Post Market Study to Evaluate Safety and Effectiveness of the InnFocus Microshunt™ (MIDI Arrow) in Patients With Primary Open Angle Glaucoma
Phase: NA
Conditions: Primary Open Angle Glaucoma
Sponsor: InnFocus Inc.

Guy Van de Weyer 
Director of Operations 
EMEA 
Phone: 
+32-3-765.05.55 
Fax: 
+32-3-765.05.56 
Email: 
gvdw@innfocusinc.com 
 
 
 
POST MARKET STUDY 
TO EVALUATE SAFETY AND EFFECTIVENESS OF 
THE INNFOCUS MICROSHUNT® 
(MIDI Arrow) IN PATIENTS WITH PRIMARY OPEN 
ANGLE GLAUCOMA 
 
INN-007 
Market Surveillance Protocol 
Version 1.4 NL 
Dated: Mar 9, 2015 
 
SPONSOR: 
InnFocus, Inc. 
12415 SW 136 Avenue 
Unit 3 
Miami, Florida 33186, USA 
 
Study Director: 
 
 
 
 
 
 
 
 
 
CONFIDENTIAL 
INN-007 
Version 1.4- NL: Mar 9, 2015 

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PROTOCOL SYNOPSIS 
 
Study Title: 
Post Market Study to evaluate Safety and Effectiveness of the 
InnFocus MicroShunt® (MIDI Arrow) in patients with primary 
open angle glaucoma 
 
Protocol number: 
INN-007 
 
 
Device: 
InnFocus MicroShunt® (“MIDI Arrow”) 
 
 
Study design: 
Prospective, multicentric, single arm post market study to gather 
safety and effectiveness data on the CE Marked InnFocus 
MicroShunt (MIDI Arrow) device in primary open angle 
glaucoma patients. 
 
Study objectives: 
The purpose of this study is to collect additional safety and 
effectiveness data on the InnFocus MicroShunt (MIDI Arrow) in 
subjects suffering from primary open angle glaucoma who are 
inadequately controlled on maximum tolerated medical therapy 
with intraocular pressure ≥ 18 mm Hg and ≤ 35 mm Hg 
and/or.where glaucoma progression warrants surgery. 
 
Endpoints: 
 
Primary effectiveness endpoint: 
 
Reduction in intraocular pressure relative to the pre-operative value will be 
assessed at each post-operative visit (D1, D7, W4, M3, M6, M9, M12 and 
M24) with a first  measurement of success at 12 months. 
 
For patients with baseline IOP ≥18 to ≤21 mmHg, success will be measured 
as a patient who achieves an IOP reduction of 20% or greater with no 
reoperation for glaucoma or loss of light perception vision. 
For patients with baseline IOP >21 mmHg, success will be measured as a 
patient with IOP<21 mmHg and IOP reduction from baseline of 20% or 
greater with no reoperation for glaucoma or loss of light perception vision. 

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Complete success is a patient who is not on supplemental medical therapy to 
obtain controlled levels of intraocular pressure. 
Qualified success is defined as a patient who requires supplemental medical 
therapy to maintain controlled levels of intraocular pressure. 
 
A reoperation to better the aqueous drainage like a trabeculectomy or an 
implantation of another drainage implant is considered a failure as it does not 
fulfill the criteria for success mentioned above.  Needling of the bleb or post- 
surgical injection of an anti-fibrotic are not considered failures. 
 
Secondary effectiveness endpoint: 
 
New measurement of success at 24 months. 
Level of glaucoma supplemental medical therapy at M12 and M24. 
 
Primary safety endpoint : 
 
Incidence of all device and/or procedure-related Adverse Events during the 
study. 
 
Secondary safety endpoints: 
 
Incidence of all Adverse Events reported during the study. 
 
Number of centers: 
Up to four (4) study centers in two (2) countries (France-Switzerland). 
 
Patient population: 
100 subjects with a goal of 25 subjects at each selected center. These 
patients will be phakic or pseudophakic and will have had no prior 
incisional glaucoma surgery and will undergo InnFocus MicroShunt 
surgery only. 
 
Inclusion criteria:  
1) Male or female, age 18 to 85 years, inclusive. 
2) Subject has mild to moderate primary open glaucoma where the IOP is not 
adequately controlled on maximum tolerated medical therapy and has 
intraocular pressure greater than or equal to 18mmHg and less than or 
equal to 35mmHg while on glaucoma medications and/or.where glaucoma 
progression warrants surgery.. 
3) Primary open angle glaucoma diagnosis based on: 

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Exclusion criteria: 
a. glaucomatous optic nerve damage as evidenced by any of the following 
optic disc or retinal nerve fiber layer structural abnormalities 
documented on slit lamp stereo biomicroscopy or in stereo disc photos: 
1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, 
especially at the inferior or superior poles. 
2. Localized abnormalities of the peripapillary retinal nerve fiber 
layer, especially at the inferior or superior poles. 
3. Optic disc neural rim asymmetry of the two eyes consistent with 
loss of neural tissue. 
4. Disc rim or peripapillary retinal nerve fiber layer hemorrhages. 
4) Subject willing to comply with study requirements. 
5) Subject who has signed an approved informed consent form. 
 
All criteria apply to the study eye unless otherwise noted 
1) Patient unwilling or unable to give informed consent, or unable to return 
for scheduled protocol visits through 2 years. 
2) Patient < 18 years or >85 years of age. 
3) Patient is pregnant or nursing or unable to use appropriate birth control. 
4) Vision level of no light perception. 
5) Active iris neovascularization, active proliferative retinopathy or other 
ophthalmic disease that could confound study results. 
6) Iridocorneal endothelial syndrome. 
7) Epithelial or fibrous downgrowth. 
8) Secondary glaucoma such as post-trauma 
9) Chronic ocular inflammatory disease. 
10) Subject already enrolled in this or another study (only one eye can 
participate in this study) or completed their participation in another study 
within 30 calendar days of the screening exam. 
11) Aphakia. 
12) Vitreous in the anterior chamber. 
13) Inability to obtain accurate IOP measurement throughout the study.  For 
example: a history of corneal surgery, corneal opacities or 
disease/pathology (Active corneal infection or Fuchs dystrophy are 
examples.). 
14) Prior ALT, SLT or MLT within 90 days of enrollment. 
15) Severe anterior or posterior blepharitis. 
16) Unwilling to discontinue contact lens use after surgery. 

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17) Previous incisional ophthalmic surgery, excluding uncomplicated clear 
corneal phacoemulsification (cataract) surgery at least 6 months prior to 
enrollment. 
18) Presence of an anterior chamber IOL (AC-IOL). 
19) Prior laser peripheral iridotomy. 
20) Need for glaucoma surgery combined with other ocular procedures or 
anticipated need for additional ocular surgery during the investigational 
period. 
21) Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA) 
22) Known allergy or other contraindication to Mitomycin C (MMC) drug. 
23) Angle closure glaucoma or narrow anatomical chamber angle as identified 
by gonioscopy and classified as Shaffer Grade 0 or 1. 
24) Any condition that prevents the investigational device implantation or 
trabeculectomy in the superior region of the study eye (e.g., peripheral 
anterior synechiae, scleral staphyloma or conjunctival scarring). 
25) Diagnosed degenerative visual disorders not associated with existing 
glaucoma condition (e.g., advanced dry or wet macular degeneration or 
other retinal disorders, central retinal artery or vein occlusion) or 
choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or 
neovascularization). 
26) Central corneal thickness that is less than 450 microns or greater than 620 
microns. 
27) Previous cyclodestructive procedure. 
28) Prior retinal laser procedure conducted for any purpose other than 
treatment of retinal tear or hole. 
29) Conditions associated with elevated episcleral venous pressure such as 
active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber 
syndrome, orbital tumors, orbital congestive disease. 
30) Clinically significant sequelae from trauma (e.g., chemical burns, blunt 
trauma, etc.) 
31) Ocular pathology or medical condition for which, in the investigator's 
judgment, the following factors would either place the subject at increased 
risk of complications or contraindicate device implantation or interfere with 
compliance to elements of the study protocol (e.g., ophthalmic 
examinations, follow-up visits), 
a. 
inability to reliably complete visual field testing over the course of the 
study, 
b. 
uncontrolled systemic disease (e.g. diabetes, hypertension) that could 
compromise their participation in the study. 
c. 
Disorders that pose a fall risk, as well as compromise ability to take a 
visual field exam and take glaucoma medications (e.g., Parkinson's 
disease), 

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d. 
inability to discontinue use of blood thinners within the surgeon’s 
standard preoperative or postoperative instructions. 
e. 
immunodeficiency concerns. 
f. 
known corticosteroid responders whose pressure increases would not 
allow them to withstand the postop corticosteroid regimen. 
32) Intraocular silicone oil. 
33) Ocular steroid use in the planned study eye or systemic steroid use anytime 
within three months of the procedure. (This would not include the use of 
inhaled or dermatologic steroids.) 
34) Chemotherapy within six months of the screening visit. 
35) Use of oral hypotensive glaucoma medications for treatment of the fellow 
eye. 
36) A requirement of general anesthesia for the procedure. 
37) Bacterial conjunctivitis 
38) Bacterial corneal ulcers 
39) Endophthalmitis 
40) Orbital cellulitis 
41) Bacteremia or septicemia 
42) Active scleritis 
43) Uveitis 
44) Severe dry eye syndrome 
45) Severe myopia 
46) Pseudo-exfoliative glaucoma 
 
Statistical analysis: 
One sample bilateral chi-square test at the 5% level, exact bilateral 95% 
confidence intervals. All results will be presented in a tabular format and 
with figures, as appropriate. 
Study duration: 
The overall duration of the study will be approximately 36 months. 
It is estimated that the inclusion period will be up to 12 months. 
Each patient will be followed-up for 24 months following 
implantation of the device. 

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Schedule of tests to be performed: 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a for non-menopausal women 
 
Study inclusion period: 
Study duration for each subject: 
Total duration of the study: 
12 months 
24 months 
36 months 
Acceptable Visit Windows 
Day 0: Operative Day 
Day 1: 
± 0 day 
Day 7: 
± 1 day 
4 weeks: 
± 2 days 
Month 3: 
Month 6: 
Month 9: 
Month 12: 
± 1 week 
± 1 week 
± 2 weeks 
± 2 weeks 
Month 24: 
± 2 weeks 
Patient History 
Informed consent 
Inclusion/Exclusion criteria 
Pachymetry 
Pregnancy testa 
Visual Acuity 
Slit Lamp 
Seidel Test 
Tonometry 
Motility evaluation 
Gonioscopy 
Ophthalmoscopy 
Perimetry 
Qualifying 
Assessment and 
Preop - Baseline 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Day 0 - Procedure 
Day 1 
x 
x 
x 
x 
x 
Day 7 
x 
x 
x 
x 
x 
4 Weeks 
x 
x 
x 
x 
x 
Month 3 
x 
x 
x 
x 
x 
Month 6 
x 
x 
x 
x 
x 
x 
Month 9 
x 
x 
x 
x 
x 
Month 12 
x 
x 
x 
x 
x 
x 
x 
Month 24 
x 
x 
x 
x 
x 
x 
x 

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TABLE OF CONTENTS 
ABBREVIATIONS .................................................................................................................................. 11 
1. 
GENERAL INFORMATION / STUDY ADMINISTRATIVE STRUCTURE ............................ 12 
2. 
INTRODUCTION ......................................................................................................................... 12 
2.1 
Justification for the study .......................................................................................................... 12 
2.2 
The InnFocus MicroShunt Configuration ................................................................................. 14 
2.3 
Summary of pre-clinical testing ................................................................................................ 15 
2.3.1 
Materials ............................................................................................................................. 15 
2.3.2 
Prior clinical studies and regulatory status ......................................................................... 15 
2.3.3 
Histology ............................................................................................................................ 16 
2.4 
Risk analysis ............................................................................................................................. 16 
2.4.1 
Benefits .............................................................................................................................. 16 
2.4.2 
Risks ................................................................................................................................... 16 
2.4.3 
Risk/Benefit Summary ....................................................................................................... 19 
2.5 
Conformity ...................................................................................................................................... 19 
3. 
STUDY OBJECTIVES .................................................................................................................. 19 
4. 
STUDY DESIGN ........................................................................................................................... 20 
5. 
PATIENT POPULATION ............................................................................................................. 20 
6. 
SELECTION OF PATIENTS ........................................................................................................ 21 
7. 
STUDY PROCEDURES ............................................................................................................... 24 
7.1 
Qualifying Assessment .............................................................................................................. 24 
7.2 
Treatment procedure ................................................................................................................. 24 
7.2.1 
Anaesthesia ........................................................................................................................ 24 
7.2.2 
Preparation of InnFocus MicroShunt ................................................................................. 24 
7.2.3 
Corneal Traction and Conjunctival Flap ............................................................................ 24 
7.2.4 Preparation of Anterior Chamber Entrance Site ..................................................................... 24 
7.2.5 
Insertion of InnFocus MicroShunt into Anterior Chamber ................................................ 25 
7.2.6 
Conjunctival Closure ......................................................................................................... 25 
8. 
PARAMETERS AND METHODS OF MEASUREMENT (FOR JUDGING OUTCOME  OF 
STUDY) ........................................................................................................................................................... 26 
8.1 
Visual Acuity ............................................................................................................................ 26 
8.2 
Slit Lamp Biomicroscopy ......................................................................................................... 28 
8.2.1 Lids ................................................................................................................................................ 29 
8.2.2 Conjunctiva .............................................................................................................................. 29 
8.2.3 Cornea ...................................................................................................................................... 29 
8.2.4 Anterior Chamber .................................................................................................................... 29 
8.2.5 Iris29 
8.2.6. Lens .............................................................................................................................................. 30 
8.3. Seidel Testing ............................................................................................................................ 30 
8.4. Tonometry ................................................................................................................................. 30 

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Goldmann Applanation Tonometry .................................................................................................. 30 
8.5. Motility Evaluation ................................................................................................................... 31 
8.6. Gonioscopy ............................................................................................................................... 31 
8.7. Peripheral Fundus Exam ........................................................................................................... 32 
8.8. Perimetry  .................................................................................................................................. 32 
9. 
SCHEDULE OF TESTS TO BE CONDUCTED .......................................................................... 34 
10. HEALTH ECONOMICS CONSIDERATIONS ............................................................................ 35 
11. STATISTICAL CONSIDERATIONS ........................................................................................... 35 
11.1 Sample size determination ........................................................................................................ 35 
11.2 Analyzed data sets ..................................................................................................................... 36 
11.3 Handling missing values ........................................................................................................... 36 
11.4 General considerations .............................................................................................................. 36 
11.5 Data Analysis Methods ............................................................................................................. 36 
12. MONITORING .............................................................................................................................. 38 
12.1 Definitions ................................................................................................................................. 38 
12.2 Severity of Adverse Events ....................................................................................................... 39 
12.3 Assessment of Relationship to Investigational Product ............................................................ 40 
12.4 Anticipated Adverse Device Effects ......................................................................................... 40 
12.5 Notification of Serious Adverse Events .................................................................................... 42 
12.6 Handling and Recording of Adverse Events ............................................................................. 43 
13. DATA QUALITY ASSURANCE ................................................................................................. 44 
13.1 Monitoring Procedures .............................................................................................................. 45 
13.2 Selection of Investigator............................................................................................................ 46 
13.3 Training ..................................................................................................................................... 46 
13.4 Patient Data Protection .............................................................................................................. 46 
13.5 Sponsor Records ....................................................................................................................... 47 
13.6 Sponsor Reports ........................................................................................................................ 47 
InnFocus, Inc. will submit reports of findings in this study to the relevant ethics committee. 
Unanticipated adverse device effects will also be reported. .................................................................. 47 
13.7 Site Record Retention Policy .................................................................................................... 47 
14. ETHICAL AND REGULATORY CONSIDERATIONS ............................................................. 47 
14.1 Role of InnFocus, Inc ..................................................................................................................... 47 
14.2 General Duties ........................................................................................................................... 48 
14.3 Investigator Responsibilities ..................................................................................................... 48 
14.5 Accountability ........................................................................................................................... 48 
14.6 Ethics Committee and Competent Authority Approval ............................................................ 49 
14.7 Supplemental Applications – Amendments .............................................................................. 49 
14.8 Annual progress report .............................................................................................................. 49 
14.9 Study Termination ..................................................................................................................... 50 
14.10 
Withdrawal .................................................................................................................................. 51 
14.11 
Protocol Deviations ............................................................................................................... 51 
14.12 Insurance ................................................................................................................................... 51 

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14.13 Patient Compensation ............................................................................................................... 51 
15. STUDY DURATION..................................................................................................................... 52 
16. PUBLICATION POLICY .............................................................................................................. 52 
17. REFERENCES ..................................................................................................................................... 53 

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ABBREVIATIONS 
 
AC-IOL 
Anterior chamber intraocular lens 
ADE 
Adverse device effect 
AE 
Adverse event 
CACG 
Chronic angle closure glaucoma 
CAI 
Carbonic anhydrase inhibitor 
CE 
Cataract extraction 
CRF: 
Case report form 
DM : 
Diabetes mellitus 
ECCE : 
Extracapsular cataract extraction 
GCP: 
Good clinical practice 
GDI: 
Glaucoma drainage implant 
ICCE : 
Intracapsular cataract extraction 
HTN : 
Arterial Hypertension 
LTP : 
Laser trabeculoplasty 
LPI : 
Laser peripheral iridotomy 
MMC : 
Mitomycin C 
PCIOL : 
Posterior chamber intraocular lens 
PG : 
Prostaglandin analogue 
POAG : 
Primary open angle glaucoma 
PXF : 
Pseudo-exfoliative glaucoma 
Trab : 
Trabeculectomy 
SADE: 
Serious adverse device effect 
SAE: 
Serious adverse event 
UADE: 
Unanticipated adverse device effect 
USADE 
Unanticipated serious adverse device effect 
WHO: 
World Health Organization 

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Guy Van de Weyer 
Director of Operations EMEA 
Phone: +32-3-765.05.55 
Fax: 
+32-3-765.05.56 
Email: gvdw@innfocusinc.com 
Emergo Europe 
Molenstraat 15 
2513 BH, The Hague 
The Netherlands 
Phone: +31.70.345.8570 
Fax : +31.70.346.7299 
MedPass International 
95 bis boulevard Pereire 
75017  Paris - France 
France 
Phone: +33-1-42 12 83 30 
Fax: +33-1-40 53 81 11 
 
 
1. 
GENERAL INFORMATION / STUDY ADMINISTRATIVE STRUCTURE 
 
Principal Investigator: A separate list of principal investigators in the study will be maintained. 
 
Sponsor: 
InnFocus, Inc. 
12415 SW 136 Avenue, Unit 3 
Miami Florida 33186 
USA 
 
Study Director: 
 
 
 
 
 
 
Authorized Representative: 
 
 
 
 
 
 
Monitor: 
 
 
 
 
 
 
 
2. 
INTRODUCTION 
 
2.1 Justification for the study 
 
Aqueous humor drainage surgery to control intraocular pressure (IOP) by the implantation of 
different devices has been used with limited success due to a buildup of fibrous extracellular 
matrix.1;2 The initial devices used to drain aqueous humor from the anterior chamber were pieces 
of horse-hair threads3; however, they failed due to fibrotic reactions to the material. Other 
materials including glass rods4, gold5, silk6 were tried without success due to uncontrollable 
fibrosis and scarring in the subconjunctival space. 

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Modern glaucoma drainage surgery began with the pioneer work of Molteno in rabbits7 that was 
extrapolated to humans8, where the aqueous humor was drained from the anterior chamber by a 
silicone tube to a polyethylene plate adjacent to the limbus. He modified his original design by 
increasing the tube length to allow the drainage of aqueous humor into a more posterior area, 
thereby decreasing the rate of extrusion9. Other major modifications in the design of glaucoma 
drainage implants were the introduction of unidirectional valve systems to avoid the 
complications associated with postoperative hypotony; however, recent studies have questioned 
the functionality of these implants10. Krupin et al reported his results with a valved system made 
of silicone rubber in 197611 and the clinical results with the Ahmed implant followed years 
later12. Subsequent designs by Molteno13 and Baerveldt14;15 were aimed at increasing the plate 
surface area in order to enhance the reduction in intraocular pressure. 
 
Novel devices without plates have been receiving much attention in the literature lately and 
include 1) the “T Mesh” made of expanded polytetrafluoroethylene16,17, 2) hydroxyapatite 
tubes18, 3) stainless steel devices such as the Ex-PRESS® Miniature Glaucoma Drainage 
Implant19, and 4) the Wilcox aqueous shunt.20 Long-term effectiveness of these devices is not 
established, but the recent results for the Ex-PRESS are indicative of success50;51. 
 
Practice patterns vary in the surgical management of glaucoma. An anonymous survey of 
members of the American Glaucoma Society (AGS) and Japanese Glaucoma Society (JGS) by 
Chen and associates in 1996 presented ten clinical situations requiring glaucoma surgical 
intervention21. The majority of respondents preferred trabeculectomy with Mitomycin C (MMC) 
for all clinical situations provided (51% to 87%), although many of those surveyed elected to use 
a glaucoma drainage implant (GDI), trabeculectomy with 5-fluoroacil (5-FU), or trabeculectomy 
without an antifibrotic agent. A follow-up study by Joshi and associates in 2002 re-administered 
the same survey to members of AGS. Respondents continued to report a preference for 
trabeculectomy with MMC in the ten clinical situations, but the percentage usage of GDIs had 
significantly increased22. In particular, selection of GDIs as the preferred surgical approach in 
eyes with a previous trabeculectomy increased from 7% to 20%, and in eyes with previous 
extracapsular or intracapsular cataract surgery increased from 8% to 22%. 
 
The lack of consensus among glaucoma surgeons regarding use of a GDI or trabeculectomy with 
an anti-fibrotic agent in eyes that have had previous cataract extraction or failed filtering surgery 
likely relates to the fact that available clinical data has not shown one surgical procedure to be 
superior to the other. Surgical results reported in case series with GDIs and 5-FU and MMC 
trabeculectomies in aphakic/pseudophakic eyes have shown success rates ranging from 50% to 
88% for GDIs23-33, and 48% to 86% for filtering surgery with an antifibrotic agent34,35 in 
aphakic/pseudophakic eyes.  Surgical results in eyes with failed filters ranged from 44% to 88% 
for GDIs23,25,27,28,30,31, and 61% to 100% for 5-FU and MMC trabeculectomies34,35,36-39,41-44. 
There are obvious difficulties in making comparisons between case series, given differences in 
study populations, follow-up periods, and criteria by which success is defined.  However, 
comparable success rates have been reported with both GDIs and filtering surgery with an anti- 

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fibrotic agent in eyes that have undergone prior cataract surgery or failed filtering surgery when 
each procedure has been studied separately. GDIs (Baerveldt, Ahmed, etc.) and the frequency of 
this procedure are increasing relative to trabeculectomies as recent publications 46-49 suggest that 
they perform better in the long-term. 
 
Although different factors are important in determining the surgical success, it is believed that 
the fibrotic and inflammatory reactions induced by different biomaterials and contaminants and 
cleavable moieties that may elute therefrom, used in the manufacture of the GDI is a major 
determinant of success in glaucoma drainage surgery.36,37,45 Other factors related to the design of 
the implant such as shape, flexibility, modulus and texture could also be associated with erosion, 
extrusion, inflammation and scarring22. Selecting a biomaterial and a design that produces a 
minimal inflammatory reaction with virtually no encapsulation or fibrotic reaction is a means to 
increase the success rate of these procedures. The material used for the InnFocus MicroShunt for 
this post market study, SIBS, was selected due to its biostability, biocompatibility, and lack of 
cleavable side groups as well as its low modulus of elasticity (less than 0.9 MPa at 100% 
elongation). The result of the combination of SIBS as a material and the change in geometry of 
the tube (smaller inside and outside diameter) should provide little or none of the encapsulation 
that has resulted in closure of existing commercialized devices over time and the new geometry 
will better control the flow of aqueous out of the anterior chamber to prevent hypotony (a flat 
anterior chamber). In addition, the elasticity of the SIBS should prevent the erosion of the 
conjunctiva caused by other GDIs. 
 
The InnFocus, Inc. InnFocus MicroShunt glaucoma drainage device has undergone extensive 
pre-clinical and clinical testing and a CE Mark was granted in January 25, 2012.  As part of the 
continuing efforts to evaluate performance and safety, a market surveillance program is being 
initiated at several institutions in Europe. This will result in the device being used by numerous 
surgeons and will provide an expanded understanding of ease of implantation, surgical success of 
the device, and relative success in a larger cross-section of patients who have glaucoma. 
 
 
2.2 The InnFocus MicroShunt Configuration 
 
The material of construction for the InnFocus MicroShunt is poly (styrene-b-isobutylene-b- 
styrene) called SIBS. The outside diameter of the tube is approximately 350 microns with a 
nominal length of 8.5 mm. The inside diameter of the tube is 70 microns. The arrow tab is 
about 1mm in width and same thickness as the tube. 

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InnFocus MicroShunt 
(All dimensions in mm) 
 
 
 
 
2.3 
Summary of pre-clinical testing 
 
2.3.1 Materials 
 
The material of construction for the InnFocus MicroShunt, poly (styrene-b- 
isobutylene-b-styrene) called SIBS, is presently being used in another 
commercialized (CE marked and FDA approved) medical device, the Taxus® 
drug-eluting coronary stent.  The SIBS is the coating material on the stent that 
releases the drug over a period of time. The material has undergone a 
comprehensive biocompatibility screen and passed prior to its use in humans. 
Furthermore, two year data from explanted stents has shown that the SIBS 
exhibits no degradation over that period of time. 
 
2.3.2 Prior clinical studies and regulatory status 
The one year results of clinical studies have demonstrated IOP reduction that is 
comparable or better than trabeculectomy or competitive glaucoma drainage 
devices.  A discussion of the complications is contained in the risks section that 
follows and supports that the risks are comparable or better than trabeculectomy 
and competitive glaucoma drainage devices.  The InnFocus MicroShunt was CE 
marked in January 25, 2012. In its review for CE marking the notified body has 
approved the instructions for use. 

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2.3.3 Histology 
 
Histology conducted on InnFocus MicroShunt explanted from the eyes of rabbits 
has shown excellent healing without the presence of myofibroblasts. 
 
2.4 
Risk analysis 
 
2.4.1 Benefits 
The InnFocus MicroShunt is intended to decrease the intraocular pressure in the 
eye caused by glaucoma to a normal level that aids in managing the long term 
effects of the disease. In the majority of cases, the normal pressure range is from 
6 mmHg to 21 mmHg, although there are cases in which the disease can be 
detrimental with pressures in the normal range. At the same time, the InnFocus 
MicroShunt has been designed to minimize the most common and feared 
immediate postoperative complication; hypotony. Low IOP is associated with 
shallow and flat anterior chambers, choroidal effusions and detachment, and 
corneal decompensation that jeopardize vision. The new glaucoma drainage 
implant was designed with a small lumen diameter of approximately 70 μm to 
avoid the excessive postoperative outflow that may occur with current drainage 
devices in the immediate postoperative period. The use of a tube with a 70 μm 
lumen was calculated from the well-known Hagen-Poiseulle equation40 which 
relates flow rate into the eye, and therefore out of the eye, with pressure, diameter 
and length of the outflow tube (the GDI), and adjusted based on experience in 
animal studies. It is noteworthy to mention that current drainage devices made 
with a silicone tube and a connecting reservoir, have approximately 300 μm of 
lumen diameter. 
 
2.4.2 
Risks 
a. The cornea or iris could be damaged during the implantation procedure 
or post implantation.  Based on prior clinical data, no cornea or iris 
damage has been observed although occasionally the device has made direct 
contact with the iris.  Additionally, surgeons are instructed on the proper 
insertion method.  This potential contact risk with the iris or cornea is 
similar to presently commercialized aqueous shunts (Ahmed, Baerveldt, 
Molteno) as they require placement of the proximal end of the tube in the 
same location as the InnFocus MicroShunt. 
b. The device may not be inserted completely into the anterior chamber. 
If this occurs, the device may be relocated to a different access tract or 
another device may be implanted.  In either case, this would result in an 
overall longer procedure.  There has only been one case with the present 
device in which a second insertion location adjacent to the original location 

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was required with the same device with a corresponding longer procedure 
time. No other complications were observed. 
c. The device could clog if it remains in contact with the iris with resultant 
low flow and increased IOP.  Although contact with the iris has been 
observed with the present device, flow has been maintained.  If the tip does 
become clogged, the physician can use a standard laser to remove the iris 
material from the tip of the device. This risk is also present with the 
proximal end of aqueous shunts which can contact the iris or cornea and 
lasers are routinely used to clear debris from the proximal end. 
d. The bleb that is typically created by the aqueous flow into the 
Tenon/sub-conjunctival pocket may develop excessive scarring (bleb 
encapsulation or also called “Tenon’s cyst”) which can result in lower 
aqueous flow through the bleb and increased IOP.  The implantation 
procedure has been refined to provide for a large pocket that is resistant to 
fibrosis and scarring.  One bleb encapsulation was observed in prior 
InnFocus MicroShunt studies and was successfully needled. A similar risk 
of scarring is observed with trabeculectomy. 
e. Choroidal effusion may occur and lead to an observable choroidal 
detachment.  This has been observed in 2 prior InnFocus MicroShunt cases 
during combined surgery with cataract removal and resolved with the use of 
cycloplegics.  There was no incidence of suprachoroidal hemorrhage in 
studies to date but this should be considered a risk of this surgery, as it is 
with trabeculectomy. 
f. Flat or shallow chambers may occur as the result of low pressure in the 
anterior chamber.  Two cases of shallow chambers were observed in 
studies to date and resolved spontaneously with no observable damage to the 
cornea or iris. 
g. Wound leaks may occur shortly after surgery and may be related to the 
suturing of the conjunctiva to the limbus.  One short term wound leak 
was observed but resolved spontaneously within the first three weeks after 
surgery.  No long term wound leaks have been observed in existing studies 
of this device. 
h. No blebitis has been observed in clinical studies to date but is a risk 
whenever a bleb is developed as a result of the surgery. 
i. No endophthalmitis has been observed but it is a risk of this type of 
surgery, especially in the event that blebitis develops. 
j. Hyphema has been observed in several cases but not at a level of 10% or 
more of the anterior chamber and typically resolves within one week of 
surgery. 
k. Aqueous misdirection is a potential risk of filtering surgery but has not 
been observed in existing studies of the device. 

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l. Decompression retinopathy has not been observed but remains a risk with 
this type of surgery. 
m. Persistent hypotony is defined as an intraocular pressure below 6mm that is 
present on two consecutive follow-ups after three months.  This can lead to 
hypotony maculopathy. No persistent hypotony or hypotony maculopathy 
have been observed in studies to date. 
n. Corneal decompensation from MMC exposure could occur if MMC 
reached the corneal endothelium as has been reported in an animal model in 
the literature and is another risk. Avoiding contact of MMC with the cornea 
endothelium by rinsing MMC out of the subconjunctival pocket prior to 
entry of the needle into the AC should assure no entry of MMC and 
therefore no effect on the endothelium.  Corneal decompensation has not 
been observed in InnFocus MicroShunt clinical studies to date. 
o. A thin-walled avascular bleb may be associated with low IOP.  This has 
not been observed in the prior InnFocus MicroShunt studies. 
p. Tube erosion over time resulting in a break in the conjunctival barrier 
and potential infection is a risk in the InnFocus MicroShunt arm of the 
study.  There have been no tube erosions in the ongoing studies of the 
InnFocus MicroShunt. 
q. Chronic or recurrent iritis is a risk associated with filtering surgery.  No 
chronic or recurrent iritis has been observed in the ongoing InnFocus 
MicroShunt clinical studies. 
r. Tube obstruction is a risk with the InnFocus MicroShunt procedure. 
There has been one transient tube obstruction from fibrin in a combined 
InnFocus MicroShunt implantation and cataract surgery in an ongoing 
study that was resolved with a flush of the AC end of the tube during the 
initial surgery. Viscoelastics have not been tested with this device. 
However, in an emergency when all other therapies have failed, the use of 
hydroxyl methyl-cellulose (HPMC) may be an option. Use of HPMC 
should be a last resort to correct a flat chamber with the InnFocus 
MicroShunt and may risk loss of flow through the device for one or more 
weeks after use necessitating close or more frequent observation of IOP. 
There have been no cases of the need to use viscoelastics to correct flat 
chamber to date. 
s. Migration of device out of anterior chamber.  There have been no cases 
of InnFocus MicroShunt migration out of the anterior chamber, but there has 
been one case where the surgeon inadvertently moved the InnFocus 
MicroShunt out of the anterior chamber during conjunctival closure at time 
of the original procedure. 

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2.4.3 
Risk/Benefit Summary 
 
The overall benefit of the InnFocus MicroShunt Glaucoma Implant outweighs its residual 
risks.  Efficacy results compare well with trabeculectomy and competitive glaucoma 
drainage devices, while complications are equivalent or better.  As compared to 
alternatives, the procedure itself is easier and the procedure time is less. 
 
2.5 
Conformity 
The study will be performed in accordance with the European Directive 93/42/EEC, and 
the standard EN ISO 14155:2011 on clinical investigations with medical devices for 
human subjects – good clinical practice, the MEDDEV 2.12-1 (Medical devices vigilance 
system), Meddev 2.7/1, the MEDDEV 2.12/2 revision 2 (Post market clinical follow-up 
studies), and recommendations guiding physicians in biomedical research involving 
human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 
and later revisions. 
In the Netherlands this study will also be performed in accordance with the Medical 
Research Involving Human Subjects Act (WMO). 
 
3. 
STUDY OBJECTIVES 
 
 
Objectives 
 
The purpose of this study is to collect additional safety and effectiveness of the InnFocus 
MicroShunt (MIDI Arrow) in subjects suffering from primary open angle glaucoma that are 
inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 
18 mm Hg and ≤ 35 mm Hg and/or.where glaucoma progression warrants surgery. 
 
Primary effectiveness endpoint: 
 
Reduction in intraocular pressure relative to the pre-operative value will be assessed at each 
post-operative visit (D1, D7, W4, M3, M6, M9, M12 and M24) with a first 
measurement of success at 12 months. 
 
For patients with baseline IOP ≥18 to ≤ 21 mmHg, success will be measured as a patient who 
achieves an IOP reduction of 20% or greater with no reoperation for glaucoma or loss of light 
perception vision. 
For patients with baseline IOP >21 mmHg, success will be measured as a patient with 
IOP<21 mmHg and IOP reduction from baseline of 20% or greater with no reoperation for 
glaucoma or loss of light perception vision. 

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Complete success is a patient who is not on supplemental medical therapy to obtain 
controlled levels of intraocular pressure. 
Qualified success is defined as a patient who requires supplemental medical therapy to 
maintain controlled levels of intraocular pressure. 
 
A reoperation to better the aqueous drainage like a trabeculectomy or an implantation of 
another drainage implant is considered a failure as it does not fulfill the criteria for success 
mentioned above.  Needling of the bleb or post-surgical injection of an anti-fibrotic are not 
considered failures. 
 
Secondary effectiveness endpoint: 
 
New measurement of success at 24 months. 
Level of glaucoma supplemental medical therapy at M12 and M24. 
 
Primary safety endpoint : 
 
Incidence of all device and/or procedure-related Adverse Events during the study. 
 
Secondary safety endpoints: 
 
Incidence of all Adverse Events reported during the study. 
 
4. 
STUDY DESIGN 
 
This is a prospective, multicentric, single arm post-market study with a CE marked device 
conducted at up to 4 European locations (France, Switzerland, Spain and the Netherlands) in 
which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will 
be implanted with a InnFocus MicroShunt in the anterior chamber of the eye. Patients will be 
followed for 24 months with an expected enrollment period of up to 12 months. Safety of the 
InnFocus MicroShunt will be confirmed with indirect and direct microscopic evaluation of the 
implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals 
for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number 
of other defined potential complications. The effectiveness of the shunt will be evaluated by 
measurement of intraocular pressure at defined intervals. 
 
 
5. 
PATIENT POPULATION 
 
The number of patients in the study at each site is planned for ≤ twenty (20).  The patient 
population will include male or female patients of ages 18 to 85 years, inclusive, with glaucoma 

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that is inadequately controlled on maximum tolerated medical therapy, with intraocular pressure 
≥ 18 mm Hg and ≤ 35 mm Hg. 
 
 
6. 
SELECTION OF PATIENTS 
 
 
Inclusion criteria:  
1) Male or female, age 18 to 85 years, inclusive. 
2) Subject has mild to moderate primary open glaucoma where the IOP is not 
adequately controlled on maximum tolerated medical therapy and has 
intraocular pressure greater than or equal to 18mmHg and less than or 
equal to 35mmHg while on glaucoma medications and/or.where glaucoma 
progression warrants surgery. 
3) Primary open angle glaucoma diagnosis based on: 
a. glaucomatous optic nerve damage as evidenced by any of the following 
optic disc or retinal nerve fiber layer structural abnormalities 
documented on slit lamp stereo biomicroscopy or in stereo disc photos: 
1. Diffuse thinning, focal narrowing, or notching of the optic disc rim, 
especially at the inferior or superior poles. 
2. Localized abnormalities of the peripapillary retinal nerve fiber 
layer, especially at the inferior or superior poles. 
3. Optic disc neural rim asymmetry of the two eyes consistent with 
loss of neural tissue. 
4. Disc rim or peripapillary retinal nerve fiber layer hemorrhages. 
4) Subject willing to comply with study requirements. 
5) Subject who has signed an approved informed consent form. 
 
Exclusion criteria: 
All criteria apply to the study eye unless otherwise noted. 
1) Patient unwilling or unable to give informed consent, , or unable to return 
for scheduled protocol visits through 2 years. 
2) Patient < 18 years or >85 years of age. 
3) Patient is pregnant or nursing or unable to use appropriate birth control. 
4) Vision level of no light perception. 
5) Active iris neovascularization, active proliferative retinopathy or other 
ophthalmic disease that could confound study results. 
6) Iridocorneal endothelial syndrome. 
7) Epithelial or fibrous downgrowth. 
8) Secondary glaucoma such as post-trauma 

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9) Chronic ocular inflammatory disease. 
10) Subject already enrolled in this or another study (only one eye can 
participate in this study) or completed their participation in another study 
within 30 calendar days of the screening exam. 
11) Aphakia. 
12) Vitreous in the anterior chamber. 
13) Inability to obtain accurate IOP measurement throughout the study. For 
example: a history of corneal surgery, corneal opacities or 
disease/pathology.  (Active corneal infection or Fuchs dystrophy are 
examples.). 
14) Prior ALT, SLT or MLT within 90 days of enrollment. 
15) Severe anterior or posterior blepharitis. 
16) Unwilling to discontinue contact lens use after surgery. 
17) Previous incisional ophthalmic surgery, excluding uncomplicated clear 
corneal phacoemulsification (cataract) surgery at least 6 months prior to 
enrollment. 
18) Presence of an anterior chamber IOL (ACIOL). 
19) Prior laser peripheral iridotomy. 
20) Need for glaucoma surgery combined with other ocular procedures or 
anticipated need for additional ocular surgery during the investigational 
period. 
21) Fellow eye with poorer than 20/200 best-corrected visual acuity (BCVA). 
22) Known allergy or other contraindication to Mitomycin C (MMC) drug. 
23) Angle closure glaucoma or narrow anatomical chamber angle as identified 
by gonioscopy and classified as Shaffer Grade 0 or 1. 
24) Any condition that prevents the investigational device implantation or 
trabeculectomy in the superior region of the study eye (e.g., peripheral 
anterior synechiae, scleral staphyloma or conjunctival scarring). 
25) Diagnosed degenerative visual disorders not associated with existing 
glaucoma condition (e.g., advanced dry or wet macular degeneration or 
other retinal disorders, central retinal artery or vein occlusion) or 
choroidopathy (e.g., choroidal detachment, effusion, choroiditis, or 
neovascularization). 
26) Central corneal thickness that is less than 450 microns or greater than 620 
microns. 
27) Previous cyclodestructive procedure. 
28) Prior retinal laser procedure conducted for any purpose other than 
treatment of retinal tear or hole. 
29) Conditions associated with elevated episcleral venous pressure such as 
active thyroid orbitopathy, cavernous sinus fistula, Sturge-Weber 
syndrome, orbital tumors, orbital congestive disease. 

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30) Clinically significant sequelae from trauma (e.g., chemical burns, blunt 
trauma, etc.) 
31) Ocular pathology or medical condition for which, in the investigator's 
judgment, the following factors would either place the subject at increased 
risk of complications or contraindicate device implantation or interfere 
with compliance to elements of the study protocol (e.g., ophthalmic 
examinations, follow-up visits), 
a. inability to reliably complete visual field testing over the course of the 
study, 
b. uncontrolled systemic disease (e.g. diabetes, hypertension) that could 
compromise their participation in the study. 
c. Disorders that pose a fall risk, as well as compromise ability to take a 
visual field exam and take glaucoma medications (e.g., Parkinson's 
disease), 
d. inability to discontinue use of blood thinners within the surgeon’s 
standard preoperative or postoperative instructions. 
e. immunodeficiency concerns. 
f. known corticosteroid responders whose pressure increases would not 
allow them to withstand the postop corticosteroid regimen. 
32) Intraocular silicone oil. 
33) Ocular steroid use in the planned study eye or systemic steroid use 
anytime within three months of the procedure. (This would not include the 
use of inhaled or dermatologic steroids.) 
34) Chemotherapy within six months of the screening visit. 
35) Use of oral hypotensive glaucoma medications for treatment of the fellow 
eye. 
36) A requirement of general anesthesia for the procedure. 
37) Bacterial conjunctivitis 
38) Bacterial corneal ulcers 
39) Endophthalmitis 
40) Orbital cellulitis 
41) Bacteremia or septicemia 
42) Active scleritis 
43) Uveitis 
44) Severe dry eye syndrome 
45) Severe myopia 
46) Pseudo-exfoliative glaucoma 

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7. 
STUDY PROCEDURES 
 
7.1 
Qualifying Assessment 
 
Each potential patient will be seen by the investigator during a first visit and will be given 
an informed consent to be signed. Then each patient who will agree to participate 
(considered as enrolled at that time)will undergo a qualifying assessment to determine 
their eligibility for the study.  Tests  are listed in the table at section 9.  Parameters for 
each test are given in section 8.  If the patient meets all of the inclusion criteria and none 
of the exclusion criteria, he will qualify for surgery. 
 
7.2 
Treatment procedure 
 
7.2.1 Anaesthesia 
 
The type of anaesthesia will be at the surgeon’s discretion. The procedure will be 
performed under local anaesthesia. 
 
7.2.2 Preparation of InnFocus MicroShunt 
 
Remove InnFocus MicroShunt from sterile packaging onto sterile field.  Dampen the 
InnFocus MicroShunt using a solution of Balanced Sterile Saline. 
 
7.2.3 Corneal Traction and Conjunctival Flap 
 
Perform corneal traction with 7-0 suture at surgeon’s discretion. 
 
Perform a peritomy between two rectus muscles of the surgeon’s choice and perform a 
posterior sub-Tenon delamination toward the equator of the eye about 8mm deep and 90- 
120º wide. 
 
7.2.4 Preparation of Anterior Chamber Entrance Site 
 
Apply 0.2mg/ml to 0.4mg/ml MMC soaked in 3 corneal Lasik shield sponges (provided 
in the kit) under the sub-conjunctival pouch over a circumference of  90o-120o at least 
8mm deep for 2-3 minutes, remove the sponges and rinse with generous amounts of BSS 
(>20ml). 
 
Note: Assure that the conjunctival wound edge does not come into contact with 
antimetabolite 

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Using the 3mm marker and the marker pen, measure a location 3 mm from the limbus for 
the scleral pocket to be made. 
 
Using the 1mm knife, make a shallow scleral pocket. 
 
Introduce a 25G needle into the scleral pocket and make a tract into the anterior chamber 
bisecting the iridocorneal angle. 
 
7.2.5 Insertion of InnFocus MicroShunt into Anterior Chamber 
 
Gently insert the InnFocus MicroShunt tube through the needle track using forceps, 
holding the IMS close to the track while keeping the arrow face parallel to the scleral 
surface with the bevel up toward the cornea and tuck the arrow into the scleral flap.  If 
there is resistance to the placement of the InnFocus MicroShunt after multiple attempts to 
position it, use a 25G blunt tip cannula to re-enter the 25G needle track and assure it is 
open.  Then attempt placement of the InnFocus MicroShunt again. 
 
After successful insertion of the InnFocus MicroShunt, check the distal end of the device 
for flow from the anterior chamber and tuck it under the conjunctival flap. 
 
Check that the InnFocus MicroShunt tube position in the AC is not in contact with the 
cornea or iris and that there is flow of aqueous. 
 
7.2.6 Conjunctival Closure 
 
Reposition the Tenon’s and conjunctiva to the limbus and suture using 10-0 sutures. 
Check for no bleb leaks. 
 
Verify the presence of the proximal end of the InnFocus MicroShunt in the anterior 
chamber. 
 
Pull corneal traction suture out if it was used. 
 
Apply antibiotic and steroidal ointment or drops post-op as appropriate. 
 
NOTE: the patients will be proposed to sign an extra consent form for recording their surgeries. The 
reasons for recording videos are: 
 
1. To observe/compare differences between surgeon techniques and see if they deviate from their original 
technique  and register long-term documentation to better understand the relationship between the 
procedure and outcomes 
2. As a means of educating or teaching prospective surgeons on the InnFocus procedure 

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3. To provide a recording that the surgeon can use for scientific presentations 
4. To be able to capture some potential missed information during the procedure to have the best 
documentation (i.e. exact MMC time used); 
5. In case of procedural not performed in the expected timelines/conditions this will allow post 
procedurally to determine for example why several attempts have been needed to implant the device, 
why the study duration has been modified; 
6. To allow a better quality control to confirm or deny post procedurally potential links between a 
complication and the procedure, to confirm that the correct materials have been used; 
 
 
7.2.7 Follow-up 
 
Monitor the patients at each follow-up per the follow-up table shown in section 9 and the 
parameters given in section 8 below. 
 
Any interim visits, i.e. an extra visit in between a normal postoperative visit, should be 
recorded on ADDITIONAL VISIT case report form. 
 
8. 
PARAMETERS AND METHODS OF MEASUREMENT (FOR JUDGING OUTCOME 
OF STUDY) 
 
8.1 Visual Acuity 
 
Visual acuity is measured before pupil dilation, tonometry, gonioscopy, or any other 
technique that could affect vision.  The Monoyer technique will be used for visual acuity 
testing.  Refraction is performed prior to formal measurement of visual acuity at the 
Qualifying Assessment and at the 6 months and annual follow-up visits. Monoyer visual 
acuity is measured at the Qualifying Assessment and at every follow-up visit.  Visual 
acuity will be Best Spectacle Corrected Visual Acuity (BSCVA).  Insure that manifest 
refraction is also conducted. 
 
8.1.1 
Subjective Refraction 
 
Subjective refraction must be performed at the Qualifying Assessment and at the 
6 months and annual follow-up visits in order to determine best-corrected visual 
acuity. It is permissible to use a phoropter to determine best-corrected Monoyer 
visual acuity. 
 
The left eye is occluded first. An approximate beginning refraction may be 
determined by retinoscopy, automated refraction, or a subjective refraction from 
a prior visit.  The sphere is refined first.  The cylinder is then refined, first the 

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axis followed by the power.  Finally, the sphere is rechecked.  The right eye is 
then occluded, and the procedure is repeated for the left eye. 
 
If the patient wears contact lenses and has glasses also, he or she is instructed not 
to wear the contact lenses on the day of the Qualifying Assessment.  Patients 
unwilling to discontinue contact lens use after surgery will be excluded from the 
study.  In the event that the patient either has no glasses or has forgotten the 
instructions and reported for the Qualifying Assessment wearing contact lenses, a 
new examination appointment should be made. 
 
8.1.2 
Visual Acuity Procedure 
 
Monoyer visual acuity may be measured using any standard visual acuity chart. 
The same type of chart must be used throughout the duration of the study. 
Monoyer visual acuity is measured during the Qualifying Assessment and at all 
follow-up visits.  Standardized refraction is performed prior to Monoyer visual 
acuity testing at the Qualifying Assessment, 6 months and annual follow-up 
examinations. 
 
The patient is not allowed to lean forward or backward so that a constant testing 
distance is maintained.  After proper instruction and refraction, the left eye is 
occluded and testing is begun with the right eye.  Progressively smaller lines are 
presented to the patient until he or she makes two or more errors in a line.  When 
a patient states he or she is unable to read a letter, he or she is encouraged to 
guess.  If a patient misses only two letters on a line, a second chance is provided 
by asking the patient to read the line backwards.  The patient is encouraged to fix 
eccentrically if this improves the visual acuity, but care must be taken to ensure 
that the fellow eye remains covered.  The Monoyer visual acuity is recorded as 
the smallest line in which the patient misses one or fewer optotypes.  If the 
patient’s visual acuity is so poor that he or she cannot read the 0.05 (20/400) line, 
assess his or her ability to count fingers. After testing of the right eye is 
completed, the procedure is repeated for the left eye. 
 
8.1.3 
Testing for Finger Counting 
 
After proper instruction and refraction, the examiner’s hand is viewed at a 
distance of two feet from the patient’s eye.  The fellow eye is closed and 
completely occluded by the palm of the patient’s or assistant’s hand. The 
examiner presents a random number of fingers to the patient.  The patient is 
asked to indicate the number of fingers seen.  If the number of fingers shown is 
correctly identified on four or more of five presentations, vision is recorded as 

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count fingers. If the number of fingers presented cannot be identified on four or 
more of five presentations, test for hand motions. 
 
8.1.4 
Testing for Hand Motions 
 
In testing for hand motion, the examiner’s hand is viewed with all fingers 
extended and separated at a distance of two feet from the patient’s eye.  The 
fellow eye is closed and completely occluded by the palm of the patient’s or 
assistant’s hand.  The patient’s glasses are not be worn.  The examiner’s hand is 
presented in a random order under three conditions:  stationary, moving back and 
forth horizontally, and moving up and down vertically.  The speed of movement 
is approximately one complete cycle of movement (up and down or back and 
forth) per second.  The patient is instructed that the examiner’s hand will be 
presented in one of these conditions.  He or she is asked to respond to the 
question, “What is my hand doing now?” with either, “still”, “back and forth”, or 
“up and down”.  The process is repeated five times.  It is considered a correct 
response if the patient states the hand is still or he or she cannot see it while it is 
stationary, and he or she is able to recognize movement and identify its direction. 
If hand motions are correctly identified on four or more of five presentations, 
vision is recorded as hand motions.  If hand motions cannot be identified on four 
or more of five presentations, test for light perception. 
 
8.1.5 
Testing for Light Perception 
 
Light perception is tested using the same complete occlusion of the fellow eye 
with no other bright lights visible from the patient’s position. The patient’s 
glasses are not worn.  The light of an indirect ophthalmoscope is directed into the 
eye from a distance of 2 feet for one or two seconds, then turned away. The 
patient is asked to report “on” when he or she sees the light, and “off” when it 
disappears.  The process is repeated five times in a non-rhythmic fashion.  The 
visual acuity is recorded as light perception if the patient responds correctly four 
or more out of five times. 
 
8.2 
Slit Lamp Biomicroscopy 
 
Examination of the anterior segment using slit lamp biomicroscopy is performed at the 
Qualifying Assessment to document the preoperative status of the eye, and at all follow- 
up examinations to detect any changes in ocular status during the course of the study 
which may be attributable to the disease or treatment.  Slit lamp biomicroscopy may be 
performed with any commercially available instrument, and it is used in a standard 
fashion starting anteriorly and working posteriorly.  Standardizing subjective grading of 
bleb leaks and lenticular opacities is difficult, if not impossible. 

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8.2.1 Lids 
 
The lids are examined for signs of blepharitis, including scales and crusting of the lashes, 
inspissated Meibomian glands, and erythema of the lid margin. Eyes with severe 
posterior blepharitis are excluded from the study. 
 
8.2.2 Conjunctiva 
 
Eyes enrolled in the study with or without previous cataract surgery. Eyes must undergo 
Seidel testing at all postoperative follow-up examinations to detect conjunctival wound 
leaks and bleb leaks.  Eyes that have undergone InnFocus MicroShunt implantation are 
examined carefully for tube erosion. The presence of an infiltrate or exudate in the bleb 
of eyes suggests the presence of a bleb-related infection. 
 
8.2.3 Cornea 
 
The cornea is examined at high magnification to evaluate the epithelium, stroma, and 
endothelium.  The techniques of diffuse illumination, scleral scatter, and retro- 
illumination may be used.  Findings consistent with a diagnosis of the iridocorneal 
endothelial (ICE) syndrome, epithelial downgrowth, or fibrous downgrowth make the 
eye ineligible for the study.  The presence of corneal epithelial or stromal edema is 
noted.  Eyes that have undergone InnFocus MicroShunt implantation are examined for 
the presence of tube-cornea touch. 
 
8.2.4 Anterior Chamber 
 
If the anterior chamber is shallow, the central anterior chamber depth is measured 
relative to the corneal thickness.  The appropriate gradation of > 3 CT, > 2 CT, > 1 CT, 
< 1 CT, or lens-cornea touch is documented.  Before fluorescein instillation or pupillary 
dilation, the degree of anterior chamber cell and flare is determined.  Eyes with chronic 
or recurrent uveitis are excluded from the study.  Eyes with vitreous in the anterior 
chamber are ineligible for the study if it is anticipated that a vitrectomy will be needed at 
the time of glaucoma surgery.  Careful assessment of the anterior chamber depth is made 
postoperatively. 
 
 
8.2.5 Iris 
 
Before pupillary dilation, the pupillary iris is examined at high magnification for the 
presence of neovascularization.  If rubeosis iridis is present, the eye is ineligible for the 
study. 

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8.2.6. Lens 
 
After pupillary dilation, the investigator assesses the lens and grades any cataract present 
as mild, moderate, or severe. In pseudophakic eyes, the presence of a posterior chamber 
or anterior chamber intraocular lens is documented. Aphakic eyes are excluded from the 
study. 
 
8.3. Seidel Testing 
 
Seidel testing must be performed at each postoperative follow-up examination. The 
Seidel test is performed using a fluorescein strip moistened with one or two drops of 
0.5% proparacaine which is then applied to the conjunctiva. The area is closely observed 
using high magnification and a broad slit beam with maximal intensity illumination 
using a cobalt blue filter.  Aqueous leakage is apparent as a light yellow stream and 
interrupts a dark green background of undiluted fluorescein.  If the Seidel test is positive, 
the leak is graded as an ooze, frank leak, or brisk leak. 
 
 
8.4. Tonometry 
 
Goldmann applanation tonometry should be taken during the Qualifying Assessment and 
during all follow ups. Goldman applanation tonometry is used to measure the intraocular 
pressure, except when irregular corneal astigmatism, corneal scarring, or corneal edema 
precludes accurate readings.  In these cases, the Tono-Pen (Mentor/Medtronic) or non- 
contact tonometry is used. The intraocular pressure is measured prior to pupillary 
dilation.  Whenever possible, the intraocular pressure should be checked at the same time 
of the day as the Qualifying Assessment to minimize the effect of diurnal fluctuation of 
intraocular pressure.  The tonometer should be calibrated at least once every 6 months. 
 
Goldmann Applanation Tonometry 
 
Clean the prism according to your institutional infection control policy.  The right eye is 
always tested first.  Following instillation of a drop of 0.5% proparacaine, a fluorescein 
strip is placed near the lateral canthus in the lower conjunctival sac.  Once the lacrimal 
fluid has been sufficiently colored, the fluorescein strip is removed.  Alternatively, one 
drop of premixed fluorescein and anesthetic may be instilled. The patient’s head is 
properly positioned in the chin rest and against the forehead rest without leaning forward 
or straining.  Any tight-fitting neckwear is loosened.  The patient is asked to look 
straight ahead at a distant object or fixation target.  If it is necessary to hold the eyelids 
open, the investigator holds the eyelids open against the orbital rim taking care not to 
apply any pressure on the globe.  The patient is instructed not to hold his or her breath. 

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If corneal astigmatism is greater than 3.0 diopters, the prism is rotated so that the axis of 
the minus cylinder on the prism graduation corresponds to the red mark on the prism 
holder.  The investigator looks through the slit lamp and gently brings the tip of the 
prism in contact with the center of the cornea.  The mires should be well focused, 
centered horizontally, and positioned vertically so that they are of equal circumference 
above and below the horizontal dividing line.  If the mires are narrower than 
approximately one tenth of their diameter, the investigator instills additional fluorescein. 
The investigator adjusts the measuring drum until the inner borders of the two mires just 
touch each other.  If pulsation is present, the measuring drum is adjusted until the mires 
separate a given distance during systole and overlap the same distance during diastole. 
The investigator removes the prism from the cornea and repeats the procedure in the 
right eye until two successive measurements are within 2 mm Hg. The investigator 
records the last two successive measurements.  After testing of the right eye is complete, 
testing of the left eye follows the same technique. 
 
 
8.5. Motility Evaluation 
 
Diplopia is a complication which historically has occurred on occasion following 
drainage device implantation.  The incidence of permanent restrictive strabismus 
associated with drainage implants is not precisely known, as this complication has not 
been studied prospectively.  In order to address this issue, a formal motility evaluation is 
performed in all patients preoperatively and in those patients with diplopia at the 6, 12 
and 24 month follow-up visit or beyond.  In addition, all patients will undergo a motility 
evaluation at the 1 year follow-up visit. Transient diplopia following drainage device 
implantation is not uncommon.  This study will focus on the incidence and nature of 
permanent restrictive strabismus associated with the drainage device implant. 
 
The cover-uncover and alternate cover tests are performed with the patient looking in 
primary gaze, as well as in upgaze, downgaze, left gaze, and right gaze.  Motility 
evaluation is performed with the patient looking in the distance and fixating at a near 
target.  Any heterophorias or heterotropias are identified, and the deviation is measured 
with hand-held prisms.  In patients who are unable to fixate for cover testing, the 
deviation may be measured by centering the corneal light reflexes with prism using the 
modified Krimsky method. 
 
8.6. 
Gonioscopy 
 
Gonioscopy is performed during the Qualifying Assessment and in further follow ups 
depending on the surgeon’s discretion. The patient sits at the slit lamp using either a 
Zeiss type four-mirror gonioprism or Goldmann single- or three-mirror lens.  An 
examination of the anterior chamber angle for neovascularization is performed under 

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high magnification for the purpose of excluding eyes with neovascularization from the 
study. 
 
8.7. 
Peripheral Fundus Exam 
 
A dilated fundus examination is performed at the Qualifying Assessment to determine 
the preoperative status of the eye, and at all postoperative follow-up examinations to 
detect any changes in ocular status produced by the disease or treatment.  After pupil 
dilation with appropriate mydriatics, the optic nerve and posterior pole are examined at 
the slit lamp using a Hruby lens, fundus contact lens, or Volk 90 diopter, 78 diopter, or 
60 diopter lens. A head-mounted indirect ophthalmoscope and hand held condensing 
lens (20 diopter or 28 diopter Nikon aspheric lens) is used to evaluate the retinal 
periphery.  A photo should be taken of the optic nerve. 
 
At the Qualifying Assessment, particular attention is paid for signs of proliferative 
retinopathy, including retinal neovascularization, neovascularization of the disc, vitreous 
hemorrhage, or preretinal hemorrhage.  Patients with active proliferative retinopathy are 
excluded from the study. At all postoperative follow-up visits, ophthalmoscopy is 
performed to evaluate for posterior segment complications, such as serous choroidal 
effusions, suprachoroidal hemorrhage, or hypotony maculopathy. 
 
8.8. 
Perimetry 
 
Visual field assessment is another important outcome measure.  Quantitative automated 
perimetry is performed using the Humphrey Field Analyzer.  The Octupus machine is an 
option; however, if used, a Humphrey print out should be collected for future analysis 
with other clinical data.  The site should be consistent to which machine to use and not 
alternate between machines if both are available. 
 
Visual field testing is performed preoperatively (not needed if a visual field has been 
done within 6 months of enrollment) and 1 year post operatively. Visual field testing is 
performed before tonometry, gonioscopy, or any other technique that could affect vision. 
A visual field should be attempted in any eye that has sufficient vision greater than 
0.1(20/200).  Eyes with poor central vision may have an intact, off-center island of 
vision which may be measured with perimetry. 
 
A 24-2 threshold test is performed in all patients capable of having visual fields done, 
using a size III white stimulus.  Visual field testing may be performed with the Swedish 
Interactive Thresholding Algorithm (SITA) or full threshold strategy, but the same 
testing strategy must be used throughout the duration of the study. The pupil diameter 
should be 3 mm or greater before visual field testing is undertaken, and this may require 
pharmacologic dilation.  Standardized refraction is performed to determine the patient’s 

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distance refraction and best-corrected visual acuity prior to visual field testing. The age 
appropriate plus lens is added to the distance refraction. Patient education is provided. 
The technician should monitor the patient during testing. 
 
8.9 
Pachymetry 
 
Pachymetry should be measured three times during the baseline exam utilizing an 
electronic pachymeter.  These three measurements are to be recorded in the source 
document and averaged; the mean value should also then be recorded in the appropriate 
location with the Case Report Form. 

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9. 
SCHEDULE OF TESTS TO BE CONDUCTED 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
a for non-menopausal women 
 
Acceptable Visit Windows 
 
Day 0: Operative Day 
Month 3: 
± 1 week 
 
Day 1: 
± 0 day 
Month 6: 
± 1 week 
Day 7: 
± 1 day 
Month 9: 
± 2 weeks 
4 weeks: 
± 2 days 
Month 12: 
± 2 weeks 
Month 24: 
± 2 weeks 
Patient History 
Informed consent 
Inclusion/Exclusion criteria 
Pachymetry 
Pregnancy testa 
Visual Acuity 
Slit Lamp 
Seidel Test 
Tonometry 
Motility evaluation 
Gonioscopy 
Ophthalmoscopy 
Perimetry 
Qualifying 
Assessment and 
Preop - Baseline 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
x 
Day 0 - Procedure 
Day 1 
x 
x 
x 
x 
x 
Day 7 
x 
x 
x 
x 
x 
4 Weeks 
x 
x 
x 
x 
x 
Month 3 
x 
x 
x 
x 
x 
Month 6 
x 
x 
x 
x 
x 
x 
Month 9 
x 
x 
x 
x 
x 
Month 12 
x 
x 
x 
x 
x 
x 
x 
Month 24 
x 
x 
x 
x 
x 
x 
x 

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10. 
HEALTH ECONOMICS CONSIDERATIONS 
 
The use of the InnFocus MicroShunt is associated with consequences both in terms of effectiveness and 
costs, as it is expected to limit the need for antiglaucoma medications and glaucoma surgical procedures. 
For further health economics modelling purposes, cost data will be collected throughout the study. 
 
Production costs incurred in the collective perspective will be collected. Costs are measured from the 
enrollment visit until the end of follow-up. Costs associated with the initial procedure and with follow- 
up procedures, either due to routine follow-up, to complications or to the natural history of disease, will 
be reported. Cost data will be reported on corresponding case report forms, without incidence on 
patient’s clinical follow-up. 
 
Cost data will be collected prospectively through the observation of resources used for each enrolled 
patient during the initial intervention and hospital stay. Resources used after the initial intervention will 
be assessed based on scheduled follow-up visits and potential adverse event reports. All used resources 
will then be valued in each country using hospital accounting and/or administrative databases. 
 
11. 
STATISTICAL CONSIDERATIONS 
 
11.1 
Sample size determination 
 
In order to estimate the necessary sample size of the study, and due to the absence of guideline in 
terms of Objective Performance Criteria, reported effectiveness results on similar devices from 
bibliography have been extensively studied (see Section 2.1). 
 
Even though a relatively large variability has been noticed, it appears that a credible level of 
performance at the 1-year follow-up for the primary endpoint should be at least above 50%. 
 
As a result, we conducted sample size calculation in order to demonstrate that the incidence of 
success using InnFocus Micro Shunt device was above 50%. We used the NQuery software and 
a one group Chi-Square test, in a bilateral situation, with an alpha level and a power fixed at 5% 
and 80% respectively. 
 
The table below summarized the resulting figure. 
 
Test significance level, alpha 
0,05 
1 or 2 sided test? 
2 
Null hypothesis proportion 
50% 
Alternative proportion 
65% 
Power ( % ) 
80 
N 
85 

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To take into account the subjects who can possibly drop-out the study before the 1-year follow- 
up, the final sample size has been increased to 100 subjects as a whole. 
 
 
11.2 
Analyzed data sets 
According to their purposes, the following patient populations apply to the statistical analyses: 
 
SAF population (‘Safety’ population): All subjects enrolled and who have signed the informed 
consent. 
 
ITT population (‘Intention To Treat’ population): All enrolled subjects from the Safety 
population who attended the procedure visit to receive the assigned therapy under evaluation 
(InnFocus MicroShunt). 
 
PP population (‘Per-Protocol’ population): will be defined as subjects from the ITT population 
without any major deviations. 
 
11.3 
Handling missing values 
In order to provide unbiased and informative findings, no replacement of missing values is 
planned for any parameters. In all applicable cases, reported analysis will mention the number of 
missing values for each outcome relatively to the considered analysis set (SAF, ITT or PP). 
 
11.4 
General considerations 
Statistical analyses will be done using SAS System®, Version 9.2 or further. 
All statistical analyses will be made on locked databases, after a careful review of the data in 
order to identify the protocol deviations and their potential impact on endpoints analysis (bias in 
result). 
Protocol Violations will then be classified as minor or major and major ones will define 
exclusion of the subjects from the Per Protocol Population, conducted to further analyze data. 
 
11.5 
Data Analysis Methods 
Major outcomes defined for this study will be analyzed with the following methods: 
 
Effectiveness endpoints (ITT and PP population): 
 
Primary effectiveness endpoint 
For patients with baseline IOP ≥18 to ≤ 21 mmHg, success will be measured as a patient who 
achieves an IOP reduction of 20% or greater with no reoperation for glaucoma or loss of light 
perception vision. 

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For patients with baseline IOP >21 mmHg, success will be measured as a patient with IOP<21 
mmHg and IOP reduction from baseline of 20% or greater with no reoperation for glaucoma or loss 
of light perception vision. 
The following Chi-Square test will be conducted at the 5% level. 
 
Ho : Incidence of success = 50% versus Ha: Incidence of success <> 50% 
 
Reduction in intraocular pressure relative to the pre-operative value will be assessed at each post- 
operative visit (D1, D7, W4, M3, M6, M9, M12 and M24) with a first measurement of success at 
12 months. 
 
These quantitative end-points will be presented in terms of mean, standard-deviation, median, 
extreme values, quartiles and number of missing data. Reduction in IOP will be also clarified by 
the means of the 95% confidence interval at each time point. 
 
Complete success is a patient who is not on supplemental medical therapy to obtain controlled levels 
of intraocular pressure. 
Qualified success is defined as a patient who requires supplemental medical therapy to maintain 
controlled levels of intraocular pressure. 
Exact bilateral confidence intervals for binomial distributions will be calculated at the 95% level 
for complete and qualified success. 
 
A reoperation to better the aqueous drainage like a trabeculectomy or an implantation of another 
drainage implant is considered a failure as it does not fulfill the criteria for success mentioned 
above. Needling of the bleb or post-surgical injection of an anti-fibrotic are not considered 
failures. 
These qualitative end-points will be presented in term of number and percentage of each 
modality. The number of missing data will be also given. Exact bilateral confidence interval for 
binomial distributions will be calculated at the 95% level. 
 
Secondary effectiveness criteria (ITT and PP population): 
 
The level of glaucoma supplemental medical therapy during the study follow-up will be 
presented as mean, standard-deviation, median, extreme values, quartiles and number of missing 
data of glaucoma medications per subject. 
 
Safety endpoints (SAF and ITT population): 
 
Incidence of all device and/or procedure-related Adverse Events during the study are of primary 
importance, but all occurred adverse events will be reported and summarized. Number of adverse 
events as a whole, number and percentage of patients with at least one device and/or procedure 
related adverse event will be presented. 

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Exact bilateral confidence intervals for binomial distributions will be calculated at the 95% level. 
 
12. 
MONITORING 
 
Subjects will be carefully monitored during the study for possible AEs. Any AE observed will be fully 
investigated by the Investigator and classified in line with the definitions below. All adverse events that 
occur during this study will be recorded on the adverse event case report forms. All adverse events will 
be followed until resolution or until the Investigator judges the outcome to be chronic or stable. 
 
Adverse events will be reported and classified by the investigator using the specific signs, symptoms or 
abnormal laboratory values, or medical diagnosis if no signs, symptoms or abnormal laboratory values 
can be identified. 
 
The investigator will classify the adverse events based on the definitions as follows (EN ISO 
14155:2011): 
 
12.1 Definitions 
 
Adverse Event (AE) – Any untoward medical occurrence, unintended disease or injury or any untoward 
clinical signs (including an abnormal laboratory finding) in subjects, users or other persons whether or 
not related to the investigational medical device. 
NOTE 1 
This includes events related to the investigational medical device 
NOTE 2 
This includes events related to the procedures involved 
NOTE 3 
For users or other persons this is restricted to events related to the investigational medical 
device. 
NOTE 4        Any significant and justified deterioration/worsening of preexisting conditions will also 
be registered   as Adverse Event 
 
All adverse events reported spontaneously by the subject or observed by the investigator or his staff will 
be recorded. 
 
Adverse Device Effect (ADE) – Adverse Event related to the use of a medical device. 
NOTE 1 This definition includes adverse events resulting from insufficient or  inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction of the 
investigational medical device. 
NOTE 2       This definition includes any event resulting from use error or from intentional misuse of 
the study medical device. 

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Serious adverse event (SAE) - adverse event that: 
 
a) 
led to a death, 
b) 
led to a serious deterioration in the health of the subject, that either resulted in: 
1. 
a life-threatening illness or injury, or 
2. 
a permanent impairment of a body structure or a body function, or 
3. 
in-patient or prolonged hospitalization, or 
4. 
medical or surgical intervention to prevent life threatening illness or injury or 
permanent impairment to a body structure or a body function. 
c) led to foetal distress, foetal death or a congenital abnormality or birth defect 
 
NOTE 1: 
A planned hospitalization for pre-existing condition, or a procedure required by the CIP, 
without a serious deterioration in health, is not considered to be a serious adverse event. 
NOTE 2: 
Any other important medical event that may not result in death, be life threatening, or 
require hospitalization, may be considered a serious adverse event when, based upon appropriate 
medical judgment, the event may jeopardize the subject or may require an intervention to prevent one of 
the outcomes listed above. 
 
Serious adverse device effect (SADE) - adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
Unanticipated serious adverse device effect (USADE) - serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the current version of the risk analysis 
report 
 
NOTE Anticipated: an effect which by its nature, incidence, severity or outcome has been previously 
identified in the risk analysis report. 
 
12.2 Severity of Adverse Events 
The following definitions for rating severity of adverse events will be used: 
Mild: 
Awareness of signs or symptoms, but easily tolerated; are of minor irritant type; causing 
no loss of time from normal activities; symptoms would not require medication or a 
medical evaluation; signs or symptoms are transient. 
 
Moderate: 
Interferes with the subject’s usual activity and/or requires symptomatic treatment. 
 
Severe: 
Symptom(s) causing severe discomfort and significant impact of the subject’s usual 
activity and requires treatment. 

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These definitions are for descriptive purposes only and are independent of the judgment of whether an 
event is classified as an AE or an SAE. 
 
12.3 Assessment of Relationship to Investigational Product 
Investigators are required to asses wither there is a reasonable possibility that the investigational 
product caused or contributed to an AE. InnFocus, Inc. defines four degrees of relatedness: not 
related, unlikely, Likely and Definite related to the investigational device. 
The following definitions will be used to assess the relationship of the adverse effect to use of 
the study device: 
 
 
Not 
Related: 
The effect is definitely not associated with use of the device. 
The adverse effect is due to an underlying or concurrent 
illness or effect of another device or drug. 
Unlikely: 
An adverse effect has little or no temporal relationship to 
the study device and/or a more likely alternative etiology 
exists. 
Likely: 
The temporal sequence between device use and the effect is 
such that the relationship is not unlikely or subject’s 
condition or concomitant therapy could have caused the AE. 
The temporal sequence is relevant or the effect subsides 
upon device completion/removal or the effect cannot be 
reasonably explained by the subject’s condition. 
Definite: 
The effect is definitely associated with use of of device. 
If any adverse event is considered to be either “likely” or “definite” related to the use of the 
investigational device, that event will classed as an ADE or a SADE. 
 
12.4 Anticipated Adverse Device Effects 
The following list includes possible adverse device effects which may possibly be 
associated with the study. This includes anticipated events related to the surgeon, 
procedures and the subject’s participation in the study. These may occur during the 
present study in relation to the implantation of the InnFocus MicroShunt. This list does 
not preclude the occurrence of other unforeseen effects. Definitions of the following 
items may be found in Annex A: 
 
• 5FU/MMC post-surgical injection of bleb area 
• Anesthesia-related complications 
• Anterior Chamber Puncture (fluid leak) 
• Aqueous Humor Misdirection (malignant glaucoma) 

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• Blebitis 
• Bleb Leak based on Seidel positive test 
• Choroidal Effusion/detachment intraoperatively 
• Choroidal Effusion/detachment post surgery 
• Choroidal hemorrhage intraoperatively 
• Choroidal hemorrhage post surgery 
• Chronic pain 
• Clinically significant corneal damage 
• Clinically significant iris damageConjunctival dehiscence 
• Conjunctival Dissection 
• Corneal Abrasion during surgery 
• Corneal Edema 
• Device malfunction 
• Diplopia 
• Encapsulated Bleb causing increased IOP 
• Endophthalmitis 
• Erosion of device through the conjunctiva 
• Event requiring unplanned ocular surgical re-interention 
• Failure to implant the device 
• Flat anterior chamber 
• Globe Perforation during the implantation or anesthesia 
• Hyphema (>10% of AC) 
• Hypotony (IOP<6mmHg) 
• Hypotony maculopathy 
• Implant migration 
• Inadequate pain control following surgery 
• Increased IOP requiring glaucoma medication 
• Increased IOP requiring treatment with oral or intravenous medication 
• Iris abrasion during surgery 
• Laser removal of blockage at tip of MicroShunt or at AC entrance point 
• Leakage of wound site based on Seidel test 
• Loss of light perception 
• Macular edema 
• Needle damaged corneal endothelium 
• Needling 
• Posterior capsule opacification 
• Prolonged inflammation resulting from surgery defined as requiring anti-inflammatory 
medication duration and dosage in excess of standard post-op instructions 
• Proptosis 
• Pupillary block 

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• Resuture scleral flap 
• Retinal complication (dialysis, flap tears, detachment, decompression or proliferative 
retinopathy) 
• Shallow Anterior Chamber 
• Strabismus 
• Subconjunctival bleeding at any time post-operatively 
• Suture abscess or other local infection 
• Tube obstruction partial or complete regardless of how long the obstruction is present 
• Tube in contact with cornea, iris or lens 
• Use of viscoelastic to limit aqueous flow 
• Vitreous Hemorrhage 
 
12.5 Notification of Serious Adverse Events 
All serious adverse events (SA(D)Es) should be phoned / faxed / e-mailed to MedPass 
International within 24 hours of learning of an event. The InnFocus, Inc SA(D)E Case Report 
Form should be used. 
 
 
 
 
 
It is the responsibility of each Investigator to report all Serious Adverse Events to the Ethics 
Committee, according to national regulations and Ethics Committee requirements. In some 
countries the safety reporting to the Ethics Committee falls under the Sponsor responsibility. 
In the Netherlands and as of 1 January 2010 the sponsor is required to report the SAEs through 
the web portal ToetsingOnline to the accredited METC that approved the protocol, within 15 
days after the sponsor has first knowledge of the serious adverse events. 
SA(D)Es that result in death or are life threatening should be reported expedited. The expedited 
reporting will occur not later than 7 days after the responsible investigator has first knowledge of 
the adverse event. This is for a preliminary report with another 8 days for completion of the 
report. InnFocus, Inc. will assure that all SAEs are reported to the Competent Authorities as 
needed as per the applicable national regulations. Moreover InnFocus, Inc. will also assure that 
its Authorized Representative will report to the Competent Authorities all Incidents meeting the 
vigilance criteria as per MEDDEV 2.12-1 on Medical Devices Vigilance system. 
MedPass International 
Attention:  Mr. Frederic Billaut, Project 
Manager 95 bis boulevard Pereire 
75017 Paris - France 
Phone: +33-1 42 12 83 30 
Fax: +33-1 40 53 81 11 
e-mail address: fredericbillaut@medpass.org 

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InnFocus, Inc. will submit intermediate safety reports to the Ethics Committee and Competent 
Authorities, according to national regulations. 
To be also noted that in the Netherlands and in accordance to section 10, subsection 1, of the 
WMO, the investigator will inform the subjects and the reviewing accredited METC if anything 
occurs, on the basis of which it appears that the disadvantages of participation may be 
significantly greater than was foreseen in the research proposal. The study will be suspended 
pending further review by the accredited METC, except insofar as suspension would jeopardize 
the subjects’ health. The investigator will take care that all subjects are kept informed. 
 
12.6 Handling and Recording of Adverse Events 
Appropriate treatment of the Subject will be initiated but the Trial follow-up will continue. 
Collection of Adverse Event data begins at the time the Subject is enrolled in the Trial and 
continues throughout the procedure and active surveillance period. 
All observations and clinical findings, including the nature and severity will be documented on 
the appropriate Case Reports Forms. The pre-existing medical conditions will be recorded on the 
pre-operative Case Report Form. Any new experience that was not present at baseline, or 
worsening in intensity or frequency of an event present at baseline, is considered an Adverse 
Event. Note: Unchanged, chronic conditions are NOT Adverse Events and should not be 
recorded on the Adverse Event page of the Case Report Form (CRF). 
The Sponsor will discuss with the Principal Investigator all Adverse Events and Serious Adverse 
Events and coordinate appropriate actions, in particular their notification to other investigators as 
applicable. 
Adverse Event terms should be recorded consistently, using acceptable medical terms. When 
possible, a diagnosis (i.e., disease or syndrome) rather than the component signs and symptoms 
should be recorded on the Case Report Form (e.g., record congestive heart failure rather than 
dyspnea, rales and cyanosis). However, signs and symptoms considered unrelated to encountered 
syndromes or diseases are to be recorded as individual Adverse Events on the Case Report Form 
(e.g., if congestive heart failure and severe headaches are observed at the same time, each 
experience is to be recorded as an individual Adverse Event). The AE should not be recorded as 
a procedure or clinical measurement (i.e., a laboratory measurement or vital sign) but should 
reflect the reason for the procedure or diagnosis. 
Death is considered to be an outcome of an Adverse Event. The cause of death (rather than the 
term “death”) should be recorded on the Serious Adverse Event Case Report Forms. 
Subjects should be encouraged to report AEs spontaneously or in response to general, non- 
directed questioning. At each required visit (or whenever reported) during the Trial, all AEs that 
have occurred since the previous visit must be recorded on the Adverse Event Case Report Form. 
For each AE, the Principal Investigator should obtain all the information required to complete 
the Adverse Event page on the CRF. 
 
All AEs, must be followed until resolution or until a stable clinical endpoint is reached. 
Depending on the event, follow up may require additional tests or medical procedures as 

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indicated, and/or referral to the general physician or a medical specialist. SAEs need to be 
reported till end of study within the Netherlands, as defined in the protocol. All measures required 
for AE management and the ultimate outcome for the AE must be recorded in the source 
document and reported to the appropriate contact. 
 
12.7 
Treatment failures, device deficiencies & malfunctions 
 
All device deficiencies related to the identity, quality, durability, reliability, safety or performance 
of the medical device shall be documented throughout the study and immediately reported to the 
sponsor (without any delay that cannot be justified and within 24 hours of occurrence). 
Investigators must report all possible device deficiencies, malfunctions or near incidents 
associated with the device, observed during the course of the trial. This includes unexpected 
outcomes or device deficiencies that might have led to a serious adverse event if a) suitable action 
had not been taken or b) intervention had not been made or c) if circumstances had been less 
fortunate. 
 
Definitions 
 
Device deficiency - inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance, such as malfunction, use error and inadequate labeling (ISO 
14155:2011). 
 
NOTE: Device deficiencies include malfunction, misuse or use error and inadequate labeling. 
 
Malfunction - failure of an investigational medical device to perform in accordance with its 
intended purpose when used in accordance with the instructions for use or CIP (ISO 14155:2011). 
 
Use Error – act or omission of an act that results in a different medical device response than 
intended by the manufacturer or expected by the user (ISO 14971) 
NOTE 1: Use error includes slips, lapses and mistakes 
NOTE 2: An unexpected physiological response of the patient does not itself constitute a use error 
 
All treatment failures and device malfunctions of the FSU device are required to be documented 
on the Procedure/ Device Observation Case Report Form. In the event of a suspected malfunction 
or device problem, or if the device is removed, the device shall be returned to the Sponsor for 
analysis. 
 
 
13. 
DATA QUALITY ASSURANCE 

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13.1 Monitoring Procedures 
Under the supervision of InnFocus, Inc., monitors will conduct clinical site monitoring to ensure 
that the investigator is in compliance with the regulatory requirements of the Standard EN ISO 
14155:2011, and with recommendations guiding physicians in biomedical research involving 
human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later 
revisions, with the protocol and with the Investigator’s Agreement. The site will be monitored to 
ensure completed electronic Case Report Forms match the hospital’s patient records and to 
resolve any differences which may be found. The monitors and InnFocus, Inc. will evaluate 
circumstances where the investigator deviates from the clinical protocol and corrective actions 
will be taken. 
InnFocus, Inc. has appointed MedPass International as Clinical Monitor for this study. MedPass 
personnel are qualified by training and experience to oversee the conduct of the study. MedPass 
will fulfill the responsibilities identified in its standard operating procedures, available for review 
at MedPass. These responsibilities include collecting and tracking data forms and trial 
compliance. 
The Monitor’s responsibilities include: maintaining regular contact with the investigational site, 
through telephone contact and on-site visits, to ensure that the investigational plan is followed; 
that complete, timely and accurate data are submitted; that problems with inconsistent and 
incomplete data are addressed; and that the site facilities continue to be adequate. Any questions 
regarding these matters should be addressed to MedPass International. 
InnFocus, Inc. and MedPass will review significant new information, including unanticipated 
adverse events, and ensure that such information is provided to the investigator, and to the 
Regulatory Authorities and Ethics Committee, as appropriate. 
As defined in the ISO 14155:2011 §3.32, an informed consent form must be signed by each 
patient to consider him as enrolled in the study and before any study related examination and 
implant of the study device. 
Informed consent will be obtained according to individual institution guidelines. These 
documents will be audited by the monitor to ensure they have been signed prior to the implant 
procedure and that the correct version was used. The Sponsor will provide centers with a sample 
informed consent document that the center may modify to meet individual institutional review 
board requirements. 
The electronic case report forms (eCRF) must be completed for all patients enrolled into the 
study. This eCRF will be a complete and accurate record of patient’s data collected during the 
study according to EN ISO 14155:2011 standard and GCP recommendations. It is the 
responsibility of the investigator to ensure the quality of the data collected and recorded. The 
eCRF will be reviewed for errors, omissions, internal consistency, and to ensure that the 
investigator has electronically signed and validated the data registered. 

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Data collection will include photographs and clinical data based on the clinical  endpoints 
outlined above. Data will be collected by study investigators and reported on the eCRF provided 
by the Sponsor. 
 
 
13.2 Selection of Investigator 
Investigators are selected based on their education and experience in the treatment of glaucoma. 
Investigators are required to sign an investigators agreement that assures that they will meet the 
protocol and all applicable regulatory requirements. 
 
13.3 Training 
The investigator will be trained in the use of the device under consideration and made familiar 
with the background and requirements of the clinical investigation methodology. 
 
 
The training of appropriate clinical site personnel will be the responsibility of the Sponsor. To 
ensure uniform data collection and protocol compliance, the Sponsor will make a formal 
presentation to study site personnel which will include a presentation of the device and the study, a 
review of the Study Plan, techniques for the identification of eligible patients, instructions for in- 
hospital data collection, methods for soliciting data from alternative sources, schedules for follow- 
up with the study site coordinators, and regulatory requirements including vigilance but also if 
applicable Safety reporting. A special review will be performed by the sponsor to each physician 
who will treat patients concerning the instructions for use. 
Devices will be provided to the participating site only once this site will have been trained, 
contracts have been signed and necessary IRB approvals to start the trail have been received. 
 
13.4 Patient Data Protection 
All information and data concerning patients or their participation in this trial will be considered 
confidential. Only authorized personnel might have access to these confidential files. All data used 
in the analysis and reporting of this evaluation will be without identifiable reference to the 
patients. 
Data will be collected at the outpatient department by a member of the study team (investigator or 
study coordinator/research assistant) All recorded data will be collected from medical file after the 
patients have given their consent. 
Direct access to the subject’s original medical records will be ganted for trial-related monitoring 
(monitors), audit (auditors), IRB/IEC review, and regulatory inspection (inspectors). Subjects will consent 
in writing for such access. 
As it is necessary to be able to trace data to an individual subject, a subject identification code list 
can be used to link the data to the subject. The code should not be based on the patient initials and 
birth-date. The principal investigator will keep filed in the regulatory binder the patient ID log 

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containing that information. This binder will be archived for 15 years after the study end following 
the local and national requirements. 
 
13.5 Sponsor Records 
InnFocus, Inc. and the CRO will maintain copies of correspondence, data, adverse device effects 
and other records related to the clinical trial. InnFocus, Inc. will maintain records related to the 
signed Investigator Agreements. 
 
13.6 Sponsor Reports 
 
InnFocus, Inc. will submit reports of findings in this study to the relevant ethics committee. 
Unanticipated adverse device effects will also be reported. 
 
13.7 Site Record Retention Policy 
The clinical sites will maintain study records in accordance with the record retention requirements 
for their respective country. A patient’s identity will not be disclosed to any third party without the 
patient’s prior, written consent. Record retention dates will be provided to all concerned by 
InnFocus, Inc. at the end of the study. 
 
 
14. 
ETHICAL AND REGULATORY CONSIDERATIONS 
The study will be performed in accordance with the standard EN ISO 14155:2011 on clinical 
investigation of medical devices for human subjects – good clinical practice, the MEDDEV 2.12-1 
(Medical devices vigilance system), the MEDDEV 2.12/2 (Post market clinical follow-up studies), and 
recommendations guiding physicians in biomedical research involving human subjects adopted by the 
18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions. 
The study plan and informed consent will be reviewed and approved before enrollment of patients by 
the appropriate ethics committee where the study will be conducted. 
 
14.1 Role of InnFocus, Inc. 
As the study Sponsor of this clinical study, InnFocus, Inc. has the overall responsibility for the 
conduct of the study, including assurance that the study meets the regulatory requirements of EN 
ISO 14155:2011 on clinical investigation of medical devices for human subjects – good clinical 
practice. InnFocus, Inc. or its representative will ensure adherence to EN ISO 14155:2011 
standard and the Sponsor general duties, selection of investigators, monitoring, supplemental 
applications, maintaining records, safety evaluation and submitting reports. 

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14.2 General Duties 
InnFocus, Inc.’s general duties consist of obtaining ethics committee approvals, and competent 
authority approvals where applicable, prior to providing the devices, selecting investigators, 
ensuring proper clinical site monitoring and ensuring subject informed consent is obtained. 
 
14.3 Investigator Responsibilities 
The clinical investigator will ensure that the study is conducted in compliance with the regulatory 
requirements of EN ISO 14155 and recommendations guiding physicians in biomedical research 
involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 
and later revisions and with the protocol and the Investigator’s Agreement. 
The clinical investigator shall be responsible for the day-to-day conduct of the investigation as 
well as for the safety and well-being of the human subjects involved in the clinical investigation. 
The clinical investigator shall have the resources to conduct the study properly and obtain from the 
Sponsor the information which she judges essential about the device and be familiar with this 
information. 
The clinical investigator shall ensure that adequate information is given to the subject both in oral 
and written form, on the nature of the study. This information shall be easily understandable by 
the subject. This information shall include the aims, expected benefits for him and/or others, risks 
and inconveniences and an explanation of any alternative methods, and of possible consequences 
of any withdrawal from the study. Subjects shall be allowed sufficient time to decide whether or 
not they wish to participate. The subjects shall be informed that his participation in the clinical 
investigation is confidential. He shall be made aware that the data relating to the study may be 
made available to third parties while maintaining anonymity. 
The investigator must obtain a written institutional review board approval prior to including any 
patient in this study. 
14.4 Patient Information and Consent 
Whereas the screening will be performed by the treating investigator, a different investigator will 
ensure the consenting process. 
All patients will receive full and adequate verbal and written information and will have at least one 
week to consider their decision to participate and to sign the informed consent form prior to their 
inclusion in the study. A copy of the approved informed consent form along with a copy of each 
patient’s signed consent form will be maintained by the investigator in a designated clinical study 
administrative file. A copy of the signed consent form must be given to each patient. 
 
14.5 Accountability 
It is the responsibility of the Investigator to ensure that all devices received at the site be 
inventoried and accounted for throughout the study and recorded in the inventory log kept in the 
site study documents.  Implant accountability will be verified by the Sponsor’s study monitor 

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during on-site monitoring visits. Access to InnFocus MicroShunt devices shall be controlled and 
the devices shall be used only in the market surveillance study and according to the protocol. 
A Device Accountability Log will be maintained by each clinical investigator or his designee. 
Each device received will be recorded in the log, together with its ultimate disposition. 
A Device Tracking Form must be completed for each implanted device.  The device label should 
be affixed to the form and filed in the subject’s study record. 
The Investigator will not supply study devices to any person except designated staff in this study. 
Study implants will only be dispensed form the designated investigational site. 
Investigator will not supply study implants to any person except designated staff in this study. 
Study implants will only be dispensed from the designated investigational site. 
The Investigator will store and dispose of FSU devices and their remnants per the Sponsor’s 
instructions.  Disposal of unused devices will be recorded in the source documents and in the 
inventory log. 
 
14.6 Ethics Committee and Competent Authority Approval 
Before commencement of the study, each Investigator, if responsible as per national regulation, 
must provide InnFocus, Inc. with written documentation of Ethics Committee approval of both the 
protocol and the informed consent form, which must comply with all requirements outlined by 
InnFocus, Inc.  In some cases, depending on the country regulation, obtaining the Ethics 
Committee approval is the responsibility of the sponsor. In any cases, this approval must refer to 
the informed consent form and the study by title and the protocol number as given by InnFocus, 
Inc.  For any Investigator, if a member of the committee, is not to participate in the decision.  This 
non-participation must be noted in the approval letter. 
No device supplies will be shipped to an Investigator until Ethics Committee approval has been 
given in writing and each Investigator has supplied InnFocus, Inc. with copies of the Ethics 
Committee approval document and the informed consent form to be used. 
If applicable by national regulations, InnFocus, Inc. will be responsible of obtaining the competent 
authority approvals and to provide it to the site before commencement of the study. 
 
14.7 Supplemental Applications – Amendments 
As appropriate, InnFocus, Inc. will submit changes in the Market Surveillance Study to the 
investigator or its designee to obtain re-approval by the ethics committee. 
 
14.8 Annual progress report 
It is expected that following national/local requirements InnFocus will have to submit a summary 
of the progress of the trial to the EC/CA once a year. Information will be provided on the date of 
inclusion of the first subject. Information regarding numbers of subjects included and numbers of 

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subjects that have completed the trial, serious adverse events, other problems, and amendments 
might be registered in this report. 
 
14.9 Study Termination 
The sponsor may suspend or prematurely terminate either the study in an individual investigation 
site or the entire study. 
A principal investigator, EC, or regulatory authority may suspend or prematurely terminate 
participation in the study at the investigation sites for which they are responsible. 
If suspicion of an unacceptable risk to subjects arises during the study, or when so instructed by 
the EC or regulatory authorities, the sponsor shall suspend the study while the risk is assessed. The 
sponsor shall terminate the study if an unacceptable risk is confirmed. 
The sponsor shall consider terminating or suspending the participation of a particular investigation 
site or investigator in the study if monitoring or auditing identifies serious or repeated deviations 
on the part of an investigator. 
If suspension or premature termination occurs, the terminating party shall justify its decision in 
writing and promptly inform the other parties with whom they are in direct communication. The 
principal investigator and sponsor shall keep each other informed of any communication received 
from either the EC or the regulatory authority. 
If suspension or premature termination occurs, 
a) the sponsor shall remain responsible for providing resources to fulfill the obligations from the 
CIP and existing agreements for following up the subjects enrolled in the study, and 
b) the principal investigator or authorized designee shall promptly inform the enrolled subjects at 
his/her investigation site, if appropriate. 
In case of premature termination, the sponsor will notify the EC and CA within 15 days, including 
the reasons for the premature termination (see also safety section 12.5 for the Netherlands). 
 
 
For the expected study termination in following the national/local requirements the sponsor, 
InnFocus, will notify the accredited EC and the competent authority of the end of the study within 
the defined period of time. The end of the study is reached when the last patient included has 
performed his last follow up visit as defined in the protocol. 
Within one year after the end of the study, the investigator/sponsor will submit a final study report 
with the results of the study, including any publications/abstracts of the study, to the ECand the 
Competent Authority. 

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14.10 Withdrawal 
Subjects can leave the study at any time for any reason if they wish to do so without any 
consequences. The subject is not obliged to provide the reason for withdrawal to the investigator. 
The investigator can decide to withdraw a subject from the study for urgent medical reasons. 
Subjects may also be considered as withdrawn if needed attempts have been made to contact them 
but without success. In that case the patient will be registered as lost to follow up. When a subject 
leaves the study or is withdrawn for urgent medical reasons, this is recorded in the patient’s paper 
medical file and in the Case Report Form. 
 
When relevant, and according to the country requirements, the Ethics Committee and/or the 
Competent Authority should be informed. 
 
14.11 Protocol Deviations 
Any deviation from the protocol shall be recorded together with an explanation for the deviation. 
Deviations shall be reported to the Sponsor who is responsible for analyzing them and assessing 
their significance. 
 
14.12 Insurance 
The sponsor has taken specific insurances for conducting the clinic study in accordance with the 
national legislation where the study takes place. 
In the Netherlands, the sponsor has a liability insurance which is in accordance with article 7, 
subsection  9 of the WMO.  The sponsor also has an insurance which is in accordance with the 
legal requirements in the Netherlands (Article 7 WMO and the Measure regarding Compulsory 
Insurance for Clinical Research in Humans of 23th June 2003). This insurance provides cover for 
damage to research subjects through injury or death caused by the study. 
1. € 450.000,-- (i.e. four hundred and fifty thousand Euro) for death or injury for each subject 
who participates in the Research; 
2. € 3.500.000,-- (i.e. three million five hundred thousand Euro) for death or injury for all 
subjects who participate in the Research; 
3. € 5.000.000,-- (i.e. five million Euro) for the total damage incurred by the organisation for all 
damage disclosed by scientific research for the Sponsor as ‘verrichter’ in the meaning of said 
Act in each year of insurance coverage. 
The insurance applies to the damage that becomes apparent during the study or within 4 years after 
the end of the study. 
 
14.13 Patient Compensation 
Patients will not receive any compensation for their participation to this study. However, they 
may be reimbursed for travel expenses following local requirements. 

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15. 
STUDY DURATION 
The overall duration of the study will be approximately 36 months. It is estimated that the 
inclusion period will be up to 12 months. 
Each patient will then be followed-up for 24 months following implantation of the device. 
 
16. 
PUBLICATION POLICY 
 
Institution and Investigator may freely publish and disseminate the results of their investigative 
findings hereunder and shall solely determine the authorship and contents (including scientific 
conclusions and professional judgments) of any such paper. Institution or Investigator, as the case 
may be, shall provide Sponsor with a copy of the papers prepared for publication by it, him/her or 
any sub-investigators at the earliest practicable time, but in any event not less than thirty (30) days 
prior to their submission to a scientific journal or presentation at scientific meetings and a 
reasonably detailed summary or abstract of any other oral or written publication not less than thirty 
(30) days prior to their submission or presentation. Sponsor may comment upon, but may not make 
any editorial changes to, the results and conclusions set forth in the papers; however, if identified 
by Sponsor, any Sponsor Confidential Information that may be contained therein shall be deleted. 
Sponsor personnel shall be acknowledged in accordance with customary scientific practice. 
Sponsor may freely use, copy and disseminate any such manuscript following its publication 
without further obligation to Institution or Investigator. 
 
 
Because the Study is part of a multi-center study, the Institution and Investigator agree that they 
will not publish until after the data from the multi-center study is published in a combined paper 
that identifies all the sites that participated in the study. In the event that the multi-center 
publication has not been completed within one (1) year from the date of the completion or 
termination of the multi-center study, Institution may publish or present its individual results, 
provided that the paper, oral disclosure or other written presentation is first reviewed by Sponsor in 
accordance with above 

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17. 
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You YA, Gu YS, Fang CT, Ma XQ. Long-term effects of simultaneous and subscleral 
mitomycin C application in repeat trabeculectomy. J Glaucoma 2002;11:110-118. 
 
45. 
Mangione CM, Lee PP, Gutierrez PR, et al. Development of the 25-item National Eye 
Institute visual function questionnaire. Arch Ophthalmol 2001;119:1050-1058. 
 
46. 
Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK, Heuer DK, Brandt JD The Tube Versus 
Trabeculectomy Study: Design and Baseline Characteristics of Study Patients. Am J 
Opthalmol 2005; 140: 275- 287. 
 
47. 
Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK, Heuer DK, Brandt JD and The Tube 
Versus Trabeculectomy Study Group. Surgical Complications in the Tube Versus 
Trabeculectomy Study During the First Year of Follow-up. Am J Ophthalmol 
2007;143:23-30. 
 
48. 
Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK, Heuer DK, Brandt JD and The Tube 
Versus Trabeculectomy Study Group. Treatment Outcomes in the Tube Versus 
Trabeculectomy Study After One Year of Follow-up. Am J Ophthalmol 2007;143:9-22. 
 
49. 
Gedde SJ, Schiffman JC, Feuer WJ, Parrish RK, Heuer DK, Brandt JD and The Tube 
Versus Trabeculectomy Study Group. Three-Year Follow-up of the Tube Versus 
Trabeculectomy Study. Am J Ophthalmol 2009;148:670-684. 
 
50. 
Maris Jr, P, Ishida K, and Netland PA. Comparison of Trabeculectomy With Ex-PRESS 
Miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma 2007;16:14-19. 
 
51. 
de Jong Leo. The Ex-PRESS Glaucoma Shunt versus Trabeculectomy in Open-Angle 
Glaucoma: a Prospective Randomized Study. Adv Ther 2009;26(3):336-345. 

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18. 
ANNEX A:  List of definitions: Potential glaucoma implant surgery-related 
complications 
• Anesthesia-related Complications 
Anesthesia related complications can occur during any surgery in which anesthesia is 
involved.  In local peribulbar or retrobulbar anesthesia, the main concerns are related to 
perforation, injury of optic nerve, and bleeding in the orbit. No patients will receive general 
anesthesia. 
 
• Anterior Capsule Puncture 
During surgery, it could be possible to puncture the anterior capsule, and this would allow 
aqueous to leak out and lead to decreased IOP (hypotony). 
 
• Anterior Chamber Entry 
If there is leak of fluid at the entry site, this would allow aqueous to leak out and lead to 
decreased IOP (hypotony) 
 
• Aqueous Humor Misdirection 
Obstruction to the flow of aqueous at the ciliary body and equator of the lens causes aqueous 
to enter the vitreal space, resulting in forward pressure on the lens and ciliary body. 
 
• Bleb-Related Complications 
o Blebitis - infection of bleb 
o Bleb leak - leak of aqueous through hole in bleb 
o Cystic bleb – surrounded by fibrotic tissue that prevents or limits drainage, bleb may 
become thick-walled or thin-walled 
o Over-filtering bleb – may cause chronic hypotony 
o Corneal dissecting bleb – extending forward within corneal epithelium 
 
• Cataract 
An opacity or haziness of the lens of the eye. A cataract is noticed particularly at night when 
oncoming headlights produce glare disability or/and discomfort. It may or may not reduce the 
vision depending on size, density and location. If a cataract reduces visual acuity 
significantly, an Ophthalmologist can replace the defective lens with an artificial lens 
. 
• Choroidal Effusion 
Fluid effusion into the suprachoroidal space has occurred, separating the choroid and all 
anterior structures from the underlying sclera. Choroidal effusion is the result of a rapid 
change in the pressure gradient between the venous pressure and the intraocular pressure. 
Lobular, elevated areas filled with fluid are seen. Detachment and anterior rotation of the 
ciliary body results in a flattened anterior chamber.  Surgical drainage is indicated only in 
cases involving "kissing choroidals" or lens-cornea adhesion.  Pressure patching to elevate 

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IOP can be considered.  The condition will resolve on its own as IOP stabilizes. Cycloplegics 
and steroids can be used to restore normal vascular permeability and, thus, speed up the 
process of resolving the condition. 
 
• Conjunctival Dissection 
When making the conjunctival pouch, there is always a risk of dissecting the conjunctiva 
 
• Corneal Abrasion 
Cornea could be scratched or irritated during surgery.  This usually results in pain 
 
• Corneal Decompensation 
Cornea can break down if not protected properly 
 
• Corneal Drying 
Proper lubrication of the cornea must be maintained 
 
• Corneal Edema 
Excess fluid in the cornea 
 
• Decreased Vision (vision loss) 
A change in the patient’s visual acuity, either near or far, as evidenced by their ability to read 
on a Monoyer chart 
 
• Endophthalmitis (infection) 
An inflammation involving the internal parts of the eye – i.e., choroid, retina, ciliary body 
and iris. A very serious condition sometimes seen after an injury to the eye by a foreign 
object. Vision is severely threatened. Large doses of cortisone and antibiotics are often 
needed. May lead to the removal of the eye. Must be treated by an eye doctor ASAP 
 
• Epiretinal Membrane Proliferation 
Fibrocellular membranes that proliferate on the surface of the retina; leads to visual 
distortion, edema and degeneration of underlying retina 
 
• Extrusion 
The tube erodes through the conjunctiva or similar eye membrane 
 
• Flat anterior chamber 
Anterior chamber closes due to extreme decrease in IOP (hypotony) 
 
• Globe Perforation 
The needle could potential pierce the eyeball during surgery 

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• Hemorrhage/Bleeding 
Blood in the eye, usually from veins or capillaries with compromised endothelium 
 
• Hyphema 
Blood in the aqueous fluid - front part of the eye, often caused by an injury. Patient should 
seek immediate medical attention since a hyphema may lead to glaucoma and permanent loss 
of vision. 
 
• Hypotony 
Decreased Intraocular Pressure 
 
• Inadequate Pain Control 
A potential risk after any surgery 
 
• Inappropriate Closure (Risk of Exposure) 
Conjunctiva is not closed properly and implant may extrude out 
 
• Increased IOP 
Glaucoma usually causes IOP to increase, leading to vision loss 
 
• Injury of cornea or iris with needle 
A potential risk during any eye surgery, where needles are used 
 
• Large track (due to wrong needle gauge or movement of needle or patient) 
Allows for potential risk of leaks 
 
• Lens Touch 
During the surgery, the lens may be touched, which could lead to vision loss or other 
problems 
 
• Lid Speculum 
If lid speculum is left in eye too long during surgery, could lead to temporary paralysis of lid 
muscle (ptosis) 
 
• Loss of light perception 
Patient’s vision may deteriorate to the point where they cannot sense light 
 
• Macular Edema 
Fluid accumulates in the macular region from a variety of causes; can lead to vision problems 

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• Malfunction of release 
Tube may not release properly into the eye 
 
• Malignant Glaucoma 
Pressure in the posterior chamber is increased, which causes a reverse in the direction of 
normal aqueous flow; this can lead to blindness 
 
• Mechanical irritation or inflammation 
With any eye surgery, there is always a risk of irritation or inflammation 
 
• Migration of tube 
Tube moves from intended location; may not function as intended. 
 
• Motility disorder 
Any of the intraocular muscles or nerves innervating the intraocular muscles are damaged; 
this can lead to double vision (diplopia) 
 
• No use of anti-inflammatories, antibiotics or patching when needed 
Could lead to inflammation, infection or extrusion of implant 
 
• Obstruction of the tube 
Tube may become obstructed by blood, debris or fibrin;  this can occur during the procedure 
and would compromise the function of the tube 
 
• Lack of Sterility 
Must maintain effective sterility techniques during surgery to prevent infection 
 
• Proptosis 
Proptosis, or exophthalmos, is a forwardly displaced or "bulging" eye. The condition is a sign 
of an underlying disorder, and not a diagnosis itself. The most common cause of proptosis in 
adults is Grave’s Disease, also known as thyroid related orbitopathy. Other common causes 
include orbital inflammatory pseudotumor, trauma with hemorrhage behind the eye 
(retrobulbar hemorrhage), and orbital tumors. 
 
• Retinal Detachment 
A retinal detachment occurs when the retina, that part of the eye that contains the 
photoreceptors, detaches from the underlying layers of cells, called the choroid. A retinal 
detachment may be the result of injury to the eye such as blunt trauma or it may result from 
other things like high myopia or age-related macular degeneration. In certain diseases, retinal 
breaks and tears occur and these may lead to a retinal detachment. Early warning signs 

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include bright dots or lights or some of your side vision may appear dark. A retinal 
detachment may be treatable if detected early, so see an Ophthalmologist. 
 
• Shallow Anterior Chamber 
Chamber becomes thin, but not completely collapsed or flat (between 0 and 5) 
 
• Suprachoroidal Hemorrhage 
Bleeding in the suprachoroidal space 
 
• Tube in contact with iris, cornea, or lens 
Could cause inflammation or irritation that could lead to pain or visual problems 
 
• Visual Field Loss 
Reduction in the size of the visual field upon follow-up 
 
• Vitreous Hemorrhage 
Blood collects inside the vitreous chamber.  The most common cause is neovascularization. 
 
• Wound Leak 
Leakage from the implant site