Primary Tube Versus Trabeculectomy Study
2 other identifiers
interventional
242
3 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2008
Longer than P75 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 23, 2008
CompletedFirst Posted
Study publicly available on registry
April 24, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
October 19, 2022
CompletedOctober 19, 2022
October 1, 2022
13 years
April 23, 2008
August 16, 2022
October 18, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 5 years
Secondary Outcomes (7)
Intraocular Pressure
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
Up to 5 years
Visual Acuity Using a Snellen Chart
At Baseline, At 5 years
Visual Acuity as Measured Using EDTRS Chart
At baseline, At 5 years
Visual Field
Up to 5 years
- +2 more secondary outcomes
Study Arms (2)
Tube shunt surgery group
EXPERIMENTALParticipants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
Trabeculectomy with Mitomycin C
EXPERIMENTALParticipants in this group will receive a Trabeculectomy surgery with Mitomycin C
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- Abbott Medical Opticscollaborator
- Research to Prevent Blindnesscollaborator
- National Eye Institute (NEI)collaborator
Study Sites (16)
University of California Davis Medical Center
Sacramento, California, 95817, United States
University of Florida
Gainesville, Florida, 32610, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Johns Hopkins
Baltimore, Maryland, 21290, United States
St. Louis University
St Louis, Missouri, 63104, United States
New York Eye and Ear Infirmary
New York, New York, 10003, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
University of Texas, Houston
Houston, Texas, 77030, United States
University of Virginia
Charlottesville, Virginia, 22908, 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
Related 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.
PMID: 29248173BACKGROUNDGedde 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.
PMID: 31727428RESULTGedde 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.
PMID: 29477688RESULTGedde 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.
PMID: 32622848RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steven Gedde, MD
- Organization
- University of Miami
Study Officials
- STUDY CHAIR
Steven J Gedde, MD
Bascom Palmer Eye Institute
- STUDY CHAIR
Dale K Heuer, MD
Medical College of Wisconsin
- STUDY CHAIR
Richard K Parrish, MD
Bascom Palmer Eye Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 23, 2008
First Posted
April 24, 2008
Study Start
April 1, 2008
Primary Completion
April 1, 2021
Study Completion
April 1, 2021
Last Updated
October 19, 2022
Results First Posted
October 19, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share