Trabeculectomy Versus 2-iStent and Prostaglandin Study

Study Overview
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Brief Summary
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Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.

Detailed Description
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This will be a prospective randomized controlled study. 20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.

Official Title
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Trabeculectomy Versus 2-iStent and Prostaglandin Study

Conditions
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Glaucoma, Open-Angle

Intervention / Treatment
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* Device: iStent and travoprost or latanoprost
* Procedure: Trabeculectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have mental capacity to give consent Age >= 21 years Pseudophakic or phakic without visually significant cataract Open angle glaucoma IOP in the range of 18-30 mmHg with 2 or more topical medications Cup-disc ratio =< 0.9 Best corrected visual acuity of 20/100 or better Exclusion Criteria: Inability to give consent Inability to tolerate or presence of allergy to prostaglandin analogs Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study Age < 21 years Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient Secondary glaucoma or angle closure glaucoma Aphakia Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy) Prior laser trabeculoplasty < 90 days prior to screening or absolute failure of prior laser trabeculoplasty.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2 iStent with travoprost or latanoprost<br>2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery | Device: iStent and travoprost or latanoprost<br>* 2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure<br>|
| Active Comparator: trabeculectomy<br>Standard trabeculectomy | Procedure: Trabeculectomy<br>* Standard trabeculectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP <= 18 mmHg | IOP | Post surgery month 4 | 
| IOP <= 15 mmHg | IOP | Post surgery month 4 | 
| IOP >= 20% reduction from untreated baseline | IOP | Post surgery month 4 |