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

NCT03551834 | Unknown Phase 1

• 1 other identifier: 97122
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Intraocular pressure(IOP)

  Goldmann applanation tonometry

  12 months post operatively

• Tube exposure

  slit lamp examination

  12 months post operatively

Secondary Outcomes (1)

• success rate

  12 months

Study Arms (2)

doing scleral patch graft glaucoma implantation

ACTIVE COMPARATOR

Other: Conventional scleral patch graft glaucoma implantation

Using short tunnel small flap technique

ACTIVE COMPARATOR

Other: New surgical method (short tunnel small flap technique)

Interventions

Conventional scleral patch graft glaucoma implantation OTHER

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

doing scleral patch graft glaucoma implantation

New surgical method (short tunnel small flap technique) OTHER

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

Using short tunnel small flap technique

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Central Study Contacts

Mohammad Pakravan, MD

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 11, 2018
• Study Start: January 20, 2017
• Primary Completion: September 20, 2017
• Study Completion: September 1, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-05

Locations

IR (1)