Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
69 participants
INTERVENTIONAL
2010-06-30
2017-12-04
Brief Summary
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A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).
Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.
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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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Arm A - Baerveldt 250 mm2
Patients receiving Baerveldt 250 mm2
Baerveldt Device surgical Procedure
Implant surgery
Arm B - Baerveldt 350 mm2
Patients receiving Baerveldt 350 mm2
Baerveldt Device surgical Procedure
Implant surgery
Interventions
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Baerveldt Device surgical Procedure
Implant surgery
Eligibility Criteria
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Inclusion Criteria
* Intra-Ocular Pressure (IOP) \> 18 mm Hg and \< 40 mm Hg on medical therapy
* Previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy)
* Consent signed
Exclusion Criteria
* Pregnant or nursing
* Neuro-Linguistic Programming (NLP) vision
* Iris neovascularization or proliferative retinopathy
* Epithelial or fibrous downgrowth
* Chronic or recurrent uveitis
* Steroid-induced glaucoma
* Severe posterior blepharitis
* Previous cyclodestructive procedure
* Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation.
* Functionally significant cataract
* Need for Baerveldt implant combined with other ocular procedures (ie cataract surgery,penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
* Prior glaucoma drainage device (tube) implant
* Prior retinal surgery with remaining silicone oil
* Prior scleral buckling procedures
18 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Michael Boland, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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University of California - Davis
Sacramento, California, United States
U. Miami/Bascom Palmer
Miami, Florida, United States
The Wilmer Eye Institute
Baltimore, Maryland, United States
Mount Sinai School of Medicine
New York, New York, United States
Wills Eye Institute
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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NA_00037146
Identifier Type: -
Identifier Source: org_study_id
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