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Trabeculectomy Versus 2-iStent and Prostaglandin Study

NCT03274323 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-01-19

No results posted yet for this study

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.

Conditions

  • Glaucoma, Open-Angle

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-12
Primary Completion
2018-01-12
Completion
2018-01-12
FDA Device
Yes

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03274323 on ClinicalTrials.gov