Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
242 participants
INTERVENTIONAL
2008-04-01
2021-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tube shunt surgery group
Participants in this group will receive a tube shunt surgery (Baerveldt Glaucoma implant).
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 with Mitomycin C
Participants in this group will receive a Trabeculectomy surgery with Mitomycin C
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.
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
Interventions
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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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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Abbott Medical Optics
INDUSTRY
Research to Prevent Blindness
OTHER
National Eye Institute (NEI)
NIH
University of Miami
OTHER
Responsible Party
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Steven J. Gedde
Dr
Principal Investigators
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Steven J Gedde, MD
Role: STUDY_CHAIR
Bascom Palmer Eye Institute
Dale K Heuer, MD
Role: STUDY_CHAIR
Medical College of Wisconsin
Richard K Parrish, MD
Role: STUDY_CHAIR
Bascom Palmer Eye Institute
Locations
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University of California Davis Medical Center
Sacramento, California, United States
University of Florida
Gainesville, Florida, United States
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
University of Texas, Houston
Houston, Texas, 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
Countries
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References
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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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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EY014801
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
20071037
Identifier Type: -
Identifier Source: org_study_id
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