NCT03274323

Trabeculectomy Versus 2-iStent and Prostaglandin Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glaucoma, Open-Angle

Interventions

Type	Name	Description
DEVICE	iStent and travoprost or latanoprost	2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure
PROCEDURE	Trabeculectomy	Standard trabeculectomy

Timeline

• Start date: 2018-01-12
• Primary completion: 2018-01-12
• Completion: 2018-01-12
• First posted: 2017-09-06
• Last updated: 2018-01-19

Regulatory

• FDA-regulated device study