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Tube Versus Trabeculectomy (TVT) Study

NCT00306852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2015-11-25

Study results available
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Summary

The purpose of the Tube Versus Trabeculectomy (TVT) Study is to compare the safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in patients with previous ocular surgery.

Conditions

Interventions

PROCEDURE

Baerveldt implant

Patients will be randomized to receive a 350 mm\^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)

PROCEDURE

Trabeculectomy with mitomycin C

Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm\^2 Baerveldt glaucoma implant

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Abbott Medical Optics

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Steven J Gedde, M.D. · Bascom Palmer Eye Institute

  • Dale K Heuer, M.D. · Medical College of Wisconsin

  • Richard K Parrish, M.D. · Bascom Palmer Eye Institute

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
1999-10-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • United States
  • United Kingdom

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 NCT00306852 on ClinicalTrials.gov