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Ahmed Versus Baerveldt Comparison Study

NCT00376363 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2015-08-20

Study results available
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Summary

The objective of this study is to compare the long-term safety and efficacy of the Ahmed and the Baerveldt implants in patients who are undergoing aqueous shunt implant surgery for glaucoma. One eye of eligible patients will be randomized. Outcome measures include intraocular pressure, visual acuity, visual field, number of glaucoma medications, glaucoma reoperations, and complications, including suprachoroidal hemorrhage, endophthalmitis, choroidal effusion, diplopia, corneal edema, and shunt/tube erosion.

Conditions

Interventions

DEVICE

Ahmed implant

placement of glaucoma drainage device to control intraocular pressure

DEVICE

Baerveldt implant

placement of glaucoma drainage device to control intraocular press

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Research to Prevent Blindness

    collaborator OTHER

  • University of Miami

    lead OTHER

Principal Investigators

  • Donald L Budenz, M.D.,M.P.H. · University of North Carolina

  • Keith Barton, M.D. · Moorfields Eye Hospital NHS Foundation Trust

  • William J Feuer, M.S. · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2013-12-31
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00376363 on ClinicalTrials.gov