Clinical trial NCT00666237: Primary Tube Versus Trabeculectomy Study
Official title: Primary Tube Versus Trabeculectomy Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: Tube shunt surgery
Trabeculectomy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Abbott Medical Optics
name: Research to Prevent Blindness
name: National Eye Institute (NEI)
First posted: 2008-04-24
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Surgical Failure
timeFrame: Up to 5 years
Secondary outcomes:
measure: Intraocular Pressure
timeFrame: At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
measure: Number of Participants With Reported Postoperative Complications
timeFrame: Up to 5 years
measure: Visual Acuity Using a Snellen Chart
timeFrame: At Baseline, At 5 years
measure: Visual Acuity as Measured Using EDTRS Chart
timeFrame: At baseline, At 5 years
measure: Visual Field
timeFrame: Up to 5 years
measure: Reoperation for Glaucoma
timeFrame: Up to 5 years
measure: Number of Glaucoma Medications
timeFrame: At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Medical Center
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Saint Louis
country: United States
facility: St. Louis University
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Houston
country: United States
facility: University of Texas, Houston
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Toronto
country: Canada
facility: University of Toronto
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
city: London
country: United Kingdom
facility: St. Thomas' Hospital
city: Sidcup
country: United Kingdom
facility: Queen Mary's Sidcup Hospital
Study officials:
affiliation: Bascom Palmer Eye Institute
name: Steven J Gedde, MD
role: STUDY_CHAIR
affiliation: Medical College of Wisconsin
name: Dale K Heuer, MD
role: STUDY_CHAIR
affiliation: Bascom Palmer Eye Institute
name: Richard K Parrish, MD
role: STUDY_CHAIR
References:
citation: Gedde SJ, Chen PP, Heuer DK, Singh K, Wright MM, Feuer WJ, Schiffman JC, Shi W; Primary Tube Versus Trabeculectomy Study Group. The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C. Ophthalmology. 2018 May;125(5):774-781. doi: 10.1016/j.ophtha.2017.10.037. Epub 2017 Dec 18.
citation: Gedde SJ, Feuer WJ, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt JD; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 3 Years of Follow-up. Ophthalmology. 2020 Mar;127(3):333-345. doi: 10.1016/j.ophtha.2019.10.002. Epub 2019 Oct 9.
citation: Gedde SJ, Feuer WJ, Shi W, Lim KS, Barton K, Goyal S, Ahmed IIK, Brandt J; Primary Tube Versus Trabeculectomy Study Group. Treatment Outcomes in the Primary Tube Versus Trabeculectomy Study after 1 Year of Follow-up. Ophthalmology. 2018 May;125(5):650-663. doi: 10.1016/j.ophtha.2018.02.003. Epub 2018 Feb 21.
citation: Gedde SJ, Feuer WJ, Chen PP, Heuer DK, Singh K, Wright MM; Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Study Groups. Comparing Treatment Outcomes from the Tube Versus Trabeculectomy and Primary Tube Versus Trabeculectomy Studies. Ophthalmology. 2021 Feb;128(2):324-326. doi: 10.1016/j.ophtha.2020.06.059. Epub 2020 Jul 2.