Prospective, Multi-Center, Single-Arm Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Phase: NA
Conditions: Open Angle Glaucoma
Sponsor: Sight Sciences, Inc.

 
 
 
 
 
Official Title : Prospective, Multi-Center, Single-
Arm Post-Market Study of Use of the OMNI® 
Surgical System in Combination with Cataract 
Extraction in Open Angle Glaucoma  
 
Unique Protocol ID: 06213 
 
NCT number : NCT03861169 
 
Document Date: 04.01.2021 
 
Sight Sciences, Inc. 

Study of OMNI System in OAG 
Protocol 06213 Rev F 
CONFIDENTIAL 
Sight Sciences 
 
Page 1 of 61 
 
 
 
 
PROSPECTIVE, MULTI-CENTER, SINGLE-ARM POST-MARKET STUDY OF USE OF THE OMNI® SURGICAL 
SYSTEM IN COMBINATION WITH CATARACT EXTRACTION IN OPEN ANGLE GLAUCOMA 
 
 
PROTOCOL ID #: 
 
06213 
CURRENT REVISION: 
 
Rev F 
REVISION DATE: 
 
April 01, 2021 
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 
A 
December 19, 2018 
2604 
B 
May 14, 2019 
2763 
C 
May 22, 2019 
2781 
D 
April 02, 2020 
3109   
E 
March 16, 2021 
3463 
F 
April 01, 2021 
3489 
 

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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 .......................................................................................................................................... 12 
5 
PRIOR INVESTIGATIONS ................................................................................................................ 12 
6 
STUDY DESIGN .............................................................................................................................. 14 
6.1 
STUDY DEVICE .................................................................................................................................... 14 
6.2 
STUDY SITES ....................................................................................................................................... 14 
7 
STUDY ENDPOINTS........................................................................................................................ 14 
7.1 
EFFECTIVENESS ENDPOINTS ................................................................................................................... 14 
7.2 
SAFETY ENDPOINTS.............................................................................................................................. 15 
8 
STUDY SELECTION CRITERIA .......................................................................................................... 15 
8.1 
INCLUSION CRITERIA ............................................................................................................................ 15 
8.2 
EXCLUSION CRITERIA ............................................................................................................................ 15 
9 
STUDY PROCEDURES ..................................................................................................................... 17 
9.1 
STUDY SCHEDULE ................................................................................................................................ 17 
9.2 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION .................................................... 18 
9.3 
INFORMED CONSENT AND POINT OF ENROLLMENT .................................................................................... 18 
9.4 
SCREENING VISIT ................................................................................................................................. 18 
9.5 
WASHOUT OF HYPOTENSIVE MEDICATIONS .............................................................................................. 19 
9.6 
BASELINE VISIT ................................................................................................................................... 20 
9.7 
SURGICAL PROCEDURE ......................................................................................................................... 20 
9.8 
FOLLOW-UP VISITS .............................................................................................................................. 21 
9.9 
MANAGEMENT OF IOP AFTER SURGERY .................................................................................................. 21 
9.10 
WITHDRAWAL AND DISCONTINUATION ............................................................................................... 23 
9.11 
SUBJECTS LOST TO FOLLOW-UP ......................................................................................................... 23 
10 
ADVERSE EVENTS (AES) ................................................................................................................. 23 
10.1 
DEFINITIONS OF AE, SAE, SADE, USADE .......................................................................................... 23 
10.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS ............................................................................... 24 
10.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS ........................................... 25 
11 
STATISTICAL CONSIDERATIONS ..................................................................................................... 26 
11.1 
HYPOTHESES AND SAMPLE SIZE CALCULATION...................................................................................... 26 
 
Sample size for the Primary Effectiveness Endpoints ....................................................... 26 
 
Sample size for the Secondary Effectiveness Endpoint .................................................... 28 
 
Sample Size of the Study .................................................................................................. 28 
11.2 
ANALYSIS POPULATIONS .................................................................................................................. 29 
11.3 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ................................................................................ 29 
11.4 
EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS ........................................................................... 29 
 
Primary Effectiveness Endpoints ...................................................................................... 30 
 
Secondary Effectiveness Endpoint .................................................................................... 30 

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Covariate Analysis ............................................................................................................ 31 
 
Additional Effectiveness Analyses .................................................................................... 31 
11.5 
SAFETY ANALYSIS ........................................................................................................................... 32 
 
Adverse Event ................................................................................................................... 32 
 
Best Corrected Visual Acuity (BCVA) ................................................................................ 32 
 
Other Safety Outcomes .................................................................................................... 33 
11.6 
INTERIM ANALYSIS .......................................................................................................................... 33 
11.7 
DEVIATION FROM THE STATISTICAL PLAN ............................................................................................ 33 
12 
MONITORING PROCEDURES ......................................................................................................... 34 
13 
DATA AND QUALITY MANAGEMENT ............................................................................................. 35 
13.1 
DATABASE MANAGEMENT ............................................................................................................... 35 
13.2 
SUBJECT IDENTIFICATION ................................................................................................................. 35 
13.3 
SUBJECT ACCOUNTABILITY ................................................................................................................ 35 
13.4 
CONFIDENTIALITY ........................................................................................................................... 35 
13.5 
SOURCE DATA AND CASE REPORT FORMS ........................................................................................... 35 
13.6 
RETENTION PERIOD......................................................................................................................... 36 
14 
PROTOCOL MODIFICATIONS AND DEVIATIONS ............................................................................. 36 
15 
DEVICE FAILURES AND MALFUNCTIONS ........................................................................................ 36 
16 
ETHICAL CONSIDERATIONS ........................................................................................................... 37 
16.1 
DECLARATION OF HELSINKI ............................................................................................................... 37 
16.2 
INSTITUTIONAL REVIEW BOARDS (IRB) ............................................................................................... 37 
16.3 
INFORMED CONSENT FORM (ICF) ..................................................................................................... 37 
16.4 
PUBLIC LISTING OF STUDY ................................................................................................................ 37 
17 
STUDY ADMINISTRATION ............................................................................................................. 38 
17.1 
EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE ..................................... 38 
17.2 
INVESTIGATOR RESPONSIBILITIES ....................................................................................................... 38 
 
General Responsibilities of Investigators ......................................................................... 38 
 
Specific Responsibilities of Investigators .......................................................................... 38 
 
Investigator Records ........................................................................................................ 39 
 
Investigator Reports ......................................................................................................... 39 
17.3 
INVESTIGATOR AGREEMENT .............................................................................................................. 40 
18 
PUBLICATION POLICY .................................................................................................................... 40 
19 
BIBLIOGRAPHY .............................................................................................................................. 42 
20 
APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES ........................................... 44 
20.1 
LIST OF STUDY PROCEDURES ............................................................................................................. 44 
20.2 
SEVERITY OF GLAUCOMA ................................................................................................................. 45 
20.4 
VISUAL ACUITY .............................................................................................................................. 46 
20.5 
MEASUREMENT OF INTRAOCULAR PRESSURE ........................................................................................ 47 
20.6 
VISUAL FIELD EXAMINATION ............................................................................................................. 50 
20.7 
DILATED FUNDUS EXAMINATION ........................................................................................................ 51 
20.8 
SLIT LAMP EXAMINATION ................................................................................................................. 51 
20.9 
GONIOSCOPY ................................................................................................................................. 54 
20.10 
OCULAR HYPOTENSIVE MEDICATIONS ................................................................................................ 54 
22 
APPENDIX B - DECLARATION OF HELSINKI ..................................................................................... 55 
 
 

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1 PROTOCOL SYNOPSIS 
Protocol Title 
Prospective, Multi-center, Single-Arm Post-market Study 
of use of the OMNI® Surgical System in Combination with 
Cataract Extraction in Open Angle Glaucoma  
Protocol ID Number 
06213 
Study Device 
OMNITM Surgical System 
Study Objective 
To prospectively assess the clinical effect of ab-interno 
transluminal viscoelastic delivery and trabeculotomy  
performed using the OMNI Surgical System in 
combination with Cataract Extraction on intraocular 
pressure (IOP) and the use of IOP-lowering medications in 
patients with mild-moderate open angle glaucoma (OAG).  
Study Design 
Prospective, multicenter, single-arm, post-market study.   
Primary Effectiveness 
Endpoints 
• Reduction in mean unmedicated diurnal IOP from 
baseline to 12 months; and 
• Reduction in mean number of IOP-lowering 
medications from screening to 12 months 
Secondary Effectiveness 
Endpoint 
• Percent of eyes with a ≥20% reduction in unmedicated 
diurnal IOP at 12 months 
• Percent of eyes with unmedicated diurnal IOP 
between 6 and 18 mmHg inclusive at 12 months 
Safety Endpoints 
• Rates of ocular adverse events (intraoperative, 
postoperative) 
• Reduction in best corrected visual acuity (BCVA) from 
baseline (note: reduction in BCVA due to PCO will not 
be treated as a safety event) 

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Inclusion Criteria 
Inclusion Criteria 
(only one eye of each subject is eligible, and all ocular 
criteria apply to the study eye): 
 
1. Male or female subjects, 22 years or older 
2. Visually significant cataract 
3. Diagnosed with mild to moderate open angle 
glaucoma (e.g. primary open angle glaucoma, 
pigmentary glaucoma, pseudoexfoliative glaucoma) as 
documented in subjects’ medical record per ICD-10 
guidelines   
4. At screening, a medicated IOP ≤33 mmHg and on 1-4 
IOP-lowering medications1 with a stable medication 
regimen for two months prior to screening visit  
5. At baseline, unmedicated diurnal IOP 21-36 mmHg and 
IOP at least 3 mmHg higher than screening IOP 
6. Scheduled for cataract extraction followed by ab-
interno transluminal viscoelastic delivery and 
trabeculotomy using the OMNI Surgical System 
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. Understands and signs the informed consent 
 
1 For combination IOP-lowering medications that consist of two or more IOP-lowering drugs, each IOP-
lowering drug component counts as a separate medication. 

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Exclusion Criteria 
(All criteria apply to the study eye; both eyes of a single 
subject need not be eligible): 
1. Any of the following prior treatments for glaucoma: 
o Laser trabeculoplasty ≤3 months prior to 
baseline 
o Implanted with iStent, Cypass, Xen, Express, 
glaucoma draining device/valve, or Hydrus 
Device 
o Prior canaloplasty, goniotomy, trabeculotomy, 
trabeculectomy, ECP or CPC 
2. Normal tension glaucoma 
3. Acute angle closure, traumatic, congenital, malignant, 
uveitic or neovascular glaucoma  
4. Severe glaucoma as documented in subjects’ medical 
record per ICD-10 guidelines   
5. Use of oral hypotensive medication treatment for 
glaucoma  
6. In the investigator’s judgement, predisposed to 
significant risk because of washout of ocular 
hypotensive medications 
7. Ocular pathology or 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, etc.), or 
interfere with compliance to elements of the study 
protocol (e.g., returning to investigator’s office for 
follow-up visits) 
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 
Number of Subjects 
Enrolled and Treated 
A total of 145 subjects will be enrolled and treated. 
Number of Sites 
Up to 20 

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Study Duration for Each 
Subject 
12 months 
Total Study Duration 
Approximately 24 months 
Schedule of Visits 
Screening, Baseline, Surgery (Day 0), Day 1, Week 1, 1 
Month, 3 Month, 6 Month, 12 Month, 12 Month Washout 
(if applicable) 
Treatments 
Cataract extraction followed by ab-interno transluminal 
viscoelastic delivery and trabeculotomy using the OMNI 
Surgical System 
2 STUDY OBJECTIVE 
The objective of this study is to prospectively assess the impact of ab-interno 
transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical 
System in combination with cataract extraction on intraocular pressure (IOP) and the 
use of IOP-lowering medications in patients with mild to moderate open angle glaucoma 
(OAG).  
3 BACKGROUND AND JUSTIFICATION FOR THE STUDY 
Glaucoma is a progressive disease leading to irreversible damage to retinal ganglion cells 
with the global burden expected to rise to 111.8 million people by the year 2040.2 OAG 
is the most prevalent form of glaucoma and it’s proven that lowering IOP is the only 
efficient way to slow down the progressive optic nerve damage and visual field loss.3 
Hypotensive eye drops are commonly used as the first line clinical management for 
OAG.4 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. 5 There is also a documented low rate of 
compliance and tolerability with eye drops that results in disease progression and loss of 
 
2 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. 
3 European Glaucoma Society. Terminology and guidelines for glaucoma 4th edition Savona, Italy: Editrice 
PubliComm, 2014. 
4 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. 
5 Kenji Inoue. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014; 8: 903–913. 
Published online 2014 May 12. doi:  10.2147/OPTH.S44708. 

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vision.6  The cost of these chronic medications and difficulty administering drops to the 
eyes contributes to poor compliance. 
 
Trabeculectomy and tube-shunt implantations remain the gold standard for surgical 
management of IOP.7 These interventions are associated with a long list of potential 
complications such as sclero-conjunctival scarring, hypotony, hypotony maculopathy, 
choroidal detachment, conjunctival leak, hyphema, and bleb related complications.8  
Surgical techniques that re-establish the aqueous outflow through the physiological 
pathways without the need for a bleb are gaining acceptance among glaucoma 
surgeons.9 Canaloplasty is one such procedure that is intended to restore the natural 
aqueous outflow system through microcatheterization and viscodilation of the entire 
length of the Schlemm's canal with a well-documented safety and efficacy profile in 
reducing IOP.10,11 Trabeculotomy is another such procedure that relieves the resistance 
to aqueous flow by cleaving the trabecular meshwork and the inner walls of Schlemm’s 
canal.12  
 
The OMNI™ Surgical System (Sight Sciences Inc, Menlo Park, CA) is a 510K-cleared 
manually operated device indicated for the delivery of small amounts of viscoelastic 
fluid and to cut trabecular meshwork tissue during trabeculotomy procedures. The 
 
6 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. 
7 Gedde SJ, Singh K, Schiffman JC, Feuer WJ. The Tube Versus Trabeculectomy Study: interpretation of 
results and application to clinical practice. Curr Opin Ophthalmol. 2012 Mar; 23(2):118-26. 
8 Zahid S, Musch DC, Niziol LM, Lichter PR, Collaborative Initial Glaucoma Treatment Study Group. Risk of 
endophthalmitis and other long-term complications of trabeculectomy in the Collaborative Initial 
Glaucoma Treatment Study (CIGTS). Am J Ophthalmol. 2013 Apr; 155(4):674-680, 680.e1. 
9 American Academy of Ophthalmology. Preferred practice pattern®. Primary open-angle glaucoma. San 
Francisco, CA. 2015. 
10 Klink T, Sauer J, Körber NJ, et al. Quality of life following glaucoma surgery: canaloplasty versus 
trabeculectomy. Clin Ophthalmol. 2014;18;9:7-16. 
11 Lewis RA, von Wolff K, Tetz M, Körber NJ, Kearney JR, Shingleton B, Samuelson TW. Canaloplasty: 
circumferential viscodilation and tensioning of Schlemm’s canal using a flexible microcatheter for the 
treatment of open-angle glaucoma in adults: interim clinical study analysis. J Cataract Refract Surg 
2007; 33:1217–1226 
12 Grover DS, Godfrey DG, Smith O, Feuer WJ, Montes de Oca, Fellman RL.  Gonioscopy-Assisted 
Transluminal Trabeculotomy, A Novel Ab Interno Trabeculotomy:  technique report and preliminary 
results. Ophthalmology. 2014; 121:855-861. 

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OMNI™ Surgical System allows doctors to perform viscodilation of Schlemm’s canal in 
conjunction with trabeculotomy through single clear corneal incision.13,14,15   
 
Cataract is often seen as a comorbidity present in patients with glaucoma and together 
they serve as leading causes of blindness worldwide.16 Cataract accounts for 33% of 
visual disability worldwide and may have a causal relationship with increased IOP in 
OAG.17  Cataract surgery is known to reduce IOP in glaucoma patients.  A review of 
cataract surgery in glaucoma patients found that in U.S. patients, cataract surgery (not 
involving washout of IOP-lowering medications) was associated with a reduction in IOP 
ranging between 0.6 to 2.5  mm Hg at one year.18,19,20   Studies that involved pre-
operative washout of IOP-lowering medications report a larger reduction in IOP for 
cataract surgery at 12 months, 6.7 mmHg ± 3.6 mmHg (N =118) in iStent inject study 
(P170043)21 and 6.3 mmHg ± 4.0 mmHg (N = 187) in Hydrus study  (P160024)22.   
 
 
13 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. 
14 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. 
15 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. 
16 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. 
17 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. 
18 Francis BA, Berke SJ, Dustin L, et al. Endoscopic cyclophotocoagulation combined with 
phacoemulsification versus phacoemulsification alone in medically controlled glaucoma. J Cataract 
Refract Surg. 2014;40:1313–1321. 
19 Arthur SN, Cantor LB, Wudunn D, et al. Efficacy, Safety, and Survival Rates of IOP-lowering Effect of 
Phacoemulsification Alone or Combined With Canaloplasty in Glaucoma Patients. Journal of Glaucoma. 
2013;23:316–320. 
20 Armstrong JJ, Wasiuta T, Kiatos E, Malvankar-Mehta M, Hutnik CML. The Effects of Phacoemulsification 
on Intraocular Pressure and Topical Medication Use in Patients With Glaucoma: A Systematic Review 
and Meta-analysis of 3-Year Data. J Glaucoma. 2017 Jun;26(6):511-522. doi: 
10.1097/IJG.0000000000000643. Review. 
21 https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170043b.pdf 
22 Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, 
Singh K; HORIZON Investigators. A Schlemm Canal Microstent for Intraocular Pressure Reduction in 
Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. 2018 Jun 23. pii: 
S0161-6420(17)33810-1. doi: 10.1016/j.ophtha.2018.05.012. 

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Combined glaucoma and cataract surgery often result in a greater decrease in IOP and 
use of glaucoma medications compared with cataract surgery alone. 21,22,23,24  When a 
patient with glaucoma also requires surgical intervention for cataract, the 
ophthalmologist often performs simultaneous cataract and glaucoma surgery.  
 
This prospective, multicenter, single-arm, post-market clinical study will evaluate the 
impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI™ 
Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive 
medications in patients with mild to moderate open angle glaucoma.  
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 use25: 
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization 
and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy 
(cutting oftrabecular meshwork) to reduce intraocular pressure in adult patients 
with primary open-angle glaucoma. . 
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 
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 
 
23 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 
24 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. 
25 OMNI 510k K202678 approval 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K202678 

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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 wheels are located on both sides of the handle.  This allows the OMNI device to be 
used in either eye (OD or OS) and in either hand of the surgeon (left or right), by turning 
the device 180 degrees along its vertical axis.   
Figure 1:  OMNI Surgical System 
 
4.3 
TRAINING 
Investigators participating in the study must be experienced in using the OMNI Surgical 
System (i.e. they must have performed at least 5 procedures with the OMNI 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 PRIOR INVESTIGATIONS 
Several case series studies have been performed to evaluate the results of ab-interno 
transluminal viscoelastic delivery and trabeculotomy performed with the OMNI device 
in patients with open angle glaucoma.   
 

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Grabska-Liberek, et al reported on 10 eyes (9 patients) with open angle glaucoma.26  
Five eyes were treated with OMNI surgery alone and 5 eyes underwent OMNI surgery 
plus cataract extraction (OMNI + CE).  In the 5 OMNI alone eyes, IOP declined from and 
average of 20.4 mmHg pre-op to 12.6 mmHg at 6 months (38.2% decline) and in the 
OMNI + CE, IOP declined from 16.4 mmHg pre-op to 11.2 mmHg at 6 months (31.7% 
decline).  Use of IOP-lowering medications also declined in both groups:  from an 
average of 3.6 pre-op to 0.4 at 6 months (OMNI surgical) and 2.8 to 0.4 in the OMNI+CE 
group.  Early post-operative complications included IOP spikes (5 cases), hyphema (6 
cases), and fibrin in the anterior chamber (1 case).  IOP spikes were observed 1-2 days 
after surgery and were treated with systemic drugs (e.g. acetazolamide or mannitol).  
Hyphema resolved within the first week post-op. 
 
Figure 2:  Results for OMNI Surgery (Grabska-Liberek et al) 
 
 
Martinez‐Rubio, et al27 reported early safety and efficacy of viscodilation and 
trabeculotomy using the OMNI Surgical System in 20 eyes with primary open angle 
glaucoma, 13 of which were treated with the OMNI device and cataract surgery and 7 
who were only treated with the OMNI device. Mean pre‐operative IOP was 24.2 ± 6.3 
mmHg and the mean number of preoperative antiglaucoma drugs used by patients was 
2.7. At 6 months, pressure had been reduced to an average of 15.9 ± 3.3 and 
medications were reduced to an average of 1.1.  Early postoperative complications 
included one case of transient toxic anterior segment syndrome (TASS) and one case of 
transient hyphema. Early follow‐up data showed a reduction of IOP, with medication 
reduction, in treatment of moderate glaucoma in adults.  
 
 
26 Grabska-Liberek I, et al.  OMNI 360 in Open-Angle Glaucoma Treatment:  A 6-Month Follow-
Up.  European Society of Cataract & Refractive Surgeons (ESCRS) 2018. 
 
27 Martinez‐Rubio, et al. OMNI‐an initial experience with a new surgical glaucoma treatment 
device. European Society of Cataract & Refractive Surgeons (ESCRS) 2018. 

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Figure 3:  Results for OMNI Surgery (Martinez‐Rubio et al) 
 
6 STUDY DESIGN 
This is a prospective, multicenter, single-arm, post-market study. 
 
6.1 
STUDY DEVICE 
The study device is the OMNI Surgical System.  Subjects enrolled in the study will 
undergo ab-interno transluminal viscoelastic delivery and trabeculotomy using the 
OMNI Surgical System in conjunction with cataract extraction. 
6.2 
STUDY SITES 
This study will be conducted at up to 20 sites in the United States.  No center will have 
more than 25% of the target enrollment. 
7 STUDY ENDPOINTS 
7.1 
EFFECTIVENESS ENDPOINTS 
The Primary effectiveness endpoints are:    
 
• Reduction in mean unmedicated diurnal IOP from baseline to 12 months; and 
• Reduction in mean number of IOP-lowering medications from screening to 12 
months 
 
The Secondary effectiveness endpoints are:  
 
• Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months 
• Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive 
at 12 months 

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7.2 
SAFETY ENDPOINTS 
Safety will be assessed by evaluating the following measures over time: 
 
• Rates of ocular adverse events (intraoperative, postoperative) 
• Reduction in best corrected visual acuity (BCVA) from baseline (note: reduction 
in BCVA due to PCO will not be treated as a safety event) 
8 STUDY SELECTION CRITERIA 
8.1 
INCLUSION CRITERIA 
For inclusion in this study, subjects must meet all the following criteria (only one eye of 
each subject is eligible, and all ocular criteria apply to the study eye only unless 
otherwise indicated): 
1. Male or female subjects, 22 years or older 
2. Visually significant cataract 
3. Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle 
glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) as documented in 
subjects’ medical record per ICD-10 guidelines   
4. At screening, a medicated IOP ≤33 mmHg and on 1-4 IOP-lowering medications with 
a stable medication regimen for two months prior to screening visit28  
5. At baseline, unmedicated diurnal IOP 21-36 mmHg and IOP at least 3 mmHg higher 
than screening IOP  
6. Scheduled for cataract extraction followed by ab-interno transluminal viscoelastic 
delivery and trabeculotomy using the OMNI Surgical System 
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. Understands and signs the informed consent. 
8.2 
EXCLUSION CRITERIA 
A subject who meets any of the criteria listed below (in the study eye, unless otherwise 
indicated) will be excluded from the study: 
 
(All criteria apply to the study eye; both eyes of a single subject need not be eligible): 
1. Any of the following prior treatments for glaucoma: 
 
28 For combination IOP-lowering medications that consist of two or more IOP-lowering drugs, each IOP-
lowering drug component counts as a separate medication. 

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o Laser trabeculoplasty ≤3 months prior to baseline 
o Implanted with iStent, Cypass, Xen, Express, glaucoma draining device/valve, 
or Hydrus Device 
o Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC 
2. Normal tension glaucoma 
3. Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular 
glaucoma 
4. Severe glaucoma as documented in subjects’ medical record per ICD-10 guidelines 
5. Use of oral hypotensive medication treatment for glaucoma  
6. In the investigator’s judgement, predisposed to significant risk because of washout 
of ocular hypotensive medications. 
7. Ocular pathology or 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, etc.), or interfere with compliance to 
elements of the study protocol (e.g., returning to investigator’s office for follow-up 
visits) 
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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9 STUDY PROCEDURES 
9.1 
STUDY SCHEDULE 
Table 1:  Study Visit Schedule 
Note: The fellow eye should be followed per the PI’s usual practice based on the ocular health of the fellow eye. 
PROCEDURE 
SCREENING  
(DAY -45 TO -6) 
BASELINE 
(DAY -7 TO 0) 
SURGERY 
(DAY 0) 
1 DAY 
(DAY 1) 
1 WK 
(DAY 5-9) 
1 M 
(DAY 21-35) 
3 M 
(DAY 70-98)  
6 M 
(DAY 150-210) 
12 M 
(DAY 330-420) 
12 M WASHOUT 29 
(DAY 330-420) 
Informed Consent 
X 
 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
 
Medical & Ocular History 
X 
X 
 
 
 
 
 
 
 
 
Medication Log 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
BCVA (ETDRS), with manifest refraction 
X 
X 
 
 
X 
X 
X 
X 
X 
 
Visual Field (Humphrey 24-2 SITA) 
X 
 
 
 
 
 
 
 
X 
 
IOP (Goldmann) 
X 
 
 
X 
X 
X 
X 
X 
X30 
 
Unmedicated diurnal IOP (Goldmann) 
 
X 
 
 
 
 
 
 
X31 
X 
Slit Lamp Exam 
X 
X 
 
X 
X 
X 
X 
X 
X 
 
Gonioscopy  
X 
 
 
 
X 
X 
X 
X 
X 
 
Dilated Fundus Exam/C:D Ratio 
X 
 
 
 
 
 
 
 
X 
 
Eligibility Assessment 
X 
X 
 
 
 
 
 
 
 
 
Cataract Extraction + ab-interno transluminal 
viscoelastic delivery and trabeculotomy 
 
 
X 
 
 
 
 
 
 
 
AE Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
29 The 12 month washout visit is only required for subjects who are taking hypotensive medications at the 12 month visit. 
30 This is only required for subjects who are taking hypotensive medications at the 12 month visit. 
31 If subject is not on any hypotensive medications, a diurnal IOP measurement should be obtained at the 12 month visit as unmedicated IOP.  

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9.2 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION 
A total of 145 subjects will be enrolled in the study.  Assuming a 40% screen failure rate, 
approximately 245 subjects will be enrolled and screened to obtain 145 enrolled and 
treated subjects.  All subjects will be followed for 12 months. 
 
It is anticipated that enrollment in the study will take approximately 12 months.  
Including the 12-month follow-up period, the study is expected to last 24 months. 
9.3 
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 procedure specifically for the study.  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. 
9.4 
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. 
 
If both eyes meet the applicable inclusion and exclusion criteria, the eye with higher IOP 
is recommended to be included in the study. In case of both eyes with same IOP at 
screening, investigator will select the study eye. The other eye will be excluded based on 
the first eye already being included in the study.  
 

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Once the study eye is identified, subjects will undergo the washout procedure described 
in Section 9.5 before the Baseline visit.   
 
Note: If a subject does not meet the inclusion/exclusion criteria, he/she may be re-
screened after 30 calendar days. Subject should be exited from the study and assigned 
another subject identification on second screening. 
 
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 90 days of the Baseline visit may serve as the Baseline 
exam. 
9.5 
WASHOUT OF HYPOTENSIVE MEDICATIONS 
Subjects who meet all screening eligibility criteria will be instructed to discontinue their 
ocular hypotensive medication regimen in the study eye only, and to return for a 
Baseline visit after completing the appropriate washout period. Glaucoma medication 
discontinuation can be staged (for patients on multiple medications) so that the 
pressure increase duration is minimized to the greatest possible extent during the 
washout period. For example, if a patient is on a prostaglandin (PGA) and a Carbonic 
Anhydrase Inhibitor (CAI), the PGA could be discontinued 4 weeks prior to the Baseline 
visit but the allowed to continue until 5 days before Baseline.  
 
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 washout and 
return for the Baseline or 12-month washout IOP visit as long as it falls within the 
specified visit window.  
 
The minimum wash-out periods are specified in Table 2 below. Note: The maximum 
washout period is 6 weeks. Therefore, if the study procedure cannot be scheduled 
within one week of the end of the washout period, the subject should be restarted on 
glaucoma medication until the Day 0 visit (but after the washed-out diurnal IOP has 
been obtained). 
 
 

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Table 2: Ocular Hypotensive Medication Washout Periods 
Brand Name/Chemical Name 
Minimum washout period 
Carbonic Anhydrase Inhibitors  
  
Diamox® (Acetazolamide) – oral Rx  
5 days  
Neptazane® (Methazolamide) – oral Rx  
5 days  
Azopt® (Brinzolamide) 
5 days  
Trusopt® (Dorzolamide Hydrochloride) 
5 days  
Muscarinic Agonists 
 
Salagen, Pilocar (Pilocarpine) 
5 days 
Alpha Adrenergic Agonist  
  
Alphagan® (Brimonidine)  
14 days  
Iopidine® (Apraclonidine Hydrochloride)  
14 days  
Beta Blockers  
  
Betagan® (Levobunolol Hydrochloride) 
28 days  
Betoptic® (Betaxalol Hydrochloride)  
28 days 
OptiPranolol® (Metipranolol) 
28 days 
Timoptic/Betimol® (Timolol Maleate) 
28 days 
Prostaglandin Analogs  
  
Lumigan® (Bimatoprost) 
28 days 
Travatan® (Travoprost)  
28 days 
Xalatan® (Latanoprost) 
28 days 
Zioptan® (Tafluprost) 
28 days 
Vyzulta® (Latanoprostene Bunod) 
28 days 
Rho Kinase Inhibitor 
 
Rhopressa® (Netarsudil) 
28 days 
Combined Medications 
 
Combigan® (Brimonidine Tartrate/Timolol Maleate) 
28 days 
Cosopt® (Dorzolamide Hydrochloride/ Timolol 
Maleate)  
28 days 
Simbrinza® (Brinzolamide/Brimonidine Tartrate) 
28 days 
Other 
Contact Sponsor 
 
9.6 
BASELINE VISIT 
During the Baseline visit, the exams and tests listed in the Baseline column of Table 1 
should be performed.  Refer to Appendix A for instructions for performing the exams. 
9.7 
SURGICAL PROCEDURE 
During the surgical procedure, cataract extraction should be performed following the 
surgeon’s standard practice.  Then, 360° ab-interno transluminal cohesive viscoelastic 

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delivery followed by 180° trabeculotomy32 using the OMNI Surgical System should be 
performed only in eyes with uneventful cataract extraction.  Eyes with complications 
related to cataract extraction or IOL implantation should be exited from the study.  The 
region where the trabeculotomy procedure is performed (e.g. superior hemisphere) 
shall be recorded on the case report forms. 
Surgeons should follow their standard peri-operative medication regimen. All the 
medications should be administered in the form of ocular drops. Any other means of 
medication administration such as intracameral or intravitreal routes should be avoided. 
9.8 
FOLLOW-UP VISITS 
Follow-up visits should be performed according to the schedule provided in Table 1 
(page 17).  All attempts should be made to conduct each follow-up visit within the time 
interval specified in Table 1.  Evaluations conducted outside the prescribed time period 
will be considered protocol deviations.   
9.9 
MANAGEMENT OF IOP AFTER SURGERY 
This protocol recommends that no IOP-lowering medications should be administered to 
subjects after the surgery (0 meds on postop day 1) unless medically warranted. 
Investigators should use their clinical judgement in determining when and why IOP-
lowering medications should be reintroduced and if a subject requires surgical re-
intervention to manage IOP. 
 
Re-introduction of hypotensive medications should follow the guidelines below: 
 
• The same medication class(es) as used preoperatively should be re-introduced. 
Dependent on preoperative IOP medication use, the reintroduction/addition of IOP 
medications postoperatively should follow the order below: 
 
1. Prostaglandin Analogues 
2. Alpha Agonists 
3. Beta Blockers 
4. Rho Kinase Inhibitor 
5. Carbonic Anhydrase Inhibitors (CAIs) 
 
• No more than one ocular hypotensive agent should be added at a single visit or 
within a 2-week period.   
 
 
32 180° trabeculotomy should be attempted in every eye enrolled in the study. There is a possibility that 
180° trabeculotomy may not be possible in each case. 

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In the event of a steroid response (IOP increase), the usual guidelines requiring a 
reproducible increase in IOP should be followed; however, topical hypotensive 
medications should be discontinued once the topical steroid has been discontinued. 
 
If a pressure rise is observed, a paracentesis may be performed as necessary. If a 
paracentesis is performed and there is no protocol-defined adverse event, the 
paracentesis will be documented in the subject’s medical record, the applicable visit CRF 
and the Ocular Procedures log. If, however, the paracentesis is performed in 
conjunction with an AE, then the AE is recorded as such, and the paracentesis is also 
recorded on the AE CRF as a treatment for the protocol-defined AE (as well as the other 
CRFs mentioned above). 
 
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 will also be documented on the follow-
up form by the investigator.   
 
A record of all ocular hypotensive medications added, discontinued or changed will be 
documented on the appropriate Case Report Form for each scheduled visit or on a Case 
Report Form 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. 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 a secondary IOP-lowering intervention will be considered treatment 
failures for the purpose of the secondary endpoint analyses.  These subjects will be 
included in the Safety Endpoint analyses through their withdrawal from the study. 

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9.10 WITHDRAWAL AND DISCONTINUATION 
All subjects have the right to withdraw at any point during the treatment without 
prejudice.  The investigator can discontinue any subject at any time 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 reason(s) 
the subject discontinued the study.  The reason must be recorded in the subject’s file 
and on the Study Exit Form.   
 
If a subject withdraws from the study post-baseline but prior to surgery, then that 
subject may be replaced in the study by a newly enrolled subject. 
9.11 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, at least 3 
phone call attempts should be made and documented.  If still no response, a registered 
letter shall be sent to the address on file for the subject in an attempt to make contact.  
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. 
10 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 do not need to be 
recorded as adverse events unless they increase in severity during the study. 
 
10.1 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 

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• 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 
identified in nature, severity, or degree of incidence in the 
clinical investigational plan; or any other 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 
 
10.2 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, cataract 
surgery, ab-interno transluminal viscoelastic delivery, trabeculotomy, and/or the risk 
analysis for OMNI System.  Adverse events may occur intra-operatively or post-
operatively. 
• Layered Hyphema ≥ 1mm (Microhyphema or Hyphema <1mm is expected and will 
not be considered an AE) 
• IOP increase ≥ 10 mmHg above baseline IOP at ≥1 month visit33 
• IOP increase requiring management with systemic medication at ≥1 month visit32 
• Need for secondary surgical intervention to manage IOP32 
• Hypotony (IOP <6 mmHg)34 with at least one of the following conditions: 
a) 
Flat anterior chamber requiring anterior chamber reformation 
b) Corneal folds 
c) 
Choroidal effusions requiring or undergoing surgical drainage 
d) Suprachoroidal hemorrhage 
 
33 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. 
34 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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e) Maculopathy 
• Corneal injury 
• Corneal edema after 1 week 
• Corneal abrasion 
• BCVA loss of ≥10 letters (ETDRS) at or after 3 months postoperative 
• Descemet’s membrane tear or detachment 
• Chronic anterior uveitis (inflammation of grade 1+ or worse persisting for more 
than 3 months post-operatively or that recurs less than three months after 
discontinuing treatment) 
• Wound leak 
• IOL dislocation and/or damage 
• Intracorneal Hematoma 
• Posterior capsular tear 
• Pupillary block 
• Cyclodialysis 
• Iridodialysis or significant iris damage 
• Peripheral Anterior Synechiae >1 clock hour 
• Suture abscess or other local infection 
• Flat or shallow anterior chamber requiring anterior chamber reformation 
• Aqueous misdirection 
• Choroidal detachment 
• Choroidal effusion requiring surgical drainage 
• Choroidal hemorrhage 
• Suprachoroidal hemorrhage 
• Vitreous hemorrhage 
• Perforation of sclera 
• Clinically significant cystoid macular edema  
• Retinal detachment 
• Retinal tear 
• Chronic pain present later than 3 months after the surgery 
• Increase in C/D ratio of > 0.3 units compared to baseline on slit lamp exam 
• TASS  
• Endophthalmitis  
10.3 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, 

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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-related serious adverse event (SAE) should be reported to the study sponsor 
within one working day of learning of the event.  Non-ocular-related SAEs should be 
reported to the study sponsor within two working days of learning of the event.  Email 
the AE CRF to OMNIsafety@sightsciences.com. 
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  
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. 
11 STATISTICAL CONSIDERATIONS 
11.1  HYPOTHESES AND SAMPLE SIZE CALCULATION 
 SAMPLE SIZE FOR THE PRIMARY EFFECTIVENESS ENDPOINTS 
First Primary Effectiveness Endpoint 
The first primary effectiveness endpoint is the reduction in the unmedicated diurnal IOP 
from baseline to 12 months postoperatively.  The study objective is to show that the 
mean unmedicated diurnal IOP reduction of the study treatment (i.e. ab-interno 
transluminal viscoelastic delivery and trabeculotomy performed with OMNI system 
performed after uneventful cataract extraction) is superior to that of the cataract 
extraction alone. Based on recent approved MIGS studies, the mean ± SD unmedicated 
diurnal IOP reduction at 12 months for the cataract extraction alone is 6.7 mmHg ± 3.6 
mmHg (N =118) for Glaukos P170043 and 6.3 mmHg ± 4.0 mmHg (N = 187) for Ivantis 
P160024.  Therefore, the mean ± SD unmedicated diurnal IOP reduction at 12 months 
for the cataract extraction alone is estimated as 6.5 mmHg ± 3.8 mmHg. 
The corresponding statistical hypotheses are as follows: 

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H0: µOMNI ≤ 6.5 mmHg and Ha: µOMNI > 6.5 mmHg, where µOMNI is the mean unmedicated 
diurnal IOP reduction at 12 months for the OMNI Surgical System in combination with 
Cataract Extraction. 
Based on a one-sample t-test with a one-sided significance level of 0.025 (or two-sided 
0.05), a sample size of 116 eyes at 12 months provides a statistical power of 80% at a 
true µOMNI of 7.5 mmHg. 
Second Primary Effectiveness Endpoint 
The second primary effectiveness endpoint is the reduction in the number of IOP-
lowering medications from screening to 12 months (before medications washed out if 
applicable) postoperatively. 
The study objective is to show that the mean reduction in number of IOP-lowering 
medications of the study treatment at 12 months is not inferior to that of the cataract 
extraction alone.  Based on P170043 and P160024, the mean ± SD of reduction in 
number of IOP-lowering medications at 12 months for the cataract surgery alone is 0.9 ± 
0.8 and 1.1 ± 1.1, respectively.  Therefore, the mean ± SD of reduction in the number of 
IOP-lowering medications at 12 months for the cataract surgery alone is estimated as 
1.0 ± 1.0.  A non-inferiority margin of 0.25 is considered.  Therefore, a difference 
between the mean reduction in number of IOP-lowing medications for the cataract 
alone (1.0) and the mean reduction in number of IOP-lowing medications for the study 
treatment (MOMNI), 1.0 - MOMNI, of < 0.25 indicates that the study treatment is not 
inferior to the cataract alone in reducing the number of IOP-lowing medications.  
The corresponding statistical hypotheses are as follows: 
H0: MOMNI ≤ 0.75 and Ha: MOMNI > 0.75 (i.e. 1.0 - MOMNI < 0.25). 
Based on a one-sample t-test with a one-sided significance level of 0.025 (or two-sided 
0.05), a sample size of 101 eyes at 12 months provides a statistical power of 80% at a 
true MOMNI of 1.0 medication. 
Sample Size for the Primary Effectiveness Endpoints 
Both of the alternative hypotheses of the two primary effectiveness endpoints need to 
be achieved in order to prove the study treatment effect, so the significance level 
adjustment for the multiplicity is not performed for the primary effectiveness 
endpoints.  Therefore, based on the two primary effectiveness endpoints discussed 
above, a sample size of 116 eyes at 12 months is needed.  Considering a drop-out rate of 
about 10%, approximately 130 eyes should be enrolled and treated with the study 
treatment.  

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 SAMPLE SIZE FOR THE SECONDARY EFFECTIVENESS ENDPOINT 
The first secondary effectiveness endpoint is the 12-month outcome of ≥ 20% reduction 
in unmedicated diurnal IOP (medication washed out if applicable) from baseline.  Based 
on P170043 and P160024, the percent of eyes achieving this outcome for the cataract 
surgery alone is 75.4% (89/118) and 70.1% (131/187).  Therefore, the percent of 
cataract-surgery-alone eyes achieving this secondary effectiveness outcome is 
estimated as 73%.  The corresponding statistical hypotheses are H0: P1OMNI ≤ 0.73 and 
Ha: P1OMNI > 0.73, where P1OMNI is the probability of eyes achieving the first secondary 
effectiveness endpoint. 
The second secondary effectiveness endpoint is the 12-month outcome of unmedicated 
diurnal IOP (medication washed out if applicable) of ≥6 mmHg and ≤ 18 mmHg.  Based 
on P170043 and P160024, the percent of eyes achieving this outcome for the cataract 
surgery alone is 63.6% (75/118) and 47.6% (89/187).  Therefore, the percent of cataract-
surgery-alone eyes achieving this secondary effectiveness outcome is estimated as 55% 
(approximate average of 63.6% and 47.6%).  The corresponding statistical hypotheses 
are H0: P2OMNI ≤ 0.55 and Ha: P2OMNI > 0.55, where P2OMNI is the probability of eyes 
achieving the second secondary effectiveness endpoint. 
The formal conclusion of the secondary effectiveness endpoints will not be determined 
if the primary effectiveness endpoints are not statistically significant.  Meanwhile, the 
conclusion of the second secondary effectiveness endpoint will not be determined if the 
first secondary effectiveness endpoint is not statistically significant (i.e., using the step-
down approach for the secondary effectiveness endpoint).  Therefore the significance 
level is two-sided 0.05 or one-sided 0.025 for both of the secondary effectiveness 
endpoints. 
Based on the binomial distribution with a one-sided significance level of 0.025 (or two-
sided 0.05), a sample size of 105 eyes at 12 months provides a statistical power of at 
least 80% at a true P1OMNI of 0.85, and a sample size of 91 eyes at 12 month provides at 
least 80% at a true P2OMNI of 0.70.  Therefore, at least 105 eyes at 12 months are needed 
for the secondary effectiveness endpoints. 
 SAMPLE SIZE OF THE STUDY 
Based on the discussion in Section 11.1.1 and 11.1.2 the sample size for the 
effectiveness endpoints is 130 eyes treated with the study device with the cataract 
surgery. 
With a sample size of 130 eyes, there is a probability of 95% to observe at least one 
incidence of a safety event with an event rate of about 2.4%. 
In May of 2019, the study protocol was revised to require at least one ocular 
hypotensive medication at the screening for the study eyes.  Since the study has treated 

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some eyes that did not have ocular hypotensive medications at screening, the planned 
sample size of the study is increased to approximately 145 eyes. 
11.2 ANALYSIS POPULATIONS 
The intent-to-treat (ITT) analysis population includes all subjects who are enrolled and 
treated, regardless of whether or not they have a protocol deviation.  Due to the 
eligibility revision in May of 2019 on requiring at least one ocular hypotensive 
medication, the modified ITT (mITT) population includes all ITT except for the treated 
eyes that were not on any ocular hypotensive medication at the screening visit. The per-
protocol analysis population (PP) is a subset of mITT, which includes all subjects who 
have taken at least one ocular hypotensive medication at screening and have uneventful 
cataract extraction followed by ab-interno transluminal viscoelastic delivery and 
trabeculotomy, 12 month IOP and medication data, and have no clinically significant 
protocol deviations. It should be noted that the mITT subjects with an uneventful study 
procedure but with SSIs before the 12-month visit will be included in the PP population 
even if they do not have the 12-month IOP and medication data.  The primary analyses 
on the primary and secondary endpoint analyses will be carried out on the per-protocol 
population.  
The safety data will be summarized based on the ITT population.  The primary and 
secondary endpoint analyses will also be performed on the mITT population. 
The data will be listed separately for the enrolled subjects that are not treated with 
OMNI and treated subjects that do not have ocular hypotensive medications at the 
screening. 
11.3 DEMOGRAPHICS AND BASELINE CHARACTERISTICS  
Demographic variables gender, race, ethnicity, and age will be summarized for all 
enrolled subjects treated with OMNI Surgical System, along with medical history.  
Descriptive statistical summaries of pre-treatment parameters (min, max, median, 
mean, standard deviation) will also be provided. The same analyses will be performed 
for the mITT and PP populations. 
11.4 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. 
 

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As described above, the primary analyses of the primary and secondary effectiveness 
endpoints will be based on the PP population (Section 11.2), although the analyses will 
also be performed on the mITT population.  The safety data will be summarized based 
on the ITT population. 
 
 
PRIMARY EFFECTIVENESS ENDPOINTS 
The IOP reduction from baseline to 12 months postoperatively and the reduction in 
number of IOP-lowering medications from baseline to 12 months will be calculated for 
each eye and summarized descriptively.  The 95% confidence interval of the mean 
reduction will be derived based on the t-distribution.  The one-sample t-test will be 
performed for testing the statistical hypotheses described in Section 11.1.1.  It should be 
noted that, for eyes with secondary surgical interventions (SSI) to control IOP or with SSI 
that can affect the IOP before 12 months, the last available observed data before the SSI 
will be used to impute the 12-month data.  For the analyses based on the mITT 
population, the following imputation for subjects with missing 12-month data but 
without SSI may be performed: 
• The within-eye worst IOP (collected after 3 months postoperatively or IOP at 
baseline for the subjects with no data after postoperative 3 months) for the 
missing 12-month IOP and worst number of IOP lowering medications (collected 
after 3 months postoperatively or IOP-lowering medication data at baseline for 
the subjects with no data after postoperative 3 months) for the missing 12-
month number of IOP-lowering medications. 
• The worst IOP (collected after 3 months postoperatively or IOP at baseline for 
the subjects with no data after postoperative 3 months) during the study for the 
missing 12-month IOP and worst number of IOP-lowering medications (collected 
after 3 months postoperatively or IOP-lowering medication data at baseline for 
the subjects with no data after postoperative 3 months) during the study for the 
missing 12-month number of IOP-lowering medications. 
• The mean IOP during the study for the missing 12-month IOP and mean number 
of IOP-lowering medications during the study for the missing 12-month number 
of IOP-lowering medications. 
• The last-observed-carry-forward approach. 
 
SECONDARY EFFECTIVENESS ENDPOINT 
The number and percent of eyes achieving the secondary effectiveness endpoint will be 
calculated.  The binomial distribution will be used to derive the exact 95% confidence 
interval of the percent and to perform the statistical hypotheses for the secondary 
effectiveness endpoint described in Section 11.1.2.  It should be noted that, for eyes 
with secondary surgical interventions (SSI) to control IOP or with SSI that can affect the 

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IOP before 12 months, the non-responder (i.e. do not achieve the secondary 
effectiveness endpoint) will be assumed for the missing 12-month response. 
For the analyses based on the mITT population, the IOP and number of IOP-lowering 
medications imputation for missing data described in Section 11.4.1 will used to derive 
the corresponding response of the secondary effectiveness endpoint. 
 
COVARIATE ANALYSIS 
The following variables will be examined for their prognostic value to the primary and 
secondary effectiveness endpoints using the PP population with the imputation used for 
the IOP-related SSIs: 
• Age group (based on observed quartiles) 
• Gender (male and female) 
• Race (White and non-White) 
• Ethnicity 
• Baseline IOP group (based on observed quartiles) 
• Screening Number of IOP-lowing medications (1, 2, 3 and 4) 
• Study site 
 
For the primary effectiveness endpoints, one-way ANOVA with one of the factors listed 
above will be used to check the possible covariate effects.  For the secondary 
effectiveness endpoint, Fisher’s test will be performed.  A p-value of 0.15 will be used 
for evaluating the possible covariate effects. 
 
ADDITIONAL EFFECTIVENESS ANALYSES 
The analyses will be based on the PP population. 
 
• The IOP, change in IOP, percent change in IOP, number of IOP-lowing 
medications, and change in number of IOP-lowing medications will be 
summarized descriptively at each visit along with the 95% confidence intervals 
based on the t-distribution. 
• The outcome of ≥ 20% reduction in IOP with no IOP-lowering medications at 
each visit will be summarized by count and percent of eyes achieving the 
outcome. 
• The outcome IOP of ≥6 mmHg and ≤ 18 mmHg with no IOP-lowering medications 
at each visit will be summarized by count and percent of eyes achieving the 
outcomes. 
• The distribution of 12-month unmedicated diurnal IOP percent change from 
baseline will be prepared for the following categories stratified by the number of 
IOP-lowing medication change from baseline and the IOP-related SSIs: 
o 40% ≤ Change (i.e. increase ≥ 40%) 
o 30% ≤ Change < 40% (i.e. 30% ≤ increase < 40%) 

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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%) 
• The distribution of 12-month unmedicated diurnal IOP will be prepared for the 
following categories stratified by the number of IOP-lowing medication change 
from baseline and the IOP-related SSIs: 
o ≥6 mmHg to ≤ 21 mmHg 
o ≥6 mmHg to ≤ 18 mmHg 
o ≥6 mmHg to ≤ 15 mmHg 
o ≥6 mmHg to ≤ 12 mmHg 
• The survival analysis (Kaplan Meier curve) for the time to the first IOP-related 
SSIs will be performed.  The survival analysis will also be performed for the time 
to first take the systemic IOP-lowering medications 
11.5 SAFETY ANALYSIS 
All safety analyses will be performed on the ITT population based on all available data.   
 ADVERSE EVENT 
Adverse events (AEs) will be classified as intraoperative or postoperative.  The number 
and the percent of eyes reporting at least 1 adverse event of a given type will be 
summarized.  Additionally, the number of reports of each type of AEs will be provided. 
For each AE, the number and the percent of eyes reported with the event will be 
summarized by the severity level.  For eyes with multiple reports of the same type of AE, 
the maximum severity will be used.  Similarly, the AE relationship to the procedure will 
be summarized.  For eyes with multiple reports of the same type of AE, the closest 
relationship to the procedure will be used. 
 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 

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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. 
 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). 
11.6 INTERIM ANALYSES 
The primary analysis for this study will occur after the final subject reaches their 12-
month follow-up. Endpoints listed below will be analyzed at an interim analysis 
performed when at least 50% subjects complete 6 month follow-up and when 100% 
patients complete 6 month follow-up. 
Effectiveness endpoints: 
1. Reduction in mean IOP from screening visit; and 
2. Reduction in mean number of IOP-lowering medications from screening visit 
3. Percent of eyes with a ≥20% reduction in IOP with no increase in IOP-lowering 
medications compared to screening visit 
4. Percent of eyes with IOP between 6 and 18 mmHg with no increase in IOP-
lowering medications compared to 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) 
 
It is noteworthy that the two interim analyses are based on the 6-month measurements, 
not the washout IOP at 12 months for the primary and secondary effectiveness 
endpoint.  Additionally, the interim analyses are not for claiming effectiveness of the 
study device and the study will not be terminated due to the 6-month outcomes.  
Therefore, the study p-values are not adjusted for the planned interim analyses.  
11.7 DEVIATION FROM THE STATISTICAL PLAN 
Any deviations from the statistical plan will be noted in the final report. 

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12 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 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. 
• 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 visit the clinical site 
routinely during the study to review charts and to perform source document 
verification, to 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 Closure:  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 study materials to the 
sponsor 
o Discussion of record retention requirements with the investigator 
o Close-out notification to the IRB   

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13 DATA AND QUALITY MANAGEMENT 
13.1 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.  
13.2 SUBJECT IDENTIFICATION 
The subjects will be identified by a five-digit subject number composed of a one-digit 
study identification number, a two-digit center identification number followed by a two-
digit sequential subject number.  The subject identification will be assigned when 
informed consent is obtained.  In this way, information contained in the study records 
will be kept as confidential as possible. 
13.3 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.   
13.4 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 (name) 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. 
13.5 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 
100% 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, 

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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 the study 
worksheets provided by the sponsor and these study worksheets will serve as the 
source data.   
 
Source data and study worksheets are to be maintained at the site in the subject 
records or in the medical records.  All entries must be made in black or blue ink and 
changes must be made by strike-through only with date and initials or signature.  All 
source documents must be completed and signed by the authorized study personnel 
(e.g., study coordinator).    No “white-out” is to be used on the source documents. 
13.6 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.  Unused medical devices are to be 
returned to the sponsor at the conclusion of the enrollment period. 
14 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 form. 
15 DEVICE FAILURES AND MALFUNCTIONS 
All device failures or malfunctions should be recorded on the Device Deficiency Form 
and reported to Sight Sciences Customer Service (877-266-1144). 

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16 ETHICAL CONSIDERATIONS 
16.1 DECLARATION OF HELSINKI 
This study shall be conducted in accordance with the Declaration of Helsinki (Appendix 
D).   
16.2 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. 
16.3 INFORMED CONSENT FORM (ICF) 
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 ICF must be 
submitted to the sponsor for review prior to submission to the IRB.  A copy of each IRB-
approved ICF version is to be made available to Sight Sciences and its CRO.  The 
approved, IRB-stamped ICF is to be kept in its full length in the study Regulatory Binder.  
Original, signed ICFs are to be maintained in the subject’s study records and must be 
made available for monitoring review.  
16.4 PUBLIC LISTING OF STUDY 
The study will be listed on the NIH website www.clinicaltrials.gov.  

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17 STUDY ADMINISTRATION 
17.1 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 
 
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.   
 
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. 
17.2 INVESTIGATOR RESPONSIBILITIES 
 
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. 
 
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. 

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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. 
 
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 13.6:  
1. 
All correspondence with another Investigator, an IRB, the Sponsor, a monitor, or 
FDA, including required reports. 
2. 
Records of each subject’s case history and exposure to the device. Case histories 
include the study CRF’s/worksheets and supporting data including, for example, 
signed and dated consent forms and medical records.  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, 
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. 
 
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. 

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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. 
17.3 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. 
18 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 

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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 
• 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. 
 
 
 
 
 
 
 

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19 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. Gedde SJ, Singh K, Schiffman JC, Feuer WJ. The Tube Versus Trabeculectomy 
Study: interpretation of results and application to clinical practice. Curr Opin 
Ophthalmol. 2012 Mar; 23(2):118-26. 
7.   Zahid S, Musch DC, Niziol LM, Lichter PR, Collaborative Initial Glaucoma 
Treatment Study Group. Risk of endophthalmitis and other long-term 
complications of trabeculectomy in the Collaborative Initial Glaucoma Treatment 
Study (CIGTS). Am J Ophthalmol. 2013 Apr; 155(4):674-680, 680.e1. 
8.   American Academy of Ophthalmology. Preferred practice pattern®. Primary 
open-angle glaucoma. San Francisco, CA. 2015. 
9.   Klink T, Sauer J, Körber NJ, et al. Quality of life following glaucoma surgery: 
canaloplasty versus trabeculectomy. Clin Ophthalmol. 2014;18;9:7-16. 
10.   Lewis RA, von Wolff K, Tetz M, Körber NJ, Kearney JR, Shingleton B, Samuelson 
TW. Canaloplasty: circumferential viscodilation and tensioning of Schlemm’s 
canal using a flexible microcatheter for the treatment of open-angle glaucoma in 
adults: interim clinical study analysis. J Cataract Refract Surg 2007; 33:1217–1226 
11.   Grover DS, Godfrey DG, Smith O, Feuer WJ, Montes de Oca, Fellman RL.  
Gonioscopy-Assisted Transluminal Trabeculotomy, A Novel Ab Interno 
Trabeculotomy:  technique report and preliminary results. Ophthalmology. 2014; 
121:855-861. 
12.   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. 
13.   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. 

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14.   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. 
15.   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. 
16.   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. 
17.   Francis BA, Berke SJ, Dustin L, et al. Endoscopic cyclophotocoagulation 
combined with phacoemulsification versus phacoemulsification alone in 
medically controlled glaucoma. J Cataract Refract Surg. 2014;40:1313–1321. 
18.   Arthur SN, Cantor LB, Wudunn D, et al. Efficacy, Safety, and Survival Rates of 
IOP-lowering Effect of Phacoemulsification Alone or Combined With 
Canaloplasty in Glaucoma Patients. Journal of Glaucoma. 2013;23:316–320. 
19.   Armstrong JJ, Wasiuta T, Kiatos E, Malvankar-Mehta M, Hutnik CML. The Effects 
of Phacoemulsification on Intraocular Pressure and Topical Medication Use in 
Patients With Glaucoma: A Systematic Review and Meta-analysis of 3-Year Data. 
J Glaucoma. 2017 Jun;26(6):511-522. doi: 10.1097/IJG.0000000000000643. 
Review. 
20.   Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, 
Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal 
Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma 
and Cataract: The HORIZON Study. Ophthalmology. 2018 Jun 23. pii: S0161-
6420(17)33810-1. doi: 10.1016/j.ophtha.2018.05.012. 
21.   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 
22.   https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170043b.pdf 
23.   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. 
24.   Grabska-Liberek I, et al.  OMNI 360 in Open-Angle Glaucoma Treatment:  A 6-
Month Follow-Up.  European Society of Cataract & Refractive Surgeons (ESCRS) 
2018.   
25.   Martinez‐Rubio, et al. OMNI‐an initial experience with a new surgical glaucoma 
treatment device. European Society of Cataract & Refractive Surgeons (ESCRS) 
2018. 
 
 

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20 APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES 
20.1 LIST OF STUDY PROCEDURES 
1. Informed Consent 
2. Demographics, Medical & Ocular History 
3. Medication Log 
4. BCVA 
5. Visual Field (Humphrey 24-2 SITA) 
6. IOP (Goldmann Tonometry) 
7. Unmedicated Diurnal IOP 
8. Slit Lamp Exam 
9. Gonioscopy  
10. Dilated Fundus Exam/C:D Ratio 
11. Eligibility Assesment 
12. Cataract Extraction + ab-interno transluminal viscoelastic delivery + 
Trabeculotomy 
13. AE Assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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20.2 SEVERITY OF GLAUCOMA 
Severity of glaucoma is graded as documented in subjects’ medical charts using the 
coding guidelines shown in Figure 3. 
 
Figure 3:  AAO/AGS/ICD-10 Glaucoma Stage Definitions
 
 
 
 
 

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20.4 VISUAL ACUITY 
ETDRS Testing Method 
Best-corrected visual acuity at Baseline and all scheduled follow-up visits will be 
measured using the ETDRS charts at 1 or 4 meters. 
 
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 testing should be done 
using 1 meter chart. For testing at 1 meter, the distance must be 1.00 (39 and 3/8 
inches). A measuring tape or meter stick should always be available to verify the chart 
distance, even if the examining chair is supposed to be immovable or if reference marks 
are placed on the floor or walls. (Custodial and other staff have been known to move 
room furnishings about and clean-off marks from the floor or wall while performing 
their duties, necessitating re-establishing the correct distances for the lane.) 
 
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, remember to add +0.75 
sphere 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 missed or read incorrectly should be noted.   
 

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In order to provide standardized and well-controlled assessment of visual acuity, all 
visual acuity assessments for a subject should be performed consistently (e.g., the same 
lighting conditions, viewing distance, etc.) at each visit. 
 
Recording and Scoring Best-Corrected Visual Acuity 
 
Using the Visual Acuity Worksheet, circle each letter the subject identifies correctly, 
write total correct for each row in the place provided, and compute the total correct for 
all rows. Do not mark letters read incorrectly or not read at all.  Each letter read 
correctly is recorded as one.  Only move to the next line if 4 or more letters are read 
correctly.  
 
The number of correct letters will be recorded on the study worksheets and entered 
into the EDC.   
20.5 MEASUREMENT OF INTRAOCULAR PRESSURE 
Each time IOP is measured, the physician or technician should use a Goldmann 
tonometer. 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.   
 
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 

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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 
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 

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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. 
 
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. 

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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. 
 
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. 
20.6 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 must be reliable at screening for 
eligibility, defined as less than 33% false positives, false negatives, and fixation losses.    
A visual field done within 90 days 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 

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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. 
20.7 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.   
20.8 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 
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 

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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) 
 
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). 35 
 
35 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: 
 
NONE 
Minimal (Top left image) 
Mild (Top right image) 
Moderate (bottom left 
image) 
Severe (bottom right image) 

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Other Slit Lamp Findings (complete for each finding) 
• 
Trace 
• 
Mild 
• 
Moderate 
• 
Severe 
20.9 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.  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. 
 
20.10 OCULAR HYPOTENSIVE MEDICATIONS 
Each ocular hypotensive medication will be recorded on the case report form.  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. 
 
 
 
 
 
 
 
 

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21 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 

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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. 
 
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. 

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III. 
RISKS, BURDENS AND BENEFITS 
 
• 
In medical practice and in medical research, most interventions involve risks 
and burdens. 
 
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 
 

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• 
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. 
 
• 
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. 
 

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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 
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. 
 

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• 
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 
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 
 

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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. 
 
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.