SOLX Gold Shunt for Refractory Glaucoma

Completed · Not applicable

Conditions studied: Glaucoma, Glaucoma, Open Angle

In brief

To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.

Key facts

Study ID

NCT01282346

Run by

SOLX, Inc.

People needed

116

Starts

2011-01-01

Expected to finish

2015-12-01

Last updated by the study team

2017-02-23

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• primary open-angle glaucoma
• 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

You may not qualify if…

• either eye with VA worse than count fingers
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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