Trabeculectomy Versus 2-iStent and Prostaglandin Study

NCT ID: NCT03274323

Last Updated: 2018-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-12
• Study Completion Date: 2018-01-12

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.

Conditions

Glaucoma, Open-Angle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 iStent with travoprost or latanoprost

2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery

Group Type: EXPERIMENTAL

iStent and travoprost or latanoprost

Intervention Type: DEVICE

2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure

trabeculectomy

Standard trabeculectomy

Group Type: ACTIVE_COMPARATOR

Trabeculectomy

Intervention Type: PROCEDURE

Standard trabeculectomy

Interventions

iStent and travoprost or latanoprost

2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure

Intervention Type: DEVICE

Trabeculectomy

Standard trabeculectomy

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB00146334

Identifier Type: -

Identifier Source: org_study_id