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Shunt Tube Exposure Prevention Study

NCT01551550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-05-18

Study results available
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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.

Conditions

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.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Bascom Palmer Eye Institute

    collaborator OTHER

  • The New York Eye & Ear Infirmary

    collaborator OTHER

  • Columbia University

    collaborator OTHER

  • BioTissue Holdings, Inc

    lead INDUSTRY

Principal Investigators

  • Hosam El Sheha, MD, PhD · BioTissue Holdings, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2016-12-31
Completion
2019-08-03

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01551550 on ClinicalTrials.gov