Trabeculectomy Versus 2-iStent and Prostaglandin Study

Not Applicable

Withdrawn

• Conditions: Glaucoma, Open-Angle
• Interventions: Device: iStent and travoprost or latanoprost; Procedure: Trabeculectomy

• Registration Number: NCT03274323
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-06
• Status Verified: 2018-01
• Study Start: 2018-01-12
• Primary Completion: 2018-01-12
• Study Completion: 2018-01-12
• Last Update Submitted: 2018-01-17
• Last Update Posted: 2018-01-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 iStent with travoprost or latanoprost	iStent and travoprost or latanoprost	2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery
trabeculectomy	Trabeculectomy	Standard trabeculectomy

Primary Outcome Measures

Name	Time	Method
IOP >= 20% reduction from untreated baseline	Post surgery month 4	IOP
IOP <= 18 mmHg	Post surgery month 4	IOP
IOP <= 15 mmHg	Post surgery month 4	IOP