Ahmed Glaucoma Valve Alone, With Amniotic Membrane or With Mitomycin C (MMC) for Treatment of Refractory Glaucoma

Phase 1

• Conditions: Refractory Glaucoma
• Interventions: Device: Ahmed Glaucoma Valve (AGV); Drug: Mitomycin C (MMC); Procedure: amniotic membrane coverage

• Registration Number: NCT00893490
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

This randomized, controlled trial (RCT) compares the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation alone, with 3 minutes MMC application or with a single layer coverage of amniotic membrane. Outcomes include intraocular eye pressure (IOP), postoperative glaucoma medication and complications. AGV implantation site will be superior or inferior based on indication and these groups will be randomized separately.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-05
• Study First Submitted: 2009-05-04
• Study First Submitted QC: 2009-05-04
• Last Update Submitted: 2009-05-04
• Study First Posted: 2009-05-06
• Last Update Posted: 2009-05-06

Recruitment & Eligibility

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

Inclusion Criteria

• patients with refractory glaucoma

Exclusion Criteria

• children under 7 years old
• adults above 75 years old
• uncooperative patients
• patients underwent the operation for second time
• patients with major operation with AGV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ahmed Glaucoma Valve (AGV) alone	Ahmed Glaucoma Valve (AGV)	-
AGV plus MMC	Ahmed Glaucoma Valve (AGV)	-
AGV plus MMC	Mitomycin C (MMC)	-
AGV plus amniotic membrane coverage	Ahmed Glaucoma Valve (AGV)	-
AGV plus amniotic membrane coverage	amniotic membrane coverage	-

Trial Locations

Locations (1)

Ophthalmic Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of