CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 212 enrolled
Drug / intervention
Baerveldt implant +1 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/NCT00306852
NCT00306852N/ACompleted
CompareCT.gov

Tube Versus Trabeculectomy (TVT) Study

University of Miami·interventional·Posted Mar 24, 2006·Updated Nov 25, 2015

In Brief

A clinical study evaluating Baerveldt implant and Trabeculectomy with mitomycin C for Glaucoma. Completed, enrolled 212 participants across 17 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma
CountriesUnited Kingdom, United States
CollaboratorsPfizer, Abbott Medical Optics

Timeline

N/ACompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 24, 2006
Enrollment StartOct 1, 1999
Primary CompletionApr 1, 2009
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 20.3 years ago

Interventions

Baerveldt implantprocedure

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)

Trabeculectomy with mitomycin Cprocedure

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