An Observational Multicenter Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System In Pseudophakic Eyes With Primary Open Angle Glaucoma (ORION 2.0)
Conditions: Glaucoma, Open-Angle
Sponsor: Sight Sciences, Inc.

Study of OMNI System in POAG 
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AN OBSERVATIONAL MULTICENTER CLINICAL STUDY TO ASSESS THE SAFETY AND EFFECTIVENESS OF THE 
OMNI® SURGICAL SYSTEM IN PSEUDOPHAKIC EYES WITH PRIMARY OPEN ANGLE GLAUCOMA (ORION 2.0) 
PROTOCOL ID #: 
 
CURRENT REVISION: 
Rev B 
REVISION DATE: 
September 22, 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 amendmen s  
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. 
o
ll
 

 
 
                 
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TABLE OF CONTENTS 
 
1 
PROTOCOL SYNOPSIS .................................................................................................................................... 6 
2 
STUDY OBJECTIVE ......................................................................................................................................... 8 
3 
BACKGROUND AND JUSTIFICATION FOR THE STUDY .................................................................................... 8 
4 
STUDY DEVICE ............................................................................................................................................ 10 
4.1 
DEVICE DESCRIPTION...................................................................................................................................... 10 
4.2 
TRAINING ..................................................................................................................................................... 11 
5 
STUDY DESIGN ............................................................................................................................................ 11 
5.1 
STUDY SITES ................................................................................................................................................. 12 
6 
STUDY ENDPOINTS ..................................................................................................................................... 12 
6.1 
PRIMARY SAFETY ENDPOINT ............................................................................................................................ 12 
     6.1.1 
Secondary Safety Endpoints ................................................................................................................. 12 
6.2 
EFFECTIVENESS ENDPOINTS ............................................................................................................................. 12 
7 
STUDY SELECTION CRITERIA ........................................................................................................................ 13 
7.1 
INCLUSION CRITERIA ....................................................................................................................................... 13 
7.2 
EXCLUSION CRITERIA ...................................................................................................................................... 13 
8 
STUDY PROCEDURES ................................................................................................................................... 14 
8.1 
STUDY SCHEDULE – PRE-OPERATIVE WASHOUT (SUBJECTS THAT UNDERWENT MEDICATION WASHOUT PRIOR TO OMNI) ... 14 
8.2 
STUDY SCHEDULE – NO PRE-OPERATIVE WASHOUT .............................................................................................. 15 
8.3 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION ............................................................... 16 
8.4 
INFORMED CONSENT AND POINT OF ENROLLMENT ............................................................................................... 16 
8.5 
ELIGIBILITY AND STUDY ENTRY .......................................................................................................................... 16 
8.6 
DATA EXTRACTION ......................................................................................................................................... 17 
8.7 
PROSPECTIVE VISITS ....................................................................................................................................... 17 
     8.7.1 
Washout of Hypotensive Medications .................................................................................................. 17 
8.8 
UNSCHEDULED VISITS ..................................................................................................................................... 19 
8.9 
MANAGEMENT OF IOP ................................................................................................................................... 19 
     8.9.1 
Paracentesis ......................................................................................................................................... 20 
    8.9.2 
Secondary IOP-Lowering Interventions to Control IOP ......................................................................... 20 
8.10 
WITHDRAWAL AND DISCONTINUATION .............................................................................................................. 20 
8.11 
SUBJECTS LOST TO FOLLOW-UP ........................................................................................................................ 21 
9 
ADVERSE EVENTS (AES)............................................................................................................................... 21 
9.1 
DEFINITIONS OF AE, SAE, ADE, SADE, UADE, USADE ...................................................................................... 21 
9.2 
LIST OF ANTICIPATED POTENTIAL ADVERSE EVENTS .............................................................................................. 22 
9.3 
REPORTING ADVERSE EVENTS AND UNANTICIPATED ADVERSE DEVICE EFFECTS .......................................................... 23 
10 
STATISTICAL CONSIDERATIONS ................................................................................................................... 24 
10.1 
SAMPLE SIZE CALCULATION ............................................................................................................................. 24 
10.2 
ANALYSIS POPULATIONS ................................................................................................................................. 24 
10.3 
DEMOGRAPHICS AND BASELINE CHARACTERISTICS ............................................................................................... 25 
10.4 
EFFECTIVENESS ENDPOINTS AND ANALYSIS METHODS ........................................................................................... 25 
10.5 
SAFETY ANALYSIS ........................................................................................................................................... 25 

 
 
                 
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       10.5.1 
Adverse Event ....................................................................................................................................... 25 
      10.5.2 
Best Corrected Visual Acuity (BCVA) ..................................................................................................... 26 
     10.5.3 
Other Safety Outcomes ........................................................................................................................ 26 
10.6 
INTERIM ANALYSIS ......................................................................................................................................... 26 
10.7 
DEVIATION FROM THE STATISTICAL PLAN............................................................................................................ 27 
11 
MONITORING PROCEDURES ....................................................................................................................... 27 
12 
DATA AND QUALITY MANAGEMENT ........................................................................................................... 28 
12.1 
DATABASE MANAGEMENT .............................................................................................................................. 28 
12.2 
SUBJECT IDENTIFICATION ................................................................................................................................. 28 
12.3 
SUBJECT ACCOUNTABILITY ............................................................................................................................... 28 
12.4 
CONFIDENTIALITY .......................................................................................................................................... 28 
12.5 
SOURCE DATA AND CASE REPORT FORMS .......................................................................................................... 29 
12.6 
RETENTION PERIOD ........................................................................................................................................ 29 
13 
PROTOCOL MODIFICATIONS AND DEVIATIONS........................................................................................... 29 
14 
ETHICAL CONSIDERATIONS ......................................................................................................................... 30 
14.1 
DECLARATION OF HELSINKI .............................................................................................................................. 30 
14.2 
INSTITUTIONAL REVIEW BOARDS (IRB) .............................................................................................................. 30 
14.3 
INFORMED CONSENT DOCUMENT (ICD) ............................................................................................................ 30 
14.4 
PUBLIC LISTING OF STUDY ............................................................................................................................... 30 
15 
STUDY ADMINISTRATION ........................................................................................................................... 31 
15.1 
EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE .................................................... 31 
15.2 
INVESTIGATOR RESPONSIBILITIES....................................................................................................................... 31 
     15.2.1 
General Responsibilities of Investigators .............................................................................................. 31 
     15.2.2 
Specific Responsibilities of Investigators .............................................................................................. 31 
     15.2.3 
Investigator Records ............................................................................................................................. 32 
     15.2.4 
Investigator Reports ............................................................................................................................. 32 
15.3 
INVESTIGATOR AGREEMENT ............................................................................................................................. 33 
16 
PUBLICATION POLICY .................................................................................................................................. 33 
17 
BIBLIOGRAPHY............................................................................................................................................ 35 
18 
APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES......................................................... 36 
18.1 
LIST OF STUDY PROCEDURES ............................................................................................................................ 36 
18.2 
PRO INSTRUMENTS ....................................................................................................................................... 36 
     18.2.1 
The OSDI© questionnaire ...................................................................................................................... 36 
18.3 
BEST CORRECTED VISUAL ACUITY ..................................................................................................................... 36 
18.4 
MEASUREMENT OF INTRAOCULAR PRESSURE ....................................................................................................... 37 
18.5 
VISUAL FIELD EXAMINATION ............................................................................................................................ 40 
18.6 
DILATED FUNDUS EXAMINATION ....................................................................................................................... 41 
18.7 
SLIT LAMP EXAMINATION ................................................................................................................................ 41 
18.8 
GONIOSCOPY ................................................................................................................................................ 43 
18.9 
OCULAR HYPOTENSIVE MEDICATIONS ............................................................................................................... 44 
19 
APPENDIX B - DECLARATION OF HELSINKI .................................................................................................. 44 
 

 
 
                 
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1 PROTOCOL SYNOPSIS 
Protocol Title 
An Observational Multicenter Clinical Study to Assess the Safety and 
Effectiveness of the OMNI® Surgical System in Pseudophakic Eyes 
with Primary Open Angle Glaucoma  
 
 
Investigational Device 
OMNI® Surgical System 
Study Objective 
 
 
 
 
 
 
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.  
Primary Safety Endpoint 
1. Rate of occurrence of sight-threatening adverse events (AEs)  
Secondary Safety 
Endpoints 
1. Rate of ocular AEs  
2. Reduction in best corrected distance visual acuity (BCVA) from 
baseline  
3. Secondary Surgical Interventions, including laser, for IOP control  
Effectiveness Endpoints 
  
 
 
  
 
  
 
 
  
 
  
 
 
 
 
  
 
 
  
 
  
 
 
  
 
  
 
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Number of Subjects 
Enrolled and Treated 
Up to 100 subjects. 
Up to 50 subjects who received OMNI intervention post medication 
washout and up to 50 subjects who received OMNI intervention 
without medication washout will be enrolled  
Number of Sites 
Up to 15 study sites in United States. 
Schedule of Visits 
The following visits will be captured retrospectively: 
- 
Subjects with preoperative medication washout: Pre-washout, 
Post-washout, Surgical  
- 
Subjects without a medication washout: Preoperative, 
Surgical 
 
The following visits will be captured prospectively: 
- 
Months 6*, 12*, 18 and 24.  
Subjects with a preoperative washout will also undergo washout for the 12- 
and 24- month visits if they are on ocular hypotensive medication   at these 
visits and return for an exam following appropriate washout period. 
 
* The 6- and 12-month data can be retrospective or prospective depending on date of 
enrollment. 
Interim analysis 
100% subjects reaching 12 Month visit 
2 STUDY OBJECTIVE 
The purpose of this study is to evaluate the safety and effectiveness of the OMNI® Surgical 
System in subjects who have undergone canaloplasty and trabeculotomy using OMNI® Surgical 
System without any concomitant surgery in pseudophakic eyes with mild to moderate primary 
open angle glaucoma (POAG) at least 150 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 POAG is the most 
prevalent form of glaucoma and elevated IOP is the only treatable risk factor.2 Hypotensive eye 
 
 
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. 

 
 
                 
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drops are commonly used as the first line clinical management for POAG.3 Ocular side effects 
such as allergies, ocular surface disorders, blepharitis, pemphigoid, abnormal pigmentation etc. 
and systemic side effects such as bradycardia, headaches, depression, anxiety, confusion, 
dysarthria, hallucinations, lethargy, polyuria, weight loss, metabolic acidosis, etc. can occur 
during long term use of topical medications.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 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 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 
 
 
3 Kass MA, Heuer DK, Higginbotham EJ, Johnson CA, et al. The Ocular Hypertension Treatment Study: a randomized 
trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle 
glaucoma. Arch Ophthalmol. 2002; 120:701–713. 
4 Kenji Inoue. Managing adverse effects of glaucoma medications. Clin Ophthalmol. 2014; 8: 903–913. Published 
online 2014 May 12. doi:  10.2147/OPTH.S44708. 
5 Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to 
Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul; 122(7):1308-16. 
6 Leske MC, Heijl A, Hussein M, et al. Factors for glaucoma progression and the effect of treatment: The Early 
Manifest Glaucoma Trial. Arch Ophthalmol 2003;121:48–56. 
7 The Advanced Glaucoma Intervention Study (AGIS): the relationship between control of intraocular pressure and 
visual field deterioration. The AGIS Investigators. Am J Ophthalmol 2000;130:429–40.  
8 Francis BA, Singh K, Lin SC, et al. Novel glaucoma procedures: a report by the American Academy of 
Ophthalmology. Ophthalmology 2011;118:1466–1480. 
9 Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin Ophthalmol 2017;28:187–193. 

 
 
                 
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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 
 
The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal 
viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) 
to reduce intraocular pressure in adult patients with primary open-angle glaucoma. 
 
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 is indicated for canaloplasty (microcatheterization and transluminal 
viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) 
to reduce intraocular pressure in adult patients with primary open-angle glaucoma.  
The OMNI is designed to function with commonly used viscoelastic fluids made commercially 
available by companies such as Johnson & Johnson Vision, 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 wheel on the handle of the device 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 and is used to advance and retract the microcatheter.  In addition, 
when the device is being used to deliver viscoelastic, retraction of the microcatheter causes the 
plunger tube to advance into the viscoelastic fluid reservoir thereby dispensing viscoelastic 
fluid.  
 
 
10 Francis BA, Singh K, Lin SC, et al. op cit. 
11 Vinod K, Gedde SJ. Clinical investigation of new glaucoma procedures. Curr Opin Ophthalmol 2017;28:187–193. 
12  Lewis RA, von Wolff K, Tetz M, et al. Canaloplasty: circumferential viscodilation and tensioning of Schlemm canal 
using a flexible microcatheter for the treatment of open-angle glaucoma in adults. Two-year interim clinical study 
results. J Cataract Refract Surg 2009;35:814-824. 
13 Sarkisian SR, Mathews B, Ding K, et al. 360°ab-interno trabeculotomy in refractory primary open-angle 
glaucoma. Clin Ophthalmol 2019;13:161-168. 
14 Grover DS, Smith O, Fellman RL, et al. Gonioscopy-assisted transluminal trabeculotomy: an ab interno 
circumferential trabeculotomy: 24 months follow-up. J Glaucoma 2018;27:393-401. 

 
 
                 
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The microcatheter can be advanced/retracted up to 20 mm per cycle.  The microcatheter can 
be fully advanced/retracted up to 5 times (i.e. 5 full cycles of 20 mm each).  Dispensation of 
viscoelastic can only occur during the first two 20-mm cycles. 
The OMNI can deliver approximately 5.5 microliters of viscoelastic in each 20 mm cycle (total 
volume = 11 microliters).  
Figure 1:  OMNI Surgical System 
            
 
4.2 
TRAINING 
All surgeons would have received training in accordance with Sight Sciences’ 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.  
 
 
 
 
 
 
     
 

 
 
                 
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The study will employ a medication washout at the 12- and 24-month endpoints only for the 
subjects that received the OMNI procedure post-medication washout.  
 
5.1 
STUDY SITES 
This clinical study will be conducted at up to 15 sites in the United States.   
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 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
   
 
 
 
 
  
 
 
 
  

 
 
                 
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7 STUDY SELECTION CRITERIA 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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8.3 
NUMBER OF SUBJECTS, DURATION OF FOLLOW-UP AND STUDY DURATION 
Up to 100 subjects meeting eligibility criteria with a minimum of 150 days of follow-up 
post-surgery using the OMNI Surgical System will be enrolled in this study. 
 
Enrollment is stratified. Up to 50 subjects will be enrolled for whom there was a pre-
surgical washout of ocular hypotensive medications; up to 50 subjects will be enrolled 
for whom there was no pre-surgery washout. 
 
It is anticipated that site initiation, data collection and site close-out will require 
approximately 30 months. 
8.4 
INFORMED CONSENT AND POINT OF ENROLLMENT 
The pre-operative and surgery data (and in some cases, depending on enrollment date, 
Month 6 and Month 12) will be collected retrospectively by performing the 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 will be presented and explained to each 
prospective subject by the Investigator or a delegated, 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 study visits.  The subject has the right to withdraw from the 
study at any time without consequences, as indicated in the Informed Consent 
Document. 
 
The subject’s signed and dated informed consent must be obtained before conducting 
any study specific procedures that are not part of the standard of care.   
 
The investigative site must retain the original, signed written Informed Consent 
Document.  A copy of the written Informed Consent Document 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, 
and for whom the date of surgery using the OMNI Surgical System is at least 150 days 
prior to enrollment in the study.  

 
 
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Rocklatan® (Netarsudil/Latanoprost) 
28 days 
Simbrinza® (Brinzolamide/Brimonidine Tartrate) 
28 days 
Xalacom® (Latanoprost/Timolol) 
28 days 
Krytantek (Brimonidine Tartrate/ Dorzolamide 
Hydrochloride/ Timolol Maleate) 
28 days 
Other 
Contact Sponsor 
 
NOTE: A safety IOP check anytime during the wash-out period may be performed at 
the Investigator’s discretion to ensure subject safety and should reported as 
unscheduled visits.  
 
8.8 
UNSCHEDULED VISITS 
An unscheduled visit will be any visit to the clinical site, other than those specified in the 
protocol, at which the subject has a complaint regarding the study eye and/or treatment 
to the study eye is required or changed. 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 medical records and on the 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. 

 
 
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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). 
8.9.2 SECONDARY IOP-LOWERING INTERVENTIONS TO CONTROL IOP 
If the subject requires another glaucoma procedure to control their IOP after enrollment 
into the study, 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.  
 
If such secondary surgical intervention had happened more than 1 month before 
enrollment into the study, the subject should be enrolled, examined as per  6-month or 
12-month visit schedule depending on the date of enrollment and exited 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, can be withdrawn by the study investigator for reason’s including 
but not limited to non-compliance, being unresponsive or no longer qualifies under the 
protocol, or 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.  

 
 
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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 
on the Adverse Event Case Report Form.  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. 
 
Adverse events that occurred intra, and post-operatively up to enrollment into the study 
will also be collected.  
9.1 
DEFINITIONS OF AE, SAE, ADE, SADE, UADE, USADE15 
Adverse Event (AE) 
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 
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 
 
 
15 All of these definitions are in conformance with the requirements 21 C.F.R. Part 803. 

 
 
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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 USADE. 
  
Adverse events may be anticipated or unanticipated. All events will be assessed for 
seriousness, and relationship to the study device. Anticipated adverse events that are 
related to the study devices are ADEs (Adverse Device Effects) and when serious SADEs 
(Serious Adverse Device Effects). Unanticipated adverse events which are related to the 
study device are UADEs (Unanticipated Adverse Device Effects) and when serious 
SUADEs (Serious Unanticipated Adverse Device Effects).  
9.2 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16 
 
 
 
 

 
 
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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 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 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 
makes such a determination and no later than 15 working days after the sponsor first 
received notice of the effect. 
 
 
 
 
 
 
 
 
 
 
 

 
 
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.   
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, standard deviation) will also be provided. The same analyses will be performed 
for the ITT and PP populations. 
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 EVENT 
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 

 
 
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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 (BCVA) 
The number and percent of eyes reporting with BCVA of 20/20 or better, 20/25 or 
better, 20/32 or better, 20/40 or better, worse than 20/40 to 20/80, worse than 20/80 
to 20/200, and worse than 20/200 at each visit will be summarized.  The number and 
percent of eyes reporting BCVA of increase ≥ 10 letters, increase 10 letters, increase ≥ 5 
letters to < 10 letters, within 5 letters change, decrease ≥ 5 letters to < 10 letters, 
decrease 10 letters, and decrease ≥ 10 letters at each postoperative visit will be 
calculated. 
10.5.3 OTHER SAFETY OUTCOMES 
The number and percent of eyes reported with each kind of slit lamp findings, 
gonioscopy findings, and dilated fundus examination findings at each visit will be 
provided. 
The descriptive statistics for the continuous variables will be derived for the visual field 
mean deviation (MD) and pattern standard deviation (PSD). 
10.6 INTERIM ANALYSIS 
An interim analysis providing descriptive statistics for the outcomes may be completed 
following completion of the Month 12 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. 
 
 
 
 
 
 
 
 
 
 
Safety endpoints: 

 
 
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10.7 DEVIATION FROM THE STATISTICAL PLAN 
Any deviations from the statistical plan will be noted in the final report. 
11 MONITORING PROCEDURES 
Sight Sciences or contract research organization (CRO) personnel will monitor the study 
in a manner consistent with FDA regulations, good clinical practices and the clinical 
research standards adopted by Sight Sciences.  Study monitoring will be executed using 
on-site and remote monitoring visits 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 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.  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 
o Records and reports 
• Interim Monitoring:  Sight Sciences or CRO personnel will conduct routine visits 
during the course of the study to review charts, perform source document 
verification, ensure proper adherence to the study protocol, and to review 
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will occur as necessary during the course of the study to ensure the proper 
progress and documentation of the study findings. 
• Study Close Out Visit:  At the conclusion of the trial there will be a study 
closure visit during which several actions, including but not limited to the 
following, will be performed: 
o A final inspection of the study binder 
o Accountability and return of all devices and non-consumable ancillary 
study supplies to the sponsor 
o Discussion of record retention requirements with the investigator 
o Close-out notification to the IRB   
12 DATA AND QUALITY MANAGEMENT 
12.1 DATABASE MANAGEMENT 
The study database will be designed using an 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 eCRF, will be validated by conducting a series of standard tests 
that demonstrate usability and correctness of the database system.  The database will 
be maintained on an ongoing basis and will be routinely backed up.  
12.2 SUBJECT IDENTIFICATION 
The subjects will be identified by a six-digit subject number composed of a double-digit 
study identification number, a two-digit center identification number followed by a 
three-digit sequential subject number.  A subject identification number will be assigned 
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 Sciences personnel, its contract research organization (CRO) and 

 
 
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governmental/regulatory agencies involved.  The results of the study may be published 
in the future for scientific and marketing purposes, but the identity of each subject will 
not be revealed.  All records will be stored in a secure area at the investigator’s facility, 
the CRO, the data management firm and at Sight Sciences, Inc. 
12.5 SOURCE DATA AND CASE REPORT FORMS 
Source data will be entered into a validated electronic system at each site by trained 
personnel in accordance with 21 CFR Part 11 requirements. Electronic entries will be 
verified against corresponding source data at the sites and queried/corrected if needed 
to the extent possible.  Medical site records serve as source data. In addition, data that 
are collected exclusively for the purpose of this study and not normally recorded in the 
subjects’ medical records can be collected directly on any study CRFs or tools provided 
by the sponsor, and these will serve as the source data.   
 
Source data and study CRFs are to be maintained at the site in the subject records or in 
the medical records.  All data entries must be made in accordance with ALCOA 
(Attributable, Legible, Contemporaneous, Original, Accurate) standards and GDP (Good 
Documentation Practices). 
 
Study data acquired from sites will be collected on Electronic Case Report Forms (eCRFs) 
for submission to sponsor. Sites will enter data entered on source documents into the 
electronic case report forms for Sponsor review and analysis.    
12.6 RETENTION PERIOD 
Clinical sites are to retain any and all clinical trial material (documentation, photographs, 
etc.) for a period of two years from the date a marketing application is approved or two 
years after the investigation has been discontinued, or as directed by their institutional 
document retention requirements, whichever is the longest.  After that time, the items 
must be returned to Sight Sciences for archiving.   
13 PROTOCOL MODIFICATIONS AND DEVIATIONS 
Protocol modifications may occur during the study. Each will be approved by the 
sponsor before implementation. Each will undergo Institutional Review Board (IRB) 
review and approval, as necessary. 
 
Any deviations from this protocol intended to protect the life or physical well-being of a 
subject in an emergency are to be reported to Sight Sciences, Inc. as well as the IRB as 
soon as possible, and no later than 5 working days after the emergency occurred. 
 
All protocol deviations will be documented using the Protocol Deviation CRF or Source 
Tool. 

 
 
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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 Adverse Events 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 Sciences or its CRO.  
 
The Investigators must file all correspondence with the IRB and forward copies of such 
correspondence to Sight Sciences. 
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 Sciences and its CRO.  The 
approved, IRB-stamped ICD is to be kept in its full length in the study Regulatory Binder.  
Original, signed ICDs are to be maintained in study records and must be made available 
for monitoring review.  
14.4 PUBLIC LISTING OF STUDY 
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15 STUDY ADMINISTRATION 
15.1 EARLY TERMINATION OR SUSPENSION OF THE STUDY OR AN INVESTIGATIONAL SITE 
Sight Sciences may terminate the study, in which case the investigators and associated 
IRBs will be notified in writing.  Possible reasons for study termination include but are 
not limited to: 
 
• The discovery of an unexpected, significant, or unacceptable risk to the study 
subjects implanted with the device 
• Withdrawal of FDA clearance of the OMNI device. 
• Insufficient enrollment in the study 
• The Sponsor determines that enough data has been collected for the study, and 
no further data are needed.  
 
Sight Sciences reserves the right to stop the study at a particular site any time after the 
initiation visit if there have been no subject enrollments or if there have been significant 
protocol deviations/violations at the site.     
 
Likewise, a principal investigator may terminate the study at his/her institution.  This 
decision must be followed by written notification to Sight Sciences within five working 
days, stating the reasons for termination. 
 
If the study is terminated, every effort should be made to obtain final follow-up from all 
subjects.   
 
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. 
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 

 
 
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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 subejct’s study clinic record, certified copies of medical record as 
applicable, and supporting documents including, signed and dated consent forms.  
Such records shall include: 
a) 
Documents evidencing informed consent. 
b) All relevant observations, including records concerning adverse device effects 
(whether anticipated or unanticipated), information and data on the condition 
of each subject upon entering, and during the course of, the investigation, 
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: 
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. 

 
 
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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 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 

 
 
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where all authors contributed equally, authorship order may be based on site 
enrollment or other criteria at Sight Sciences’ discretion. 
• Other authors include those who significantly contributed to the specific work.   
• At least one person from each clinical site whose study subjects appear in the 
work will be acknowledged in the manuscript/presentation in some way, either 
as an author group member, a non-author contributor, or listed in the 
acknowledgements, depending on the particular policies of the journal or 
conference. 
 
Single Site Data 
After publication of the multi-center study results in a peer-reviewed journal, or if 
Sponsor has not submitted a manuscript for publication in a peer-reviewed journal 
within twelve (12) months after the study has been completed, whichever occurs first, 
Investigators may publish the results of the Study generated by the Investigator, subject 
to the obligations of the Clinical Trial Agreement between Sight Sciences and the 
Investigator, and the prior approval of Sponsor in writing.   
 
Publications Review Policy 
Investigators must submit all presentations, posters, abstracts and manuscripts 
pertaining to this study to Sight Sciences for review in advance of their submission.  
Sight Sciences conducts this review to protect its proprietary rights to information, 
inventions, or products developed under the Study.  Please use the following guideline 
to determine the absolute minimum advance time for submitting an item to Sight 
Sciences for review: 
 
• Presentations/Posters: 5 business days in advance of presentation 
• 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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17 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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18 APPENDIX A – METHODS FOR EXAMS, TESTS AND QUESTIONNAIRES 
18.1 LIST OF STUDY PROCEDURES 
1. Informed Consent 
2. Demographics, Medical & Ocular History 
3. Medication Log 
4. Patient-Reported Outcomes (PRO): OSDI  
5. BCVA  
6. Visual Field test 
7. IOP (Goldmann Tonometry) 
8. Unmedicated Diurnal IOP   
9. Gonioscopy 
10. Slit Lamp Exam 
11. Dilated Fundus Exam/C:D Ratio 
12. Eligibility Assessment 
13. AE Assessment 
 
18.2 PRO INSTRUMENTS 
18.2.1  THE OSDI© QUESTIONNAIRE  
The OSDI Questionnaire consists of 12 questions regarding ocular symptoms, 
environmental triggers, and vision-related functioning in patients with dry eye disease 
(Schiffman et al, 2000).  The patient will be asked to rate each symptom using a 5-point 
scale (0 to 4), where 0 indicates none of the time; 1, some of the time; 2, half of the 
time; 3, most of the time; and 4, all of the time.  Seven questions related to visual 
functioning allow a response of “N/A” (not applicable); no more than 3 of these 7 
questions may be answered as N/A for the questionnaire to be evaluable.  The total 
OSDI score is calculated as: ([sum of scores for all questions answered] X 100)/([total 
number of questions answered] X 4). 
 
The OSDI questionnaire will only be administered to subjects who also had an OSDI 
administered at the pre-surgery visit.  
18.3 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.  

 
 
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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. 
 
18.4 MEASUREMENT OF INTRAOCULAR PRESSURE 
The Goldmann tonometer should be used each time IOP is measured. 
 
For the retrospective visits the type of tonometer should be Goldman tonometer 
however the method 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. 
 
Guidelines for performing Goldmann tonometry during prospective study visits are as 
follows: 
 
1. The subject is told the purpose of the test and is reassured that the 
measurement is not painful. The subject is instructed to relax, maintain his or 
her position, and hold his or her eyes open widely. 
2. One drop of a topical anesthetic, such as 0.5% proparacaine or 0.4% 
benoxinate, is placed in each eye, and the tip of a moistened fluorescein strip 
is touched to the tear layer on the inner surface of each lower lid.  
Alternatively, one drop of a combined anesthetic-fluorescein strip is touched 
to the tear layer on the inner surface of each lower lid.  The tonometer and 
prism are set in correct position on the slit lamp. 
3. The tension knob is set at 1 g.  If the knob is set at 0, the prism head may 
vibrate when it touches the eye and damage the corneal epithelium.  The 1 g 
position is used before each measurement.  As a rule, it is more accurate to 
measure intraocular pressure by increasing rather than decreasing the force 
of applanation. 
4. The 0 graduation mark of the prism is set at the white line on the prism 
holder.  If the subject has more than 3 diopters of corneal astigmatism, the 
area of contact between the cornea and the prism is elliptic rather than 

 
 
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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 
Diurnal IOP (IOP) will be completed as shown in Table 1 or 2 as applicable. In order to 
determine the mean diurnal intraocular pressure measurements at 12 months and 24-
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. 
18.5 VISUAL FIELD EXAMINATION 
Visual field tests obtained prior to enrollment into the study may be of the investigator’s 
discretion (SITA Standard or G-pattern 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 
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. 
 

 
 
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The appropriate trial lens as defined by the perimeter should be used. 
18.6 DILATED FUNDUS EXAMINATION 
A mydriatic should be used to dilate the pupil so that an examination of the fundus can 
be conducted with an indirect ophthalmoscope and slit lamp biomicroscopy (with 
contact lens, Hruby lens or 60-, 66-, 78-, or 90 diopter lens).  The appearance of the 
optic disc, macula, vessels and periphery should be evaluated and reported on the 
applicable study visit form.  A measurement of the cup to disc ratio should be made and 
reported.   
18.7 SLIT LAMP EXAMINATION 
The clinician will examine the conjunctiva, cornea, anterior chamber, lens and anterior 
vitreous of the eye with the aid of a slit lamp, which is a table-mounted binocular 
microscope.  Fluorescein dye will be instilled into the ocular cul-de-sac to facilitate this 
examination.  In addition to the following, any evidence of pigment dispersion visible in 
slit lamp examination should be evaluated and noted. 
 
Iris 
Findings of Atrophy/Erosion; Peaking; and Rubeosis should be noted. Each will be 
evaluated using a scale of None (0), Mild (+1), Moderate (+2) and Severe (+3).   
 
Cornea - Edema 
None (0)  
Transparent and clear or less than mild 
Mild (+1)  
Dull glassy appearance 
Moderate (+2) Dull glassy appearance of epithelium with large number of vacuoles 
Severe (+3)  
Epithelial bullae and/or stromal edema, localized or diffuse, with or 
without stromal striae 
Cornea - Staining/Erosion 
None (0) 
No fluorescein staining of epithelium, OR less than mild 
Mild (+1)  
Slight fluorescein staining confined to a small focus 
Moderate 
(+2) 
Regionally dense fluorescein staining (1 mm or greater in diameter) with 
underlying structure moderately visible 
Severe (+3)  
Marked fluorescein staining or epithelial loss 
 
Anterior Chamber 
The following system is recommended for grading of aqueous cells and flare using a slit 
beam 1.0 mm wide and 1.0 mm long.  
Cells 
0 = < 1 cell seen 
0.5+ = 1-5 cells seen 

 
 
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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).18 
 
 
 
 
 
18 http://www.aao.org/image/hyphema-grading-system-2 

 
 
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Posterior Capsule Opacification 
As a routine part of the slit lamp examination, posterior capsule opacification (PCO) will 
be evaluated using the following scale: 
 
 
 
 
 
 
 
 
 
 
 
 
Other Slit Lamp Findings (complete for each finding) 
• 
Trace 
• 
Mild 
• 
Moderate 
• 
Severe 
18.8 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.  Gonioscopy. 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. 
NONE 
Minimal (Top left image) 
Mild (Top right image) 
Moderate (bottom left 
image) 
Severe (bottom right image) 

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

 
 
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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. 
 
III. 
RISKS, BURDENS AND BENEFITS 
 

 
 
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• 
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 
 
• 
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 

 
 
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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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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 
 
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 

 
 
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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.