Primary Tube Versus Trabeculectomy Study
- Conditions
- Glaucoma
- Interventions
- Registration Number
- NCT00666237
- Lead Sponsor
- University of Miami
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tube shunt surgery group Tube shunt surgery Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant). Trabeculectomy with Mitomycin C Trabeculectomy Participants in this group will receive a Trabeculectomy surgery with Mitomycin C Trabeculectomy with Mitomycin C Mitomycin C Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
- Primary Outcome Measures
Name Time Method Number of Participants With Surgical Failure 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 Outcome Measures
Name Time Method Visual Acuity as Measured Using EDTRS Chart At baseline, At 5 years Visual acuity will be reported as the number of correctly identified letters on the Early Treatment Diabetic Retinopathy Study (EDTRS) chart. Total score ranges from 0-100 with the higher score indicating better visual acuity.
Visual Field Up to 5 years Visual fields will be measured using standard automated perimetry.
Reoperation for Glaucoma Up to 5 years The number of participants requiring reoperation for glaucoma will be reported
Number of Participants With Reported Postoperative Complications Up to 5 years Number of participants with early and late postoperative complications will be reported as per treating physician assessment
Intraocular Pressure At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Visual Acuity Using a Snellen Chart At Baseline, At 5 years Visual acuity will be measured using a Snellen chart on logMAR (Logarithm of Minimal Angle of Resolution) scale. Letter-by letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Number of Glaucoma Medications At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used
Trial Locations
- Locations (16)
St. Louis University
🇺🇸Saint Louis, Missouri, United States
New York Eye and Ear Infirmary
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Toronto
🇨🇦Toronto, Canada
Moorfields Eye Hospital
🇬🇧London, United Kingdom
St. Thomas' Hospital
🇬🇧London, United Kingdom
Queen Mary's Sidcup Hospital
🇬🇧Sidcup, United Kingdom
University of Florida
🇺🇸Gainesville, Florida, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
University of Texas, Houston
🇺🇸Houston, Texas, United States
Glaucoma Associates of Texas
🇺🇸Dallas, Texas, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Cincinnati Eye Institute
🇺🇸Cincinnati, Ohio, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
University of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States