CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 82 enrolled
Drug / intervention
GDD +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01551550
NCT01551550N/ACompleted
CompareCT.gov

Amniotic Membrane Versus Pericardium in Reducing Glaucoma Drainage Tube Exposure: A Randomized Clinical Trial

BioTissue Holdings, Inc·interventional·Posted Mar 12, 2012·Updated May 18, 2022

In Brief

A clinical study evaluating GDD, Amniotic Membrane Graft, and 1 other intervention for Glaucoma. Completed, enrolled 82 participants across 4 sites.

Detailed Summary

This is a multi-site randomized clinical trial to evaluate the long-term efficacy of the thicker amniotic membrane graft (AmnioGuard™, Bio-Tissue, Inc, Miami, FL) in reducing shunt tube exposure in patients undergoing glaucoma drainage device implantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma
CountriesUnited States
CollaboratorsNational Eye Institute (NEI), Bascom Palmer Eye Institute, The New York Eye & Ear Infirmary, Columbia University

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 12, 2012
Enrollment StartJun 1, 2013
Primary CompletionDec 1, 2016
Study CompletionAug 3, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 14.3 years ago

Interventions

GDDprocedure

The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.

Amniotic Membrane Graftprocedure

For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.

Pericardial Graftprocedure

For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.