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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
242
The procedure involves implantation of a Baerveldt consisting of a tube that is connected to an end plate. The tube is inserted into the anterior chamber and shunts aqueous humor to the end plate located in the equatorial region of the eye. The aqueous humor is then absorbed by the tissues around the eye.
The procedure involves removal of a small portion of trabecular meshwork and adjacent tissue under a partial thickness scleral flap. Aqueous humor drains into the subconjunctival space producing a filtering bleb. The aqueous humor then diffuse out of the bleb.
A fluid retaining sponge soaked in 0.4 mg/ml Mitomycin C will be applied in the region of Trabeculectomy site for about 2 minutes
University of California Davis Medical Center
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
Number of Participants With Surgical Failure
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
Time frame: Up to 5 years
Intraocular Pressure
Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.
Time frame: At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
Number of Participants With Reported Postoperative Complications
Number of participants with early and late postoperative complications will be reported as per treating physician assessment
Time frame: Up to 5 years
Visual Acuity Using a Snellen Chart
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.
Time frame: At Baseline, At 5 years
Visual Acuity as Measured Using EDTRS Chart
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.
Time frame: At baseline, At 5 years
Visual Field
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Bascom Palmer Eye Institute
Miami, Florida, United States
Johns Hopkins
Baltimore, Maryland, United States
St. Louis University
St Louis, Missouri, United States
New York Eye and Ear Infirmary
New York, New York, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
...and 6 more locations
Visual fields will be measured using standard automated perimetry.
Time frame: Up to 5 years
Reoperation for Glaucoma
The number of participants requiring reoperation for glaucoma will be reported
Time frame: Up to 5 years
Number of Glaucoma Medications
The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used
Time frame: At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years