N/A
Completed N=212
Tube Versus Trabeculectomy (TVT) Study
Source: ClinicalTrials.gov NCT00306852 ↗Enrolled (actual)
212
Serious AEs
13.2%
Results posted
Nov 2015
Primary outcomePrimary: Change in Intraocular Pressure — 12.6; 14.4 mm Hg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure |
12.6; 14.4 | — |
| PRIMARY Rate of Complications |
39; 33; 38; 36 | — |
| SECONDARY Visual Acuity |
56; 33; 44; 46 | — |
| SECONDARY Reoperations for Glaucoma |
15; 20 | — |
| SECONDARY Need for Supplemental Medical Therapy |
1.2; 1.4 | — |
| SECONDARY Failure Rate |
46.9; 29.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 85 years
- Intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
- Previous trabeculectomy, cataract extraction with intraocular lens implantation, or both
Exclusion Criteria
- Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
- Pregnant or nursing women
- No light perception vision
- Active iris neovascularization or active proliferative retinopathy
- Iridocorneal endothelial syndrome
- Epithelial or fibrous downgrowth
- Aphakia
- Vitreous in the anterior chamber for which a vitrectomy is anticipated
- Chronic or recurrent uveitis
- Severe posterior blepharitis
- Unwilling to discontinue contact lens use after surgery
- Previous cyclodestructive procedure, scleral buckling procedure, or presence of silicone oil
- Conjunctival scarring precluding a trabeculectomy superiorly
- Need for glaucoma surgery combined with other ocular procedures (eg cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
Data sourced from ClinicalTrials.gov (NCT00306852). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.