A Prospective, Multi-center, Randomized, Masked, Controlled, Post-market Study Of Use Of The OMNI® Surgical System In Combination With Cataract Extraction In Open Angle Glaucoma (VERITA)
Phase: NA
Conditions: Glaucoma, Open-Angle
Sponsor: Sight Sciences, Inc.

Study of OMNI System in OAG 
Protocol # Rev A 
CONFIDENTIAL 
Sight Sciences 
 
Page 1 of 59 
 
 
 
 
A PROSPECTIVE, MULTI-CENTER, RANDOMIZED, MASKED, CONTROLLED, POST-MARKET STUDY OF USE 
OF THE OMNI® SURGICAL SYSTEM IN COMBINATION WITH CATARACT EXTRACTION IN OPEN ANGLE 
GLAUCOMA 
 
 
PROTOCOL ID #: 
 
 
CURRENT REVISION: 
 
Rev A 
REVISION DATE: 
 
July 31, 2020 
 
 
SPONSOR: 
Sight Sciences, Inc. 
4040 Campbell Avenue 
Suite 100 
Menlo Park, CA  94025 
877-266-1144 
 
 
Agreement of Principal Investigator 
I,  
 
 
 
 
 
 agree to conduct this trial in accordance 
with this clinical protocol and any amendments. 
 
 
 
 
 
 
 
 
 
 
 
Signature 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
Center Name  
 
 
 
 
City, State, Country 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation.  It must be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission. 
 

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Revision History 
 
Revision 
Date Issued 
ECO 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS ...................................................................................................................... 5 
2 
STUDY OBJECTIVE ........................................................................................................................... 8 
3 
BACKGROUND AND JUSTIFICATION FOR THE STUDY....................................................................... 8 
4 
STUDY DEVICE ............................................................................................................................... 11 
4.1 
INDICATIONS FOR USE .................................................................................................................... 11 
4.2 
DEVICE DESCRIPTION ...................................................................................................................... 11 
4.3 
TRAINING .................................................................................................................................... 13 
5 
STUDY DESIGN .............................................................................................................................. 13 
5.1 
STUDY DEVICE .............................................................................................................................. 13 
5.2 
STUDY SITES ................................................................................................................................. 13 
6 
STUDY ENDPOINTS........................................................................................................................ 13 
6.1 
EFFECTIVENESS ENDPOINTS .............................................................................................................. 13 
6.2 
SAFETY ENDPOINTS ........................................................................................................................ 14 
7 
STUDY SELECTION CRITERIA .......................................................................................................... 14 
7.1 
INCLUSION CRITERIA ....................................................................................................................... 14 
7.2 
EXCLUSION CRITERIA ...................................................................................................................... 15 
8 
STUDY PROCEDURES ..................................................................................................................... 16 
8.1 
STUDY SCHEDULE .......................................................................................................................... 16 
8.2 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION .................................................. 17 
8.3 
INFORMED CONSENT AND POINT OF ENROLLMENT................................................................................. 17 
8.4 
SCREENING VISIT ........................................................................................................................... 18 
8.5 
WASHOUT OF HYPOTENSIVE MEDICATIONS.......................................................................................... 18 
8.6 
BASELINE VISIT ............................................................................................................................. 19 
8.7 
SURGICAL PROCEDURE .................................................................................................................... 20 
8.8 
FOLLOW-UP VISITS ........................................................................................................................ 20 
8.9 
UNSCHEDULED VISITS ..................................................................................................................... 21 
8.10 
MANAGEMENT OF IOP AFTER SURGERY ......................................................................................... 21 
8.11 
WITHDRAWAL AND DISCONTINUATION ........................................................................................... 22 
8.12 
SUBJECTS LOST TO FOLLOW-UP .................................................................................................... 23 
9 
ADVERSE EVENTS (AES) ................................................................................................................. 23 
9.1 
DEFINITIONS OF AE, SAE, SADE, USADE .......................................................................................... 23 
9.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS ................................................................................ 24 
9.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS ............................................. 25 
10 
STATISTICAL CONSIDERATIONS ..................................................................................................... 26 
10.1 
SAMPLE SIZE CALCULATION ......................................................................................................... 26 
10.2 
ANALYSIS POPULATIONS ............................................................................................................. 26 
10.2.1 
Safety Population ........................................................................................................ 27 
10.2.2 
As Treated ................................................................................................................... 27 
10.3 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ............................................................................. 28 
10.4 
EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS ........................................................................ 28 
10.4.1 
Primary Effectiveness Endpoint .................................................................................... 28 

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10.4.2 
Sensitivity Analysis ...................................................................................................... 29 
10.4.3 
Covariate Analysis ....................................................................................................... 30 
10.4.4 
Other Important Clinical Effectiveness Outcomes ......................................................... 30 
10.4.5 
Additional Effectiveness Analyses ................................................................................ 31 
10.5 
SAFETY ANALYSIS ...................................................................................................................... 32 
10.5.1 
Adverse Event.............................................................................................................. 32 
10.5.2 
Best Corrected Visual Acuity (BCVA) ............................................................................. 32 
10.5.3 
Other Safety Outcomes ................................................................................................ 32 
10.6 
INTERIM ANALYSIS..................................................................................................................... 33 
10.7 
DEVIATION FROM THE STATISTICAL PLAN ........................................................................................ 33 
11 
MONITORING PROCEDURES ......................................................................................................... 33 
12 
DATA AND QUALITY MANAGEMENT ............................................................................................. 34 
12.1 
DATABASE MANAGEMENT .......................................................................................................... 34 
12.2 
SUBJECT IDENTIFICATION ............................................................................................................ 34 
12.3 
SUBJECT ACCOUNTABILITY ........................................................................................................... 35 
12.4 
CONFIDENTIALITY ...................................................................................................................... 35 
12.5 
SOURCE DATA AND CASE REPORT FORMS ....................................................................................... 35 
12.6 
RETENTION PERIOD ................................................................................................................... 35 
13 
PROTOCOL MODIFICATIONS AND DEVIATIONS ............................................................................. 36 
14 
DEVICE FAILURES AND MALFUNCTIONS ........................................................................................ 36 
15 
ETHICAL CONSIDERATIONS ........................................................................................................... 36 
15.1 
DECLARATION OF HELSINKI .......................................................................................................... 36 
15.2 
INSTITUTIONAL REVIEW BOARDS (IRB) ........................................................................................... 36 
15.3 
INFORMED CONSENT DOCUMENT (ICD) ......................................................................................... 37 
15.4 
PUBLIC LISTING OF STUDY ........................................................................................................... 37 
16 
STUDY ADMINISTRATION ............................................................................................................. 37 
16.1 
EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE ................................... 37 
16.2 
INVESTIGATOR RESPONSIBILITIES ................................................................................................... 38 
16.2.1 
General Responsibilities of Investigators ...................................................................... 38 
16.2.2 
Specific Responsibilities of Investigators ....................................................................... 38 
16.2.3 
Investigator Records .................................................................................................... 38 
16.2.4 
Investigator Reports .................................................................................................... 39 
16.3 
INVESTIGATOR AGREEMENT ......................................................................................................... 39 
17 
PUBLICATION POLICY .................................................................................................................... 40 
18 
BIBLIOGRAPHY .............................................................................................................................. 41 
19 
APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES ........................................... 43 
19.1 
LIST OF STUDY PROCEDURES ........................................................................................................ 43 
19.2 
PRO ...................................................................................................................................... 44 
19.3 
VISUAL ACUITY WITH MANIFEST REFRACTION ................................................................................... 44 
19.4 
MEASUREMENT OF INTRAOCULAR PRESSURE .................................................................................... 45 
19.5 
VISUAL FIELD EXAMINATION ........................................................................................................ 49 
19.6 
DILATED FUNDUS EXAMINATION ................................................................................................... 49 
19.7 
SLIT LAMP EXAMINATION ............................................................................................................ 49 
19.8 
GONIOSCOPY ........................................................................................................................... 52 
19.9 
OCULAR HYPOTENSIVE MEDICATIONS ............................................................................................ 52 
20 
APPENDIX B - DECLARATION OF HELSINKI ..................................................................................... 53 

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1 PROTOCOL SYNOPSIS 
Protocol Title 
A Prospective, Multi-center, Randomized, Controlled, Masked, Post-market 
Study of use of the OMNI® Surgical System in Combination with Cataract 
Extraction in Open Angle Glaucoma 
 
Protocol ID 
Number 
 
Study Device 
OMNI® Surgical System 
Control Group or 
Device  
 
Study Objective 
First, to prospectively compare the clinical effect of the transluminal 
viscoelastic delivery and trabeculotomy using the OMNI Surgical System to 
the 
 used with Cataract Extraction in eyes with open angle 
glaucoma (OAG) and second, to prospectively compare the clinical effect of 
the transluminal viscoelastic delivery using the OMNI Surgical System to the 
 used with Cataract Extraction in eyes with open angle 
glaucoma (OAG) 
Study Design 
Randomized, controlled, multi-center, post-market prospective study 
Primary 
Effectiveness 
Endpoint 
Primary inference will be based on a planned analysis when all subjects 
have completed the 12-month visit.  
• Mean change in unmedicated DIOP from baseline at the 12-month 
postoperative examination 
Other 
Effectiveness 
Endpoints 
• Proportion of eyes with a ≥ 20% decrease in unmedicated mean diurnal 
IOP (DIOP) from baseline  
• Proportion of eyes with unmedicated mean DIOP between 6 and 18 
mmHg inclusive  
• Mean change in the number of ocular hypotensive medications 
compared to Screening  
• Percent change in unmedicated DIOP from baseline  
Safety Endpoints 
• Rates of ocular adverse events (intraoperative, postoperative) 
• Reduction in best corrected distance visual acuity (BCVA) from baseline 
(note: reduction in BCVA due to posterior capsular opacity (PCO) will 
not be treated as a safety event) 
• Secondary Ocular Surgical Interventions, including laser, for IOP control 

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Exclusion Criteria 
A subject who meets any of the exclusion criteria listed below will not 
receive the study procedure: 
1. Any of the following prior treatments for glaucoma: 
o Laser trabeculoplasty ≤3 months prior to baseline 
o Implanted with iStent (All types), Cypass, Xen, Express, glaucoma 
draining device/valve, or Hydrus Device 
o Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, 
ECP or CPC 
2. Acute angle closure, normal tension, traumatic, congenital, malignant, 
uveitic, neovascular or severe glaucoma as documented in subjects’ 
medical record. 
3. Concurrent IOP-lowering procedure other than one of the study 
procedures listed under inclusion criterion 6 at the time of cataract 
surgery (e.g. ECP, CPC, etc.)  
4. In the Investigator’s judgement, predisposed to significant risk because 
of washout of ocular hypotensive medications. 
5. Concurrent ocular pathology or systemic medical condition which, in the 
Investigator's judgment, would either place the subject at increased risk 
of complications, contraindicate surgery, place the subject at risk of 
significant vision loss during the study period (e.g., wet AMD, corneal 
edema, Fuch’s dystrophy, active intraocular infection or inflammation 
within 30 days prior to Screening Visit, etc.), or interfere with 
compliance to elements of the study protocol (e.g., returning to 
Investigator’s office for follow-up visits). 
6. History of penetrating keratoplasty or another corneal transplant; 
corneal abnormality that would prevent reliable IOP measurement; e.g. 
kearatoconus or abnormally thick or thin cornea. 
7. BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to 
cataract. 
8. Participation (≤ 30 days prior to baseline) in an interventional trial which 
could have a potential effect on the study outcome, as determined by 
the study investigator. 
9. Women of childbearing potential if they are currently pregnant or 
intend to become pregnant during the study period; are breast-feeding; 
or are not in agreement to use adequate birth control methods to 
prevent pregnancy throughout the study. 

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OAG.3 Ocular side effects such as allergies, ocular surface disorders, blepharitis, 
pemphigoid, abnormal pigmentation etc. and systemic side effects such as bradycardia, 
headaches, depression, anxiety, confusion, dysarthria, hallucinations, lethargy, polyuria, 
weight loss, metabolic acidosis, etc. can occur during long term use of topical 
medications for management of OAG. 4 There is also a documented low rate of 
compliance and tolerability with eye drops that results in disease progression and loss of 
vision.5  The cost of these chronic medications and difficulty administering drops to the 
eyes contributes to poor compliance.  
 
The Ocular Hypertension Treatment Study showed that reduction of IOP by an average 
of 22.5% through medical intervention decreased conversion from ocular hypertension 
to glaucoma over a 5-year period to approximately half that of untreated controls (4.4 
vs. 9.5%).4 Similarly, the EMGT showed that treatment of newly diagnosed primary OAG 
with argon laser trabeculoplasty plus betaxolol reduced the risk of disease progression 
at 6 years to half of that for untreated controls (hazard ratio, 0.50; 95% confidence 
interval, 0.35–0.71).6 Each mmHg of IOP reduction decreased the risk of progression by 
approximately 10%.7 AGIS showed that eyes with 100% of visits with IOP less than 18 
mmHg over 6 years had mean changes from baseline in visual field defect score close to 
zero during follow-up.7  
 
Minimally (or micro) invasive glaucoma surgery (MIGS) provides an alternative to more 
invasive surgical methods (i.e. trabeculectomy or glaucoma drainage devices) or to laser 
procedures. MIGS procedures can generally be done along with cataract surgery 
minimizing additional risk or as standalone procedures. Several studies have 
demonstrated MIGS to provide long-term IOP lowering and the potential to reduce or 
eliminate the need for medications (and therefore reliance on patient adherence).8,9 
 
MIGS techniques that re-establish the aqueous outflow through the physiological 
pathways are gaining acceptance among glaucoma surgeons. Canaloplasty (originally 
 
3 Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, et al. The Ocular Hypertension Treatment Study: a 
randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of 
primary open-angle glaucoma. Arch Ophthalmol. 2002; 120:701–713. 
4 Kenji Inoue. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014; 8: 903–913. 
Published online 2014 May 12. doi:  10.2147/OPTH.S44708. 
5 Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common 
Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul; 
122(7):1308-16. 
6 Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: The 
Early Manifest Glaucoma Trial. Arch Ophthalmol 2003;121:48–56. 
7 The Advanced Glaucoma Intervention Study (AGIS): the relationship between control of intraocular 
pressure and visual field deterioration. The AGIS Investigators. Am J Ophthalmol 2000;130:429–40.  
8 Francis BA, Singh K, Lin SC, et al. Novel glaucoma procedures: a report by the American Academy of 
Ophthalmology. Ophthalmology 2011;118:1466–1480. 
9 Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin Ophthalmol 
2017;28:187–193. 

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OAG.19  Cataract surgery is known to reduce IOP in glaucoma patients.  Combined 
glaucoma and cataract surgery often result in a greater decrease in IOP and use of 
glaucoma medications compared with cataract surgery alone.20,21  When a patient with 
glaucoma also requires surgical intervention for cataract, the ophthalmologist often 
performs simultaneous cataract and glaucoma surgery.     
 
Note: A summary of known and potential risks to humans, as identified in the 
literature or through preclinical testing and/or prior clinical evaluations for the study 
devices can be found in the Instructions for Use for the OMNI Surgical System 
 
 
 
This prospective, multicenter, randomized controlled, post-market clinical trial will 
evaluate and compare clinical outcomes of i) ab-interno transluminal viscoelastic 
delivery and trabeculotomy using OMNI™ Surgical System, ii) ab-interno transluminal 
viscoelastic delivery using the OMNI™ Surgical System and iii) TM implantation 
 
 in patients with mild to moderate open angle glaucoma undergoing 
cataract surgery.  
4 STUDY DEVICE 
4.1 
INDICATIONS FOR USE 
The OMNI Surgical System has been 510k cleared by the US Food and Drug 
Administration (FDA) for the following indication for use: 
The OMNI® PLUS Surgical System is a manually operated device for delivery of 
small amounts of viscoelastic fluid, for example Healon® PRO or Healon GV® PRO 
from Johnson & Johnson Vision, Amvisc® from Bausch & Lomb, or PROVISC® 
from Alcon, during ophthalmic surgery. It is also indicated to cut trabecular 
meshwork tissue during trabeculotomy procedures.  
4.2 
DEVICE DESCRIPTION 
The OMNITM Surgical System (“OMNI”) is a sterile, single use, manually operated 
instrument used by ophthalmologists to deliver small, controlled amounts of viscoelastic 
 
19 Bourne RRA, Stevens GA, White RA, et al. Causes of vision loss worldwide, 1990-2010: a systematic 
analysis. Lancet Glob Heal. 2013;1:339–349. 
20 Zhang ML, Hirunyachote P, and Jampel H. Combined surgery versus cataract surgery alone for eyes with 
cataract and glaucoma. Cochrane Database Syst Rev. 2015; 7: CD008671 
21 Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, Brown RH, Ianchulev T; CyPass Study 
Group. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in 
Patients with Open-Angle Glaucoma and Cataracts. Ophthalmology. 2016 Oct;123(10):2103-12. doi: 
10.1016/j.ophtha.2016.06.032. 

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into the anterior segment of the eye during ophthalmic surgery. It is also indicated to 
cut trabecular meshwork tissue during trabeculotomy procedures.  
The OMNI is designed to function with commonly used viscoelastic fluids made 
commercially available by companies such as Abbott Medical Optics (AMO), Bausch & 
Lomb, and Alcon. The OMNI dispenses fluid on the principle of exchanging volumes 
much like a syringe. The handheld instrument includes a cannula, microcatheter, 
internal reservoir and plunger tube, and finger wheels. The finger wheels on the handle 
of the device are used to advance and retract the microcatheter.  In addition, when the 
device is being used to deliver viscoelastic, retraction of the microcatheter causes the 
plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing 
viscoelastic fluid.  
The microcatheter can be advanced/retracted up to 20 mm per cycle.  The 
microcatheter can be fully advanced/retracted up to 5 times (i.e. 5 full cycles of 20 mm 
each).  Dispensation of viscoelastic can only occur during the first two 20-mm cycles. 
The OMNI can deliver approximately 5.5 microliters of viscoelastic in each 20 mm cycle 
(total volume = 11 microliters). The Plus configuration can deliver approximately 10.5 
microliters of viscoelastic in each 20 mm cycle. The total volume of viscoelastic that can 
be delivered by the OMNI Plus is approximately 21 microliters.  
Figure 1:  OMNI Surgical System 
 

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4.3 
TRAINING 
Investigators participating in the study must be experienced in using the OMNI 2.0 
(OMNI NextGen) Surgical System.  All study staff will receive training on the protocol 
and execution of the study according to applicable regulations and Good Clinical 
Practices. 
5 STUDY DESIGN 
This is a prospective, randomized, controlled, multicenter, comparative study in which a 
total of 459 subjects will be randomized in an equal allocation ratio (1:1:1) to either the 
OMNI (transluminal viscoelastic delivery AND trabeculotomy), OMNI (transluminal 
viscoelastic delivery only), or 
 and followed for 36 months after surgery.  
 
The study will employ a medication washout 
 
 which eliminates the potential confounding influence of ocular 
hypotensive medications in the assessment of device effectiveness. 
 
5.1 
STUDY DEVICES 
The study device is the OMNI Surgical System.  Subjects randomized to one of the two 
OMNI treatment groups will undergo either  
•Ab-interno transluminal viscoelastic delivery (up to 360 degrees) and trabeculotomy 
(at least 180 degrees and up to 360 degrees) using the OMNI Surgical System  
•Ab-interno transluminal viscoelastic delivery (up to 360 degrees) using the OMNI 
Surgical System 
The Comparator group is the 
. 
 
 
 
5.2 
STUDY SITES 
This study will be conducted at up to 30 sites in the United States.   
6 STUDY ENDPOINTS 
6.1 
EFFECTIVENESS ENDPOINTS 
The Primary effectiveness endpoint is:    
 
• Mean change in unmedicated DIOP from baseline at 12-month postoperative 
examination  

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5. At baseline, 
 IOP at least 3 mmHg higher 
than screening IOP. 
6. Scheduled for cataract extraction followed by either: 
a) ab-interno transluminal viscoelastic delivery with trabeculotomy using OMNI 
surgical System  
d) ab-interno transluminal viscoelastic delivery using OMNI surgical System  
e) 
 
7. Shaffer grade of ≥ III in all four quadrants. 
8. Potential of good best corrected visual acuity post cataract extraction, in the 
investigator's judgment 
9. Able and willing to comply with the protocol, including all follow-up visits. 
10. Understand and sign the informed consent. 
7.2 
EXCLUSION CRITERIA 
A subject who meets any of the exclusion criteria listed below will not receive the study 
procedure: 
1. Any of the following prior treatments for glaucoma: 
o Laser trabeculoplasty ≤3 months prior to baseline 
o Implanted with iStent (All types), Cypass, Xen, Express, glaucoma draining 
device/valve, or Hydrus Device 
o Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC 
2. Acute angle closure, normal tension, traumatic, congenital, malignant, uveitic, 
neovascular or severe glaucoma as documented in subjects’ medical record. 
3. Concurrent IOP-lowering procedure other than one of the study procedures listed 
under inclusion criterion 6 at the time of cataract surgery (e.g. ECP, CPC, etc.)  
4. In the Investigator’s judgement, predisposed to significant risk because of washout 
of ocular hypotensive medications. 
5. Concurrent ocular pathology or systemic medical condition which, in the 
Investigator's judgment, would either place the subject at increased risk of 
complications, contraindicate surgery, place the subject at risk of significant vision 
loss during the study period (e.g., wet AMD, corneal edema, Fuch’s dystrophy, active 
intraocular infection or inflammation within 30 days prior to Screening Visit, etc.), or 
interfere with compliance to elements of the study protocol (e.g., returning to 
Investigator’s office for follow-up visits). 
6. History of penetrating keratoplasty or another corneal transplant; corneal 
abnormality that would prevent reliable IOP measurement; e.g. kearatoconus or 
abnormally thick or thin cornea. 
7. BCVA of logMAR 1.0 (20/200) or worse in the fellow eye not due to cataract. 
8. Participation (≤ 30 days prior to baseline) in an interventional trial which could have 
a potential effect on the study outcome, as determined by the study investigator. 
9. Women of childbearing potential if they are currently pregnant or intend to become 
pregnant during the study period; are breast-feeding; or are not in agreement to use 
adequate birth control methods to prevent pregnancy throughout the study. 

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8.2 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION 
Approximately 459 subjects will be randomized (1:1:1) to treatment, 
 
 
 
 No site 
will randomize more than 25% of the total number of subjects without prior approval 
from Sponsor. 
 
 
 
 
Study subject participation will be from approximately 35 months, (at a minimum) to 40 
months, depending on the length of the required medication washout prior to baseline 
and if additional washout is needed 
 for subjects presenting at 
these visits with ocular hypotensive medication. 
 
It is anticipated that the enrollment period for the study will last approximately 24 
months.  Including the 40-month follow-up period, the study is expected to last 54 
months. 
8.3 
INFORMED CONSENT AND POINT OF ENROLLMENT 
The IRB-approved informed consent will be presented and explained to each 
prospective subject by the investigator or a trained clinical professional.  Once the 
subject has had ample time to read the consent form, has been informed of all aspects 
of the study, and has had an opportunity to ask questions, the subject will be given a 
choice to voluntarily confirm his or her participation in the study as documented by 
completion of the Informed Consent.  After signing the Informed Consent and the HIPAA 
(Health Insurance Portability and Accountability Act) authorization, the subject can then 
proceed with the screening visit.  The subject has the right to withdraw from the study 
at any time without consequences, as indicated in the Informed Consent Document. 
 
The subject’s signed and dated informed consent must be obtained before conducting 
any study specific procedures that are not part of the standard of care.  Subjects are 
enrolled upon signing the ICD even if they subsequently fail to meet the eligibility 
criteria.   
 
The principal investigator(s) must retain the original, signed written Informed Consent 
Document.  A copy of the written Informed Consent Document must be given to the 
subject. 

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8.4 
SCREENING VISIT 
After obtaining an understanding of the purpose of this study, then reviewing and 
signing the Informed Consent Document, all potential subjects will undergo an initial 
screening examination in order to determine their eligibility for the study. Exams and 
tests listed in the Screening column of Table 1 should be performed.  Refer to Appendix 
A for instructions for performing the exams. 
 
 
 
Exam data collected on subjects prior to enrollment as part of the routine clinical 
practice may serve as Screening data as long as it was collected within 15 days prior to 
the visit.  The only exceptions to this are: 
 
• IOP and IOP-lowering medications.  These data must be collected at the 
Screening visit. 
• Visual field:  Visual Fields conducted per the protocol method (Humphrey 24-2 
SITA standard) within 6 months of the screening visit will be acceptable. 
8.5 
WASHOUT OF HYPOTENSIVE MEDICATIONS 
Subjects on ocular hypotensive medication who meet all eligibility criteria at the 
screening visit will be instructed to discontinue their ocular hypotensive medication 
regimen, and to return for a Baseline visit after completing the appropriate washout 
period. The final eligibility assessment will happen at baseline visit. 
 
 
 
 
 
 
  
 
If the study subject fails to remember to not use ocular hypotensive medication for the 
study eye per the required washout period, they can be reinstructed to restart washout 
and return for the Baseline or other washout IOP visits as long as it falls within the 
specified visit window. If deemed necessary by the PI, a subject can be given 
hypotensive medications after the baseline visit until the day of surgery. An oral 
hypotensive medication can be used between baseline to surgery. The minimum wash-
out periods are specified in Table 2 below.  
 
 
 

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Sponsor at all times is the health and safety of the subjects. Usage of hypotensive 
medications specifically indicated for prevention of IOP spikes following Nd:YAG 
capsulotomy and administered for up to 72 hours after Nd:YAG 
capsulotomy will not be considered rescue therapy.  
 
Medications which have been re-started by the Investigator may be discontinued if the 
Investigator’s judgment is that the target intraocular pressure has been reached and the 
continued use of some or all of the therapy may not be required. Discontinuation of 
medications after re-introduction is recommended to be in the reverse order of re-
introduction.  The rationale for discontinuation should also be documented in the 
subject’s medical record.   
 
A record of all ocular hypotensive medications added, discontinued or changed will be 
documented on the appropriate CRF for each scheduled visit or on a CRF for an 
Unscheduled Visit, if necessary. 
 
Another potential reason for intervention is hypotony.  Intervention should only be 
considered if the hypotony has caused or is likely to cause sequelae such as a flat 
chamber or retinal detachment. No intervention is indicated when the vision is 
unchanged from screening, there is no persistent choroidal detachment, the anterior 
chamber is not flat with lens corneal touch, or the patient is asymptomatic.  No 
intervention should be undertaken for hypotony which is not causing, or threatening to 
cause, a reduction in vision. 
 
Secondary IOP-Lowering Interventions to Control IOP 
 
If the subject requires another glaucoma procedure to control their IOP, the subject 
should continue to be followed according to standard of care until the adverse event 
resolves or 1-month post-re-intervention, whichever is longer.  Following this, the 
subject should be withdrawn from the study. 
 
Subjects who have had a secondary IOP-lowering intervention will be considered 
treatment failures for the purpose of the endpoint analyses.  For the primary 
effectiveness endpoint of the study, the corresponding baseline unmedicated DIOP will 
be used to impute the 12-month unmedicated DIOP.  These subjects will be included in 
the Safety Endpoint analyses through their withdrawal from the study. 
8.11 WITHDRAWAL AND DISCONTINUATION 
All subjects have the right to withdraw at any point during the study without prejudice.  
The investigator can discontinue any subject at any time at his/her discretion, or if 
continued participation in the study would result in harm to the subject.  All efforts 
should be made by the investigator to retain the subject in the study.  If a subject 
withdraws prematurely from the study, a genuine effort must be made to determine the 

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reason(s) the subject discontinued the study.  The reason must be recorded in the 
subject’s file and on the Study Exit Form.   
8.12 SUBJECTS LOST TO FOLLOW-UP 
Subjects who do not show up for a follow-up must be contacted to attempt to have 
them come for the follow-up.  For those subjects who cannot be reached, every attempt 
to contact with the subject should be documented. If a subject misses two consecutive 
follow-up visits without any contact with the study staff, the subject will be considered 
lost-to-follow-up unless there is a further communication by the subject. 
9 ADVERSE EVENTS (AES) 
Adverse Events are defined below.  Adverse events that occur in the eye during the trial, 
whether they are considered to be device related or not, must be documented in the 
subject’s records.  Date of the event, its severity, treatment (if any) and the assessed 
relationship of the event to the study device will be recorded on the Adverse Event 
Form.  Conditions which exist at the time the subject is enrolled will be considered pre-
existing conditions and do not need to be recorded as adverse events unless they 
increase in severity during the study. Sites should document any known existing medical 
and ophthalmic conditions at the time of screening. 
 
9.1 
DEFINITIONS OF AE, SAE, SADE, USADE 
Adverse Event 
Any untoward medical occurrence in a subject who has been 
treated with the device that does not necessarily have causal 
relationship with the treatment. 
Adverse Device 
Effect 
Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease that is possibly related 
to the study device. 
Serious Adverse 
Event (SAE) 
Any untoward medical occurrence that: 
• Results in death 
• Is life-threatening 
• Requires in-patient hospitalization or prolongs existing 
hospitalization 
• Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent 
damage to a body structure 
• Sight-threatening 
Unanticipated 
Adverse Device 
Effect 
Any serious adverse effect on health or safety, any life-
threatening problem or death caused by, or associated with a 
device if that effect, problem, or death was not previously 

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identified in nature, severity, or degree of incidence in the 
clinical investigational plan; or any other unanticipated serious 
problem associated with a device that relates to the rights, 
safety, or welfare of subjects (21 CFR 812.3(s)). Any sight-
threatening event, whether listed in the protocol or not, is 
considered to be reportable as a UADE. 
 
9.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS 
Anticipated potential adverse events listed below include those that might reasonably be 
expected to occur in this study because they are associated with glaucoma, ab-interno 
transluminal viscoelastic delivery, trabeculotomy, trabecular bypass stent, and/or the risk 
analysis for OMNI System. Adverse events may occur intra-operatively or post-
operatively. 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
 
 
 
 
 
 
 
 
 
 
22 To avoid double counting an event, events of IOP ≥ 10 mmHg above baseline IOP at ≥1 month visit that 
require management with systemic medication or secondary surgical intervention should be reported 
as “IOP increase requiring management with systemic medication at ≥1 month visit” or “Need for 
secondary surgery intervention to manage IOP,” respectively. 
23 Hypotony is defined as “early” if it occurs within 2 weeks of surgery and “late” if it occurs more than 2 
weeks after surgery 

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• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
9.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS 
Identification, collection and reporting of adverse event information is the responsibility 
of the principal investigator.  The investigator records the date of the event, its severity, 
treatment (if any) and the assessed relationship of the event to the study device on the 
Adverse Event Case Report Form (AE CRF).   
Any ocular serious adverse event (SAE) should be reported to the study sponsor within 
one business day of learning of the event.  Non-ocular SAEs should be reported to the 
study sponsor within two working days of learning of the event. Email the AE CRF to 

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OMNIsafety@sightsciences.com and enter data in EDC system within two working days 
of learning of the event. 
Any unanticipated adverse device effects (UADE) must be reported to the following 
two entities: 
1. The study sponsor – Within one working day of the investigator first learning of 
the event, e-mail the AE CRF to OMNIsafety@sightsciences.com and enter data 
in EDC; and  
2. The reviewing IRB – As soon as possible, but no later than 10 working days after 
the investigator first learns of the event, report per the IRB’s instructions.  
The sponsor will conduct an evaluation of unanticipated adverse device effects.  If the 
sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to subjects, parts of the investigation presenting risks will be 
terminated. Termination will occur no later than 5 working days after the sponsor 
makes such a determination and no later than 15 working days after the sponsor first 
received notice of the effect. 
10 STATISTICAL CONSIDERATIONS 
10.1  SAMPLE SIZE CALCULATION 
The sample size calculation is based on the primary effectiveness endpoint, mean 
change in unmedicated DIOP from baseline at the 12-month postoperative examination.  
The study goal is to determine, in reducing the IOP in eyes with OAG undergoing 
cataract extraction, either OMNI (ab-interno transluminal viscoelastic delivery AND 
trabeculotomy) is superior 
, or OMNI (ab-interno transluminal 
viscoelastic delivery alone) is not inferior to the 
 in lowering the IOP with a 
non-inferiority margin of 1.5 mmHg.  Due to the multiplicity, the significance level is 
adjusted to a two-sided significance level of 0.025 for each of the two hypotheses.  The 
statistical hypotheses for the primary effectiveness endpoint are as follows: 
Hypothesis I: 
H0: µO2 = µi versus Ha: µO2 < µi, where µO2 and µi are the mean change in unmedicated 
DIOP from baseline at the 12-month postoperative examination for the OMNI (ab-
interno transluminal viscoelastic delivery AND trabeculotomy) and 
 groups, 
respectively.  A negative mean change represents a mean reduction.  The alternative 
hypothesis (Ha: µO2 < µi) is to prove that the mean change in unmedicated DIOP of the 
OMNI (ab-interno transluminal viscoelastic delivery AND trabeculotomy) group is lower 
than that of the iStent inject group.  In other words, the OMNI (ab-interno transluminal 
viscoelastic delivery AND trabeculotomy) is superior to the 
 group in 
lowering the IOP. 

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the primary and other effectiveness endpoints.  The effectiveness analyses may be 
performed for the ITT population if needed. 
10.3 DEMOGRAPHICS AND BASELINE CHARACTERISTICS  
Subject demographics (age, race/ethnicity and gender) will be summarized by study 
group for the ITT, AT, and Safety populations using descriptive statistics.  Age will be 
summarized as a continuous variable and categorized into the four groups based on the 
observed quartiles. 
 
The baseline medicated IOP and washout (unmedicated) IOP will be summarized by 
study groups for the ITT and AT populations.  They will be treated as continuous 
variables.  The number of glaucoma medications in use at enrollment will be prepared 
for each of the study groups using descriptive statistics for categorical variables. 
Medical and Ocular history will be summarized for each study group by number and 
percentage of subjects in the ITT and AT population. 
 
For the Safety Population, ITT, and AT populations, subject accountability will be 
prepared based on Table G.1 of ANSI Z80.27-2014. 
10.4 EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS 
Descriptive statistics on continuous variables will include mean, standard deviation, 
median, minimum, and maximum.  Confidence intervals for change from baseline will be 
included for selected endpoints. Categorical variables will be summarized using 
frequency counts and percentages.  Exact confidence intervals for point estimates may 
be provided.  Statistical testing will be one-sided with a significance level of 0.025 or 
two-sided significance level of 0.05 unless specify otherwise.  Data listings of individual 
subject data may be provided. 
 
10.4.1 PRIMARY EFFECTIVENESS ENDPOINT 
The primary analysis of the primary effectiveness endpoint will be based on the AT 
population.  The Baseline unmedicated DIOP will be used to impute the 12-month 
unmedicated DIOP for the subjects meeting any of the following criteria: 
• Ocular hypotensive medications cannot be washed out properly at 12 months 
due to safety reasons. 
• Have secondary surgical interventions (such as laser procedure or MIGS) to 
control IOP before the 12-month washout. 
• Have any ocular procedures that can affect the IOP before the 12-month 
washout. 

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• Have IOP below 6 mmHg at 1 month or later 
• Do not have the 12-month washed out DIOP due to any other reasons. 
 
The change in unmedicated DIOP from baseline at 12 months will be calculated for each 
study eye as change = (12-month unmedicated DIOP – Baseline unmedicated DIOP).   
 
The descriptive statistics (such as mean, standard deviation, median, minimum, and 
maximum) of the medication-free mean diurnal IOP and the change from baseline and 
the 95% confidence interval of the mean will be calculated for each of the three study 
groups.  A two-sample t-test with a one-sided significance level of 0.025 will be used to 
compare the mean unmedicated DIOP change from baseline at 12 months for 
Hypotheses I and II described in Section 10.1.  The two-sided 95% confidence interval 
based on the t-distribution will also be provided for the mean difference.  In order to 
assess the pattern of the distribution, box-plots will be prepared for the medication-free 
mean diurnal IOP and its change from baseline for each of the three study groups. 
10.4.2  SENSITIVITY ANALYSIS 
A tipping-point analysis will be performed for the primary effectiveness endpoint.  Let n 
and m be the number of OMNI and 
 subjects that do not have the 12-month 
washed out DIOP due to any reasons other than the first four criteria listed in Section 
10.4.1.  The tipping-point analysis for Hypothesis I in Section 10.1 will be performed as 
follows: 
Let XO2 be the sample mean of the unmedicated DIOP change from baseline at 12 
months for all OMNI (transluminal viscoelastic delivery AND trabeculotomy) subjects 
except for the n subjects and let Xi be that of the 
 excluding the m 
subjects.  Let ω and ν be the worst and best unmedicated DIOP change from baseline at 
12 months observed from the subjects.  The increment of 0.05 mmHg will be used in the 
tipping-point analysis.  The first iteration in the tipping point analysis is to use XO2 to 
impute the missing values for the n subjects, use Xi to impute the missing values for the 
m subjects, and calculate the p-value of the statistical test described in Section 10.4.1.  
The second iteration is to use XO2 + 0.05 (i.e., worse than XO2) to impute the missing 
values for the n subjects and Xi - 0.05 (i.e., better than Xi) to impute the missing values 
for the m subjects.  The ith iteration is to use XO2 + 0.05 × i to impute the missing values 
for the n subjects and Xi – 0.05 × i to impute the missing values for the m subjects.  The 
iterations will stop when the p-value becomes insignificant or the imputed value for the 
OMNI (transluminal viscoelastic delivery AND trabeculotomy) group is worse than the ω 
value or the imputation for the 
 is better than the ν value, which 
comes first. A figure of p-value as the Y-axis and iteration as the X-axis will be provided. 
The same tipping point analysis will also be performed for Hypothesis II in Section 10.1. 

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10.4.3  COVARIATE ANALYSIS 
The following variables will be examined for their prognostic value to the primary 
effectiveness endpoint using the AT population with the imputation used for the 
primary analyses: 
• Age group (based on observed quartiles) 
• Gender (male and female) 
• Race/ethnicity 
• Baseline unmedicated DIOP group (based on observed quartiles) 
• Number of ocular hypotensive medications at screening 
• Study Site 
For the primary effectiveness endpoint, two-way ANOVA with study group (three 
groups), one of the factors listed above, and the interaction between the study group 
and the factor will be used to check the possible covariate effects.  A p-value of 0.15 will 
be used for evaluating the possible covariate effects.  It should be noted that the 
subgroups of these covariates will be re-examined and may be re-categorized or 
eliminated due to small sample size (if there are < 10 subjects within each subgroup). 
The scatter plots of the 12-month unmedicated DIOP versus the baseline unmedicated 
DIOP along with a 45º line will be provided.  The scatter plot of the percent change in 
unmedicated DIOP from baseline to 12 months versus the baseline unmedicated DIOP 
will also be provided.  The Box plots of the change and percent change in unmedicated 
DIOP from baseline to 12 months will be prepared for each category of the covariates 
(except for the study site). 
10.4.4 OTHER IMPORTANT CLINICAL EFFECTIVENESS OUTCOMES 
The statistical analyses for the other effectiveness endpoints will be based on the 
available data of the AT population.  The percent change in unmedicated DIOP from 
baseline at 12 months will be calculated for each study eye as  
% change = (12-month unmedicated DIOP – Baseline unmedicated DIOP) ÷ 
(Baseline unmedicated DIOP) × 100%.   
The number and percent of subjects achieving ≥ 20% reduction in unmedicated DIOP 
from baseline at 12 months (i.e., 12-month responder) will be calculated.  The exact 95% 
confidence interval of the 12-month responder rate will be calculated by the binomial 
distribution for each study group separately.  The difference in the 12-month responder 
between OMNI (transluminal viscoelastic delivery AND trabeculotomy) and 
 
groups and the corresponding 95% confidence interval per normal distribution will be 
calculated.  The same statistics will be provided for the difference in the 12-month 
responder between OMNI (transluminal viscoelastic delivery) and 
 groups.  
The same statistical methods will be used to summarize the subjects with an 
unmedicated DIOP between 6 and 18 mmHg inclusive at 12 months. 

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The descriptive statistics for the continuous variables will be used to summarize the 
change in number of ocular hypotensive medications used from screening to 12 months.  
The ANOVA with study treatment group (three groups) as the factor will be used to 
compare the mean difference in the change in number ocular hypotensive medications 
used from screening to 12 months.  The mean difference between OMNI (transluminal 
viscoelastic delivery AND trabeculotomy) and 
 and that between 
OMNI (transluminal viscoelastic delivery) and 
 will be evaluated using 
Dunnett's test.  The same methods will be used to analyze the percent change in 
unmedicated DIOP from baseline to 12 months. 
 
The analyses described in this section are exploratory in nature. 
10.4.5 ADDITIONAL EFFECTIVENESS ANALYSES 
The analyses described in this section are exploratory in nature.  All the analyses will be 
based on the observed data of the AT population by the three study groups. 
• Count and percent of subjects with the following DIOP change from baseline to 
12 months stratified by the use of ocular hypotensive medication and/or SSI that 
can affect the IOP: 
o 40% ≤ Change (i.e. increase ≥ 40%) 
o 30% ≤ Change < 40% (i.e. 30% ≤ increase < 40%) 
o 20% ≤ Change < 30% (i.e. 20% ≤ increase < 30%) 
o 10% ≤ Change < 20% (i.e. 10% ≤ increase < 20%) 
o 0% < Change < 10% (i.e. 0% < increase < 10%) 
o Change = 0% (i.e. no change) 
o -10% < Change < 0% (i.e. 0% < decrease < 10%) 
o -20% < Change ≤ -10% (i.e. 10% ≤ decrease < 20%) 
o -30% < Change ≤ -20% (i.e. 20% ≤ decrease < 30%) 
o -40% < Change ≤ -30% (i.e. 30% ≤ decrease < 40%) 
o -50% < Change ≤ -40% (i.e. 40% ≤ decrease < 50%) 
o Change ≤ -50% (i.e. decrease ≥ 50%) 
• Count and percent of subjects with the following DIOP 12 months stratified by 
the use of ocular hypotensive medication and/or SSI that can affect the IOP: 
o ≥6 mmHg to ≤ 21 mmHg 
o ≥6 mmHg to ≤ 18 mmHg 
o ≥6 mmHg to ≤ 15 mmHg 
o ≥6 mmHg to ≤ 12 mmHg 
• IOP, IOP change, and IOP percent change from baseline at each visit (excluding 
use of ocular hypotensive medication and/or SSIs that can affect the IOP) 
• The number of ocular hypotensive medications and change in the number of 
ocular hypotensive medications from screening to each post-operative 

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examination (including at 12 months prior to washout) excluding subjects 
treated with SSIs that can affect the IOP. 
• The survival analysis (Kaplan Meier curve) with the log-rank test for the time to 
the first secondary surgery intervention (SSI) for controlling the IOP. 
• The survival analysis with the log-rank test for the time to the first ocular 
hypotensive medications at or after 1 month postoperative.  The analysis will 
include the cases with medications taken before 1 month and ongoing after 1 
month. 
• The survival analysis with the log-rank test for the time to the first SSI or the first 
ocular hypotensive medications at or after 1 month postoperative, whichever 
comes first. 
10.5 SAFETY ANALYSIS 
All safety analyses will be performed on the safety analysis population based on all 
available data by the three study groups separately. 
10.5.1 ADVERSE EVENT 
AE will be classified as pretreatment, intraoperative, or postoperative. The number and 
the percent of eyes reporting at least 1 AE of a given type will be summarized.  
Additionally, the number of reports of each type of AE will be provided. 
Each AE will be summarized by incidence, percentage and the corresponding 95% 
confidence interval. 
10.5.2 BEST CORRECTED VISUAL ACUITY (BCVA) 
The number and percent of eyes reporting with BCVA of 20/20 or better, 20/25 or 
better, 20/32 or better, 20/40 or better, worse than 20/40 to 20/80, worse than 20/80 
to 20/200, and worse than 20/200 at each visit will be summarized.  The number and 
percent of eyes reporting BCVA of increase ≥ 10 letters, increase 10 letters, increase ≥ 5 
letters to < 10 letters, within 5 letters change, decrease ≥ 5 letters to < 10 letters, 
decrease 10 letters, and decrease ≥ 10 letters at each postoperative visit will be 
calculated. 
10.5.3 OTHER SAFETY OUTCOMES 
The number and percent of eyes reported with each kind of slit lamp findings, 
gonioscopy findings, and dilated fundus examination findings at each visit will be 
provided. 
The descriptive statistics for the continuous variables will be derived for the visual field 
mean deviation (MD) and pattern standard deviation (PSD). 

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10.6 INTERIM ANALYSIS 
An interim analysis providing descriptive statistics for the outcomes may be completed 
following completion of the Month 6 follow-up visit by 80% of the randomized subjects. 
Endpoints listed below will be analyzed at an interim analysis. No device effectiveness 
will be claimed based on the interim analysis outcomes. 
 
Effectiveness outcomes up to 6 months will be summarized descriptively: 
1. Percent of eyes with a ≥20% reduction in IOP with no increase in IOP-lowering 
medications compared to screening visit 
2. Percent of eyes with IOP between 6 and 18 mmHg with no increase in IOP-
lowering medications compared to screening visit 
3. Percent of eyes with IOP between 6 and 21 mmHg with no increase in IOP-
lowering medications compared to screening visit 
4. Reduction in mean IOP from screening visit; and 
5. Reduction in mean number of IOP-lowering medications from screening visit for 
the subjects who are on medications at the screening visit 
 
Safety endpoints: 
 
1. Rates of ocular adverse events (intraoperative, postoperative) 
2. Reduction in best corrected visual acuity (BCVA) from baseline (note: reduction 
in BCVA due to PCO will not be treated as a safety event) 
10.7 DEVIATION FROM THE STATISTICAL PLAN 
Any deviations from the statistical plan will be noted in the final report. 
11 MONITORING PROCEDURES 
Sight Sciences or contract research organization (CRO) personnel will monitor the study 
in a manner consistent with FDA regulations, good clinical practices and the clinical 
research standards adopted by Sight Sciences.  Study monitoring will be executed using 
on-site and remote monitoring visits. Study monitoring will involve the following 
elements: 
 
• Site Qualification:  Sight Sciences or CRO personnel will meet with investigators 
and clinical study staff prior to the initiation of the study in order to review the 
adequacy of the subject population, facilities, and equipment with respect to 
the needs of the study, and to familiarize the investigator with the study 
protocol.  If Sight Sciences or the CRO have recently been involved with an 
investigator for another study, a site qualification visit may not be necessary. 

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• Site Initiation:  Sight Sciences and/or CRO personnel will meet with the 
investigator(s) and clinical study staff when the site is ready to begin enrolling 
subjects in order to train them in how to properly select subjects, perform the 
study procedure, and record study data.  This visit will include, but not be 
limited to a review of the following: 
o Detailed review of the protocol 
o Informed consent procedures 
o Instructions for the surgical procedure 
o Records and reports 
• Interim Monitoring:  Sight Sciences or CRO personnel will conduct routine visits 
during the course of the study to review charts, perform source document 
verification, ensure proper adherence to the study protocol, and to review 
regulatory documents.  Interim monitoring visits and telephone consultation 
will occur as necessary during the course of the study to ensure the proper 
progress and documentation of the study findings. 
• Study Close Out Visit:  At the conclusion of the trial there will be a study 
closure visit during which several actions, including but not limited to the 
following, will be performed: 
o A final inspection of the study binder 
o Accountability and return of all devices and non-consumable ancillary 
study supplies to the sponsor 
o Discussion of record retention requirements with the investigator 
o Close-out notification to the IRB   
12 DATA AND QUALITY MANAGEMENT 
12.1 DATABASE MANAGEMENT 
The study database will be designed using an electric data capture (EDC) system that is 
compliant with 21 CFR Part 11 and relevant guidance documents.  The EDC will be 
developed and maintained by an independent, qualified data management firm. 
 
The database will incorporate time-stamped audit trails, protection of human subjects, 
restricted access, and data security at the component level.  Each database module, 
including each individual eCRF, will be validated by conducting a series of standard tests 
that demonstrate usability and correctness of the database system.  The database will 
be maintained on an ongoing basis and will be routinely backed up.  
12.2 SUBJECT IDENTIFICATION 
The subjects will be identified by a six-digit subject number composed of a double-digit 
study identification number, a two-digit center identification number followed by a 
three-digit sequential subject number.  A subject identification number will be assigned 

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after informed consent is obtained.  This will ensure that identifiable subject 
information has been removed and kept confidential. 
12.3 SUBJECT ACCOUNTABILITY 
All subjects enrolled and treated in this clinical investigation shall be monitored for the 
duration of the investigation. The clinical investigation shall be considered completed 
when all subjects that have been enrolled in the investigation have reached the final 
reporting period, excluding subjects who were withdrawn.   
12.4 CONFIDENTIALITY 
All medical records associated with the clinical investigation will be made available for 
review by Sight Sciences personnel, its contract research organization (CRO) and 
governmental/regulatory agencies involved.  The results of the study may be published 
in the future for scientific and marketing purposes, but the identity of each subject will 
not be revealed.  All records will be stored in a secure area at the investigator’s facility, 
the CRO, the data management firm and at Sight Sciences, Inc. 
12.5 SOURCE DATA AND CASE REPORT FORMS 
Source data will be entered into a validated electronic system at each site by trained 
personnel in accordance with 21 CFR Part 11 requirements. Electronic entries will be 
verified against corresponding source data at the sites and queried/corrected if needed 
to the extent possible.  Medical site records serve as source data. In addition, data that 
are collected exclusively for the purpose of this study and not normally recorded in the 
subjects’ medical records can be collected directly on any study CRFs or tools provided 
by the sponsor, and these will serve as the source data.   
 
Source data and study CRFs are to be maintained at the site in the subject records or in 
the medical records.  All data entries must be made in accordance with ALCOA 
(Attributable, Legible, Contemporaneous, Original, Accurate) standards and GDP (Good 
Documentation Practices). 
 
Study data acquired from sites will be collected on Electronic Case Report Forms (eCRFs) 
for submission to sponsor. Sites will enter data entered on source documents into the 
electronic case report forms for Sponsor review and analysis.    
12.6 RETENTION PERIOD 
Clinical sites are to retain any and all clinical trial material (documentation, photographs, 
etc.) for a period of two years from the date a marketing application is approved or two 
years after the investigation has been discontinued, or as directed by their institutional 
document retention requirements, whichever is the longest.  After that time, the items 
must be returned to Sight Sciences for archiving.   

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13 PROTOCOL MODIFICATIONS AND DEVIATIONS 
Protocol modifications may occur during the study.   Each will be approved by the 
sponsor before implementation. Each will undergo Institutional Review Board (IRB) 
review and approval, as necessary. 
 
Any deviations from this protocol intended to protect the life or physical well-being of a 
subject in an emergency are to be reported to Sight Sciences, Inc. as well as the IRB as 
soon as possible, and no later than 5 working days after the emergency occurred. 
 
All protocol deviations will be documented using the Protocol Deviation CRF or Source 
Tool. 
14 DEVICE FAILURES AND MALFUNCTIONS 
All study device failures (OMNI surgical system) or malfunctions should be recorded on 
the Customer Experience Form and reported to Sight Sciences Customer Service (877-
266-1144). 
15 ETHICAL CONSIDERATIONS 
15.1 DECLARATION OF HELSINKI 
This study shall be conducted in accordance with the Declaration of Helsinki (Appendix 
D).   
15.2 INSTITUTIONAL REVIEW BOARDS (IRB) 
The study shall not begin at a site until approval has been obtained from the reviewing 
IRB.  It is the Investigators’ responsibility to obtain and maintain written approval of the 
study protocol and Informed Consent documents from the appropriate IRB.  It is also the 
Investigators’ responsibility to notify that body about any amendments to these 
documents and to follow the IRBs rules regarding the reporting of Adverse Events and 
Protocol Deviations related to the device and/or this study.  Copies of all written 
approvals (identifying the study, the submitted and approved documents and the date 
reviewed) and the approved versions of the documents must be provided to Sight 
Sciences or its CRO.  
 
The Investigators must file all correspondence with the IRB and forward copies of such 
correspondence to Sight Sciences. 

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15.3 INFORMED CONSENT DOCUMENT (ICD) 
An Informed Consent template that covers all protocol procedures and follows GCP 
Guidelines will be prepared by Sight Sciences and made available to each Investigator.  
The Investigator may adapt these templates to the requirements of the local IRB and of 
the institution where the study is conducted, but any revisions made to the ICD must be 
submitted to the sponsor for review prior to submission to the IRB.  A copy of each IRB-
approved ICD version is to be made available to Sight Sciences and its CRO.  The 
approved, IRB-stamped ICD is to be kept in its full length in the study Regulatory Binder.  
Original, signed ICDs are to be maintained in study records and must be made available 
for monitoring review.  
15.4 PUBLIC LISTING OF STUDY 
The study will be listed on the NIH website www.clinicaltrials.gov.  
16 STUDY ADMINISTRATION 
16.1 EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE 
Sight Sciences may terminate the study, in which case the investigators and associated 
IRBs will be notified in writing.  Possible reasons for study termination include but are 
not limited to: 
 
• The discovery of an unexpected, significant, or unacceptable risk to the study 
subjects implanted with the device 
• Withdrawal of FDA clearance of the OMNI device. 
• Insufficient enrollment in the study 
• The Sponsor determines that enough data has been collected for the study, and 
no further data are needed.  
 
Sight Sciences reserves the right to stop the study at a particular site any time after the 
initiation visit if there have been no subject enrollments or if there have been significant 
protocol deviations/violations at the site.     
 
Likewise, a principal investigator may terminate the study at his/her institution.  This 
decision must be followed by written notification to Sight Sciences within five working 
days, stating the reasons for termination. 
 
If the study is terminated, every effort should be made to obtain final follow-up from all 
subjects.   
 

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In the event that there are significant human use issues with the device, the investigator 
will be consulted to make a determination of whether the study should be terminated 
or not. 
16.2 INVESTIGATOR RESPONSIBILITIES 
16.2.1 
GENERAL RESPONSIBILITIES OF INVESTIGATORS 
An Investigator is responsible for ensuring that an investigation is conducted according 
to the signed agreement, the investigational plan and applicable FDA regulations, for 
protecting the rights, safety, and welfare of subjects under the Investigator’s care, and 
for the control of devices under investigation. An Investigator also is responsible for 
ensuring that informed consent is obtained in accordance with 21 CFR part 50. 
16.2.2 
SPECIFIC RESPONSIBILITIES OF INVESTIGATORS 
1. 
Awaiting approval - An Investigator may determine whether potential subjects 
would be interested in participating in an investigation but shall not request the 
written informed consent of any subject to participate, and shall not allow any 
subject to participate before obtaining IRB approval. 
2. 
Subject Qualification -The Investigator is responsible for ensuring that all subjects 
entering the study conform to the subject selection criteria. 
3. 
Compliance - An Investigator shall conduct an investigation in accordance with the 
signed agreement with the Sponsor, the investigational plan, all applicable FDA 
regulations, and any conditions of approval imposed by an IRB. 
16.2.3 
INVESTIGATOR RECORDS 
A participating Investigator shall maintain the following accurate, complete, and current 
records relating to the Investigator’s participation in an investigation for the period 
specified in Section 12.6:  
1. 
All correspondence with another Investigator, an IRB, the Sponsor, a clinical 
research associate (CRA) or monitor, or FDA, including required reports. 
2. 
Records of each subject’s case history and exposure to the device. Case histories 
include the subejct’s study clinic record, certified copies of medical record as 
applicable, and supporting documents including, signed and dated consent forms.  
Such records shall include: 
a) 
Documents evidencing informed consent. 
b) All relevant observations, including records concerning adverse device effects 
(whether anticipated or unanticipated), information and data on the condition 
of each subject upon entering, and during the course of, the investigation, 

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including information about relevant previous medical history and the results 
of all diagnostic tests. 
3. 
The protocol, with documents showing the dates and reasons for each deviation 
from the protocol. 
4. 
Any other records that FDA requires to be maintained by regulation or by specific 
requirement for a category of investigations or a particular investigation. 
16.2.4 
INVESTIGATOR REPORTS 
An Investigator shall prepare and submit the following complete, accurate, and timely 
reports: 
1. 
Unanticipated Adverse Device Effects - An Investigator shall submit to the Sponsor 
and to the reviewing IRB a report of any unanticipated adverse device effect 
occurring during an investigation as soon as possible, but in no event later than 10 
working days after the Investigator first learns of the effect. 
2. 
Withdrawal of IRB Approval - An Investigator shall report to the Sponsor, within 5 
working days, a withdrawal of approval by the reviewing IRB of the Investigator’s 
part of an investigation. 
3. 
Progress - An Investigator shall submit progress reports on the investigation to the 
Sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event 
less often than yearly. 
4. 
Deviations from the Investigational Plan - An Investigator shall document and 
report to the Sponsor any deviation from the investigational plan.  
5. 
Informed Consent - If an Investigator enrolls a subject without obtaining informed 
consent, the Investigator shall report such use to the Sponsor and the reviewing 
IRB within 5 working days after the use occurs. 
6. 
Final Report - An Investigator shall, within 3 months after termination or 
completion of the investigation or the Investigator’s part of the investigation, 
submit a final report to the Sponsor and the reviewing IRB. 
7. 
Other - An Investigator shall, upon request by a reviewing IRB or FDA, provide 
accurate, complete, and current information about any aspect of the investigation. 
16.3 INVESTIGATOR AGREEMENT 
The principal investigators in each center shall agree to the clinical protocol and any 
amendments and indicate their approval and agreement by signing and dating the cover 
page of the study protocol and the Investigator Responsibility Agreement. 

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17 PUBLICATION POLICY 
Sight Sciences recognizes the value of disseminating research results.  It is understood 
that the Study is part of the Multi-Center Clinical Trial and publication of results is 
expected.  This publications policy applies to journal articles, conference abstracts, and 
conference presentations (posters and slides) covering Sight Sciences-sponsored clinical 
studies.  This policy is in addition to any arrangement contained in the Clinical Trial 
Agreement between Sight Sciences and the investigator.  
 
Multi-Site Data 
Clinical site investigators are encouraged to propose publications and abstracts that 
include clinical or research data from multiple clinical sites; such projects will be 
coordinated by Sight Sciences.  Authorship of papers and abstracts resulting from these 
projects will be determined collaboratively according to the following guidelines:  
 
• The first author on such publications will be the person who primarily wrote the 
paper and took the lead on the research.  In the case of clinical trial papers 
where all authors contributed equally, authorship order may be based on site 
enrollment or other criteria at Sight Sciences’ discretion. 
• Other authors include those who significantly contributed to the specific work.   
• At least one person from each clinical site whose study subjects appear in the 
work will be acknowledged in the manuscript/presentation in some way, either 
as an author group member, a non-author contributor, or listed in the 
acknowledgements, depending on the particular policies of the journal or 
conference. 
 
Single Site Data 
After publication of the multi-center study results in a peer-reviewed journal, or if 
Sponsor has not submitted a manuscript for publication in a peer-reviewed journal 
within twelve (12) months after the study has been completed, whichever occurs first, 
Investigators may publish the results of the Study generated by the Investigator, subject 
to the obligations of the Clinical Trial Agreement between Sight Sciences and the 
Investigator, and the prior approval of Sponsor in writing.   
 
Publications Review Policy 
Investigators must submit all presentations, posters, abstracts and manuscripts 
pertaining to this study to Sight Sciences for review in advance of their submission.  
Sight Sciences conducts this review to protect its proprietary rights to information, 
inventions, or products developed under the Study.  Please use the following guideline 
to determine the absolute minimum advance time for submitting an item to Sight 
Sciences for review: 
 
• Presentations/Posters: 5 business days in advance of presentation 

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• Abstracts: 5 business days in advance of submission 
• Manuscripts: 30 calendar days in advance of submission for publication 
 
In accordance with the Clinical Trial Agreement, these items must receive written 
approval from Sight Sciences in order for them to be submitted or presented.  If an item 
is not received in the timeframe listed above, approval may not be granted due to 
insufficient time for considered review. In addition, since most of our Clinical Trial 
Agreements require that Sight Sciences has 60 days to review publications, Sight 
Sciences reserves the rights granted in those Agreements if circumstances require a 
longer review. 
 
18 BIBLIOGRAPHY 
1.   Tham YC, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of 
glaucoma burden through 2040: a systematic review and meta-analysis. 
Ophthalmology. 2014;121:2081–2090. 
2.   European Glaucoma Society. Terminology and guidelines for glaucoma 4th 
edition Savona, Italy: Editrice PubliComm, 2014. 
3.   Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, et al. The Ocular 
Hypertension Treatment Study: a randomized trial determines that topical ocular 
hypotensive medication delays or prevents the onset of primary open-angle 
glaucoma. Arch Ophthalmol. 2002; 120:701–713. 
4.   Kenji Inoue. Managing adverse effects of glaucoma medications. Clin 
Ophthalmol. 2014; 8: 903–913. Published online 2014 May 12. doi:  
10.2147/OPTH.S44708. 
5.   Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee 
PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-
Sectional Survey. Ophthalmology. 2015 Jul; 122(7):1308-16. 
6.   Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the 
effect of treatment: The Early Manifest Glaucoma Trial. Arch Ophthalmol 
2003;121:48–56. 
7.   The Advanced Glaucoma Intervention Study (AGIS): the relationship between 
control of intraocular pressure and visual field deterioration. The AGIS 
Investigators. Am J Ophthalmol 2000;130:429–40.  
8.   Francis BA, Singh K, Lin SC, et al. Novel glaucoma procedures: a report by the 
American Academy of Ophthalmology. Ophthalmology 2011;118:1466–1480. 
9.   Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin 
Ophthalmol 2017;28:187–193. 
10.   Francis BA, Singh K, Lin SC, et al. Novel glaucoma procedures: a report by the 
American Academy of Ophthalmology. Ophthalmology 2011;118:1466–1480. 
11.   Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin 
Ophthalmol 2017;28:187–193. 

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12.    Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: circumferential viscodilation 
and tensioning of Schlemm canal using a flexible microcatheter for the 
treatment of open-angle glaucoma in adults. Two-year interim clinical study 
results. J Cataract Refract Surg 2009;35:814-824. 
13.   Sarkisian SR, Mathews B, Ding K, et al. 360°ab-interno trabeculotomy in 
refractory primary open-angle glaucoma. Clin Ophthalmol 2019;13:161-168. 
14.   Grover DS, Smith O, Fellman RL, et al. Gonioscopy-assisted transluminal 
trabeculotomy: an ab interno circumferential trabeculotomy: 24 months follow-
up. J Glaucoma 2018;27:393-401. 
15.   Clara Martinez‐Rubio, Ioan Alexandru Placinta, Rodrigo Molina‐Pallete, Paula 
Martínez Lopez‐Corell, Jorge Vila‐Arteaga. OMNI‐an initial experience with a new 
surgical glaucoma treatment device. ESCRS 2018. 
16.   Iwona Grabska‐Liberek, Julita Majszyk‐Ionescu, Agnieszka Skowyra, Monika 
Rogowska, Anna Plichta, Patrycja Duda, Ingrid Kane OMNI 360TM in Open‐Angle 
Glaucoma Treatment: A 6‐month Follow‐up. ESCRS 2018. 
17.   Paula Martínez Lopez‐Corell, Rodrigo Molina‐Pallete, Clara Martinez‐Rubio, Ioan 
Alexandru Placinta, Jorge Vila‐Arteaga Procedural Steps For OMNI, A New 
Surgical Technique For Glaucoma Treatment, In Combination With Cataract 
Surgery ESCRS 2018. 
18.   Resnikoff S, Pascolini D, Etya'ale D, Kocur I, Pararajasegaram R, Pokharel GP, 
Mariotti SP Bull World Health Organ. Global data on visual impairment. 2016 
Nov; 82(11):844-51. 
19.   Bourne RRA, Stevens GA, White RA, et al. Causes of vision loss worldwide, 1990-
2010: a systematic analysis. Lancet Glob Heal. 2013;1:339–349. 
20.   Zhang ML, Hirunyachote P, and Jampel H. Combined surgery versus cataract 
surgery alone for eyes with cataract and glaucoma. Cochrane Database Syst Rev. 
2015; 7: CD008671 
21.   Vold S, Ahmed II, Craven ER, Mattox C, Stamper R, Packer M, Brown RH, 
Ianchulev T; CyPass Study Group. Two-Year COMPASS Trial Results: Supraciliary 
Microstenting with Phacoemulsification in Patients with Open-Angle Glaucoma 
and Cataracts. Ophthalmology. 2016 Oct;123(10):2103-12. doi: 
10.1016/j.ophtha.2016.06.032. 
 
 
 
 
 
 
 
 
 
 

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19 APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES 
19.1 LIST OF STUDY PROCEDURES 
1. Informed Consent 
2. Demographics, Medical & Ocular History 
3. Medication Log 
4. Patient-Reported Outcomes (PROs): OSDI and GQL-15 
5. BCVA ETDRS 
6. Visual Field (Humphrey 24-2 SITA- Standard) 
7. IOP (Goldmann Tonometry) 
8. Unmedicated Diurnal IOP 
9. Gonioscopy 
10. Slit Lamp Exam 
11. Dilated Fundus Exam/C:D Ratio 
12. Eligibility Assessment 
13. Randomization 
14. Surgical procedure 
15. AE Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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19.2 PRO INSTRUMENTS 
19.2.1  THE OSDI© QUESTIONNAIRE  
The OSDI Questionnaire consists of 12 questions regarding ocular symptoms, 
environmental triggers, and vision-related functioning in patients with dry eye disease 
(Schiffman et al, 2000).  The patient will be asked to rate each symptom using a 5-point 
scale (0 to 4), where 0 indicates none of the time; 1, some of the time; 2, half of the 
time; 3, most of the time; and 4, all of the time.  Seven questions related to visual 
functioning allow a response of “N/A” (not applicable); no more than 3 of these 7 
questions may be answered as N/A for the questionnaire to be evaluable.  The total 
OSDI score is calculated as: ([sum of scores for all questions answered] X 100)/([total 
number of questions answered] X 4). 
19.2.2  THE GQL-15 QUESTIONNAIRE  
The GQL-15 questionnaire was developed by Nelson et al and is comprised of 15 vision-
related items. The item-level responses for each factor are coded on a five-point scale (1 
meaning no difficulty and 5 meaning severe difficulty), while 0 is marked if the 
participant does not perform the activity as a result of non-visual cause. These items are 
grouped into four subscales: 1) “Central and near vision” (two items); 2) “Peripheral 
vision” (six items); 3) “Dark adaptation and glare” (six items); and 4) “Outdoor mobility” 
(one item). Total score is derived by summing all item-level response scores. Higher 
GQL-15 scores are revealing lower QOL. Subscale scores are derived by coding the item-
level responses on a numerical interval scale ranging from 0 (no difficulty) to 100 (severe 
difficulty). Subscale scores are average of the sum of scores generated for the item-level 
subscale responses. Higher subscale scores are indicating lower QOL and greater 
difficulty with subscale specific tasks. 
19.3 VISUAL ACUITY WITH MANIFEST REFRACTION 
ETDRS will be used in testing and documenting subject visual acuity.  
 
ETDRS Testing Method 
Best-corrected visual acuity (BCVA) will be tested and scored using the ETDRS system, 
and will be obtained at the screening and baseline visits for both eyes, and  at all 
scheduled follow-up visits for the study eye only.   
 
The ETDRS chart must be placed at a distance of 4.00 meters (13 feet and 1.5 inches, or 
157.5 inches) from cornea to chart surface, when using a 4-meter chart.  For the 
patients unable to read the topmost line of 4.00 meter chart VA should be tested at 1 
meter. For testing at 1 meter, the distance must be 1.00 (39 and 3/8 inches).  
 

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The 1-meter distance is measured from the eye of the participant, seated comfortably in 
a chair with his/her back firmly placed against the chair, to the center of the 2nd or 4th 
letter of the 3rd line of the chart. The measuring device can be homemade (e.g., a dowel 
rod accurately cut to a length of 1.00 m) or 1 meter ruler may be purchased. 
 
Note:  If it is necessary to refract at the 1-meter distance, a +0.75 sphere lens should be 
added to the trial frame. Subtract the +0.75 sphere from the final refraction obtained at 
the 1-meter distance before recording the refraction on the form.  
 
Methods 
 
The subject should attempt to read each letter, line-by-line, left to right, beginning with 
line 1 at the top of the chart. The subjects should be told that the chart has letters only, 
no numbers.  If the subject reads a number, he or she should be reminded that the chart 
contains no numbers, and the examiner should then request a letter in lieu of the 
number. The subject should be asked to read slowly, about one letter per second, so as 
to achieve the best identification of each letter.  He/she is not to proceed to the next 
letter until he/she has given a definite response. 
 
A maximum effort should be made to identify each letter on the chart.  When the 
subject says he/she cannot read a letter, the subject should be encouraged to guess.  If 
the subject identified two (2) letters (e.g., A or B), the subject should be asked to choose 
one letter and, if necessary, to guess. When it becomes evident that no further 
meaningful readings can be made despite encouragement to read or guess, the 
examiner should stop the testing for that eye.  However, all letters on the last line 
should be attempted as letter difficulties vary and the last letter may be the only one 
read correctly. The number of letters read correctly should be recorded.   
 
In order to provide a standardized and well-controlled assessment of visual acuity, visual 
acuity assessments for all subjects should be performed under consistent conditions 
(e.g., the same lighting conditions, viewing distance, etc.) at each visit. 
 
19.4 MEASUREMENT OF INTRAOCULAR PRESSURE 
Goldmann tonometer should be used each time IOP is measured. To minimize observer 
bias, follow a reader-operator technique to measure and record the IOP; the individual 
operating the tonometer (operator) should not view the dial during the measurement. A 
separate individual (reader/recorder) should view the dial and note the measurement. 
Take two measurements of IOP. If the measurements differ by more than 2 mmHg, take 
a third measurement.  If two measurements are taken, record the mean on the case 
report form.  If three measurements are taken, record the median on the case report 
form.   
 

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At all scheduled visits every attempt should be made to have these measurements taken 
at the same time interval to minimize the effect of daily fluctuations in pressure. 
 
Guidelines for performing Goldmann tonometry are as follows: 
 
1. The subject is told the purpose of the test and is reassured that the 
measurement is not painful. The subject is instructed to relax, maintain his or 
her position, and hold his or her eyes open widely. 
2. One drop of a topical anesthetic, such as 0.5% proparacaine or 0.4% 
benoxinate, is placed in each eye, and the tip of a moistened fluorescein strip 
is touched to the tear layer on the inner surface of each lower lid.  
Alternatively, one drop of a combined anesthetic-fluorescein strip is touched 
to the tear layer on the inner surface of each lower lid.  The tonometer and 
prism are set in correct position on the slit lamp. 
3. The tension knob is set at 1 g.  If the knob is set at 0, the prism head may 
vibrate when it touches the eye and damage the corneal epithelium.  The 1 g 
position is used before each measurement.  As a rule, it is more accurate to 
measure intraocular pressure by increasing rather than decreasing the force 
of applanation. 
4. The 0 graduation mark of the prism is set at the white line on the prism 
holder.  If the subject has more than 3 diopters of corneal astigmatism, the 
area of contact between the cornea and the prism is elliptic rather than 
circular.  In this situation the prism should be rotated to 45 degrees from the 
long axis of the ellipse-that is, the prism graduation corresponding to the 
least curved meridian of the cornea should be set at the red mark on the 
prism holder.  An alternative approach is to average the intraocular pressure 
readings obtained with the axis of the prism horizontal and then vertical. 
5. The cobalt filter is used with the slit beam opened maximally.  The angle 
between the illumination and the microscope should be approximately 60º.  
The room illumination is reduced. 
6. The subject is seated in a comfortable position on an adjustable stool or 
examining chair facing the slit lamp.  The heights of the slit lamp, chair and 
chin rest are adjusted until the subject is comfortable and in the correct 
position for the measurement.  The subject's chin is supported by the chin 
rest and the forehead by the forehead bar.  The forehead bar should be well 
above the subject's eyebrows so the frontalis muscle can be used to open the 
eyes widely.  The subject's collar and tie should be loosened if necessary.  
The subject should breathe normally during the test to avoid Valsalva's 
maneuver. 
7. The palpebral fissure is a little wider if the subject looks up.  However, the 
gaze should be no more than 15° above the horizontal to prevent an 
elevation of intraocular pressure that is especially marked in the presence of 
restrictive neuromuscular disease. A fixation light may be placed in front of 
the fellow eye.  The subject should blink his eyes once or twice to spread the 

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fluorescein-stained tear film over the cornea and then should keep his eyes 
open widely.  In some subjects it is necessary for the examiner to hold the 
eyelids open with the thumb and forefinger of one hand.  Care must be taken 
not to place any pressure on the globe because this raises intraocular 
pressure. 
8. The operator sits opposite the subject in position to look through the 
microscope.  The clinician moves the assembly toward the subject.  When 
the black circle near the tip of the prism moves slightly, it indicates contact 
between the prism and the globe. 
9. Alternatively, the assembly is advanced toward the subject until the limbal 
zone has bluish hue.  The biprism should not touch the lids or lashes because 
this stimulates blinking and squeezing. Touching the lids also thickens the 
fluorescein rings, which may cause an overestimation of intraocular pressure. 
10. The clinician observes the applanation through the biprism at low power. A 
monocular view is obtained of the central applanated zone and the 
surrounding fluorescein stained tear film.  Using the control stick, the 
observer raises and lowers and centers of the assembly until two equal 
semicircles are seen in the center of the field of view.  If the two semicircles 
are not equal in size, intraocular pressure is overestimated.  The clinician 
turns the tension knob in both directions to ensure that the instrument is in 
good position. If the semicircles cannot be made "too small," the instrument 
is too far forward. If the semicircles cannot be made "too large," the 
instrument is too far from the eye. 
11. The fluorescein rings should be approximately 0.25 to 0.3 mm in thickness, 
that is, one tenth the diameter of the flattened area.  If the rings are too 
narrow, the subject should blink two or three times to replenish the 
fluorescein; additional fluorescein may be added if necessary.  If the 
fluorescein rings are too wide, the subject should dry his eyes lightly with a 
tissue, and the front surface of the prism should be dried with lint-free 
material.  An excessively wide fluorescein ring is less of a problem than a very 
narrow ring but can cause the intraocular pressure to be overestimated. 
12. The fluorescein rings normally undergo a rhythmic movement in response to 
the cardiac cycle. The tension knob is rotated until the inner borders of the 
fluorescein rings touch each other at the midpoint of their pulsations.  The 
intraocular pressure is the mean of these 2 readings. 
13. Intraocular pressure is measured in the study eye twice.  If the 2 readings 
differ by 2 mmHg or less the average is the IOP.  If the 2 readings differ by > 2 
mm Hg, a third reading is taken.  
14. The reading obtained in grams is multiplied by 10 to give the intraocular 
pressure in millimeters of mercury.  This value is recorded along with the 
date, time of day, list of ocular medications, and time of last instillation of 
ocular medication if IOP is measured on different days, an attempt should be 
made to standardize the time. 
 

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Errors in measurement can arise from a number of factors, including the 
following: 
 
1. Inadequate fluorescein staining of the tear film causes an underestimation of 
intraocular pressure. 
2. Elevating the eyes more than 15° above the horizontal causes an 
overestimation of intraocular pressure. Widening the lid fissure excessively 
causes an overestimation of intraocular pressure. 
3. Repeated tonometry reduces intraocular pressure, causing an 
underestimation of the true level. This effect is greatest between the first 
and second readings, but the trend continues through a number of 
repetitions. 
4. A scarred, irregular cornea distorts the fluorescein rings and makes it difficult 
to estimate intraocular pressure. 
5. The thickness of the cornea affects intraocular pressure readings. If the 
cornea is thick because of edema, intraocular pressure is underestimated. If 
the cornea is thick because of additional tissue, intraocular pressure is 
overestimated. The Goldmann tonometer is accurate after epikeratophakia. 
6. If the examiner presses on the globe or if the subject squeezes his eyelids, 
intraocular pressure is overestimated. 
7. If corneal astigmatism is greater than 3 diopters, intraocular pressure is 
underestimated for with the rule astigmatism and overestimated for against 
the rule astigmatism. The intraocular pressure reading is inaccurate 1 mm Hg 
for every 3 diopters of astigmatism. 
 
Calibration and Documentation 
The calibration of the tonometer will be checked at least once every three months with 
the weight system at 0, 2, and 6 grams as supplied by the manufacturer. When the 
calibration steps provide readings within ± 2 mmHg of the target value for each weight, 
the tonometer is considered adequately calibrated. However, if the variation exceeds 
this amount, a different adequately calibrated instrument should be used for IOP 
measurements.  
 
The investigator must maintain written documentation in a log (hardcopy or electronic 
format acceptable) of the calibration of each tonometer used at the beginning and 
throughout the study period and make these records available to study monitors for 
review. Documentation must describe the unit (by model and serial number or other 
permanent identifier), the date of each calibration, the name or initials of the person 
performing the calibration, and an indication as to whether or not the unit passed the 
calibration. If not calibrated successfully, a note should be entered in the log about 
contacting the authorized manufacturer’s representative for repair and what repairs 
were required. Following any repair, another calibration should be documented prior to 
clinical use. 
 

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Diurnal IOP 
In order to determine the mean diurnal intraocular pressure (IOP) measurements at 
baseline and 12 months, IOP measurements should be taken at 9:00AM ±1.5 hours, 
12:00PM ± 1 hour, and 4:00PM ± 2 hours. The three IOP measurements should then be 
averaged to determine the mean diurnal IOP. 
19.5 VISUAL FIELD EXAMINATION 
Visual fields must be automated threshold visual fields, 24-2 Humphrey Stimulus III. The 
SITA Standard must be used for the visual field conducted at the pre-operative 
evaluation and all subsequent evaluations.  Visual fields should be reliable as 
determined by the Investigator. A visual field done within 6 months prior to the subject 
informed consent date and in accordance with the 24-2 SITA Standard requirements can 
be used for the baseline evaluation. For visual fields that do not meet the reliability 
standards, the test should be repeated within two weeks. 
 
Visual fields are to be performed with a non-dilated pupil unless, in the opinion of the 
investigator, the pupil is so miotic that dilation is required (e.g., < 3mm).  If dilation was 
performed at screening, it should be performed at all subsequent visual field 
examinations.  However, dilation should not be performed before the IOP measurement 
on the appropriate visits. 
 
It is recommended that the following set up occur for the visual field: 
SITA Standard 24-2 test  
• using the white, size III stimulus,  
• Foveal Threshold ON,  
• Head Tracking ON and  
• Vertex Monitoring OFF.  
The appropriate trial lens as defined by the perimeter should be used. 
19.6 DILATED FUNDUS EXAMINATION 
A mydriatic should be used to dilate the pupil so that an examination of the fundus can 
be conducted with an indirect ophthalmoscope and slit lamp biomicroscopy (with 
contact lens, Hruby lens or 60-, 66-, 78-, or 90 diopter lens).  The appearance of the 
optic disc, macula, vessels and periphery should be evaluated and reported on the 
Baseline form.  A measurement of the cup to disc ratio should be made and reported.   
19.7 SLIT LAMP EXAMINATION 
The clinician will examine the conjunctiva, cornea, anterior chamber, lens and anterior 
vitreous of the eye with the aid of a slit lamp, which is a table-mounted binocular 
microscope.  Fluorescein dye will be instilled into the ocular cul-de-sac to facilitate this 

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examination.  In addition to the following, any evidence of pigment dispersion visible in 
slit lamp examination should be evaluated and noted. 
 
Iris 
Findings of Atrophy/Erosion; Peaking; and Rubeosis should be noted. Each will be 
evaluated using a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3).   
 
Cornea - Edema 
None (0)  
Transparent and clear or less than mild 
Mild (+1)  
Dull glassy appearance 
Moderate (+2) Dull glassy appearance of epithelium with large number of vacuoles 
Severe (+3)  
Epithelial bullae and/or stromal edema, localized or diffuse, with or 
without stromal striae 
Cornea - Staining/Erosion 
None (0) 
No fluorescein staining of epithelium, OR less than mild 
Mild (+1)  
Slight fluorescein staining confined to a small focus 
Moderate 
(+2) 
Regionally dense fluorescein staining (1 mm or greater in diameter) with 
underlying structure moderately visible 
Severe (+3)  
Marked fluorescein staining or epithelial loss 
 
Anterior Chamber 
The following system is recommended for grading of aqueous cells and flare using a slit 
beam 1.0 mm wide and 1.0 mm long.  
Cells 
0 = < 1 cell seen 
0.5+ = 1-5 cells seen 
1+ = 6-15 cells seen   
2+ = 16-25 cells seen 
3+ = 26-50 cells seen 
4+ = > 50 cells seen 
 
Flare 
0 = None 
1+ = Faint 
2+ = Moderate (iris and lens details clear)  
3+ = Marked (iris and lens details hazy) 
4+ = Intense (fibrin or plastic aqueous) 
 

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The presence of hypopyon is recorded separately.  The presence of “microhyphema” or “layered 
hyphema” in the anterior chamber should also be recorded. Layered hyphema will be graded using the 
following scale (If Grade 1, also record size in mm on the CRF).24 
 
 
 
 
24 http://www.aao.org/image/hyphema-grading-system-2 

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Posterior Capsule Opacification 
As a routine part of the slit lamp examination, posterior capsule opacification (PCO) will 
be evaluated using the following scale: 
 
 
 
 
 
 
 
 
 
 
 
 
Other Slit Lamp Findings (complete for each finding) 
• 
Trace 
• 
Mild 
• 
Moderate 
• 
Severe 
19.8 GONIOSCOPY 
Gonioscopy will be conducted as part of the screening process to verify that the subject 
has an open angle and to identify any anterior synechiae as well as determine if there is 
any pigment dispersion.  Gonioscopy will be repeated post-operative follow up visit as 
per Table 1. A Zeiss, Sussman or similar lens should be used and gonioscopy conducted 
in a dark room with a narrow, short slit beam that does not pass through the pupil and 
without a fixation light being used.  The Shaffer method will be used as follows: grade 4, 
wide open (35°-45°): grade 3, moderately open (25°-34°); grade 2, moderately narrow 
(20°); grade 1, very narrow (10°); grade 0, closed (0°).  The grade number will be 
reported for each quadrant of the eye in the appropriate location on the form. 
 
19.9 OCULAR HYPOTENSIVE MEDICATIONS 
Each ocular hypotensive medication will be recorded on the study record.  If subjects 
are taking combination medications such as Cosopt this is to be counted as two 
medications even though this is only in 1 bottle. 
NONE 
Minimal (Top left image) 
Mild (Top right image) 
Moderate (bottom left 
image) 
Severe (bottom right image) 

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20 APPENDIX B - DECLARATION OF HELSINKI 
I. 
PREAMBLE 
 
1. 
The World Medical Association (WMA) has developed the Declaration of 
Helsinki as a statement of ethical principles for medical research involving 
human subjects, including research on identifiable human material and data. 
 
The Declaration is intended to be read as a whole and each of its constituent 
paragraphs should be applied with consideration of all other relevant 
paragraphs. 
 
2. 
Consistent with the mandate of the WMA, the Declaration is addressed 
primarily to physicians. The WMA encourages others who are involved in 
medical research involving human subjects to adopt these principles. 
 
II. 
GENERAL PRINCIPLES 
 
1. 
The Declaration of Geneva of the WMA binds the physician with the words, 
“The health of my patient will be my first consideration,” and the International 
Code of Medical Ethics declares that, “A physician shall act in the patient's best 
interest when providing medical care.” 
 
2. 
It is the duty of the physician to promote and safeguard the health, well-being 
and rights of patients, including those who are involved in medical research. 
The physician's knowledge and conscience are dedicated to the fulfilment of 
this duty. 
 
3. 
Medical progress is based on research that ultimately must include studies 
involving human subjects. 
 
4. 
The primary purpose of medical research involving human subjects is to 
understand the causes, development and effects of diseases and improve 
preventive, diagnostic and therapeutic interventions (methods, procedures 
and treatments). Even the best proven interventions must be evaluated 
continually through research for their safety, effectiveness, efficiency, 
accessibility and quality. 
 
5. 
Medical research is subject to ethical standards that promote and ensure 
respect for all human subjects and protect their health and rights. 
 

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6. 
While the primary purpose of medical research is to generate new knowledge, 
this goal can never take precedence over the rights and interests of individual 
research subjects. 
7. 
It is the duty of physicians who are involved in medical research to protect the 
life, health, dignity, integrity, right to self-determination, privacy, and 
confidentiality of personal information of research subjects. The responsibility 
for the protection of research subjects must always rest with the physician or 
other health care professionals and never with the research subjects, even 
though they have given consent. 
 
8. 
Physicians must consider the ethical, legal and regulatory norms and standards 
for research involving human subjects in their own countries as well as 
applicable international norms and standards. No national or international 
ethical, legal or regulatory requirement should reduce or eliminate any of the 
protections for research subjects set forth in this Declaration. 
 
9. 
Medical research should be conducted in a manner that minimizes possible 
harm to the environment. 
 
10. Medical research involving human subjects must be conducted only by 
individuals with the appropriate ethics and scientific education, training and 
qualifications. Research on patients or healthy volunteers requires the 
supervision of a competent and appropriately qualified physician or other 
health care professional. 
 
11. Groups that are underrepresented in medical research should be provided 
appropriate access to participation in research. 
 
12. Physicians who combine medical research with medical care should involve 
their patients in research only to the extent that this is justified by its potential 
preventive, diagnostic or therapeutic value and if the physician has good 
reason to believe that participation in the research study will not adversely 
affect the health of the patients who serve as research subjects. 
 
13. Appropriate compensation and treatment for subjects who are harmed as a 
result of participating in research must be ensured. 
 
III. 
RISKS, BURDENS AND BENEFITS 
 
• 
In medical practice and in medical research, most interventions involve risks 
and burdens. 
 

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Medical research involving human subjects may only be conducted if the 
importance of the objective outweighs the risks and burdens to the research 
subjects. 
 
• 
All medical research involving human subjects must be preceded by careful 
assessment of predictable risks and burdens to the individuals and groups 
involved in the research in comparison with foreseeable benefits to them and 
to other individuals or groups affected by the condition under investigation. 
 
Measures to minimize the risks must be implemented. The risks must be 
continuously monitored, assessed and documented by the researcher. 
 
• 
Physicians may not be involved in a research study involving human subjects 
unless they are confident that the risks have been adequately assessed and can 
be satisfactorily managed. 
 
When the risks are found to outweigh the potential benefits or when there is 
conclusive proof of definitive outcomes, physicians must assess whether to 
continue, modify or immediately stop the study. 
 
IV. 
VULNERABLE GROUPS AND INDIVIDUALS 
 
• 
Some groups and individuals are particularly vulnerable and may have an 
increased likelihood of being wronged or of incurring additional harm. 
 
All vulnerable groups and individuals should receive specifically considered 
protection. 
 
• 
Medical research with a vulnerable group is only justified if the research is 
responsive to the health needs or priorities of this group and the research 
cannot be carried out in a non-vulnerable group. In addition, this group should 
stand to benefit from the knowledge, practices or interventions that result 
from the research. 
 
V. 
SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS 
 
• 
Medical research involving human subjects must conform to generally 
accepted scientific principles, be based on a thorough knowledge of the 
scientific literature, other relevant sources of information, and adequate 
laboratory and, as appropriate, animal experimentation. The welfare of 
animals used for research must be respected. 
 

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• 
The design and performance of each research study involving human subjects 
must be clearly described and justified in a research protocol. 
 
The protocol should contain a statement of the ethical considerations involved 
and should indicate how the principles in this Declaration have been 
addressed. The protocol should include information regarding funding, 
sponsors, institutional affiliations, potential conflicts of interest, incentives for 
subjects and information regarding provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in 
the research study. 
 
In clinical trials, the protocol must also describe appropriate arrangements for 
post-trial provisions. 
 
VI. 
RESEARCH ETHICS COMMITTEES 
 
• 
The research protocol must be submitted for consideration, comment, 
guidance and approval to the concerned research ethics committee before the 
study begins. This committee must be transparent in its functioning, must be 
independent of the researcher, the sponsor and any other undue influence and 
must be duly qualified. It must take into consideration the laws and regulations 
of the country or countries in which the research is to be performed as well as 
applicable international norms and standards but these must not be allowed to 
reduce or eliminate any of the protections for research subjects set forth in 
this Declaration. 
 
The committee must have the right to monitor ongoing studies. The researcher 
must provide monitoring information to the committee, especially information 
about any serious adverse events. No amendment to the protocol may be 
made without consideration and approval by the committee. After the end of 
the study, the researchers must submit a final report to the committee 
containing a summary of the study’s findings and conclusions. 
 
VII. PRIVACY AND CONFIDENTIALITY 
 
• 
Every precaution must be taken to protect the privacy of research subjects and 
the confidentiality of their personal information. 
 
 
VIII. INFORMED CONSENT 
 
• 
Participation by individuals capable of giving informed consent as subjects in 
medical research must be voluntary. Although it may be appropriate to consult 
family members or community leaders, no individual capable of giving 

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informed consent may be enrolled in a research study unless he or she freely 
agrees. 
 
• 
In medical research involving human subjects capable of giving informed 
consent, each potential subject must be adequately informed of the aims, 
methods, sources of funding, any possible conflicts of interest, institutional 
affiliations of the researcher, the anticipated benefits and potential risks of the 
study and the discomfort it may entail, post-study provisions and any other 
relevant aspects of the study. The potential subject must be informed of the 
right to refuse to participate in the study or to withdraw consent to participate 
at any time without reprisal. Special attention should be given to the specific 
information needs of individual potential subjects as well as to the methods 
used to deliver the information. 
 
After ensuring that the potential subject has understood the information, the 
physician or another appropriately qualified individual must then seek the 
potential subject’s freely-given informed consent, preferably in writing. If the 
consent cannot be expressed in writing, the non-written consent must be 
formally documented and witnessed. 
 
All medical research subjects should be given the option of being informed 
about the general outcome and results of the study. 
 
• 
When seeking informed consent for participation in a research study the 
physician must be particularly cautious if the potential subject is in a 
dependent relationship with the physician or may consent under duress. In 
such situations the informed consent must be sought by an appropriately 
qualified individual who is completely independent of this relationship. 
 
• 
For a potential research subject who is incapable of giving informed consent, 
the physician must seek informed consent from the legally authorized 
representative. These individuals must not be included in a research study that 
has no likelihood of benefit for them unless it is intended to promote the 
health of the group represented by the potential subject, the research cannot 
instead be performed with persons capable of providing informed consent, and 
the research entails only minimal risk and minimal burden. 
 
• 
When a potential research subject who is deemed incapable of giving informed 
consent is able to give assent to decisions about participation in research, the 
physician must seek that assent in addition to the consent of the legally 
authorized representative. The potential subject’s dissent should be respected. 
 
• 
Research involving subjects who are physically or mentally incapable of giving 
consent, for example, unconscious patients, may be done only if the physical or 

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mental condition that prevents giving informed consent is a necessary 
characteristic of the research group. In such circumstances the physician must 
seek informed consent from the legally authorized representative. If no such 
representative is available and if the research cannot be delayed, the study 
may proceed without informed consent provided that the specific reasons for 
involving subjects with a condition that renders them unable to give informed 
consent have been stated in the research protocol and the study has been 
approved by a research ethics committee. Consent to remain in the research 
must be obtained as soon as possible from the subject or a legally authorized 
representative. 
 
• 
The physician must fully inform the patient which aspects of their care are 
related to the research. The refusal of a patient to participate in a study or the 
patient’s decision to withdraw from the study must never adversely affect the 
patient-physician relationship. 
 
• 
For medical research using identifiable human material or data, such as 
research on material or data contained in biobanks or similar repositories, 
physicians must seek informed consent for its collection, storage and/or reuse. 
There may be exceptional situations where consent would be impossible or 
impracticable to obtain for such research. In such situations the research may 
be done only after consideration and approval of a research ethics committee. 
 
IX. 
USE OF PLACEBO 
 
• 
The benefits, risks, burdens and effectiveness of a new intervention must be 
tested against those of the best proven intervention(s), except in the following 
circumstances: 
 
Where no proven intervention exists, the use of placebo, or no intervention, is 
acceptable; or 
 
Where for compelling and scientifically sound methodological reasons the use 
of any intervention less effective than the best proven one, the use of placebo, 
or no intervention is necessary to determine the efficacy or safety of an 
intervention 
 
and the patients who receive any intervention less effective than the best 
proven one, placebo, or no intervention will not be subject to additional risks 
of serious or irreversible harm as a result of not receiving the best proven 
intervention. 
 
Extreme care must be taken to avoid abuse of this option. 
 

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X. 
POST-TRIAL PROVISIONS 
 
• 
In advance of a clinical trial, sponsors, researchers and host country 
governments should make provisions for post-trial access for all participants 
who still need an intervention identified as beneficial in the trial. This 
information must also be disclosed to participants during the informed consent 
process. 
 
XI. 
RESEARCH REGISTRATION AND PUBLICATION AND DISSEMINATION OF RESULTS 
 
• 
Every research study involving human subjects must be registered in a publicly 
accessible database before recruitment of the first subject. 
 
• 
Researchers, authors, sponsors, editors and publishers all have ethical 
obligations with regard to the publication and dissemination of the results of 
research. Researchers have a duty to make publicly available the results of 
their research on human subjects and are accountable for the completeness 
and accuracy of their reports. All parties should adhere to accepted guidelines 
for ethical reporting. Negative and inconclusive as well as positive results must 
be published or otherwise made publicly available. Sources of funding, 
institutional affiliations and conflicts of interest must be declared in the 
publication. Reports of research not in accordance with the principles of this 
Declaration should not be accepted for publication. 
 
XII. UNPROVEN INTERVENTIONS IN CLINICAL PRACTICE 
 
In the treatment of an individual patient, where proven interventions do not exist, 
or other known interventions have been ineffective, the physician, after seeking 
expert advice, with informed consent from the patient or a legally authorized 
representative, may use an unproven intervention if in the physician's judgment it 
offers hope of saving life, re-establishing health or alleviating suffering. This 
intervention should subsequently be made the object of research, designed to 
evaluate its safety and efficacy. In all cases, new information must be recorded 
and, where appropriate, made publicly available.