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Trabeculectomy Versus 2-iStent and Prostaglandin Study — TIPS  

Glaucoma, Open-Angle Clinical Trial

Official title:
Trabeculectomy Versus 2-iStent and Prostaglandin Study

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03274323
Study type Interventional
Source Johns Hopkins University
Contact
Status Withdrawn
Phase N/A
Start date January 12, 2018
Completion date January 12, 2018
View Details
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