A Prospective Single Center Clinical Study for Femtosecond Laser Glaucoma Surgery Using the ViaLase Laser
Phase: NA
Conditions: Glaucoma, Glaucoma, Open-Angle
Sponsor: Vialase, Inc.

 
 
 
COVER PAGE 
 
Oﬃcial Title:  A ProspecƟve Single Center Clinical Study for 
Femtosecond Laser Glaucoma Surgery Using the ViaLase Laser 
 
 
NCT Number:  NCT04949802 
 
 
Document Date:  08/21/2020 

 
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A Prospective Single Center Clinical Study for  
Femtosecond Laser Glaucoma Surgery Using the ViaLase Laser 
 
Study Number  VIA-001 
Sponsor  ViaLase Inc. 
26800 Aliso Viejo Pkwy, Suite 225 
Aliso Viejo, CA  92656 
Clinical Investigator 
 Zoltan Nagy, M.D. 
 
 
 
 
 
Medical Monitor 
 John Berdahl, M.D. 
 
 
 
 
 
Ethics Committee  Semmelweis University 
39 Maria St. 
Budapest, Hungary-1085 
Phone: 011-36-20-815-8468 
 
 
 
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Investigator’s Agreement 
 
 
I have read and agree to follow the study procedures as outlined in this protocol. 
 
 
_________________________________ 
  Print Name of Investigator 
 
 
_________________________________ 
__________________ 
  Investigator’s Signature 
  Date 
 
This protocol contains confidential proprietary information with respect to the ViaLase laser and clinical 
trials of this product.  I agree to hold this information in confidence and not to disclose it to any third 
parties for a period of three (3) years from the date of this agreement, or until said information shall 
become a matter of public knowledge or until a formal written agreement for that purpose has been 
entered into by the parties. 
 
 
_________________________________ 
__________________ 
  Investigator’s Signature 
  Date 
 
 
 
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Table of Contents 
Investigator’s Agreement.............................................................................................................................. ii 
Table of Contents ......................................................................................................................................... iii 
1.
PRELIMINARY OVERVIEW .......................................................................................................... 1 
1.1 
 Study Synopsis .......................................................................................................................... 1 
1.2 
 Study Rationale ......................................................................................................................... 3 
1.3 
 Study Objective ......................................................................................................................... 5 
1.4 
 Study Design ............................................................................................................................. 5 
1.5 
 Safety Outcomes ....................................................................................................................... 5 
1.6 
 Effectiveness Endpoints .............................................................................................................6
1.7 
 Study Population ....................................................................................................................... 6 
2.
 STUDY MATERIALS AND METHODS ........................................................................................ 10 
2.1 
 Device Description .................................................................................................................. 10 
2.2 
 Procedure Summary ............................................................................................................... 12 
3.
 STUDY PROTOCOL ................................................................................................................... 13 
3.1 
 Subject Entry ........................................................................................................................... 13 
3.2 
 Surgical Procedure .................................................................................................................. 14 
3.3 
 Postoperative Instructions: ..................................................................................................... 15 
3.4 
 Examination Schedule:............................................................................................................ 15 
3.5 
 Schedule of Visits and Clinical Assessments ........................................................................... 16 
3.6 
 Subject Accounting Procedure ................................................................................................ 16 
3.7 
 Adverse Events ........................................................................................................................ 17 
3.8 
 Source Documentation and Data Reporting ........................................................................... 21 
3.9 
 Statistical Methods ................................................................................................................. 21 
3.10 
Study Monitoring ..................................................................................................................... 21 
4.
 BIBLIOGRAPHY ........................................................................................................................ 22 
APPENDIX A – SCHEDULE OF VISITS AND CLINICAL ASSESSMENTS ............................................................ 24 
APPENDIX B – METHODS OF CLINICAL EVALUATION.................................................................................. 26 
B.1
 Corrected Visual Acuity ........................................................................................................... 26 
B.2
 Manifest Refraction and Best Spectacle Corrected Visual Acuity (ETDRS) ............................. 26 
B.3
 Pinhole Visual Acuity (Snellen) ............................................................................................... 26 
B.4
 Slit Lamp Exam ........................................................................................................................ 26 
B.5
 Applanation Tonometry .......................................................................................................... 29 
B.6
 Gonioscopy ............................................................................................................................. 29 
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B.7 
 Visual Field Examination ......................................................................................................... 29 
B.8 
 Pachymetry ............................................................................................................................. 30 
B.9 
 Endothelial Cell Count............................................................................................................. 30 
APPENDIX C – INFORMED CONSENT DOCUMENT ...................................................................................... 31 
APPENDIX D – SPONSOR’S COMMITMENTS ............................................................................................... 36 
APPENDIX E – INVESTIGATOR’S QUALIFICATIONS AND RESPONSIBILITIES ................................................ 37 
E.1 
 Subject Selection ..................................................................................................................... 37 
E.2 
 Informed Consent ................................................................................................................... 37 
E.3 
 Institutional Review Board (IRB) Approval ............................................................................. 37 
E.4 
 Subject Evaluations and Data Reporting................................................................................. 37 
E.5 
 Record Retention .................................................................................................................... 37 
APPENDIX F – DECLARATION OF HELSINKI ................................................................................................. 38 
F.1 
 PREAMBLE ............................................................................................................................... 38 
F.2 
 GENERAL PRINCIPLES .............................................................................................................. 38 
F.3 
 RISKS, BURDENS AND BENEFITS ............................................................................................. 39 
F.4 
 Vulnerable Groups and Individuals ......................................................................................... 40 
F.5 
 Scientific Requirements and Research Protocols ................................................................... 40 
F.6 
 Research Ethics Committees................................................................................................... 40 
F.7 
 Privacy and Confidentiality ..................................................................................................... 41 
F.8 
 Informed Consent ................................................................................................................... 41 
F.9 
 Use of Placebo ........................................................................................................................ 42 
F.10 
Post-Trial Provisions ................................................................................................................ 42 
F.11 
Research Registration and Publication and Dissemination of Results .................................... 42 
F.12 
Unproven Interventions in Clinical Practice ............................................................................ 43 
 
 
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is not a necessary indication for glaucomatous damage (3).  It is generally bilateral, but often 
asymmetric.  POAG is believed to be caused by an increased resistance to the normal outflow of 
aqueous humor from the eye. The major source of outflow obstruction that raises intraocular pressure 
(IOP) is thought to be the juxtacanalicular trabecular meshwork (TM), and an increase in the 
accumulation of extracellular material in both the TM and ciliary muscle, which further contribute to the 
reduction of normal outflow, resulting in increased IOP (4; 5; 6).  Elevated IOP eventually leads to an 
acquired optic neuropathy in which the neuro retinal rim is thinned due to loss of retinal ganglion cells. 
When loss of optic nerve tissue is significant, patients develop optic nerve related visual field loss. 
Management of glaucoma requires chronic, life-long treatment with a spectrum of therapeutic options 
including medications (7), laser treatment (8; 9; 10; 11), ab-interno trabeculectomy (12), and surgically 
implanted internal or external drainage devices (12; 13; 14; 15; 16). The common goal among the 
various therapies is to lower intraocular pressure (IOP) to target levels to prevent loss of visual fields 
from excessive pressure on the optic nerve.  In order to relieve elevated IOP, it is proposed to increase 
the outflow through the juxtacanalicular trabecular meshwork by surgically creating canals that span 
from the anterior chamber, through the juxtacanalicular trabecular meshwork, and reaching the inner 
wall of Schlemm’s canal.  Such a canal can clear the outflow obstruction and provide a fluid pathway for 
aqueous humor. 
One such therapy is the minimally invasive glaucoma surgery (MIGS) in which a trans-trabecular shunt is 
implanted.  The interest in MIGS stems from a desire for an alternative surgical option for the treatment 
of glaucoma that is associated with less risk and fewer complications than established procedures. 
Furthermore, MIGS may help reduce the burdens of patients’ compliance with medication schedules 
and side effects associated with medical therapy (17). Suboptimal compliance to medical therapy to 
manage glaucoma is common and has been linked to poor outcomes and increased health care costs. 
Femtosecond lasers for ophthalmic surgery have been commercially available since 1999 (18; 19; 20).  
The ViaLase Laser is a femtosecond laser that is similar to other femtosecond surgical lasers, specifically, 
it is an infrared femtosecond laser that creates incisions in tissue using an imaging system with a live-
video camera that monitors the surgical area (20; 21).  The mechanism of operation and the safety 
profile of the ViaLase Laser is the same as other marketed femtosecond laser devices used in LASIK and 
cataract surgery.  Unlike previous devices, the ViaLase Laser incorporates a specialized optical delivery 
system that directs the surgical laser and imaging light through the peripheral cornea, into the 
iridocorneal angle, and onto the surgical area over the trabecular meshwork (Figure 1).  
The ViaLase Laser is intended to create trabecular canals or apertures to increase the flow of aqueous 
humor through the trabecular meshwork, juxtacanalicular tissue, and inner wall of Schlemm’s canal for 
the treatment of open angle glaucoma. 
 
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Figure 1 – Illustration showing the general optical path  
of the surgical beam to the iridocorneal angle. 
1.3  
Study Objective 
To obtain initial evidence of safety of image guided, femtosecond laser glaucoma surgery using the ViaLase 
Laser for the treatment of primary open angle glaucoma.  The ViaLase Laser is intended to create apertures 
through the trabecular meshwork for drainage of aqueous humor in the treatment of open angle glaucoma. 
1.4  
Study Design 
This is a prospective, single-center, and single arm clinical trial of ViaLase Laser for the treatment of 
open angle glaucoma.  Subjects will be screened for qualification as per the inclusion/exclusion criteria 
and must meet the inclusion/exclusion criteria in at least one eye to be enrolled.  Up to 20 subjects will 
be consented as per the informed consent process.  Subjects will be treated with the ViaLase Laser in 
one eye and followed for 12 months.   
Eligible subjects will be examined preoperatively to obtain ocular and medical history and to establish a 
baseline ocular condition.  Baseline and postoperative measurements will include distance visual acuity 
(best corrected), manifest refraction, intraocular pressure (IOP at baseline, 6 months and 12 months 
required), slit-lamp examination, gonioscopy, visual field, dilated fundus examination, specular 
microscopy (at baseline, 6 months and 12 months), and pachymetry.  
Subjects who are on IOP lowering medications will be allowed to continue prior to laser treatment and 
up to one-month post-treatment.  It is the investigator’s discretion whether to add, continue or stop the 
medications after one month.   
1.5  
Safety Outcomes 
Safety outcomes are assessed immediately after laser surgery and over 12 months after surgery.   
1.5.1 
Immediate Safety Outcomes 
Immediate safety outcomes will be assessed during the Operative day (day-0), 1-day and 1-week visits:   
• 
Percentage patients with elevated IOP equal or greater than 6 mmHg at 1-hour post-treatment 
• 
Percentage of patients with iritis, anterior chamber flare and cells  
• 
Percentage of patients with hyphema 
• 
Percentage of patients with corneal haze 
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• 
Percentage of patients with hypotony 
1.5.2 
Long-Term Safety Outcomes 
Additional, longer-termed, safety outcomes will be assessed by monitoring clinical data including: 
• 
Changes in best spectacle corrected visual acuity 
• 
Peripheral anterior synechiae (PAS) 
• 
Cornea endothelial cell count 
• 
Slit lamp findings 
• 
Corneal thickness (Pachymetry) 
• 
Visual field 
• 
Fundus findings 
• 
Other gonioscopic findings additional to PAS 
• 
Adverse events 
• 
Procedure-related complications 
1.5.3 
Adverse Events 
All adverse events will be summarized, tabulated, and analyzed by: 
• 
Seriousness 
• 
Severity 
• 
Outcome 
• 
Relationship to the study device 
• 
Relationship to the study procedure. 
1.6  
Study Population 
Effectiveness endpoints for this study will be: 
• 
The proportion of subjects with an IOP reduction of 20% or more from baseline at each post-
operative visit. 
• 
The proportion of subjects with an IOP reduction of 20% or more from baseline after 6 months 
while using the same number or fewer medications. 
 
 
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1.7  
Study Population 
1.7.1 
Inclusion Criteria 
The study eye must meet all the criteria below: 
1. 
Diagnosis of primary open-angle glaucoma (including pigmentary and pseudoexfoliative 
glaucoma).   
2. 
Glaucomatous visual field defects consistent with optic nerve defects and defined as one or 
more of the following: 
a. A cluster of 3 or more points in an expected location of the visual field depressed below 
the 5% level, at least 1 of which is depressed below the 1% level on the pattern 
deviation (PD) plot; or 
b. Glaucoma hemi-field test “outside normal limits” 
Note:  Visual field reliability indices (i.e., fixation losses, false positives, and false 
negatives) should all be less than 33%. For subjects with a screening visual acuity of 
20/100 or worse, a visual field is not required, and the above criteria do not need to 
be met. 
3. 
Nerve abnormality characteristic of glaucoma as evaluated by clinical ophthalmoscopy defined 
as one or more of the following: 
a. Diffuse thinning, focal narrowing or notching of the optic disc rim especially at inferior 
or superior poles. 
b. Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at 
inferior or superior poles. 
c. Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue. 
4. 
Subject eye is phakic  
a. If phakic, then the crystalline lens will not have visually significant cataract that is 
expected to require cataract surgery within next one year.  Cataract will be evaluated by 
using the AREDS clinical lens grading system (ARLNS).  Specifically, crystalline lens must 
have ARLNS grade of ≤ 1.5 for signs of nuclear opalescence, cortical or posterior 
subcapsular opacities.  Lenticular opacities not characterized by the ARLNS grading 
system shall also be evaluated (e.g. anterior subcapsular cataracts). 
5. 
Mean IOP with medication at screening between 21 mmHg and 35 mmHg, inclusive. 
6. 
Iridocorneal angle anatomy defined as follows: 
a. Trabecular meshwork visible on gonioscopy defined by Shaffer grade ≥ 3. 
b. Normal anatomy as determined by gonioscopy. 
7. 
Light perception or better in the study eye at screening. 
Note: The non-study eye must not have a Snellen corrected visual acuity (CVA) of worse than 
20/200 at screening. 
8. 
Age 45 years or older 
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9. 
Available, willing, with sufficient cognitive awareness to comply with examination procedures 
and schedules. 
10. 
Signed written informed consent. 
1.7.2 
Exclusion Criteria 
The study eye must not meet any of the criteria below: 
1. 
Previous glaucoma surgeries including stent implantation or other laser surgeries on study eye. 
2. 
Prior intraocular surgery. 
3. 
Glaucoma types as follows: 
a. Traumatic, uveitic, neovascular, or angle-closure.  
b. Glaucoma associated with vascular disorders. 
4. 
Corneal status as follows: 
a. Any condition that would preclude safe participation in the study or reliable IOP 
assessments including active inflammation, edema, keratitis, keratoconjunctivitis, 
keratouveitis. 
b. Clinically significant dystrophy such as bullous keratopathy or Fuch’s dystrophy. 
c. Guttata that would preclude safe participation in the study or reliable study 
assessments. 
d. Anticipated surgery of any type (including LASIK, LASEK, PRK, cataract, etc.) during the 
study that may alter IOP measurement. 
e. Corneal opacities or disorders that would inhibit visualization of the angle (such as 
severe arcus senilis). 
f. Central corneal thickness less than 440 microns or greater than 620 microns. 
5. 
Choroid status as follows: 
a. Choroidal detachment 
b. Effusion 
c. Choroiditis 
d. Neovascularization 
e. Any active choroidopathy. 
6. 
Retinal or optic nerve disorders, either degenerative or evolutive, that are not associated with 
the existing glaucoma condition including:  proliferative diabetic retinopathy, central retinal 
artery occlusion, central retinal vein occlusion, wet age-related macular degeneration, dry age-
related macular degeneration (e. g., presence of numerous large drusen associated with 
disturbance to or elevation of the retinal pigment epithelium), significant retinal pigment 
epithelial changes or optic atrophy, pathological myopia, red disease.   
Note:  Minor diabetic retinopathy or hypertensive retinopathy are permitted. 
7. 
Elevated episcleral venous pressure associated with: 
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a. Active thyroid orbitopathy. 
b. Cavernous sinus fistula. 
c. Sturge-Weber syndrome. 
d. Orbital tumors. 
e. Orbital congestive disease. 
8. 
Other ocular conditions as follows: 
a. Sequelae from trauma that would preclude safe participation in the study or reliable 
study assessments (e.g., chemical burns, blunt trauma, etc.) 
b. Chronic ocular inflammatory disease or presence of active ocular inflammation or 
infection (e.g., uveitis, iritis, iridocyclitis, retinitis) 
c. Any pathology for which, in the investigator’s judgement, the following would be either 
at risk or contraindicated: 
i. Compliance to elements of the study protocol (e.g., ophthalmic examinations, 
follow- up visits) 
ii. Subjects with inadequate space in the anterior chamber and/or angle as 
determined by slit lamp examination and gonioscopy. 
9. 
Subject status as follows: 
a. Uncontrolled systemic disease (e.g. diabetes, hypertension) that could compromise their 
participation in the study. 
b. Use of systemic medications (either current, within 30 calendar days of screening exam, 
or anticipated) that may cause an increase in IOP, (e.g. systemic steroids including oral 
or IV formulation, topical steroids applied on the periorbital surface within ¼” of the 
external lid margins and oral inhaled steroids). Nasal inhaled steroids are allowed. 
c. Active concurrent enrollment in any investigational trial or previous participation in any 
investigational trial within 30 days of the screening exam. 
d. Women who are nursing, are pregnant or are of childbearing potential who refuse to 
use reliable contraception. 
 
 
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2.  
STUDY MATERIALS AND METHODS 
2.1  
Device Description 
The ViaLase Laser is a precision ophthalmic surgical device designed for the creation of trabecular 
apertures in the treatment of open angle glaucoma.  The ViaLase Laser is like other commercially 
available surgical femtosecond lasers in ophthalmology that use focused femtosecond laser pulses to 
create incisions and separate tissue.  The primary difference between the ViaLase Laser and other 
devices is a specialized optical delivery system that focuses light into the iridocorneal angle.  Like other 
femtosecond lasers, the ViaLase Laser creates planes of micron-sized photodisruptions sites within a 
volume of tissue.  An incision, aperture or canal is achieved by contiguously placed micro-
photodisruptions scanned by a computer-controlled delivery system. 
 
 
 
 
 
 
 
 
 
   
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3.  
STUDY PROTOCOL 
3.1  
Subject Entry 
Prior to enrollment in the study, the subject will be evaluated to determine eligibility.  All inclusion 
criteria and no exclusion criterion will be met by an eligible subject.  The investigator will explain the 
study purpose, procedures, and patient responsibilities to the potential participant.  The subject’s 
willingness and ability to meet the follow-up requirements will be determined. 
When it has been established that the subject may be eligible, written informed consent will be 
obtained.  The subject will sign and date the informed consent form in the presence of a witness.  The 
investigator or designees will also sign and date the consent form.  The original will be retained with the 
subject records and a copy will be provided to the subject.  An affidavit of Informed Consent (Appendix 
C) will be completed and returned to ViaLase to confirm that consent was obtained.  The subject will 
then be considered enrolled in the study. 
3.2  
Informed Consent 
In accordance with GCP, the Investigator is responsible for fully reviewing the nature of the study, the 
possible risks, and alternative treatments with prospective subjects prior to their enrollment in the 
study.  The Investigator is responsible for obtaining written Informed Consent for each subject, prior to 
enrollment in the trial. A copy of the signed Informed Consent Form will be maintained in the subject's 
medical record or research chart, and a copy of the signed Informed Consent Form will become an 
integral part of each Case Report file provided to the Sponsor. 
3.3  
Preoperative Evaluation 
Preoperative evaluation consists of two patient visits, a screening visit, and a baseline visit.  During the 
screening visit, occurring 1 to 30 days prior to the baseline visit, the investigator informs the subject of 
the study and, after the subject provides consent, the investigator collects initial subject data including 
the subjects, demographics, ocular history, a list of ocular and non-ocular medications, and medical 
history.  The investigator will also assess the subjects corrected visual acuity and perform a slit lamp 
examination. 
During the baseline visit, occurring 3 to 60 days prior to the operative day, the investigator confirms the 
subject’s list of ocular and non-ocular medications.  The investigator then performs manifest refraction, 
best corrected spectacled visual acuity, and an endothelial cell count. 
3.4  
Preoperative Care 
Subjects included in this study present with uncontrolled refractive Primary Open Angle Glaucoma 
(POAG) using 1 or more IOP lowering medications.  Included subjects will be instructed to continue all 
current glaucoma medication. 
  
 
 
  
 
 
 
 
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3.3  
Postoperative Instructions 
Refer to Appendix B for complete instructions associated with Methods of Clinical Evaluation. 
1. 
Following surgery, the investigator or designee will instruct subjects to adhere to the following 
antibiotic/anti-inflammatory medication regimen for the study eye only: 
a. Topical antibiotic that is utilized as investigator’s routine postop regiments. 
b. Continuation of glaucoma medications. 
2. 
During the study, the discontinuation or a reduction in the dose or frequency of topical IOP 
lowering medication may be warranted whenever it is in the interest of patient safety.  
Conditions that may warrant discontinuation or frequency reduction in medication include 
hypotonous condition, an adverse reaction, or other systemic side effect.  
3. 
If a pressure rise is observed, a paracentesis may be performed, as necessary. If a paracentesis is 
performed and there is no protocol-defined adverse event, the paracentesis will be documented 
in the applicable clinical report form (CRF). If, however, the paracentesis is performed and an 
anticipated adverse event is determined, then the AE will be recorded, and the paracentesis will 
be recorded on the applicable CRF as a treatment for the AE. 
3.4  
Examination Schedule: 
Follow-up visits (as shown in Appendix A) will be scheduled over the course of 6 months. A CRF will be 
completed for each scheduled, unscheduled, and interim exam. Scheduled visits are defined as visits 
outlined in the schedule of visits. Interim visits are defined as study related visits deemed necessary by 
the protocol or the PI that are in addition to scheduled visits, and unscheduled visits are defined as visits 
that are not scheduled or interim. Subjects will be examined and evaluated according to the following 
scheduled visits: 
3.4.1 
Preoperative 
• 
Screening - Visit 1  (range 1 – 30 days prior to Baseline) 
• 
Baseline - Visit 2 (range 3 to 60 days prior to Operative) 
3.4.2 
Operative 
• 
Surgery – Visit 3 (Day 0 occurring ≥ 3 days and ≤ 60 days after Baseline) 
3.4.3 
Postoperative 
• 
Day 1 - Visit 4 (1-day post-op) 
• 
Week 1 - Visit 5 (range 5 - 9 days post-op) 
• 
Month 1 - Visit 6 (range 21 - 35 days post-op) 
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• 
Month 3 – Visit 7 (range 70 – 105 days post-op) 
• 
Month 6 – Visit 8 (range 168 – 196 days post-op) 
• 
Month 12 – Visit 9 (range 330 – 420 days post-op) 
3.5  
Schedule of Visits and Clinical Assessments  
All required clinical assessments should be performed at each scheduled visit as specified in Appendix A.  
Methods for performing assessments are described in Appendix B. 
For interim visits, clinical assessments that are required by the protocol or as deemed necessary by the 
Investigator will be conducted.  Assessments will be performed according to methods described in 
Appendix B and recorded on an interim visit CRF. Unscheduled visit clinical assessments will be 
conducted according to standard of care and documented on an unscheduled visit CRF. 
3.6  
Subject Accounting Procedure 
All consented subjects will be accounted for as follows: 
1. 
Subject completion - Subjects are considered to have completed the study if they have 
completed follow-up examinations through and including 6months. 
2. 
Screen Failure - Subjects are not considered enrolled in the study until they undergo surgery. 
Subjects are considered screen failures if they fail to meet screening criteria or baseline criteria 
as outlined in Section 1.7, or if they withdraw consent. 
3. 
Early exit of enrolled subjects - Subjects may be exited from the investigation in the event of a 
condition that may cause them harm if participation were to be continued. Subjects may also 
withdraw voluntarily. 
4. 
Subject lost to follow up - Subjects who do not return for their postoperative study visits and 
cannot be contacted within a reasonable timeframe via letter or telephone, will be considered 
lost to follow-up. The site will make at least three (3) telephone calls to the subject. If the three 
telephone contacts are unsuccessful, the site will send a registered letter with return receipt to 
the subject. The letter will request the subject to contact and return to the study site. If the 
subject is unresponsive to the first letter, the site will send a second registered letter with return 
receipt to the subject notifying them that they have been exited from the study due to lack of 
response on the part of the subject to the telephone calls and first registered letter. The site will 
then exit the subject from the study and the subject considered lost to follow- up.  All attempts 
at contacting the subject (including telephone call logs, copies of registered letters and 
registered letter receipts) must be documented and maintained with the subject’s study source 
documentation. 
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3.7  
Adverse Events 
3.7.1 
Recording Adverse Events 
If adverse events (AEs) occur, the first concern will be the welfare of the subject, including any 
treatment the Investigator believes is appropriate. 
Adverse events that occur during the trial whether they are device related or not, will be documented. An 
adverse event is defined as any clinically significant new or changed untoward condition, or a condition 
requiring treatment, either surgical or medical  intervention. 
1. 
Recording of all AEs shall include the AE term and assessed relationship of the event to the study 
device/procedure.  Additionally: 
a. Recording of ocular AEs and related AEs shall include the start and resolution dates, 
severity, and treatment (if any). 
b. Recording of non-ocular AEs that are not related to the study treatment will be limited 
to documenting the start and resolution dates (if any) from subject self- reports or other 
avenues and no additional information will be recorded. 
c. All AEs will be documented on the AE CRF. 
2. 
Postoperative inflammation within or at 30 days post-surgery will be reported as an AE for cells 
and flare graded as 3+ or 4+. 
3. 
Ocular events occurring greater than 30 days postoperatively that meet the following criteria 
will be reported as AEs. 
a. For evaluations for which a standard grading scale is available, ocular AEs will be 
captured for significant (2-grade) worsening. 
b. For evaluations where a standard grading scale is not available, clinically significant 
events assessed as mild, moderate, or severe will be captured as AEs. 
4. 
For related, systemic AEs or all ophthalmic AEs treated with surgical intervention, the 
intervention should be recorded in the Ocular Procedure Log as a treatment for the AE, and the 
interventional treatment will not be recorded as a separate AE. If a single condition results in 
multiple protocol defined AE’s, the root cause AE will be recorded, and the other events will be 
recorded as sequelae. (For example, an increase in crystalline lens opacity of greater than 3 half 
step increments that leads to a VF Mean Deviation loss of greater than 2.5dB. The crystalline 
lens opacity is recorded as an AE, and the VF Mean Deviation loss is recorded as a sequela). 
5. 
The severity (intensity) of AEs will be rated as follows: 
a. Mild: subject has no, transient, or mild discomfort (< 48 hours); signs and symptoms are 
transient; symptoms do not interfere with the subject’s daily activities; symptoms do 
not require medication or a medical evaluation. 
b. Moderate: subject has moderate discomfort; signs and symptoms are persistent; 
subject has some limitation in activity, or some assistance may be needed; symptoms 
may require no treatment or minimal medical intervention/therapy. 
c. Severe: subject has marked limitation in activity; signs and symptoms are persistent; 
symptoms interrupt participant’s usual daily activity and may require medical 
intervention/therapy or surgery. 
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6. 
Adverse Events will be assessed by the PI for relatedness to the device / procedure. The 
relatedness will be determined to be: 
a. Definitely Unrelated: The cause of the AE is in no way related to any aspect of the study 
procedure, device, or study testing. 
b. Unlikely Related: The adverse event is unlikely to be related to the study procedure, 
device, or study testing, and other more likely causes are present. Relatedness cannot 
be ruled out with certainty. 
c. Possibly Related: An AE is possibly related when there is a reasonable possibility that the 
event might have been caused by the study procedure, device, or study testing. A 
possibly related event may follow no known pattern of response and an alternative 
cause seems more likely. In other circumstances there may be significant uncertainty 
about the cause of the event, or a possible relationship to study participation cannot 
reasonably be ruled out. 
d. Probably Related: An AE is probably related when there is a reasonable possibility that 
the event is likely to have been caused by the study procedure, device, or study testing. 
The AE has a timely relationship to the study procedure(s) and follows a known pattern 
of response, but a potential alternative cause may be present. 
e. Definitely Related: An AE is definitely related to study participation if the event was 
caused by the study procedure, device, or study testing. A definitely related event has a 
strong temporal relationship and an alternative cause is unlikely. 
Throughout the course of the study, all efforts will be made to remain alert to possible adverse 
experiences or untoward findings. 
3.7.2 
Adverse events knowing to occur during or after laser procedures 
Specific examples of adverse events that potentially may occur during or after laser surgery (regardless 
of likelihood) include but are not limited to: 
• 
Choroidal hemorrhage 
• 
Choroidal effusion 
• 
Cyclodialysis cleft 
• 
Significant hyphema (i.e. ≥ 10% of anterior chamber) 
• 
Significant iris damage 
Possible postoperative adverse events: 
• 
Allergic reaction 
• 
Intraocular inflammation (not pre-existing) remaining or arising after the protocol’s specified 
medication regimen is complete 
• 
Choroidal effusion 
• 
Choroidal hemorrhage 
• 
Aqueous misdirection 
• 
Chronic pain in the study eye present greater than 3 months postoperative 
• 
Clinically significant cystoid macular edema 
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• 
Corneal abrasion 
• 
Flat or shallow anterior chamber (e.g., shallowing of the anterior chamber that causes any 
amount of iris-cornea touch) 
• 
Hypotony (IOP < 6 mmHg) associated with clinically significant findings. (Clinically significant 
hypotony is defined as hypotony maculopathy or hypotony with flat anterior chamber requiring 
reformation, corneal folds, choroidal effusions requiring drainage, and/or suprachoroidal 
hemorrhage) 
• 
Increase in C/D ratio of > 0.3 units  
• 
IOP increase requiring management with oral or intravenous medications or with surgical 
intervention  
• 
IOP increase ≥ 10 mmHg vs. baseline IOP occurring at any visit 
• 
Iridodialysis 
• 
Loss of best spectacle corrected visual acuity (BSCVA) of 2 lines or more (logMAR scale; 10 
letters or more on ETDRS chart)  
• 
Pupillary block 
• 
Secondary surgical intervention 
• 
Significant corneal complications including opacification and decompensation 
• 
Significant corneal edema (NOTE: A classification of mild to moderate corneal edema up to and 
including the Week 1 postoperative exam is NOT considered an adverse event) 
• 
Significant hyphema (≥ 10% of anterior chamber) 
• 
Vitreous hemorrhage 
• 
Worsening in visual field of mean deviation (MD) of ≥ 2.5 dB compared to the MD used to 
determine subject eligibility (confirmed in at least 2 out of 3 postoperative visual field tests 
performed within a 90-day period) 
3.7.3 
Serious Adverse Events (SAES) 
Serious adverse events are defined as any findings that suggest a significant hazard, contraindication, 
side effect, or precaution. Any adverse event is considered a serious adverse event if it results in any of 
the following outcomes: 
- 
Death 
- 
Life- or sight-threatening 
- 
Overnight hospitalization or prolongation of an existing hospitalization  
- 
A persistent or significant disability or incapacity 
- 
A congenital anomaly or birth defect 
 
The terms “mild,” “moderate”, and “severe” are measures of intensity; thus, a severe AE is not 
necessarily serious. For example, nausea of several hours duration may be rated as severe but may not 
be clinically serious. 
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Important medical events that may not result in death, be life-threatening, or require overnight 
hospitalization may be considered a serious adverse experience when, based upon appropriate medical 
judgment, they may jeopardize the subject and may require medical or surgical intervention to prevent 
one of the outcomes listed above. A life-threatening event is any event that places the subject at 
immediate risk of death from the event as it occurred; it does not refer to an event that hypothetically 
might have caused death if it were more severe. A sight- threatening event is any event that places the 
subject at immediate risk of permanently losing vision in either eye as a direct result of the event. 
Serious, alarming, and/or unusual adverse events must be reported to ViaLase within 24 hours of the 
investigator's knowledge of the event: 
Phone:  +1 (949) 466-3928 
Fax: +1 (949) 900-2090 
Email:  clinical@vialase.com 
An AE Form and supplemental SAE Report Forms must be completed as much as possible for all serious 
adverse events and faxed to ViaLase within 24 hours of knowledge of the event. 
When new significant information (including the outcome of the event) is obtained, the investigator 
should inform ViaLase by telephone, facsimile, or email as soon as possible. Depending on the nature 
and seriousness of the AE, ViaLase may request copies of the ophthalmic and medical record of the 
subject as well as results of laboratory tests. If the subject was hospitalized, a copy of the discharge 
summary must be forwarded to ViaLase as soon as possible. 
Sight-threatening AEs include but are not limited to events such as endophthalmitis and corneal 
decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal 
detachment, and aqueous misdirection. 
Sight-threatening AEs will be reported to ViaLase and to the Investigator’s IRB as soon as possible, but in 
no event later than 10 working days after the Investigator first learns of the event. Subjects who are 
terminated from the study due to adverse experiences will be followed until their medical outcome is 
determined; written reports will be provided to the ViaLase  Clinical Research Department by the 
Investigator. 
3.7.4 
Unanticipated Adverse Device Effect 
Unanticipated adverse device effect (UADE) is defined as any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, 
or death was not previously identified in nature, severity, or degree of incidence in the investigational 
plan or application (including a supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare of subjects. Date and time 
of the event, its severity, treatment if any, and the assessed relationship of the event to the study device 
will be recorded on the AE form. 
Unanticipated adverse device effects must be reported to ViaLase and to the Investigator’s IRB as soon 
as possible, but in no event later than 10 working days after the Investigator first learns of the event. 
Subjects who are exited from the study due to unanticipated adverse device effects will be followed 
until their medical outcome is determined; the Investigator must provide written reports to the ViaLase 
Study Manager. 
3.7.5 
Follow-up after Adverse Events 
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Related systemic and all ophthalmic AEs for either eye at any level of potential relatedness (unlikely 
related, possibly related, probably related, or definitely related) will be followed and documented until 
complete resolution, resolution with sequelae, until the subject exits from the study for conditions with 
no possibility of resolution (e.g., iris atrophy, macular degeneration), or for one month after study exit. 
Subjects with AEs will continue to be followed according to the protocol, unless continuing to do so 
would place the subject at undue risk (e.g., if they are hospitalized). 
If a subject requires additional glaucoma surgery, the subject will continue to be seen for the duration of 
the study at required follow-up visits so that safety and effectiveness can continue to be monitored. 
3.8  
Source Documentation and Data Reporting 
A Case Report Form booklet will be provided by ViaLase for each subject enrolled in the study.  The 
appropriate Case Report Form will be completed at each examination.  The original forms, not copies, 
will be returned to the sponsor along with an affidavit of obtaining signed Informed consent.  Copies will 
be retained by the site. 
ViaLase personnel will monitor all clinical studies in a manner consistent with applicable health authority 
regulations and the clinical research standards adopted by ViaLase, Inc. 
3.9  
Statistical Methods 
Descriptive statistics will be used for reporting available study results.  Baseline and demographic 
characteristics will be presented.  Continuous variables will be summarized by descriptive statistics such 
as mean, standard deviation, median, minimum, and maximum.  Discrete variables will be summarized 
by frequency tables and percentages. 
Adverse events will be summarized by presenting the number and percentage of patients experiencing 
any adverse event.  Any other information collected such as seriousness, severity, and relationship to 
study device and procedure will be listed as appropriate.    
IOP change from baseline will be summarized at each evaluation by mean, standard deviation, and 
range.  Changes in IOP from baseline (Day 0 prior to assigned treatment) will be summarized at each 
visit.  The proportion of subjects with an IOP reduction of 20% or more from baseline will be tallied at 
each post-operative visit.  The number and frequency of medications will be tallied at each visit. 
Slit lamp exam and fundus exam findings will be summarized at each visit using frequency and 
percentage. 
3.10 Study Monitoring 
Data will be monitored according to the study data monitoring plan which includes 100% source 
document verification (SDV). Conduct of the investigation will be done in compliance with the currently 
approved protocol version, with GCP, and with Ethics Committee requirements. 
 
 
 
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4.  
BIBLIOGRAPHY 
1. Global Prevalence of Glaucoma and Projections of Glaucoma Burden through 2040. Tham, YC, et al. 
2014, Ophthalmology, Vol. 121, pp. 2081-2090. 
2. The genetics of open-angle glaucoma: The story of GLC1A and myocilin. Alward, WL. Pt. 3B, 2000, Eye, 
Vol. 14, pp. 429-436. 
3. 'Ocular Hypertension' or 'Early Glaucoma'? 'Ocular Hypertension' vs Open-Angle Glaucoma. Chandler, 
PA and Grant, WM. 4, 1977, Arch Ophthalmology, Vol. 95, pp. 585-586. 
4. Uveoscleral outflow. Alm, A. 2000, Eye, Vol. 14, pp. 488-491. 
5. Unconventional aqueous humor outflow: A review. Johnson, M, McLaren, JW and Overby, DR. 5, 
2017, Experimental Eye Research, Vol. 158, pp. 94-111. 
6. Flow of Aqueous Humor in Humans. Brubaker, RF. 13, 1991, Investigative Ophthalmology & Visual 
Scienc3, Vol. 32, pp. 3145-3166. 
7. Effects of prostaglandin analogues on aqueous humor outflow pathways. Winkler, NS and Fautsch, 
MP. 2-3, 2014, Journal of Ocular Pharmacology and Therapeutics, Vol. 30, pp. 102-109. 
8. Comparison of long-term outcomes of selective laser trabeculoplasty versus argon laser 
trabeculoplasty in open-angle glaucoma. Juzych, MS, et al. 10, 2004, Ophthalmology, Vol. 111, pp. 1853-
1859. 
9. Mechanisms of selective laser trabeculoplasty: a review. Kagan, DB, Dorfinkel, NS and Hutnik, CM. 
2014, Clinical and Experimental Ophthalmology, Vol. 42, pp. 675-681. 
10. Selective laser trabeculoplasty. Latina, MA and de Leon, JM. 3, 2005, Ophthalmology Clinics of North 
America , Vol. 18, pp. 409-419. 
11. Excimer laser trabeculotomy: a new minimally invasive procedure for patients with glaucoma. 
Wilmsmeyer, S, Philippin, H and Funk, J. 4, 2006, Graefes Archive for Clinical and Experimental 
Ophthalmology, Vol. 244, pp. 670-676. 
12. Minimally invasive glaucoma surgery: current status and future prospects. Richter, GM and 
Coleman, AL. 189-206, 2016, Clinical Ophthalmology, Vol. 10. 
13. Long-term titrated IOP control with one, two, or three trabecular micro-bypass stents in open-angle 
glaucoma subjects on topical hypotensive medication: 42-month outcomes. Katz, LJ, et al. 2018, Clinical 
Ophthalmology, Vol. 12, pp. 255-262. 
14. Prospective Evaluation of Two iStent® Trabecular Stents, One iStent Supra® Suprachoroidal Stent, and 
Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Myers, JS, et al. 3, 2018, 
Advances in Therapy, Vol. 35, pp. 395-407. 
15. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. Batlle, JF, et al. 2, 2016, Journal of 
Glaucoma, Vol. 25, pp. e58-e65(e). 
16. Two-Year COMPASS Trial Results: Supraciliary Microstenting with Phacoemulsification in Patients 
with Open-Angle Glaucoma and Cataracts. Vold, S, et al. 10, 2016, Ophthalmology, Vol. 123, pp. 2103-
2112. 
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17. Noncompliance with Ocular Hypotensive Treatment in Patients with Glaucoma or Ocular 
Hypertension: An Evidence-Based Review. Olthoff, CMG, et al. 6, June 2005, Ophthalmology, Vol. 112, 
pp. 953-961. 
18. Corneal Refractive Surgery with Femtosecond Lasers. Juhasz, T, et al. 4, 1999, IEEE Journal of 
Selected Topics in Quantum Electronics, Vol. 5, pp. 902-910. 
19. Ultra-short pulse (femtosecond) laser surgery: initial use in LASIK flap creation. Ratkay-Traub, I, et al. 
June 01, 2001, Ophthalmology Clinics of North America, Vol. 14, pp. 347-355. 
20. Femtosecond laser cataract surgery. Nagy, Z and McAlinden, C. 11, 2015, Eye and Vision, Vol. 2. 
21. Laser-assisted cataract surgery: benefits and barriers. Hatch, KM and Talamo, JH. 2014, Current 
Opinion in Ophthalmology, Vol. 25, pp. 54-61. 
22. The Standaradizatoin of Uveitis Nomenclature (SUN) Project - Development of a Clinical Evidence 
Base Utiliziting Informatics Tools and Techniques. Trusko, B, et al. 3, 2013, Methods of Information in 
Medicine, Vol. 52, pp. 259-265. 
 
 
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APPENDIX A – SCHEDULE OF VISITS AND CLINICAL ASSESSMENTS 
Table B – Table of Scheduled Visits and Clinical Assessments 
Visit Windows 
Screening 
Baseline 
Operative  
Day 0 
Day 1 
Week 1 
Month 1 
Month 3 
Month 6 
Month 12 
Window Range 
1-30 days 
before 
Baseline 
3-60 days 
before 
Operative 
3-60 days 
after 
Baseline 
1-day  
post-op 
5-9 days  
post-op 
21-35 days 
post-op 
70-105 days 
post-op 
168-196 
days post-op 
330-420 
days post-op 
Informed Consent 
X 
 
 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
 
 
Ocular History 
X 
 
 
 
 
 
 
 
 
Ocular Medication Assessment 
X 
X 
 
X 
X 
X 
X 
X 
X 
Medical History 
X 
 
 
 
 
 
 
 
 
Medication Assessment 
X 
X 
 
X 
X 
X 
X 
X 
X 
Pinhole VA (Snellen) 
 
 
 
X 
X 
 
 
 
 
Corrected VA (CVA) 
X1 
 
 
X 
X 
X2 
X2 
X2 
X 
Manifest Refraction 
 
X 
 
 
 
 
 
 
X 
Best Spectacle Corrected VA 
(ETDRS) 
 
X 
 
 
 
 
 
 
X 
Endothelial Cell Density 
 
X 
 
 
 
X 
 
X 
X 
Slit Lamp Exam3 
X 
 
 
X 
X 
X 
X 
X 
X 
 
1 Snellen chart will be used for assessing corrected VA at the Screening visit. 
2 ETDRS chart will be used for assessing corrected VA at Months 1, 3 and 6. If corrected VA indicates a greater than or equal to 10 letter loss from screening, a refraction should 
be performed followed by a best spectacle corrected VA assessment using an ETDRS chart. 
3 Slit lamp exam includes lenticular opacity grading. 
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Visit Windows 
Screening 
Baseline 
Operative  
Day 0 
Day 1 
Week 1 
Month 1 
Month 3 
Month 6 
Month 12 
Window Range 
1-30 days 
before 
Baseline 
3-60 days 
before 
Operative 
3-60 days 
after 
Baseline 
1-day  
post-op 
5-9 days  
post-op 
21-35 days 
post-op 
70-105 days 
post-op 
168-196 
days post-op 
330-420 
days post-op 
IOP via Goldmann Applanation 
Tonometry 
X 
 
X4 
X 
X 
X 
X 
X 
 
Diurnal IOP via Goldmann 
Applanation Tonometry  
(8:00 am, 12:00pm, and 4:00 pm) 
 
X 
 
 
 
 
X 
 
X 
Gonioscopy 
X 
 
 
 
X 
X  
X 
X 
X 
Dilated Fundus Exam5 
X 
 
 
 
 
X 
X 
X 
X 
Visual Field6 
 
X 
 
 
 
 
X 
X 
 
Pachymetry 
X 
 
 
 
 
 
 
X 
X 
Ocular Biometry 
X 
 
 
 
 
 
 
 
 
Surgery 
 
 
X 
 
 
 
 
 
 
Adverse Event Assessment 
X 
X 
X 
X 
X 
X 
X 
X 
 
Exit 
 
 
 
 
 
 
 
 
X 
 
4 IOP will be assessed after surgery on Day 0 and can be done at any time per investigator discretion 
5 Includes vertical C/D ratio assessment. 
6 Subjects with a visual acuity at screening of 20/100 or worst are not required to have a visual field performed. 
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APPENDIX B – METHODS OF CLINICAL EVALUATION 
B.1  
Corrected Visual Acuity 
Corrected visual acuity (CVA) using either a Snellen chart or ETDRS chart will be performed at specified 
visits according to Appendix A. 
B.2  
Manifest Refraction and Best Spectacle Corrected Visual Acuity (ETDRS) 
Manifest refraction (MR) and Best Spectacle Corrected Visual Acuity (BSCVA) will be performed at 
specified visits according to Appendix A.  MR will be conducted utilizing the site’s standard refractive 
techniques. MR must be performed prior to BSCVA testing. BSCVA testing should precede slit lamp 
examination, intraocular pressure measurement, the administration of topical anesthetic agents, or any 
examination requiring contact with the eye.  
BSCVA will be assessed using the Early Treatment of Diabetic Retinopathy study (ETDRS) charts at 4 
meters (13 feet and 1.5 inches, or 157.5 inches) by trained technicians. ETDRS visual acuity will be 
performed at specified visits according to Appendix A. BSCVA using ETDRS Chart 1 (right eye) or Chart 2 
(left eye) at 4 meters will be performed at Baseline and the Month 6 visits. Corrected visual acuity (CVA) 
with the subject’s habitual correction will be assessed using the ETDRS chart at 4 meters. If the CVA 
indicates a greater than or equal to 10 letter loss from baseline, then a refraction will be performed 
followed by a BSCVA assessment using the BSCVA method. 
The ETDRS visual acuity chart may be either retro-illuminated (“back-lit”), or reflectance illuminated. If 
the latter, then the illumination must be checked at regular intervals to be consistent with ETDRS 
guidelines. The standard chart requires a distance from subject to chart of 4 meters. Ideally, the subject 
should be seated. Sites are directed to refer to the instructions on the commercial ETDRS charts. 
The subject should attempt to read each letter, line by line, left to right, beginning with line 1 at the top 
of the chart (20/200 line) or a line in which they can comfortably read all the letters. The subjects should 
be told that the chart has letters only, no numbers. If the subject reads a number, he or she should be 
reminded that the chart contains no numbers, and the examiner should then request a letter in lieu of 
the number. The subjects should be asked to read slowly, about one letter per second, to achieve the 
best identification of each letter. He/she is not to proceed to the next letter until he/she has given a 
definite response. To provide standardized and well-controlled assessment of visual acuity during the 
study, all visual acuity assessments for a subject must be performed consistently (e.g., the same lighting 
conditions, viewing distance, etc.) during the entire study. Refer to the study manual for further 
instruction on assessing ETDRS visual acuity. 
NOTE: The study coordinator or technician can perform refractions and ETDRS visual acuity assessments 
if they are delegated to perform these tasks on the delegation of authority log. 
B.3  
Pinhole Visual Acuity (Snellen) 
Pinhole visual acuity testing will be performed using an uncorrected pinhole technique using a Snellen 
chart at specified visits according to Appendix A. 
B.4  
Slit Lamp Exam 
The slit lamp exam will be performed at the screening visit and at all postoperative visits starting with 
the Day 1 exam. The slit lamp exam will include the measurement of aqueous cell and flare by a 
standard grading system and an evaluation for the presence of corneal abnormalities, pupillary 
irregularities, iris atrophy and pigment dispersion. 
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For the evaluation of aqueous cells and flare, use the following SUN grading schemes (22): 
B.4.1 
Grading Scheme for Anterior Chamber Cells 
Table C – Anterior Chamber Cell Grade Scheme 
Grade 
Cells in Field* 
0 
<1 
0.5+ 
1-5 
1+ 
6-15 
2+ 
16-25 
3+ 
26-50 
4+ 
>50 
*Field size is a 1mm by 1mm slit beam 
B.4.2 
Grading Scheme for Anterior Chamber Flare 
Table D – Anterior Chamber Flare Grade Scheme 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens detail clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
 
B.4.3 
Grading Scheme for AREDs 2008 Clinical Lens Opacity 
1. 
Dilate pupils to at least 5 mm diameter. 
2. 
Use slit lamp with approximately 10X magnification. 
3. 
Use brightest beam intensity. 
4. 
Nuclear opacity 
a. Orient beam at 45° to viewing axis. 
b. Adjust slit beam to standard parameters: 8 mm height and 0.3 mm width. 
c. Compare opalescence of nucleus with that in standard photos. 
5. 
Cortical and PSC opacities 
a. Select wide slit beam setting optimum for retro-illumination of lens. 
b. Visualize lens opacities against red fundus reflex background Count only opacities visible 
against red reflex. 
c. Mentally combine all cortical opacities into contiguous area. 
d. Compare total opacity area with that in standard photos. 
6. 
Classify each opacity with scale defined by 3 standard photos. 
7. 
Select nearest half-step. 
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a. Similar to standard or between two standards. 
b. Obviously less than mildest standard or greater than most. 
 
Figure 3 – AREDS 2008 Lens Opacity Standard 
 
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B.5  
Applanation Tonometry 
Applanation tonometry using a Goldmann tonometer will be used to measure intraocular pressure (IOP) 
at all visits. At each visit, IOP will be measured prior to gonioscopy or dilation of the pupil. Subjects 
should be instructed to take their medication(s), if any, as usual the day of the  visit. 
IOP will be measured by 2 observers. Observer 1 (masked to real time IOP reading) will look through the 
slit lamp and turn the dial, with Observer 2 using the sponsor supplied IOP dial view blocking card and 
associated procedure. Observer 2 will read the result from the Goldmann tonographer knob and record 
the IOP readings. 
At each IOP timepoint measurement, two measurements will be taken, and the mean recorded on the 
case report form unless they differ by more than 2 mmHg, in which case a third measurement is taken 
and the mean is computed. 
Tonometer calibration for all study tonometers used in the study must be performed monthly and 
documented in the calibration log in the study regulatory binder. 
B.6  
Gonioscopy 
Gonioscopy will be performed on all subjects and will be used to assess angle abnormalities including 
presence of goniosynechiae, angle anatomy and stent location (post-implantation). Please refer to 
Appendix A. At the screening exam, the Shaffer system for grading the angle anatomy will be used as 
follows: 
B.6.1 
Gonioscopic Angle Grade 
Table E – Gonioscope Angle Grade Scheme 
Angle - θ 
Grade 
0° ≤ θ < 10° 
Closed 
10° ≤ θ < 15° 
I 
15° ≤ θ < 25° 
II 
25° ≤ θ < 35° 
III 
> 35° 
IV 
 
B.7  
Visual Field Examination 
Screening visual fields are used to determine subject eligibility prior to enrollment into the study, and as 
safety measures through the course of the study. For subjects with a screening visual acuity of 20/100 or 
worse, a visual field is not required at screening. 
Visual fields must be automated threshold visual fields using Humphrey 24-2, SITA Standard. This 
program will be used for the duration of the study at the required visits (refer to Appendix A). Visual field 
testing can be performed dilated or undilated if the method is consistent at each visit. There are no 
restrictions on how to prepare subject’s eyes for the visual field exam. NOTE: Visual field exams 
conducted ≤ 3 months of the screening visit can be used as part of the subject’s evaluation for inclusion 
in (or exclusion from) the study as long as the test is performed with Humphrey 24-2, SITA Standard 
methodology.  Values for mean deviation will be recorded. 
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B.8  
Pachymetry 
Pachymetry is performed to determine central corneal thickness. For each evaluation, three 
measurements (or sequential independent measurement sessions for instruments that automatically 
take multiple readings from one corneal touch) are to be taken utilizing an ultrasonic pachymeter and the 
mean recorded. There are no restrictions on the type of pachymeter used in collection of data for this 
study. For those pachymeters that are not self-calibrating, calibration must be performed on a quarterly 
basis and documented in the calibration log in the study regulatory binder. 
B.9  
Endothelial Cell Density 
Specular microscopy for endothelial cell density will be performed in all subjects.  Specular microscopic 
images will be taken at Screening, 1-month, 6 month, and 12-month visits.  These images will be taken 
at the central corneal position of both eyes. Endothelial cell density, percent hexagonality and the 
coefficient of variation will be assessed from specular microscope images.  Images will be stored on the 
computer hard drive and copied onto recordable media. Media will be labeled with the protocol 
number, investigator number, subject number, image date, visit number. 
 
B.10 Biometric Data 
Upon availability of an eye mapping device, the following biometric data may be collected at baseline:  
the temporal to nasal white-to-white diameter of anterior chamber depth; the anterior corneal radius of 
curvature; the posterior corneal radius of curvature; and the anterior chamber depth. 
 
 
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APPENDIX D – SPONSOR’S COMMITMENTS 
 
ViaLase, Inc. is committed to: 
 
1. 
Complying with the Declaration of Helsinki, and all applicable health authority regulations 
governing the conduct of clinical research studies. 
2. 
Protecting the rights, health, safety, and welfare of study subjects. 
3. 
Informing the clinical Investigators of any new information about the study which may affect the 
health, safety, or welfare of the subjects, or may influence their decision to continue 
participation in the study. 
4. 
Providing the clinical Investigators with the study protocol, and a full set of Case Report Forms 
on which to document the study evaluation variables for each subject entered the study. 
5. 
Providing the statistical analysis and study report writing resources necessary to complete 
reporting of the study results. 
6. 
Ensuring equity of consideration among all Investigators in multicenter studies in all matters of 
publications, meeting presentations, etc. 
7. 
Certifying that IRB approval of the protocol and Investigators Agreement will be completed prior 
to treatment at an investigational site. 
 
 
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APPENDIX E – INVESTIGATOR’S QUALIFICATIONS AND RESPONSIBILITIES 
Each Investigator must be a licensed physician who has completed a residency or preceptorship in 
ophthalmology.  The Investigators have the following responsibilities: 
E.1  
Subject Selection 
The Investigator is responsible for assuring that all subjects entering the study conform to the subject 
selection criteria. 
E.2  
Informed Consent 
The Investigator is responsible for fully reviewing the nature of the study, the possible risks, and 
alternative treatments with prospective subjects prior to their enrollment in the study. The Investigator is 
responsible for obtaining written Informed Consent in compliance with 21 CFR 50 for each subject, prior 
to enrollment in the trial. A copy of the signed Informed Consent Form will be maintained in the 
subject's medical record or research chart, and a copy of the signed Informed Consent Form will become 
an integral part of each Case Report file provided to the Sponsor. 
E.3  
Institutional Review Board (IRB) Approval 
The Investigator must obtain approval for participation in this protocol from the IRB for the institution at 
which the procedure will be performed, prior to entering any subjects in the study. The Informed Consent 
document to be used will also be submitted by the Investigator to the IRB for approval prior to initiation 
of the study. Assurance that the IRB approval of the study protocol and Informed Consent has been 
obtained will be provided to the Sponsor prior to initiation of the study. 
E.4  
Subject Evaluations and Data Reporting 
The Investigator is responsible for performing all subject evaluations as described in the study protocol. All 
information generated by the subject evaluation will be recorded on the Subject Case Report Forms 
provided by the Sponsor. The Investigator is responsible for working with their staff and study subjects to 
provide all study data requested because missing data could jeopardize the integrity and scientific value 
of the study. Case Report Forms will be filled out in ink. Any corrections will be made by lining out with 
initials and date. Correction fluid will not be used. The Investigator will sign and date each set of forms 
upon its completion and will return the originals, not copies, to ViaLase. Copies of all Case Report Forms 
will be retained in the Investigator's office to be available for monitoring by ViaLase personnel or by 
authorized FDA personnel. 
Following completion of each subject examination the completed, signed and dated Subject Case Report 
Form shall be collected by the Sponsor in a timely manner for review and statistical analysis. 
Investigator(s) will not deviate from the study protocol without prior approval of ViaLase unless protection 
of the health, safety or welfare of study subjects requires prompt action. 
E.5  
Record Retention 
The Investigator shall maintain all subject records for whichever of the following periods is shortest: 
1. 
A period of two years after the date on which the FDA approves the marketing of the device for 
the purpose that was the subject of the study. 
2. 
A period of five years after the date on which the results of the study are submitted to the FDA 
in support of the marketing of the device for the purpose that was the subject of the study. 
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APPENDIX F – DECLARATION OF HELSINKI 
 
Declaration of Helsinki  
Ethical Principles for Medical Research Involving Human Subjects 
Publication Date, October 2013 
 
F.1  
PREAMBLE 
1. 
The World Medical Association (WMA) has developed the Declaration of Helsinki as a 
statement of ethical principles for medical research involving human subjects, including 
research on identifiable human material and data. 
The Declaration is intended to be read as a whole and each of its constituent paragraphs 
should be applied with consideration of all other relevant paragraphs. 
2. 
Consistent with the mandate of the WMA, the Declaration is addressed primarily to 
physicians. The WMA encourages others who are involved in medical research involving 
human subjects to adopt these principles. 
F.2  
GENERAL PRINCIPLES 
3. 
The Declaration of Geneva of the WMA binds the physician with the words, “The health of my 
patient will be my first consideration,” and the International Code of Medical Ethics declares 
that, “A physician shall act in the patient’s best interest when providing medical care.” 
4. 
It is the duty of the physician to promote and safeguard the health, well-being, and rights of 
patients, including those who are involved in medical research. The physician’s knowledge 
and conscience are dedicated to the fulfilment of this duty. 
5. 
Medical progress is based on research that ultimately must include studies involving human 
subjects. 
6. 
The primary purpose of medical research involving human subjects is to understand the 
causes, development and effects of diseases and improve preventive, diagnostic and 
therapeutic interventions (methods, procedures, and treatments). Even the best proven 
interventions must be evaluated continually through research for their safety, effectiveness, 
efficiency, accessibility, and quality. 
7. 
Medical research is subject to ethical standards that promote and ensure respect for all 
human subjects and protect their health and rights. 
8. 
While the primary purpose of medical research is to generate new knowledge, this goal can 
never take precedence over the rights and interests of individual research subjects. 
9. 
It is the duty of physicians who are involved in medical research to protect the life, health, 
dignity, integrity, right to self-determination, privacy, and confidentiality of personal 
information of research subjects. The responsibility for the protection of research subjects 
must always rest with the physician or other health care professionals and never with the 
research subjects, even though they have given consent. 
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10. 
Physicians must consider the ethical, legal, and regulatory norms and standards for research 
involving human subjects in their own countries as well as applicable international norms and 
standards. No national or international ethical, legal, or regulatory requirement should 
reduce or eliminate any of the protections for research subjects set forth in this Declaration. 
11. 
Medical research should be conducted in a manner that minimizes possible harm to the 
environment. 
12. 
Medical research involving human subjects must be conducted only by individuals with the 
appropriate ethics and scientific education, training, and qualifications. Research on patients 
or healthy volunteers requires the supervision of a competent and appropriately qualified 
physician or other health care professional. 
13. 
Groups that are underrepresented in medical research should be provided appropriate access 
to participation in research. 
14. 
Physicians who combine medical research with medical care should involve their patients in 
research only to the extent that this is justified by its potential preventive, diagnostic or 
therapeutic value and if the physician has good reason to believe that participation in the 
research study will not adversely affect the health of the patients who serve as research 
subjects. 
15. 
Appropriate compensation and treatment for subjects who are harmed as a result of 
participating in research must be ensured. 
F.3  
RISKS, BURDENS AND BENEFITS 
16. 
In medical practice and in medical research, most interventions involve risks and burdens. 
Medical research involving human subjects may only be conducted if the importance of the 
objective outweighs the risks and burdens to the research subjects. 
17. 
All medical research involving human subjects must be preceded by careful assessment of 
predictable risks and burdens to the individuals and groups involved in the research in 
comparison with foreseeable benefits to them and to other individuals or groups affected by 
the condition under investigation. 
Measures to minimize the risks must be implemented. The risks must be continuously 
monitored, assessed, and documented by the researcher. 
18. 
Physicians may not be involved in a research study involving human subjects unless they are 
confident that the risks have been adequately assessed and can be satisfactorily managed. 
When the risks are found to outweigh the potential benefits or when there is conclusive proof 
of definitive outcomes, physicians must assess whether to continue, modify or immediately 
stop the study. 
 
 
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F.4  
Vulnerable Groups and Individuals 
19. 
Some groups and individuals are particularly vulnerable and may have an increased likelihood 
of being wronged or of incurring additional harm. 
All vulnerable groups and individuals should receive specifically considered protection. 
20. 
Medical research with a vulnerable group is only justified if the research is responsive to the 
health needs or priorities of this group and the research cannot be carried out in a non-
vulnerable group. In addition, this group should stand to benefit from the knowledge, 
practices or interventions that result from the research. 
F.5  
Scientific Requirements and Research Protocols 
21. 
Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant 
sources of information, and adequate laboratory and, as appropriate, animal 
experimentation. The welfare of animals used for research must be respected. 
22. 
The design and performance of each research study involving human subjects must be clearly 
described and justified in a research protocol. 
The protocol should contain a statement of the ethical considerations involved and should 
indicate how the principles in this Declaration have been addressed. The protocol should 
include information regarding funding, sponsors, institutional affiliations, potential conflicts 
of interest, incentives for subjects and information regarding provisions for treating and/or 
compensating subjects who are harmed as a consequence of participation in the research 
study. 
In clinical trials, the protocol must also describe appropriate arrangements for post-trial 
provisions. 
F.6  
Research Ethics Committees 
23. 
The research protocol must be submitted for consideration, comment, guidance, and 
approval to the concerned research ethics committee before the study begins. This 
committee must be transparent in its functioning, must be independent of the researcher, 
the sponsor and any other undue influence and must be duly qualified. It must take into 
consideration the laws and regulations of the country or countries in which the research is to 
be performed as well as applicable international norms and standards but these must not be 
allowed to reduce or eliminate any of the protections for research subjects set forth in this 
Declaration. 
The committee must have the right to monitor ongoing studies. The researcher must provide 
monitoring information to the committee, especially information about any serious adverse 
events. No amendment to the protocol may be made without consideration and approval by 
the committee. After the end of the study, the researchers must submit a final report to the 
committee containing a summary of the study’s findings and conclusions. 
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F.7  
Privacy and Confidentiality 
24. 
Every precaution must be taken to protect the privacy of research subjects and the 
confidentiality of their personal information. 
F.8  
Informed Consent 
25. 
Participation by individuals capable of giving informed consent as subjects in medical research 
must be voluntary. Although it may be appropriate to consult family members or community 
leaders, no individual capable of giving informed consent may be enrolled in a research study 
unless he or she freely agrees. 
26. 
In medical research involving human subjects capable of giving informed consent, each 
potential subject must be adequately informed of the aims, methods, sources of funding, any 
possible conflicts of interest, institutional affiliations of the researcher, the anticipated 
benefits and potential risks of the study and the discomfort it may entail, post-study 
provisions and any other relevant aspects of the study. The potential subject must be 
informed of the right to refuse to participate in the study or to withdraw consent to 
participate at any time without reprisal. Special attention should be given to the specific 
information needs of individual potential subjects as well as to the methods used to deliver 
the information. 
After ensuring that the potential subject has understood the information, the physician or 
another appropriately qualified individual must then seek the potential subject’s freely given 
informed consent, preferably in writing. If the consent cannot be expressed in writing, the 
non-written consent must be formally documented and witnessed. 
All medical research subjects should be given the option of being informed about the general 
outcome and results of the study. 
27. 
When seeking informed consent for participation in a research study the physician must be 
particularly cautious if the potential subject is in a dependent relationship with the physician 
or may consent under duress. In such situations the informed consent must be sought by an 
appropriately qualified individual who is completely independent of this relationship. 
28. 
For a potential research subject who is incapable of giving informed consent, the physician 
must seek informed consent from the legally authorized representative. These individuals 
must not be included in a research study that has no likelihood of benefit for them unless it is 
intended to promote the health of the group represented by the potential subject, the 
research cannot instead be performed with persons capable of providing informed consent, 
and the research entails only minimal risk and minimal burden. 
29. 
When a potential research subject who is deemed incapable of giving informed consent is 
able to give assent to decisions about participation in research, the physician must seek that 
assent in addition to the consent of the legally authorized representative. The potential 
subject’s dissent should be respected. 
30. 
Research involving subjects who are physically or mentally incapable of giving consent, for 
example, unconscious patients, may be done only if the physical or mental condition that 
prevents giving informed consent is a necessary characteristic of the research group. In such 
circumstances the physician must seek informed consent from the legally authorized 
representative. If no such representative is available and if the research cannot be delayed, 
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the study may proceed without informed consent provided that the specific reasons for 
involving subjects with a condition that renders them unable to give informed consent have 
been stated in the research protocol and the study has been approved by a research ethics 
committee. Consent to remain in the research must be obtained as soon as possible from the 
subject or a legally authorized representative. 
31. 
The physician must fully inform the patient which aspects of their care are related to the 
research. The refusal of a patient to participate in a study or the patient’s decision to withdraw 
from the study must never adversely affect the patient-physician relationship. 
32. 
For medical research using identifiable human material or data, such as research on material 
or data contained in biobanks or similar repositories, physicians must seek informed consent 
for its collection, storage and/or reuse. There may be exceptional situations where consent 
would be impossible or impracticable to obtain for such research. In such situations the 
research may be done only after consideration and approval of a research ethics committee. 
F.9  
Use of Placebo 
33. 
The benefits, risks, burdens, and effectiveness of a new intervention must be tested against 
those of the best proven intervention(s), except in the following circumstances: 
Where no proven intervention exists, the use of placebo, or no intervention, is acceptable; or 
Where for compelling and scientifically sound methodological reasons the use of any 
intervention less effective than the best proven one, the use of placebo, or no intervention is 
necessary to determine the efficacy or safety of an intervention 
and the patients who receive any intervention less effective than the best proven one, 
placebo, or no intervention will not be subject to additional risks of serious or irreversible 
harm as a result of not receiving the best proven intervention. 
Extreme care must be taken to avoid abuse of this option. 
F.10 
Post-Trial Provisions 
34. 
In advance of a clinical trial, sponsors, researchers, and host country governments should 
make provisions for post-trial access for all participants who still need an intervention 
identified as beneficial in the trial. This information must also be disclosed to participants 
during the informed consent process. 
F.11 
Research Registration and Publication and Dissemination of Results 
35. 
Every research study involving human subjects must be registered in a publicly accessible 
database before recruitment of the first subject. 
36. 
Researchers, authors, sponsors, editors, and publishers all have ethical obligations with 
regard to the publication and dissemination of the results of research. Researchers have a 
duty to make publicly available the results of their research on human subjects and are 
accountable for the completeness and accuracy of their reports. All parties should adhere to 
accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results 
must be published or otherwise made publicly available. Sources of funding, institutional 
affiliations and conflicts of interest must be declared in the publication. Reports of research 
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not in accordance with the principles of this Declaration should not be accepted for 
publication. 
F.12 
Unproven Interventions in Clinical Practice 
37. 
In the treatment of an individual patient, where proven interventions do not exist or other 
known interventions have been ineffective, the physician, after seeking expert advice, with 
informed consent from the patient or a legally authorized representative, may use an 
unproven intervention if in the physician’s judgement it offers hope of saving life, re-
establishing health or alleviating suffering. This intervention should subsequently be made 
the object of research, designed to evaluate its safety and efficacy. In all cases, new 
information must be recorded and, where appropriate, made publicly available. 
 
 
 
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