Shunt Tube Exposure Prevention Study

NACompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

August 3, 2019

Conditions
Glaucoma
Interventions
PROCEDURE

GDD

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.

PROCEDURE

Amniotic Membrane Graft

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

PROCEDURE

Pericardial Graft

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

Trial Locations (4)

10003

New York Eye and Ear Infirmary, New York

10021

Manhattan Eye, Ear, and Throat Hospital, New York

10032

Harkness Eye Institute/ Columbia University, New York

33136

Bascom Palmer Eye Institute, Miami

All Listed Sponsors
collaborator

National Eye Institute (NEI)

NIH

collaborator

Bascom Palmer Eye Institute

OTHER

collaborator

The New York Eye & Ear Infirmary

OTHER

collaborator

Columbia University

OTHER

lead

BioTissue Holdings, Inc

INDUSTRY

NCT01551550 - Shunt Tube Exposure Prevention Study | Biotech Hunter | Biotech Hunter