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

NCT ID: NCT03551834

Last Updated: 2018-06-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2018-09-30

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.

Conditions

Glaucoma

Study Design

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

Study Groups

doing scleral patch graft glaucoma implantation

Group Type: ACTIVE_COMPARATOR

Conventional scleral patch graft glaucoma implantation

Intervention Type: OTHER

conventional AGV implantation by using scleral patch graft to cover the tube and prevent tube exposure

Using short tunnel small flap technique

Group Type: ACTIVE_COMPARATOR

New surgical method (short tunnel small flap technique)

Intervention Type: OTHER

a novel technique named short tunnel small flap (STSF) by tunneling the sclera to pass the AGV tube without using scleral patch graft.

Interventions

Conventional scleral patch graft glaucoma implantation

conventional AGV implantation by using scleral patch graft to cover the tube and prevent tube exposure

Intervention Type: OTHER

New surgical method (short tunnel small flap technique)

a novel technique named short tunnel small flap (STSF) by tunneling the sclera to pass the AGV tube without using scleral patch graft.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ophthalmic Research Center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Mohammad Pakravan, MD

Role: CONTACT

labbafi@hotmail.com

009822591616

Facility Contacts

Mohammad Pakravan, MD

Role: primary

labbafi@hotmail.com

009822591616

Other Identifiers

97122

Identifier Type: -

Identifier Source: org_study_id