A Multicenter Clinical Study To Assess The Long-Term Safety And Effectiveness Of The OMNI® Surgical System In Combination With Cataract Surgery In Eyes With Open Angle Glaucoma (GEMINI 2.0)
Conditions: Glaucoma, Open-Angle
Sponsor: Sight Sciences, Inc.

   Study of OMNI System in POAG
Protocol #07408 Rev B 
CONFIDENTIAL
Sight Sciences
Page 1 of 53
AN OBSERVATIONAL MULTICENTER CLINICAL STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFECTIVENESS OF
THE OMNI® SURGICAL SYSTEM IN COMBINATION WITH CATARACT SURGERY IN EYES WITH OPEN ANGLE
GLAUCOMA (GEMINI 2.0)
PROTOCOL ID #:
07408
CURRENT REVISION:
Rev B
REVISION DATE:
03/18/2022
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 
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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.
or
ag
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amendments.
mendments.
Name
me
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This protoco
designate
designat
Document
venue
, CA  94025
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1144
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ClinicalTrials.gov NCT #05044793 

                                                                Study of OMNI System in POAG 
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Revision History 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol 
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PROTOCOL SUMMARY OF CHANGES
Revision 
Section 
Description and Rationale for Change 
Location of 
Change 
A 
N/A 
Original 
N/A 
B 
N/A 
The protocol was revised to include a second 
cohort of subjects who did not receive 
hypotensive medication washout prior to 
treatment 
Th oughout 
the Protocol 
Synopsis & 
Section 2 
Study Objective: Revised this section to specify 
the subjects who will be enrolled and observed n 
the study 
Pages 6 and 10 
Synopsis & 
Section 6.2 
Effectiveness Endpoints: Revised the 
effectiveness endpoints to reflect how study 
endpoints will be reviewed for the second c hort 
Pages 7 and 14 
Synopsis & 
Section 7.1 
Inclusion Criteria: Elaborated on inclu ion 
criterion # 1 to reflect the second cohort 
Pages 8 and 14 
Synopsis & 
Section 7.2 
Removed exclusion crit
ion # 4 
Pages 9 and 15 
5 
The Study Desig  section was revised to clarify 
that only subjects who underwent hypotensive 
medicatio  washout p or to OMNI surgery will 
receive a washout of hypotensive medications at 
the 24- a d 36-month visits, if using hypotensive 
m dication(s) at those visits.  
Page 13 
8 
Revised this section to show 2 study visit 
schedule : One for each cohort. Table 1 to reflect 
a Washout visit, and Table 2 without a washout 
visit.  
Page 16 
8.3 
Revised this section to clarify the number of 
subjects to be enrolled in each cohort, and which 
subjects will receive a hypotensive medication 
washout  
Page 18 
8.7.1 
Revised this section to specify which subjects will 
receive a hypotensive medication washout 
Page 19 
17 
Revised Appendix A, to specify what procedures 
should be completed for each cohort: Washout of 
hypotensive medications, BCVA, Visual field and 
IOP 
Pages 38-46 
N/A 
Insignificant editorial changes were made to 
provide further clarity as needed 
Throughout 
the Protocol 
led Doc
e

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TABLE OF CONTENTS 
 
1 
PROTOCOL SYNOPSIS .................................................................................................................................... 6 
2 
STUDY OBJECTIVE ....................................................................................................................................... 10 
3 
BACKGROUND AND JUSTIFICATION FOR THE STUDY .................................................................................. 10 
4 
STUDY DEVICE ............................................................................................................................................ 12 
4.1 
DEVICE DESCRIPTION...................................................................................................................................... 12 
4.2 
TRAINING ..................................................................................................................................................... 13 
5 
STUDY DESIGN ............................................................................................................................................ 13 
5.1 
STUDY SITES ................................................................................................................................................. 13 
6 
STUDY ENDPOINTS ..................................................................................................................................... 14 
6.1 
PRIMARY SAFETY ENDPOINT ............................................................................................................................ 14 
     6.1.1 
Secondary Safety Endpoints ................................................................................................................. 14 
6.2 
EFFECTIVENESS ENDPOINTS ............................................................................................................................. 14 
7 
STUDY SELECTION CRITERIA ........................................................................................................................ 14 
7.1 
INCLUSION CRITERIA ....................................................................................................................................... 14 
7.2 
EXCLUSION CRITERIA ...................................................................................................................................... 15 
8 
STUDY PROCEDURES ................................................................................................................................... 16 
8.1 
STUDY SCHEDULE – PRE-OPERATIVE WASHOUT  ...................................................................................... 16 
8.2 
STUDY SCHEDULE – NO PRE-OPERATIVE WASHOUT ................................................................................. 17 
8.3 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION ............................................................... 18 
8.4 
INFORMED CONSENT AND POINT OF ENROLLMENT ............................................................................................... 18 
8.5 
ELIGIBILITY AND STUDY ENTRY .......................................................................................................................... 18 
8.6 
DATA EXTRACTION ......................................................................................................................................... 19 
8.7 
PROSPECTIVE VISITS ....................................................................................................................................... 19 
     8.7.1 
Washout of Hypotensive Medications .................................................................................................. 19 
8.8 
UNSCHEDULED VISITS ..................................................................................................................................... 21 
8.9 
MANAGEMENT OF IOP ................................................................................................................................... 21 
     8.9.1 
Paracentesis ......................................................................................................................................... 21 
     8.9.2 
Secondary IOP-Lowering Interventions to Control IOP ......................................................................... 22 
8.10 
WITHDRAWAL AND DISCONTINUATION .............................................................................................................. 22 
8.11 
SUBJECTS LOST TO FOLLOW-UP ........................................................................................................................ 22 
9 
ADVERSE EVENTS (AES)............................................................................................................................... 22 
9.1 
DEFINITIONS OF AE, SAE, SADE, USADE ......................................................................................................... 23 
9.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS .............................................................................................. 23 
9.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS .......................................................... 25 
10 
STATISTICAL CONSIDERATIONS ................................................................................................................... 26 
10.1 
SAMPLE SIZE CALCULATION ............................................................................................................................. 26 
10.2 
ANALYSIS POPULATIONS ................................................................................................................................. 26 
10.3 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ............................................................................................... 26 

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10.4 
EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS ........................................................................................... 27 
10.5 
SAFETY ANALYSIS ........................................................................................................................................... 27 
     10.5.1 
Adverse Events ..................................................................................................................................... 27 
     10.5.2 
Best Corrected Visual Acuity ................................................................................................................. 27 
     10.5.3 
Other Safety Outcomes ........................................................................................................................ 28 
10.6 
INTERIM ANALYSIS ......................................................................................................................................... 28 
10.7 
DEVIATION FROM THE STATISTICAL PLAN............................................................................................................ 28 
11 
MONITORING PROCEDURES ....................................................................................................................... 29 
12 
DATA AND QUALITY MANAGEMENT ........................................................................................................... 30 
12.1 
DATABASE MANAGEMENT .............................................................................................................................. 30 
12.2 
SUBJECT IDENTIFICATION ................................................................................................................................. 30 
12.3 
SUBJECT ACCOUNTABILITY ............................................................................................................................... 30 
12.4 
CONFIDENTIALITY .......................................................................................................................................... 30 
12.5 
SOURCE DATA AND CASE REPORT FORMS .......................................................................................................... 31 
12.6 
RETENTION PERIOD ........................................................................................................................................ 31 
13 
PROTOCOL MODIFICATIONS AND DEVIATIONS........................................................................................... 31 
14 
ETHICAL CONSIDERATIONS ......................................................................................................................... 32 
14.1 
DECLARATION OF HELSINKI .............................................................................................................................. 32 
14.2 
INSTITUTIONAL REVIEW BOARDS (IRB) .............................................................................................................. 32 
14.3 
INFORMED CONSENT DOCUMENT (ICD) ............................................................................................................ 32 
14.4 
PUBLIC LISTING OF STUDY ............................................................................................................................... 32 
15 
STUDY ADMINISTRATION ........................................................................................................................... 33 
15.1 
EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE .................................................... 33 
15.2 
INVESTIGATOR RESPONSIBILITIES....................................................................................................................... 33 
     15.2.1 
General Responsibilities of Investigators .............................................................................................. 33 
     15.2.2 
Specific Responsibilities of Investigators .............................................................................................. 34 
     15.2.3 
Investigator Records ............................................................................................................................. 34 
     15.2.4 
Investigator Reports ............................................................................................................................. 34 
15.3 
INVESTIGATOR AGREEMENT ............................................................................................................................. 35 
16 
PUBLICATION POLICY .................................................................................................................................. 35 
BIBLIOGRAPHY ..................................................................................................................................................... 37 
17 
APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES......................................................... 38 
17.1 
LIST OF STUDY PROCEDURES ............................................................................................................................ 38 
17.2 
BEST CORRECTED VISUAL ACUITY ..................................................................................................................... 38 
17.3 
MEASUREMENT OF INTRAOCULAR PRESSURE ....................................................................................................... 38 
17.4 
VISUAL FIELD EXAMINATION ............................................................................................................................ 42 
17.5 
DILATED FUNDUS EXAMINATION ....................................................................................................................... 43 
17.6 
SLIT LAMP EXAMINATION ................................................................................................................................ 43 
17.7 
GONIOSCOPY ................................................................................................................................................ 46 
17.8 
OCULAR HYPOTENSIVE MEDICATIONS ............................................................................................................... 46 
18 
APPENDIX B - DECLARATION OF HELSINKI .................................................................................................. 46 
 

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1 PROTOCOL SYNOPSIS 
Protocol Title 
An observational multicenter clinical study to assess the 
long-term safety and effectiveness of the OMNI® Surgical 
System in combination with cataract surgery in eyes with 
open angle glaucoma (Gemini 2.0) 
Protocol ID Number 
 
Study Device 
OMNI® Surgical System 
Study Objective 
The purpose of this study is to evaluate the long-term 
safety and effectiveness of the OMNI® Surgical System in 
subjects who were treated with the OMNI Surgical System 
following Cataract Extraction, at least 700 days prior to 
enrollment.  
Study Design 
This is a multicenter, observational study with no planned 
surgical interventions. Both prospective and retrospective 
data on participating subjects will be collected in the 
study. 
Primary Safety Endpoint 
• Rate of occurrence of sight-threatening adverse events 
(AEs) 
Secondary Safety 
Endpoints 
• Rates of ocular AEs  
• Reduction in best corrected distance visual acuity 
(BCVA) from baseline  
• Secondary Ocular Surgical Interventions, including 
laser, for intraocular pressure (IOP) control  

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Effectiveness Endpoints 
For eyes that underwent washout prior to OMNI surgery: 
• Reduction in mean unmedicated diurnal IOP (DIOP) 
from the preoperative unmedicated DIOP 
• Reduction in mean number of IOP-lowering 
medications from screening  
• Percent of eyes with a ≥20% reduction in unmedicated 
diurnal IOP from the preoperative unmedicated DIOP 
• Percent of eyes with unmedicated diurnal IOP 
between 6 and 18 mmHg inclusive  
 
For eyes that did not undergo washout prior to OMNI 
surgery: 
• Reduction in mean medicated IOP from pre-operative 
medicated IOP  
• Reduction in mean number of IOP-lowering 
medications from screening  
• Percent of eyes with a ≥20% reduction in mean 
medicated IOP from pre-operative medicated IOP 
• Percent of eyes with medicated IOP between 6 and 18 
mmHg inclusive 
 

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Inclusion Criteria 
Inclusion Criteria 
To be included in the study, individuals must meet each 
eligibility criterion presented as follows: 
1. Treated with the OMNI Surgical System in combination 
with cataract extraction 
 
. Two cohorts will be enrolled:  
a. Subjects who underwent a pre-operative washout 
of ocular hypotensive medications with post-
washout DIOP of 
   OR 
b. Subjects without a preoperative washout of ocular 
           hypotensive medications with pre-operative        
medicated IOP 
 mmHg and on 
 
hypotensive medications 
Note: Mild to moderate open angle glaucoma as 
documented in subjects’ medical record substantiated 
using funduscopic exam or OCT and at least one visual 
field test. 
 
The visual field test may be historical (within 6 months 
prior to OMNI surgery). 
 
2. Is able to understand study requirements and willing 
to follow study instructions 
3. Is willing to return for required study follow-up visits  

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Exclusion Criteria 
The presence of any of the following characteristics will 
exclude individuals from study participation: 
• Systemic disease that, in the opinion of the 
Investigator, would put the subject's health at risk 
and/or prevent completion of required study visits 
• Ocular pathology which, in the Investigator's 
judgment, would either place the subject at increased 
risk of complications, contraindicate washout, place 
the subject at risk of significant vision loss during the 
study period (e.g., wet age macular degeneration 
(AMD), corneal edema, Fuch’s dystrophy, active 
intraocular infection or inflammation within 30 days 
prior to Screening Visit, etc.), or interfere with 
compliance to elements of the study protocol (e.g., 
returning to Investigator’s office for follow-up visits) 
• 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 
Up to 130 subjects will be enrolled  
Number of Sites 
Up to 15 study sites in US  
Schedule of Visits 
24 Month, 36 Month  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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2 STUDY OBJECTIVE 
The purpose of this study is to evaluate the long-term safety and effectiveness of the OMNI® 
Surgical System in subjects who were treated  with the OMNI Surgical System in combination 
with Cataract Extraction, at least 700 days prior to enrollment. 
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 2040.1 Primary open 
angle glaucoma (POAG) is the most prevalent form of glaucoma and elevated IOP is the only 
treatable risk factor.2 Hypotensive eye drops are commonly used as the first line clinical 
management for POAG.3 Ocular side effects, such as allergies, ocular surface disorders, 
blepharitis, pemphigoid, and abnormal pigmentation, and systemic side effects, such as 
bradycardia, headaches, depression, anxiety, confusion, dysarthria, hallucinations, lethargy, 
polyuria, weight loss, and metabolic acidosis, can occur during long term use of topical 
medications.4 There is also a documented low rate of compliance with eye drops that increases 
the risk of disease progression and loss of vision.5  
 
The Ocular Hypertension Treatment Study showed that reduction of IOP by an average of 
22.5% through medical intervention decreased conversion from ocular hypertension to 
glaucoma over a 5-year period to approximately half that of untreated controls (4.4 vs. 9.5%).4 
Similarly, the Early Manifest Glaucoma Trial (EMGT) showed that treatment of newly diagnosed 
POAG with argon laser trabeculoplasty plus betaxolol reduced the risk of disease progression at 
6 years to half of that for untreated controls (hazard ratio, 0.50; 95% confidence interval, 0.35–
0.71).6 Each mmHg of IOP reduction decreased the risk of progression by approximately 10%.7 
 
 
1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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The Advanced Glaucoma Intervention Study (AGIS) showed that eyes with 100% of visits with 
IOP less than 18 mmHg over 6 years had mean changes from baseline in visual field defect score 
close to zero during follow-up.7  
 
Minimally (or micro) invasive glaucoma surgery (MIGS) provides an alternative to more invasive 
surgical methods (i.e. trabeculectomy or glaucoma drainage devices). MIGS procedures can 
generally be done along with cataract surgery or as standalone procedures. Several studies 
have demonstrated MIGS to provide long-term IOP lowering and the potential to reduce or 
eliminate the need for medications (and therefore reliance on patient adherence).8,9 
 
MIGS techniques that re-establish the aqueous outflow through the physiological pathways are 
gaining acceptance among glaucoma surgeons. Canaloplasty (originally described as ab externo) 
is one such procedure that is intended to restore the natural aqueous outflow system through 
microcatheterization and viscodilation of Schlemm's canal with a well-documented safety and 
efficacy profile in reducing IOP.10,11,12 Trabeculotomy is another such procedure that relieves 
the resistance to aqueous flow by cleaving the trabecular meshwork and the inner wall of 
Schlemm’s canal, resulting in pressure reductions.13,14 
 
Cataract is often seen as a comorbidity present in patients with glaucoma; together, they serve 
as leading causes of blindness worldwide.15 Cataract accounts for 33% of visual disability 
worldwide and may have a causal relationship with increased IOP in OAG.16 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 
 
 
7 
 
 
 
 
 
 
 
 
 
 

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year.
 
 
 
 
 
 
Combined glaucoma and cataract surgery often result in a greater decrease in IOP and use of 
glaucoma medications compared with cataract surgery alone. 20,21,22,23 When a patient with 
glaucoma also requires surgical intervention for cataract, the ophthalmologist often performs 
simultaneous cataract and glaucoma surgery.  
 
Note: A summary of known and potential risks to humans, as identified in the 
literature or through preclinical testing and/or prior clinical evaluations for the study devices 
can be found in the Instructions for Use for the OMNI Surgical System. 
 
This is a multicenter, observational clinical study with no planned surgical intervention. Both 
prospective and retrospective data on participating subjects will be collected in the study.   
4 STUDY DEVICE 
4.1 
DEVICE DESCRIPTION 
The OMNI® Surgical System (“OMNI”) is indicated for canaloplasty (microcatheterization and 
transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular 
meshwork) to reduce IOP in adult patients with POAG.  
 
 
17 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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4.2 
TRAINING 
All surgeons would have received training in accordance with Sight Sciences, Inc.’s requirement 
for using the OMNI Surgical System. OMNI surgery will not be conducted in this trial therefore 
study specific training on the device will not be required.  
5 STUDY DESIGN 
This is a multicenter, observational research study with no planned surgical interventions. Both 
prospective and retrospective data on participating subjects will be collected in the study.  
Up to 130 subjects will be enrolled. Subjects will be followed from 24-months (700 – 1040 days) 
through 36-months (1,050 – 1,110 days) post-surgery. Pre-operative and surgery data will be 
collected retrospectively. 
Prospective data will be collected for all study specific post-operative visits following  
enrollment into the study. 
 
The study will employ a medication washout at the 24-, and 36-month endpoints for the 
subjects who received medication washout prior to the OMNI procedure and are using 
hypotensive medications at those visits.  
 
5.1 
STUDY SITES 
This clinical study will be conducted at up to 15 sites in the United States.  

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6 STUDY ENDPOINTS 
6.1 
PRIMARY SAFETY ENDPOINT 
Rate of occurrence of sight-threatening adverse events (AEs) 
6.1.1 SECONDARY SAFETY ENDPOINTS 
• Rate of ocular AEs  
• Reduction in best corrected distance visual acuity (BCVA) from baseline  
• Secondary Ocular Surgical Interventions, including laser, for IOP control 
6.2 
EFFECTIVENESS ENDPOINTS 
For eyes that underwent washout prior to OMNI surgery:  
• Reduction in mean unmedicated diurnal IOP (DIOP) from the preoperative unmedicated 
DIOP 
• Reduction in mean number of IOP-lowering medications from screening  
• Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP from the 
preoperative unmedicated DIOP  
• Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive 
 
For eyes that did not undergo washout prior to OMNI surgery: 
• Reduction in mean medicated IOP from pre-operative medicated IOP  
• Reduction in mean number of IOP-lowering medications from screening  
• Percent of eyes with a ≥20% reduction in mean medicated IOP from pre-operative 
medicated IOP  
• Percent of eyes with medicated IOP between 6 and 18 mmHg inclusive 
 
7 
 
7.1 
 
 
 
 
 
 

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b. 
 
 
 
 
 
 
 
 
 
 
 
 
7.2 
EXCLUSION CRITERIA 
 
 
 
 
 
 
 
 
3. 
 
 

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8.3 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION 
Up to 130 subjects will be enrolled. Eligible subjects will be enrolled at the 24-month 
follow up timepoint as shown by Table 1 or 2 as applicable. At least 50 subjects will be 
enrolled in each cohort. For subjects in cohort A, diurnal IOP measurements will be 
measured at both visits for those subjects who underwent medication washout and 
where DIOP was measured pre-operatively (Cohort A). Cohort A subjects using ocular 
hypotensive medication(s) at 24 and 36 months will undergo a medication washout 
(Table 3) and return for diurnal IOP measurements at a second visit within the same 
window, as shown in Table 1. There will be no diurnal IOP measurements for subjects in 
cohort B. IOP measurements will be measured as shown in Table 2.  
 
It is anticipated that site initiation, recruitment and follow-up of subjects, data collection 
and site close-out will require approximately 60 months. 
8.4 
INFORMED CONSENT AND POINT OF ENROLLMENT 
The pre-operative and Surgery data will be collected retrospectively by performing a 
review of medical charts. Any patients identified as meeting the study eligibility criteria 
will then be consented for the study for the prospective observational data collection.  
 
The IRB-approved informed consent document (ICD) will be presented and explained to 
each prospective subject by the Investigator or a delegated, trained clinical professional. 
Once the patient 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 patient will be 
given a choice to voluntarily confirm his or her participation in the study as documented 
by completion of the informed consent document. After signing the ICD and the HIPAA 
(Health Insurance Portability and Accountability Act) authorization, the subject can then 
proceed with the study visits. The subject has the right to withdraw from the study at 
any time without consequences, as indicated in the ICD. 
 
The subject’s signed and dated informed consent must be obtained before conducting 
any study-specific procedures that are not part of the standard of care.   
 
The investigative site must retain the original, signed written ICD. A copy of the written 
ICD must be given to the subject. 
8.5 
ELIGIBILITY AND STUDY ENTRY 
Subjects will be recruited from the Investigators’ patient records. Eligible subjects will 
consist of those patients meeting all inclusion criteria and none of the exclusion criteria.  
 

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8.6 
DATA EXTRACTION 
Data for the pre-operative) and surgery visits will be collected retrospectively onto case 
report forms (CRFs). The data collected will be in accordance with Tables 1 and 2 (8.1 &  8.2: 
Study Schedule).  
 
Following signing of the ICD, a subject ID number will be assigned consisting of a two-digit 
study identification number, a two-digit site identification number followed by a two-digit 
subject number (
 Subject ID numbers will be assigned sequentially. 
 
Medical records will be reviewed for demographic and medical history information, pre-
operative, medication use data, adverse events, and surgical information, including clock 
hours of canaloplasty and trabeculotomy. Intra-operative complications will be abstracted 
from the Operative Notes.  
8.7 
PROSPECTIVE VISITS 
After obtaining an understanding of the purpose of this study and reviewing and signing 
the ICD, all subjects will begin the prospective study visits. These visits should be 
performed according to the schedule provided in Tables 1 and 2. All attempts should be 
made to conduct each visit within the time interval specified in Tables 1 and 2. 
Evaluations conducted outside the prescribed time period will be considered protocol 
deviations.   
 
 
 
8.7.1 WASHOUT OF HYPOTENSIVE MEDICATIONS 
Subjects who underwent washout prior to OMNI surgery (Cohort A) and who are taking 
hypotensive medications at the 24- and 36-month visits will be instructed to discontinue 
their ocular hypotensive medication regimen and to return for a post-washout visit after 
completing the appropriate washout period.  
 
 
 
 
 
If the study subject fails to remember to not use ocular hypotensive medication for the 
study eye per the required washout period, they can restart washout and return for the 

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8.8 
UNSCHEDULED VISITS 
An unscheduled visit will be any visit to the clinical site, other than those specified in the 
protocol. The Investigator and/or qualified investigational staff will perform the 
procedures necessary to evaluate the study participant at these visits and will record the 
visit in the subject’s CRF. No specific testing is required. 
8.9 
MANAGEMENT OF IOP  
For subject safety, a change in medical therapy may be implemented or additional 
surgical measures may be performed at any time during the study at the Investigator’s 
discretion in the event it is required. The primary concern of the Investigator and 
Sponsor at all times is the health and safety of the subjects. Usage of hypotensive 
medications specifically indicated for prevention of IOP spikes following Nd:YAG 
capsulotomy and administered for up to 72 hours after Nd:YAG capsulotomy will not be 
considered rescue therapy.  
 
Medications which have been re-started by the Investigator may be discontinued if the 
Investigator’s judgment is that the target intraocular pressure has been reached and the 
continued use of some or all of the therapy may not be required. Discontinuation of 
medications after re-introduction is recommended to be in the reverse order of re-
introduction. The rationale for discontinuation should also be documented in the 
subject’s medical record.   
 
A record of all ocular hypotensive medications added, discontinued or changed will be 
documented on the appropriate CRF for each scheduled visit or on a CRF for an 
Unscheduled Visit, if necessary. 
 
8.9.1 PARACENTESIS 
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). 

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8.9.2 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 procedure, 
the subject should be withdrawn from the study. 
 
Subjects who have had a secondary IOP-lowering intervention will be considered 
treatment failures for the purpose of the endpoint analyses.   
8.10 WITHDRAWAL AND DISCONTINUATION 
All subjects have the right to withdraw at any point during the study without prejudice. 
The Investigator can discontinue any subject at any time at his/her discretion, or if 
continued participation in the study would result in harm to the subject. All efforts 
should be made by the Investigator to retain the subject in the study. If a subject 
withdraws prematurely from the study, a genuine effort must be made to determine the 
reason(s) the subject discontinued the study. The reason must be recorded in the 
subject’s file and on the Study Exit Case Report Form. A subject may withdraw from the 
study on his/her own or can be withdrawn by the study investigator for reasons 
including but not limited to non-compliance, being unresponsive, or no longer qualifying 
under the protocol. A subject may be withdrawn by the Sponsor for reasons including 
but not limited to early closure or discontinuation of the study. For every subject that 
withdraws/is withdrawn from the study prior to completing the study, the study 
investigator should bring the subject back for a final study visit if possible unless the 
subject has had a recent visit and, in the Investigator’s discretion, does not need a final 
visit. If a subject cannot be returned for a final study visit, the reason should be 
documented in the subject’s study record.  
8.11 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, every attempt 
to contact with the subject should be documented. If a subject misses two consecutive 
follow-up visits without any contact with the study staff, the subject will be considered 
lost-to-follow-up unless there is a further communication by the subject. 
9 ADVERSE EVENTS (AES) 
Adverse Events are defined below. Adverse events that occur in the eye during the trial 
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 

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on the Adverse Event CRF. Conditions which exist at the time the subject is enrolled will 
be considered pre-existing conditions and will not be recorded as adverse events unless 
they increase in severity during the study. Sites should document any known existing 
medical and ophthalmic conditions at the time of eligibility determination. 
 
Information regarding adverse events that occurred intra and post-operatively up to 
enrollment into the study will also be collected.  
9.1 
DEFINITIONS OF AE, SAE, SADE, USADE 
Adverse Event 
Any untoward medical occurrence in a subject who has been 
treated with the device that does not necessarily have causal 
relationship with the treatment. 
Adverse Device 
Effect 
Any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease that is possibly related 
to the study device. 
Serious Adverse 
Event (SAE) 
Any untoward medical occurrence that: 
• Results in death 
• Is life-threatening 
• Requires in-patient hospitalization or prolongs existing 
hospitalization 
• Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent 
damage to a body structure 
• Sight-threatening 
Unanticipated 
Adverse Device 
Effect 
Any serious adverse effect on health or safety, any life-
threatening problem or death caused by, or associated with a 
device if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the 
clinical investigational plan; or any other unanticipated serious 
problem associated with a device that relates to the rights, 
safety, or welfare of subjects (21 CFR 812.3(s)). Any sight-
threatening event, whether listed in the protocol or not, is 
considered to be reportable as a UADE. 
9.2 
 
 
 
 
 
 
  

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• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
24 
 
 
 
 
 
 

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• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
  
 
Adverse events may occur intra-operatively or post-operatively. 
9.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS 
Identification, collection and reporting of adverse event information is the responsibility 
of the Principal Investigator.  The Investigator records the date of the event, its severity, 
treatment (if any) and the assessed relationship of the event to the study device on the 
AE CRF.   
Any ocular serious adverse event (SAE) should be reported to the study sponsor within 
one business day of learning of the event.  Non-ocular SAEs should be reported to the 
study sponsor within two working days of learning of the event. Enter data in electronic 
data capture (EDC) system within two working days of learning of the event. 
Any unanticipated adverse device effects (UADE) must be reported to the following 
two entities: 
1. The study sponsor – Within one working day of the investigator first learning of 
the event enter data in EDC; and  
2. The reviewing IRB – As soon as possible, but no later than 10 working days after 
the investigator first learns of the event, report per the IRB’s instructions.  
The sponsor will conduct an evaluation of unanticipated adverse device effects.  If the 
sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to subjects, parts of the investigation presenting risks will be 
terminated. Termination will occur no later than 5 working days after the sponsor 

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makes such a determination and no later than 15 working days after the sponsor first 
received notice of the effect. 
10 STATISTICAL CONSIDERATIONS 
10.1 SAMPLE SIZE CALCULATION 
This is a descriptive study and is not designed to test pre-planned hypotheses. The 
sample size is based on an understanding of the approximate number of eligible 
patients available at the participating sites and not on formal sample size calculation. 
With an assumed standard deviation of 3.5 mmHg for intraocular pressure, a minimum 
change in IOP of 5.0 mmHg from a pre-operative baseline of mean = 21 mmHg, and 
alpha = 0.05, a sample size of minimum 50 subjects is required to get at least 90% power 
to detect statistical significance. 
With a total sample size of up to 130, adverse events with a frequency of approximately 
3% would be detected with 97.5% probability. 
10.2 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.  The per-protocol 
analysis population (PP) is a subset of ITT, which includes all subjects who have 
canaloplasty and trabeculotomy after uneventful cataract surgery, 36-month IOP (or 
hypotensive medications washed out IOP if the medications can be washed out) and 
medication data, and have no clinically significant protocol deviations. It should be 
noted that the ITT subjects with an uneventful study procedure but with secondary 
surgical interventions (SSIs) before the 36-month visit will be included in the PP 
population even if they do not have the 36-month IOP and medication data.   
The safety data will be summarized based on the ITT population.   
10.3 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, and standard deviation) will also be provided. The same analyses will be 
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10.4 EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS 
Descriptive statistics on continuous variables will include mean, standard deviation, 
median, minimum, and maximum. Confidence intervals for change from baseline will be 
included for selected endpoints. Categorical variables will be summarized using 
frequency counts and percentages. Exact confidence intervals for point estimates may 
be provided. Statistical testing will be one-sided with a significance level of 0.025 or 
two-sided significance level of 0.05 unless specify otherwise. Data listings of individual 
subject data may be provided. 
 
Subjects with washout and those without washout will be analyzed separately. 
 
10.5 SAFETY ANALYSIS 
All safety analyses will be performed on the ITT population based on all available data 
descriptively.   
10.5.1 ADVERSE EVENTS 
AEs will be classified as pretreatment, 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. 
10.5.2 BEST CORRECTED VISUAL ACUITY 
The number and percent of eyes reporting with BCVA of 20/20 or better, 20/25 or 
better, 20/32 or better, 20/40 or better, worse than 20/40 to 20/80, worse than 20/80 
to 20/200, and worse than 20/200 at each visit will be summarized. The number and 
percent of eyes reporting BCVA of increase ≥ 10 letters, increase 10 letters, increase ≥ 5 
letters to < 10 letters, within 5 letters change, decrease ≥ 5 letters to < 10 letters, 
decrease 10 letters, and decrease ≥ 10 letters at each postoperative visit will be 
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10.5.3 OTHER SAFETY OUTCOMES 
The number and percent of eyes reported with each kind of slit lamp findings, 
gonioscopy findings, and dilated fundus examination findings at each visit will be 
provided. 
The descriptive statistics for the continuous variables will be derived for the visual field 
mean deviation (MD) and pattern standard deviation (PSD). 
10.6 INTERIM ANALYSIS 
An interim analysis providing descriptive statistics for the outcomes may be completed 
following completion of the 24-Month follow-up visit by 100% of the enrolled subjects. 
Endpoints listed below will be analyzed at an interim analysis. No device effectiveness 
will be claimed based on the interim analysis outcomes. 
 
Subjects with washout and those without washout will be analyzed separately. 
 
Effectiveness outcomes up to 24 months will be summarized descriptively, as follows: 
1. Percent of eyes with a ≥20% reduction from pre-operative baseline in IOP with 
no increase in IOP-lowering medications compared to the pre-operative visit; 
2. Percent of eyes with IOP between 6 and 18 mmHg with no increase in IOP-
lowering medications compared to pre-operative visit; 
3. Percent of eyes with IOP between 6 and 21 mmHg with no increase in IOP-
lowering medications compared to pre-operative visit; 
4. Mean reduction in DIOP from the pre-operative DIOP (Cohort A), or Mean 
reduction in medicated IOP from the pre-operative medicated IOP (Cohort B); 
and 
5. Reduction in mean number of IOP-lowering medications from the pre-operative 
visit. 
 
 
The primary safety endpoint is the rate of occurrence of sight-threatening AEs.  
 
The secondary safety endpoints are the rates of ocular adverse events, the reduction in 
BCVA from baseline, and secondary ocular surgical interventions, including laser, for IOP 
control. 
10.7 DEVIATION FROM THE STATISTICAL PLAN 
Any deviations from the statistical plan will be noted in the final report. 

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11 MONITORING PROCEDURES 
Sight Sciences, Inc. (“Sight”) or contract research organization (CRO) personnel will 
monitor the study in a manner consistent with FDA regulations, good clinical practices 
(GCPs), and the clinical research standards adopted by Sight. Study monitoring will be 
executed using on-site and remote monitoring visits as needed and as determined by 
the study team. The frequency and necessity of visits will be determined by the study 
team. Study monitoring will involve the following elements: 
 
• Site Qualification:  Sight 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 or the CRO have recently been involved with an investigator 
for another study, a site qualification visit may not be necessary. 
• Site Initiation:  Sight 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. The site initiation visit may be conducted 
remotely and may include a grouping of multiple sites. 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; and 
o Records and reports. 
• Interim Monitoring:  Sight or CRO personnel will conduct routine visits during 
the course of the study to review charts, perform source document 
verification, ensure proper adherence to the study protocol, and to review 
regulatory documents. Interim monitoring visits and telephone consultation 
will occur as necessary during the course of the study to ensure the proper 
progress and documentation of the study findings. 
• Study Close Out Visit:  At the conclusion of the trial there will be a study 
closure visit during which several actions, including but not limited to the 
following, will be performed: 
o A final inspection of the study binder; 
o Accountability and return of all devices and non-consumable ancillary 
study supplies to the sponsor; 
o Discussion of record retention requirements with the investigator; and 
o Close-out notification to the IRB.   

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12 DATA AND QUALITY MANAGEMENT 
12.1 DATABASE MANAGEMENT 
The study database will be designed using an electronic 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 electronic case report form (eCRF), will be validated by 
conducting a series of standard tests that demonstrate usability and correctness of the 
database system. The database will be maintained on an ongoing basis and will be 
routinely backed up.  
12.2 SUBJECT IDENTIFICATION 
The subjects will be identified by a six-digit subject number composed of a double-digit 
study identification number, a two-digit center identification number followed by a two-
digit sequential subject number. A subject identification number will be assigned after 
informed consent is obtained. This will ensure that identifiable subject information has 
been removed and kept confidential. 
12.3 SUBJECT ACCOUNTABILITY 
All subjects enrolled in this clinical investigation shall be monitored for the duration of 
the investigation. The clinical investigation shall be considered completed when all 
subjects that have been enrolled in the investigation have reached the final reporting 
period, excluding subjects who were withdrawn.   
12.4 CONFIDENTIALITY 
All medical records associated with the clinical investigation will be made available for 
review by Sight personnel, its CRO, and governmental/regulatory agencies involved. The 
results of the study may be published in the future for scientific and marketing 
purposes, but the identity of each subject will not be revealed. All records will be stored 
in a secure area at the investigator’s facility, the CRO, the data management firm, and 
Sight. 

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12.5 SOURCE DATA AND CASE REPORT FORMS 
Source data will be entered into a validated electronic system at each site by trained 
personnel in accordance with 21 CFR Part 11 requirements. Electronic entries will be 
verified against corresponding source data at the sites and queried/corrected if needed 
to the extent possible. Medical site records serve as source data. In addition, data that 
are collected exclusively for the purpose of this study and not normally recorded in the 
subjects’ medical records can be collected directly on any study CRFs or tools provided 
by the sponsor, and these will serve as the source data.   
 
Source data and study CRFs are to be maintained at the site in the subject records or in 
the medical records.  All data entries must be made in accordance with ALCOA 
(Attributable, Legible, Contemporaneous, Original, Accurate) standards and GDP (Good 
Documentation Practices). 
 
Study data acquired from sites will be collected on eCRFs for submission to sponsor. 
Sites will enter data entered on source documents into the electronic case report forms 
for Sponsor review and analysis.    
12.6 RETENTION PERIOD 
Clinical sites are to retain any and all clinical trial material (documentation, photographs, 
etc.) for a period of two years from the date a marketing application is approved or two 
years after the investigation has been discontinued, or as directed by their institutional 
document retention requirements, whichever is the longest. After that time, the items 
must be returned to Sight for archiving.   
13 PROTOCOL MODIFICATIONS AND DEVIATIONS 
Protocol modifications may occur during the study. Each will be approved by the 
sponsor before implementation. Each will undergo Institutional Review Board (IRB) 
review and approval, as necessary. 
 
Any deviations from this protocol intended to protect the life or physical well-being of a 
subject in an emergency are to be reported to Sight and the IRB as soon as possible, and 
no later than 5 working days after the emergency occurred. 
 
All protocol deviations will be documented using the Protocol Deviation CRF or Source 
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14 ETHICAL CONSIDERATIONS 
14.1 DECLARATION OF HELSINKI 
This study shall be conducted in accordance with the Declaration of Helsinki (Appendix 
D).   
14.2 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 and obtain approval from (if needed) that body 
about any amendments to these documents and to follow the IRBs rules regarding the 
reporting of AEs and Protocol Deviations related to the investigational 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 or its CRO.  
 
The Investigators must file all correspondence with the IRB and forward copies of such 
correspondence to Sight. 
14.3 INFORMED CONSENT DOCUMENT (ICD) 
An Informed Consent template that covers all protocol procedures and follows GCP 
guidelines will be prepared by Sight Sciences and made available to each Investigator. 
The Investigator may adapt these templates to the requirements of the local IRB and of 
the institution where the study is conducted, but any revisions made to the ICD must be 
submitted to the sponsor for review prior to submission to the IRB. A copy of each IRB-
approved ICD version is to be made available to Sight and its CRO. The approved, IRB-
stamped ICD is to be kept in its full length in the study Regulatory Binder. Original, 
signed ICDs are to be maintained in study records and must be made available for 
monitoring review.  
14.4 PUBLIC LISTING OF STUDY 
The study will be listed on the NIH website www.clinicaltrials.gov.  

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15 STUDY ADMINISTRATION 
15.1 EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE 
Sight 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;  
• Withdrawal of FDA clearance of the OMNI device; 
• Insufficient enrollment in the study; and 
• Determination by the Sponsor that enough data has been collected for the 
study, and no further data are needed.  
 
Sight 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 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. 
15.2 INVESTIGATOR RESPONSIBILITIES 
15.2.1 
GENERAL RESPONSIBILITIES OF INVESTIGATORS 
An Investigator is responsible for ensuring that an investigation is conducted according 
to the signed agreement, the investigational plan and applicable FDA regulations, for 
protecting the rights, safety, and welfare of subjects under the Investigator’s care, and 
for the control of devices under investigation. An Investigator also is responsible for 
ensuring that informed consent is obtained in accordance with 21 CFR Part 50. 

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15.2.2 
SPECIFIC RESPONSIBILITIES OF INVESTIGATORS 
1. 
Awaiting approval - An Investigator may determine whether potential subjects 
would be interested in participating in an investigation but shall not request the 
written informed consent of any subject to participate, and shall not allow any 
subject to participate before obtaining IRB approval. 
2. 
Subject Qualification -The Investigator is responsible for ensuring that all subjects 
entering the study conform to the subject selection criteria. 
3. 
Compliance - An Investigator shall conduct an investigation in accordance with the 
signed agreement with the Sponsor, the investigational plan, all applicable FDA 
regulations, and any conditions of approval imposed by an IRB. 
15.2.3 
INVESTIGATOR RECORDS 
A participating Investigator shall maintain the following accurate, complete, and current 
records relating to the Investigator’s participation in an investigation for the period 
specified in Section 12.6:  
1. 
All correspondence with another Investigator, an IRB, the Sponsor, a clinical 
research associate (CRA) or monitor, or FDA, including required reports. 
2. 
Records of each subject’s case history and exposure to the device. Case histories 
include the subject’s study clinic record, certified copies of medical record as 
applicable, and supporting documents including, signed and dated consent forms. 
Such records shall include: 
a) 
Documents evidencing informed consent. 
b) All relevant observations, including records concerning adverse device effects 
(whether anticipated or unanticipated), information and data on the condition 
of each subject upon entering, and during the course of, the investigation, 
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. 
15.2.4 
INVESTIGATOR REPORTS 
An Investigator shall prepare and submit the following complete, accurate, and timely 
reports: 

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1. 
Unanticipated Adverse Device Effects - An Investigator shall submit to the Sponsor 
and to the reviewing IRB a report of any unanticipated adverse device effect 
occurring during an investigation as soon as possible, but in no event later than 10 
working days after the Investigator first learns of the effect. 
2. 
Withdrawal of IRB Approval - An Investigator shall report to the Sponsor, within 5 
working days, a withdrawal of approval by the reviewing IRB of the Investigator’s 
part of an investigation. 
3. 
Progress - An Investigator shall submit progress reports on the investigation to the 
Sponsor, the monitor, and the reviewing IRB at regular intervals, but in no event 
less often than yearly. 
4. 
Deviations from the Investigational Plan - An Investigator shall document and 
report to the Sponsor any deviation from the investigational plan.  
5. 
Informed Consent - If an Investigator enrolls a subject without obtaining informed 
consent, the Investigator shall report such use to the Sponsor and the reviewing 
IRB within 5 working days after the use occurs. 
6. 
Final Report - An Investigator shall, within 3 months after termination or 
completion of the investigation or the Investigator’s part of the investigation, 
submit a final report to the Sponsor and the reviewing IRB. 
7. 
Other - An Investigator shall, upon request by a reviewing IRB or FDA, provide 
accurate, complete, and current information about any aspect of the investigation. 
15.3 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. 
16 
 
 
 
 
 
  
 
 

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BIBLIOGRAPHY 
1. Tham YC, Li X, Wong TY, et al. Global prevalence of glaucoma and projections of 
glaucoma burden through 2040: a systematic review and meta-analysis. 
Ophthalmology. 2014;121:2081–2090. 
2. European Glaucoma Society. Terminology and guidelines for glaucoma 4th 
edition Savona, Italy: Editrice PubliComm, 2014. 
3. Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, et al. The Ocular 
Hypertension Treatment Study: a randomized trial determines that topical ocular 
hypotensive medication delays or prevents the onset of primary open-angle 
glaucoma. Arch Ophthalmol. 2002; 120:701–713. 
4. Kenji Inoue. Managing adverse effects of glaucoma medications. Clin 
Ophthalmol. 2014; 8: 903–913. Published online 2014 May 12. doi:  
10.2147/OPTH.S44708. 
5. Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. 
The Most Common Barriers to Glaucoma Medication Adherence: A Cross-
Sectional Survey. Ophthalmology. 2015 Jul; 122(7):1308-16. 
6. Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the 
effect of treatment: The Early Manifest Glaucoma Trial. Arch Ophthalmol 
2003;121:48–56. 
7. The Advanced Glaucoma Intervention Study (AGIS): the relationship between 
control of intraocular pressure and visual field deterioration. The AGIS 
Investigators. Am J Ophthalmol 2000;130:429–40.  
8. Francis BA, Singh K, Lin SC, et al. Novel glaucoma procedures: a report by the 
American Academy of Ophthalmology. Ophthalmology 2011;118:1466–1480. 
9. Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin 
Ophthalmol 2017;28:187–193. 
10. Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin 
Ophthalmol 2017;28:187–193. 
11. Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: circumferential viscodilation 
and tensioning of Schlemm canal using a flexible microcatheter for the 
treatment of open-angle glaucoma in adults. Two-year interim clinical study 
results. J Cataract Refract Surg 2009;35:814-824. 
12. Sarkisian SR, Mathews B, Ding K, et al. 360°ab-interno trabeculotomy in 
refractory primary open-angle glaucoma. Clin Ophthalmol 2019;13:161-168. 
13. Grover DS, Smith O, Fellman RL, et al. Gonioscopy-assisted transluminal 
trabeculotomy: an ab interno circumferential trabeculotomy: 24 months follow-
up. J Glaucoma 2018;27:393-401. 
   
 
 

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17 APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES 
17.1 LIST OF STUDY PROCEDURES 
1. Informed Consent 
2. Demographics, Medical & Ocular History 
3. Medication Log 
4. BCVA  
5. Visual Field (Humphrey 24-2 SITA- Standard)  
6. IOP (Goldmann Tonometry) 
7. Unmedicated Diurnal IOP 
8. Gonioscopy 
9. Slit Lamp Exam 
10. Dilated Fundus Exam/C:D Ratio 
11. Eligibility Assessment 
12. AE Assessment 
 
17.2 BEST CORRECTED VISUAL ACUITY 
Best corrected visual acuity (BCVA) will be collected using the same method that was 
used at the pre-surgery baseline visit. For the prospective scheduled study visits, a 
manifest refraction should be conducted if the initial BCVA acquired is ≥ 2 lines worse 
compared to the pre-surgery baseline. If the BCVA continues to be ≥ 2 lines worse 
compared to baseline even after manifest refraction, pinhole visual acuity should be 
completed.  
 
In order to provide a standardized and well-controlled assessment of visual acuity, visual 
acuity assessments for all subjects should be performed under consistent conditions 
(e.g., the same lighting conditions, viewing distance, etc.) at each visit. 
 
 
17.3 MEASUREMENT OF INTRAOCULAR PRESSURE 
The Goldmann tonometer will be used for measuring intraocular pressure for all visits 
including the retrospective visits. IOP should be measured as shown in Table 1.  
 
For the retrospective visits the type of tonometer should be the Goldman tonometer 

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however, the method (e.g. operator/reader) for measuring IOP will be based on the 
Investigator’s discretion 
 
For the prospective visits, a reader-operator technique for measuring and recording the 
IOP should be followed to minimize observer bias; the individual operating the 
tonometer (operator) should not view the dial during the measurement. A separate 
individual (reader/recorder) should view the dial and note the measurement. Take two 
measurements of IOP. If the measurements differ by more than 2 mmHg, take a third 
measurement.  If two measurements are taken, record the mean on the case report 
form.  If three measurements are taken, record the median on the case report form.   
 
At all scheduled study 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. 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 

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5. 
 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Errors in measurement can arise from a number of factors, including the 
following: 
 
1. Inadequate fluorescein staining of the tear film causes an underestimation of 
intraocular pressure. 
2. Elevating the eyes more than 15° above the horizontal causes an 
overestimation of intraocular pressure. Widening the lid fissure excessively 
causes an overestimation of intraocular pressure. 
3. Repeated tonometry reduces intraocular pressure, causing an 
underestimation of the true level. This effect is greatest between the first 
and second readings, but the trend continues through a number of 
repetitions. 
4. A scarred, irregular cornea distorts the fluorescein rings and makes it difficult 
to estimate intraocular pressure. 
5. The thickness of the cornea affects intraocular pressure readings. If the 
cornea is thick because of edema, intraocular pressure is underestimated. If 
the cornea is thick because of additional tissue, intraocular pressure is 
overestimated. The Goldmann tonometer is accurate after epikeratophakia. 
6. If the examiner presses on the globe or if the subject squeezes his eyelids, 
intraocular pressure is overestimated. 
7. If corneal astigmatism is greater than 3 diopters, intraocular pressure is 
underestimated for with the rule astigmatism and overestimated for against 
 

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the rule astigmatism. The intraocular pressure reading is inaccurate 1 mm Hg 
for every 3 diopters of astigmatism. 
 
Calibration Verification 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 
verification 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 documentation of the calibration checks 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 check, and an 
indication as to whether or not the unit meets the calibration requirement at each 
check. If a unit does not meet calibration parameters, this should be documented, and 
the unit should not be used for study measurements until it has been brought back into 
calibration specifications. Following any repair or recalibration, another verification 
should be conducted, and the results documented to show that the unit is back within 
calibration parameters, prior to using in the study. Where applicable, sites should keep 
significant documentation in regard to calibration/recalibration or repair of a tonometer 
that is being used in the study.  
 
Diurnal IOP 
Diurnal IOP (IOP) will be completed as shown in Table 1 for the Cohort A subjects (those 
who had a pre-operative, post-washout DIOP at baseline). In order to determine the 
mean diurnal intraocular pressure measurements at 24 months and 36-months,
 
 
. The three IOP measurements should then be averaged to determine the mean 
diurnal IOP. 
17.4 VISUAL FIELD EXAMINATION 
Visual field tests obtained prior to enrollment into the study may be of the investigator’s 
discretion (SITA Standard with 24-2 algorithm is preferred but not required). For 
consistency, the type of visual field test or standard used pre-operatively should be used 
for the post-operative visits. 
 
Visual field tests 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 
 

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was performed at the pre-surgery visit, it should be performed at all subsequent visual 
field examinations.  However, dilation should not be performed before the IOP 
measurement on the appropriate visits. 
 
The appropriate trial lens as defined by the perimeter should be used. 
17.5 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 
applicable study visit form.  A measurement of the cup to disc ratio should be made and 
reported.   
17.6 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 
 
Anterior Chamber 
 

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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).26 
 
 
26 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 
17.7 GONIOSCOPY 
During eligibility determination, prospective subject charts will be reviewed to confirm 
eligible gonioscopy data is present and will be repeated at post-operative follow up 
visits as shown in Table 1. Gonioscopy information will be used 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. 
17.8 OCULAR HYPOTENSIVE MEDICATIONS 
Each ocular hypotensive medication will be recorded on the study record. Combination 
medications will be counted by their individual components. For example,  if a subject is 
taking Cosopt this is to be counted as two medications even though this is only in 1 
bottle. 
18 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. 
 
 

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

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applicable international norms and standards. No national or international 
ethical, legal or regulatory requirement should reduce or eliminate any of the 
protections for research subjects set forth in this Declaration. 
 
9. 
Medical research should be conducted in a manner that minimizes possible 
harm to the environment. 
 
10. Medical research involving human subjects must be conducted only by 
individuals with the appropriate ethics and scientific education, training and 
qualifications. Research on patients or healthy volunteers requires the 
supervision of a competent and appropriately qualified physician or other 
health care professional. 
 
11. Groups that are underrepresented in medical research should be provided 
appropriate access to participation in research. 
 
12. Physicians who combine medical research with medical care should involve 
their patients in research only to the extent that this is justified by its potential 
preventive, diagnostic or therapeutic value and if the physician has good 
reason to believe that participation in the research study will not adversely 
affect the health of the patients who serve as research subjects. 
 
13. Appropriate compensation and treatment for subjects who are harmed as a 
result of participating in research must be ensured. 
 
III. 
RISKS, BURDENS AND BENEFITS 
 
• 
In medical practice and in medical research, most interventions involve risks 
and burdens. 
 
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. 
 
 

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• 
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 ha e an 
increased likelihood of being wronged or of incurring additional harm. 
 
All vulnerable groups and individuals should receive specifi ally considered 
protection. 
 
• 
Medical research with a vulnerable group is only ju tified 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 gr up. In addition, this group should 
stand to benefit from the knowledge, practices or interventions that result 
from the research. 
 
V. 
SCIENTIFIC REQUIREMENTS AND RESEARCH PROTOCOLS 
 
• 
Medical resea ch invol ng human subjects must conform to generally 
accepted scientif c pri ciples, 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 
animal  used f r 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. 
 
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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 ubjec  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 submi  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 heir personal information. 
 
VIII. INFORMED CONSENT 
 
• 
Part cipation 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 
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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 ent ils o ly minimal risk and minimal burden. 
 
• 
When a potential research subject who is deemed incapable of giving informed 
consent is able to give assent to decisions about participation in research, the 
physician must seek that assent in addition to the consent of the legally 
authorized representative. The potential subject’s dissent should be respected. 
 
• 
Research involving subjects who are physically or mentally incapable of giving 
consent, for example, unconscious patients, may be done only if the physical or 
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 
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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 effectivene s 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 compell ng and scientifically sound methodological reasons the use 
of any intervention le s effective than the best proven one, the use of placebo, 
or no intervention is necessary to determine the efficacy or safety of an 
intervention 
 
and he 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 
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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. 
 
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