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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COMPLETED
NA
116 participants
INTERVENTIONAL
2011-01-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SOLX Gold Shunt
SOLX Gold Shunt
Single use implant
Interventions
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SOLX Gold Shunt
Single use implant
Eligibility Criteria
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Inclusion Criteria
* age 21 or over
* refractory glaucoma, with IOP ≥ 24 mmHg on medications and failed prior incisional glaucoma surgery
* detectable visual field defect (negative MD score)
* written informed consent
* available for up to 24 months follow-up
Exclusion Criteria
* angle closure glaucoma episode within past 12 months
* uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular glaucoma
* diagnosis of pigmentary glaucoma or pseudoexfoliative glaucoma
* other significant ocular disease, except cataract
* active ocular infection
* expected ocular surgery in next 12 months
* no suitable quadrant for implant
* systemic corticosteroid therapy \> 5 mg/day prednisone
* intolerance to gonioscopy or other eye exams
* mental impairment interfering with consent or compliance
* pregnancy
* known sensitivity to anticipated medications used at surgery
* significant co-morbid disease
* concurrent enrollment in another drug or device study
21 Years
ALL
No
Sponsors
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SOLX, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Nilay Shah, MD
Role: STUDY_DIRECTOR
The Emmes Company, LLC
Locations
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University of Alabama
Birmingham, Alabama, United States
Vold Vision, PLLC
Springdale, Arkansas, United States
University of California, Irvine
Irvine, California, United States
Yale University
New Haven, Connecticut, United States
Illinois Eye Institute
Chicago, Illinois, United States
Glaucoma Associates of New York
New York, New York, United States
Ophthalmic Partners of Pennsylvania
Bala-Cynwyd, Pennsylvania, United States
University Eye Surgeons
Maryville, Tennessee, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
University of Virginia
Charlottsville, Virginia, United States
Memmen, Ltd
Green Bay, Wisconsin, United States
University of Campinas
Campinas, , Brazil
Clarity Eye Institute
Vaughan, Ontario, Canada
Institut de l'oeil des Laurentides
Boisbriand, Quebec, Canada
Bellevue Ophthalmology Clinic
Montreal, Quebec, Canada
Medical Research Infrastructure Department and Health Services Fund by the Sheba Medical Center (R.A.)
Tel Litwinsky, , Israel
Centro Medico Docente La Trinidad
Caracas, , Venezuela
Countries
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Other Identifiers
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SLX84
Identifier Type: -
Identifier Source: org_study_id
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