Primary Tube Versus Trabeculectomy Study

Glaucoma Clinical Trial

Official title:

Primary Tube Versus Trabeculectomy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666237
• Other study ID #: 20071037
• Secondary ID: EY014801
• Status: Completed
• Phase: Phase 4
• Start date: April 1, 2008
• Est. completion date: April 1, 2021

Study information

• Verified date: October 2022
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• Tube shunt surgery
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.
• Trabeculectomy
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.

Drug:
• Mitomycin C
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

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto
United Kingdom	Moorfields Eye Hospital	London
United Kingdom	St. Thomas' Hospital	London
United Kingdom	Queen Mary's Sidcup Hospital	Sidcup
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Virginia	Charlottesville	Virginia
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	University of Florida	Gainesville	Florida
United States	University of Texas, Houston	Houston	Texas
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	New York Eye and Ear Infirmary	New York	New York
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of California Davis Medical Center	Sacramento	California
United States	St. Louis University	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
University of Miami	Abbott Medical Optics, National Eye Institute (NEI), Research to Prevent Blindness

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

References & Publications (4)

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. — View 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. Oph — View 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 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Surgical Failure	Surgical failure is defined as: Inadequate Intraocular Pressure (IOP) Reduction (IOP > 21 mmHg or reduced < 20% below baseline on 2 consecutive follow-up visits after 3 months); Reoperation for glaucoma; Persistent hypotony (IOP = 5 mmHg on 2 consecutive visits after 3 months); Loss of light perception vision	Up to 5 years
Secondary	Intraocular Pressure	Intraocular pressure will be reported in mmHg and measured using Goldmann applanation tonometry or a Tono-Pen.	At baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years
Secondary	Number of Participants With Reported Postoperative Complications	Number of participants with early and late postoperative complications will be reported as per treating physician assessment	Up to 5 years
Secondary	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.	At Baseline, At 5 years
Secondary	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.	At baseline, At 5 years
Secondary	Visual Field	Visual fields will be measured using standard automated perimetry.	Up to 5 years
Secondary	Reoperation for Glaucoma	The number of participants requiring reoperation for glaucoma will be reported	Up to 5 years
Secondary	Number of Glaucoma Medications	The need for supplemental glaucoma medications will be reported as the number of glaucoma medications used	At Baseline, At 1 year, At 18 months, At 2 years, At 3 years, At 4 years, At 5 years