Primary Tube Versus Trabeculectomy Study
Overview
- Phase
- Phase 4
- Intervention
- Tube shunt surgery
- Conditions
- Glaucoma
- Sponsor
- University of Miami
- Enrollment
- 242
- Locations
- 16
- Primary Endpoint
- Number of Participants With Surgical Failure
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Steven J. Gedde
Dr
University of Miami
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
Arms & Interventions
Tube shunt surgery group
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Intervention: Tube shunt surgery
Trabeculectomy with Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Intervention: Trabeculectomy
Trabeculectomy with Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
Intervention: Mitomycin C
Outcomes
Primary Outcomes
Number of Participants With Surgical Failure
Time Frame: Up to 5 years
Surgical failure is defined as: 1. Inadequate Intraocular Pressure (IOP) Reduction (IOP \> 21 mmHg or reduced \< 20% below baseline on 2 consecutive follow-up visits after 3 months) 2. Reoperation for glaucoma 3. Persistent hypotony (IOP ≤ 5 mmHg on 2 consecutive visits after 3 months) 4. Loss of light perception vision
Secondary Outcomes
- Visual Acuity as Measured Using EDTRS Chart(At baseline, At 5 years)
- Visual Field(Up to 5 years)
- Reoperation for Glaucoma(Up to 5 years)
- Number of Participants With Reported Postoperative Complications(Up to 5 years)
- Intraocular Pressure(At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years)
- Visual Acuity Using a Snellen Chart(At Baseline, At 5 years)
- Number of Glaucoma Medications(At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years)