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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03551834
• Other study ID #: 97122
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 20, 2017
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: Mohammad Pakravan, MD
• Phone: 009822591616
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 2018
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma

Intervention

Other:
• Conventional scleral patch graft glaucoma implantation
conventional AGV implantation by using scleral patch graft to cover the tube and prevent tube exposure
• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure(IOP)	Goldmann applanation tonometry	12 months post operatively
Primary	Tube exposure	slit lamp examination	12 months post operatively
Secondary	success rate	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	12 months