Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft

Phase 1

• Conditions: Glaucoma
• Interventions: Other: Conventional scleral patch graft glaucoma implantation; Other: New surgical method (short tunnel small flap technique)

• Registration Number: NCT03551834
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Glaucoma implants have been used for refractory glaucoma and are gaining popularity as a primary procedure in selected patients. In order to prevent tube erosion, a biologic material such as pericardium, cornea, and sclera is used as coverage over the tube. Despite this preventive measures, patch graft thinning and silicon tube exposure are still a serious complications and may occur in 1%-7% of eyes after glaucoma implantation. In this study we used a novel technique named short tunnel small flap (STSF) by tunneling the sclera without using any biological material . efficacy and safety of this technique is comparing with conventional scleral patch graft.

This randomized clinical trial, was performed at the Glaucoma Clinic of Labbafinejad Medical Center, Tehran, IRAN from September 2015 to January 2017 . The study was approved by the ethics committee at the Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and followed the tenets of the Declaration of Helsinki. After explaining all therapeutic options and their side effects, the written consent form was obtained from all patient. 80 eyes of 80 patients with refractory glaucoma underwent AGV implantation by short tunnel small flap technique (group1) or scleral patch graft (group2) randomly. Primary outcome measure is Intraocular pressure(IOP) and Tube exposure, and secondary outcome measure is success rate that is defined as intraocular pressure (IOP) \> 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma. Outcome measures are compared at 1, 3 , 6 and 12 months postoperatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-20
• Primary Completion: 2017-09-20
• Status Verified: 2018-05
• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-29
• Last Update Submitted: 2018-05-29
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Iranian patients with Caucasian ethnicity, and at least 25 years old who had inadequately controlled glaucoma.

Exclusion Criteria

• Primary congenital glaucoma, thin sclera, no light perception vision, pregnant or nursing women, iridocorneal endothelial syndrome, epithelial or fibrous down growth, and unwillingness to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
doing scleral patch graft glaucoma implantation	Conventional scleral patch graft glaucoma implantation	-
Using short tunnel small flap technique	New surgical method (short tunnel small flap technique)	-

Primary Outcome Measures

Name	Time	Method
Intraocular pressure(IOP)	12 months post operatively	Goldmann applanation tonometry
Tube exposure	12 months post operatively	slit lamp examination

Secondary Outcome Measures

Name	Time	Method
success rate	12 months	Success rate defined as intraocular pressure (IOP) \> 5 mmHg, ≤ 21 mmHg, and IOP reduction ≥ 20% from baseline at two consecutive visits after three months, no reoperation for glaucoma

Trial Locations

Locations (1)

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