Phase 4
N=242
Primary Tube Versus Trabeculectomy Study
Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT00666237 ↗Enrolled (actual)
242
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Number of Participants With Surgical Failure — 31; 23; 18; 9 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tube shunt surgery (Procedure); Trabeculectomy (Procedure); Mitomycin C (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Surgical Failure |
31; 23; 18; 9; 0; 1 | — |
| SECONDARY Intraocular Pressure |
23.3; 23.9; 13.8; 12.4; 13.5; 12.8 | — |
| SECONDARY Number of Participants With Reported Postoperative Complications |
24; 40; 27; 32 | — |
| SECONDARY Visual Acuity Using a Snellen Chart |
0.20; 0.25; 0.30; 0.42 | — |
| SECONDARY Visual Acuity as Measured Using EDTRS Chart |
73; 73; 69; 66 | — |
| SECONDARY Visual Field |
— | — |
| SECONDARY Reoperation for Glaucoma |
21; 12 | — |
| SECONDARY Number of Glaucoma Medications |
3.1; 3.2; 2.1; 0.9; 2.1; 0.8 | — |
Summary
The purpose of the Primary Tube Versus Trabeculectomy (PTVT) Study is to compare the long-term safety and efficacy of nonvalved tube shunt surgery to trabeculectomy with mitomycin C in eyes that have not had previous ocular surgery.
Eligibility Criteria
Inclusion Criteria
- Age 18-85 years
- Glaucoma that is inadequately controlled on tolerated medical therapy with Intraocular Pressure (IOP) greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg
- No previous incisional ocular surgery
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 ingrowth
- Chronic or recurrent uveitis
- Steroid-induced glaucoma
- Severe posterior blepharitis
- Unwilling to discontinue contact lens use after surgery
- Previous cyclodestructive procedure
- Conjunctival scarring from prior ocular trauma or cicatrizing disease precluding a superior trabeculectomy
- Functionally significant cataract
- Need for glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery
Data sourced from ClinicalTrials.gov (NCT00666237). 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.