible and will also be sterilized and sanitized 
accordingly. The device does not meet the 4 criteria for Significant Risk device in accordance with 21CRF 
812.3(m), because (1) it is not intended as an implant (2) It Is not purported or represented to be for a use 
in supporting or sustaining human life (3) It Is not for a use of substantial importance in diagnosing, 
curing, mitigating, or treating disease, or otherwise preventing impairment of human health; (4) Does not 

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Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject. The results of 
the imaging using the investigational device will not be used to make a clinical diagnosis or guide care. 
6.1.1
Acquisition
Silicone components of the device will be supplied by the manufacturer, Zetar and will be shipped directly 
to the Principal Investigator in the NYU Ophthalmology Clinic. Any components that are made from some 
form of metal will be purchased and sourced directly from the mainstream hardware suppliers, such as 
McMaster Carr. The remainder of parts will be produced and acquired by the hospital makerspace or 
machine shop.  
6.1.2
Formulation, Appearance, Packaging, and Labeling
The device is comprised of various components. Depending on the complexity and availability for these 
components to be sourced off the shelf the remainder will either be manufactured in house by the 
mechanical engineers and machinists in NYU and the silicone related parts will be manufactured by 
Zetar, a Silicone manufacturing factory in China. All components will be sourced with the constraint of 
each material being biocompatible as to not cause any irritation to the subjects when they are resting their 
head on the chin and forehead rest.  
6.1.3 Product Storage and Stability 
The device storage requirements include: 
1. -20 to 80 degrees Celsius, as outside that range the ABS parts mechanical properties vary with 
temperature  
2. Avoid being in areas containing a high humidity as that can increase the rate of corrosion of the 
stainless steel components  
3. Secured in a container as to avoid contamination of the components   
6.1.4 Preparation 
Preparation of the device includes solely the mounting of the device to the existing OCT Imaging devices 
one time before a day of imaging subjects by the study staff.  
The instructions are as follows:   
1. Remove the device from the container and calibrate the device by measuring the length of the 
subject’s face. 
2. Attach the chinrest mount to the OCT Imaging devices by placing the top and bottom parts of the 
invention, shown in the provisional patent attached, to the existing chinrest of the imaging device  
3. Click into place the right and left pieces into the extruded holes in the top and bottom parts of the 
attachment, shown in the second configuration of the chinrest mount in the provisional patent  
4. Push the ball joint section of the plate into one of the two grooved holes on the top of the 
attachment, either the right or left one depending on whether the OD/OS will be imaged first 
5. Wipe the exposed parts of the chinrest with an alcohol swab 
6. Secure the forehead rest attachment to the existing Cirrus device by sliding the clip down the 
front of the existing forehead rest  
7. Wipe the exposed parts of the forehead rest with an alcohol swab 
6.1.5 Administration 
The order in which a subject will be imaged on either OCT imaging device C/N and whether the Imager 
will begin with either the OD/OS eye will be randomized. This will be done by providing the NYU 
Ophthalmology Clinic with a total of 90 envelopes that the Imager will choose from a mixed pile in which 
they will be evenly divided with a message to begin with device C/N and to begin with eye OD/OS.  
The Standard Operating Procedure as to how to operate the novel device for imaging a subject can be 
seen below:  

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1. Sanitize chin and forehead rest  
2. Seat subject by device  
3. Move chinrest to either OD/OS  
a. Slide chinrest to either right/left side  
4. Size chinrest 
a. Subject should place their chin in the rest and technician should either pull apart/push 
together the chin rest to either make it larger/smaller to fit the patient  
5. Size mount of chinrest  
a. Pull apart the mount easily to allow for the chinrest’s length to be extended  
6. Lock extension  
a. Rotate knobs on both sides 
7. Find correct/comfortable angular position of the chinrest 
a. Push/move chinrest to position that it is comfortable i.e. not protruding into subject’s neck 
and subject feels relaxed  
8. Lock rotation  
a. Tighten the bolt placed around the ball joint  
9. Subject should rest forehead against the rest  
10. Technician /imager should check if subject has to be adjusted closer to the device (based on the 
image from the device)  
a. push/pull forehead rest by side of device so it will be adjusted along the grooved slot  
11. Size forehead rest  
a. tighten/loosen the strap on the side of the forehead rest to either make it smaller/larger 
for the patient (it will automatically lock into place) 
12. Check if subject is comfortable, adjust if need be  
13. Image subject according to scan protocol  
6.1.6 Duration of Therapy 
The duration of therapy includes one imaging session in which the subject is imaged on both device A 
and B for both eyes and has 1 scan of their Macula and 1 scan of their ONH acquired.  
For the second objective, an evaluable participant should be consistent with Section 10, Statistical 
Considerations and/or Statistical Analysis Plan (SAP) which will include the minimum time duration it can 
take for an image to be acquired which can provide a result yielding in a statistically significant value.  
 
6.1.7 Device Specific Considerations 
The device is comprised of multiple assemblies:  
1. Chinrest Assembly  
a. chinrest 
b. mount  
c. attachment to existing device 
2. Forehead rest Assembly  
a. forehead rest  
b. attachment to existing device  
 
While the shapes of the aforementioned assemblies are complex, their overall dimensions are in IPS unit 
system and have a tolerance of .01”, unless stated otherwise, are as follows: 
1.   
a. 4.40” x 3.40” x 0.77”    
b. 3.50” x 2.0” x 0.38”  

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c. 5.67” x 1.22” x 1.65” 
2.   
a. 5.0” x 2.10” x 0.61” 
b. 5.0” x 1.80” x 0.25”   
 
Furthermore, the frequency of exposure will be for just one imaging session.  
 
7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
7.1.1 Standard of Care Study Procedures 
Medical history will be obtained from medical records
 
Medication history should include medications currently being taken  
7.2
Imaging Procedures
 
Chin and forehead rest will be adjusted for each individual subject by following the appropriate 
procedure, shown in standard operating procedure attached 
 
OCT Imaging should include for each eye  
o 
Acquisition of 1 image of the Macula  
o 
Acquisition of 1 image of the ONH  
 
Two separate questionnaires will be provided to the subject before and after being imaged 
7.2.1 Clinical Laboratory Evaluations 
Not applicable as no labs will be needs.  
7.3 Concomitant Medications, Treatments, and Procedures
Not applicable.  
8 Assessment of Safety 
8.1 Safety, 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. 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 the 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. 
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. 

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Imaging will be performed using commercial (FDA approved) and non-commercial (non-FDA approved) 
OCT 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. 
 
8.1.1
Adverse Event
The IRB and participants will be notified immediately of any new information, in regards to this study. 
Expected and serious adverse events that occur will be reported to the 
IRB according to the IRB Reference Manual. 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 investigator 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 until resolution, stabilization, or until it has been determined that participation in the 
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 sub-investigators to 
determine whether the study should be continued, should be changed, or should be terminated. A copy of 
the DSMB report will be submitted to the IRB at the time of renewal. 
 
The PI will be ultimately responsibility for the data safety monitoring of the overall study. ADSMB will include 
the PI, sub-investigators  and clinical coordinators in conjunction with a licensed ophthalmologist, Dr. Joel 
Schuman, who will meet once every two months to monitor cumulative data points such as patient 
questionnaire, data acquisition time, adverse events, serious adverse events, withdrawals, early 
terminations recruitment, retention, confidentiality and adherence to the study protocol. At the time of 
obtaining renewal approval from the IRB, a report indicating whether there is any change in the risk benefit 
considerations of the study will be submitted. There are no specific stopping rules for this study. 
8.2 Time Period and Frequency for Event Assessment and Follow-Up 
The occurrence of an AE or SAE may come to the attention of study personnel during study visits and 
interviews of a study participant presenting for medical care, or upon review by a study monitor. All AEs 
including local and systemic reactions not meeting the criteria for SAEs will be captured on the 
appropriate RF. Information to be collected includes event description, time of onset, clinician’s 
assessment of severity, relationship to study product (assessed only by those with the training and 
authority to make a diagnosis), and time of resolution/stabilization of the event. All AEs occurring while on 
study must be documented appropriately regardless of relationship. All AEs will be followed to adequate 
resolution. 
Any medical condition that is present at the time that the participant is screened will be considered as 
baseline and not reported as an AE. However, if the study participant’s condition deteriorates at any time 
during the study, it will be recorded as an AE. UPs will be recorded in the data collection system 
throughout the study. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration of the event 
at each level of severity to be performed. AEs characterized as intermittent require documentation of 
onset and duration of each episode. 

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The PI will record all reportable events with start dates occurring any time after informed consent is 
obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation. At 
each study visit, the investigator will inquire about the occurrence of AE/SAEs since the last visit. Events 
will be followed for outcome information until resolution or stabilization.  
 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.  At the last scheduled visit, the 
investigator should instruct each subject to report any subsequent event(s) that the subject, or the 
subject’s personal physician, believes might reasonably be related to participation in this study.  The 
investigator should notify the IRB of any death or adverse event occurring at any time after a subject has 
discontinued or terminated study participation that may reasonably be related to this study.  The IRB 
should also be notified if the investigator should become aware of the development of cancer or of a 
congenital anomaly in a subsequently conceived offspring of a subject that has participated in this study.  
 
8.2.1
Unanticipated Problem Reporting
Incidents or events that meet the OHRP criteria for UPs require the creation and completion of an UP 
report form. The site investigator will report the UP to the IRB. The UP report will include the following 
information: 
 Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
 A detailed description of the event, incident, experience, or outcome; 
 An explanation of the basis for determining that the event, incident, experience, or outcome 
represents an UP; 
 A description of any changes to the protocol or other corrective actions that have been taken or 
are proposed in response to the UP. 
 
To satisfy the requirement for prompt reporting, UPs will be reported using the following timeline: 
 
 UPs that are SAEs will be reported to the IRB within a timeline that is in accordance with the policy 
of the investigator becoming aware of the event. 
 Any other UP will be reported to the IRB within a timeline that is in accordance with the policy of 
the investigator becoming aware of the problem. 
 All UPs should be reported to appropriate institutional officials (as required by an institution’s 
written reporting procedures), the supporting agency head (or designee), and OHRP within a 
timeline that is in accordance with the policy of the IR’s receipt of the report of the problem from 
the investigator. 
 
9  Clinical Monitoring 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable 
regulatory requirement(s). 
 
 Each clinical site will perform internal quality management of study conduct, data collection, 
documentation and completion. An individualized quality management plan will be developed to 
describe a site’s quality management. 

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10 Statistical Considerations
10.1 Statistical Hypotheses 
We hypothesize there will be a significant difference between the patient's experience in terms of comfort 
while being scanned using the attachment of the chin and forehead rest mounted on the existing 
ophthalmic devices. Additionally, we expect to see a significant improvement in time duration of adjusting 
motion artifacts. 
 
10.2 Sample Size Determination
Let P1 be the proportion of patients who report improvement of comfort and then P0=1-P1 be the proportion 
of patients who report no difference between two devices. The primary outcome of interest is to see if P_1 
is significantly bigger than 50% or not. With sample size of N=90 subjects, we will achieve 80% power to 
detect that P1 > 65.7% using a two-sided exact test of proportion with a significance level of 0.05. These 
results assume that the population proportion P1 under the null hypothesis is 50%. 
10.3 Statistical Methods
Unless otherwise specified, descriptive statistics for continuous variables include the number of patients 
with data (N), mean, standard deviation (SD), median, minimum, and maximum. The same number of 
decimal places as in the observed value are presented when reporting median, minimum, and maximum; 
one more decimal place than in the observed value is presented when reporting mean and quartiles; and 
two more decimal places than in the observed value is presented when reporting SD.  
Categorical data are presented using frequency counts and percentages. All percentages are rounded to 
one decimal place, unless otherwise specified. Percentages equal to 100 are presented as 100% and no 
percentages are presented for zero frequencies. Where individual variable values are missing, 
summaries of categorical data are based on reduced denominators (i.e., the denominators include only 
patients with available data) and the number of missing values is presented. 
The improvement of patient’s experience in terms of comfort will be assessed using two-sided exact test 
of proportion to compare P1 and P0. Further, the comfort levels of each device from all patients will be 
compared using t test. Linear mixed effect models will be utilized to compare the time duration of 
adjusting motion artifacts between two devices while accounting for inter-eyes correlations. The p values 
less than 0.05 will be considered as significant. 
 
10 Source Documents and Access to Source Data/Documents 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in 
source documents.  Examples of these original documents, and data records include: hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. It is acceptable to use CRFs as source 
documents. If this is the case, it should be stated in this section what data will be collected on CRFs and 
what data will be collected from other sources. 
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data 
requested on the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is 

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left blank because the procedure was not done or the question was not asked, write “N/D”.  If the item is 
not applicable to the individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any 
entry error has been made, to correct such an error, draw a single straight line through the incorrect entry 
and enter the correct data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR 
WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the clarification above the 
item, then initial and date it. 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, government regulatory bodies, 
and University compliance and quality assurance groups of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data etc.).  The investigator will 
ensure the capability for inspections of applicable study-related facilities (e.g. pharmacy, diagnostic 
laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
 
11 Quality Assurance and Quality Control 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be 
run on the database will be generated. Any missing data or data anomalies will be communicated to the 
site(s) for clarification/resolution. 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the study staff and inspection by local and 
regulatory authorities. 
12 Ethics/Protection of Human Subjects 
12.1 Ethical Standard
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
and/or the ICH E6. 
 
12.2 Institutional Review Board
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval. Approval of both the protocol and the consent form must be 
obtained before any participant is enrolled. Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study. All changes to the consent form 
will be IRB approved; a determination will be made regarding whether previously consented participants 
need to be re-consented. 
 

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12.3 Informed Consent Process
12.3.1 Consent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study agent, study procedures, and risks are given to the 
participant and written documentation of informed consent is required prior to starting 
intervention/administering study product.  
12.3.2 Consent Procedures and Documentation
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
benefits of participation will be provided to the participants and their families. Consent forms will be IRB-
approved and the participant will be asked to read and review the document. The investigator will explain 
the research study to the participant and answer any questions that may arise. All participants will receive 
a verbal explanation in terms suited to their comprehension of the purposes, procedures, and potential 
risks of the study and of their rights as research participants. Participants will have the opportunity to 
carefully review the written consent form and ask questions prior to signing. The participants should have 
the opportunity to discuss the study with their relatives or think about it prior to agreeing to participate. 
The participant will sign the informed consent document prior to any procedures being done specifically 
for the study. The participants may withdraw consent at any time throughout the course of the trial. A 
copy of the signed informed consent document will be given to the participants for their records. The 
rights and welfare of the participants will be protected by emphasizing to them that the quality of their 
medical care will not be adversely affected if they decline to participate in this study. 
 
A copy of the signed informed consent document will be stored in the subject’s research record. The 
consent process, including the name of the individual obtaining consent, will be thoroughly documented in 
the subject’s research record. Any alteration to the standard consent process (e.g. use of a translator, , 
consent document presented orally, etc.) and the justification for such alteration will likewise be 
documented.  
12.4 Participant and Data Confidentiality
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
 What protected health information (PHI) will be collected from subjects in this study 
 Who will have access to that information and why 
 Who will use or disclose that information  
 The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
 
Participant confidentiality is strictly held in trust by the participating investigators, their staff, and their 
agents. This confidentiality is extended to cover testing of biological samples and genetic tests in addition 
to the clinical information relating to participants. Therefore, the study protocol, documentation, data, and 
all other information generated will be held in strict confidence. No information concerning the study or the 
data will be released to any unauthorized third party without prior written approval of the study staff. 
 

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The study monitor, other authorized representatives of the study staff, representatives of the IRB or 
pharmaceutical company supplying study product may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, medical records (office, clinic, or hospital) and 
pharmacy records for the participants in this study. The clinical study site will permit access to such 
records. 
 
The study participant’s contact information will be securely stored at each clinical site for internal use 
during the study. At the end of the study, all records will continue to be kept in a secure location for as 
long a period as dictated by local IRB and Institutional regulations. 
 
Study participant research data, which is for purposes of statistical analysis and scientific reporting, will 
be transmitted to and stored at NYU Langone Medical Center. This will not include the participant’s 
contact or identifying information. Rather, individual participants and their research data will be identified 
by a unique study identification number. The study data entry and study management systems used by 
clinical sites and by NYU Langone Medical Center research staff will be secured and password protected. 
At the end of the study, all study databases will be de-identified and archived at the NYU Langone 
Medical Center. 
 
To further protect the privacy of study participants, a Certificate of Confidentiality will be obtained from the 
NIH. This certificate protects identifiable research information from forced disclosure. It allows the 
investigator and others who have access to research records to refuse to disclose identifying information 
on research participation in any civil, criminal, administrative, legislative, or other proceeding, whether at 
the federal, state, or local level. By protecting researchers and institutions from being compelled to 
disclose information that would identify research participants, Certificates of Confidentiality help achieve 
the research objectives and promote participation in studies by helping assure confidentiality and privacy 
to participants. 
 
13 Data Handling and Record Keeping 
13.1 Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, 
cross out the original entry with a single line, and initial and date the change. DO NOT ERASE, 
OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for 
recording data for each participant enrolled in the study. Data reported in the eCRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained 
and captured in a progress note and maintained in the participant’s official electronic study record. 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) will be 
entered into Trialmaster, a 21 CFR Part 11-compliant data capture system managed by NYULH 
DataCore. The data system includes password protection and internal quality checks, such as automatic 
range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical data will be 
entered directly from the source documents. 
13.2 Study Records Retention 

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Study documents will be retained for the longer of 3 years after close-out, 5 years after final 
reporting/publication, or 2 years after the last approval of a marketing application is approved for the 
device for the indication for which it is being investigated or 2 years after the investigation is discontinued 
and FDA is notified if no application is to be filed or if the application has not been approved for such 
indication. No records will be destroyed without the written consent of the study staff, if applicable. It is the 
responsibility of the study staff to inform the investigator when these documents no longer need to be 
retained. 
 
13.3 Protocol Deviations
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the participant, the investigator, or 
the study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
 
These practices are consistent with ICH E6: 
 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
 5.1 Quality Assurance and Quality Control, section 5.1.1 
 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site PI/study staff to use continuous vigilance to identify and report deviations 
within 1 working days of identification of the protocol deviation, or within 5 working days of the scheduled 
protocol-required activity. 
 
All protocol deviations must be addressed in study source documents, reported to a specific NIH IC 
Program Official.  
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the MOP. 
 
13.4 Publication and Data Sharing Policy
This study will comply with the NIH Public Access Policy, which ensures that the public has access to the 
published results of NIH funded research. It requires scientists to submit final peer-reviewed journal 
manuscripts that arise from NIH funds to the digital archive PubMed Central upon acceptance for 
publication. 
 
The International Committee of Medical Journal Editors (ICMJE) member journals have adopted a clinical 
trials registration policy as a condition for publication. The ICMJE defines a clinical trial as any research 
project that prospectively assigns human subjects to intervention or concurrent comparison or control 
groups to study the cause-and-effect relationship between a medical intervention and a health outcome. 
Medical interventions include drugs, surgical procedures, devices, behavioral treatments, process-of-care 
changes, and the like. Health outcomes include any biomedical or health-related measures obtained in 
patients or participants, including pharmacokinetic measures and adverse events. The ICMJE policy, and 
the Section 801 of the Food and Drug Administration Amendments Act of 2007, requires that all clinical 
trials be registered in a public trials registry such as ClinicalTrials.gov, which is sponsored by the National 
Library of Medicine. Other biomedical journals are considering adopting similar policies. For interventional 
clinical trials performed under NIH IC grants and cooperative agreements, it is the grantee’s responsibility 
to register the trial in an acceptable registry, so the research results may be considered for publication in 
ICMJE member journals. The ICMJE does not review specific studies to determine whether registration is 
necessary; instead, the committee recommends that researchers who have questions about the need to 

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register err on the side of registration or consult the editorial office of the journal in which they wish to 
publish. 
FDAAA mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register 
and report results of certain "applicable clinical trials": 
 
 Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations 
of a product subject to FDA regulation; 
 Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation 
(other than small feasibility studies) and pediatric post market surveillance studies. 
 NIH grantees must take specific steps to ensure compliance with NIH implementation of FDAAA. 
 
14 Study Finances 
14.1 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 NEI-R01-EY013178. 
 
14.2 Costs to the Participant 
Subjects will not be required to pay for any associated costs resulting from this study. 
14.3 Participant Reimbursements or Payments 
All participating subjects will receive $20 as compensation for their time. 
15 Interest Policy 
The PI, Dr. Wollstein, has potential conflicts of interest with this project. NYU COI committee have 
established a management plan that will be implemented for this project. 
 

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16 References
1. Park KH, Kim TW. OCT Imaging in Glaucoma : A Guide for Practitioners. Springer; 2021. 
2. CDC. Don’t Let Glaucoma Steal Your Sight! Centers for Disease Control and Prevention. 
Published November 24, 2020. https://www.cdc.gov/visionhealth/resources/features/glaucoma-
awareness.html 
3. Orbis International. Global blindness was slowing prior to pandemic study reveals. Orbis. 
Published October 11, 2021. https://www.orbis.org/en/news/2021/new-global-blindness-data 
 
 

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17 Attachments
These documents are relevant to the protocol, but they are not considered part of the protocol.  They are 
stored and modified separately. As such, modifications to these documents do not require protocol 
amendments. 
 
1. New Research Project Feasibility Questionnaire  
2. Questionnaire for Subjects  
3. Provisional Patent for the Novel Device  
4. Recruitment telephone script 

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CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as authorized in writing by the study sponsor
Interventional Template Version: 11 JAN 2019
 
18 Schedule of Events 
Activity 
Study 
Visit 
Study team procedures
Consent subject
X
Select randomized imaging protocol
X 
Clean first imaging device and attachments
X 
Adjust chin rest / head mount 
X 
Image subject 
X 
First imaging session survey 
X 
Clean second imaging device and attachments 
X 
Adjust chin rest / head mount 
X 
Image subject 
X 
Second imaging session survey 
X