SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
Paused · Phase 3
Conditions studied: Glaucoma, Glaucoma, Open Angle
In brief
Study Objective: To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmed™ Glaucoma Valve Model FP7, in the ability to reduce intraocular pressure (IOP) associated with glaucoma in eyes where medical and conventional surgical treatments have failed.
Key facts
- Study ID
- NCT00382395
- Run by
- SOLX, Inc.
- People needed
- 180
- Starts
- 2005-11-01
- Expected to finish
- 2017-07-01
- Last updated by the study team
- 2015-09-18
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Primary open-angle, pseudoexfoliative, or pigmentary glaucoma
- Age 21 or over
- refractory glaucoma, with IOP >21 mmHg on medications and failed prior incisional glaucoma surgery
- detectable visual field defect (negative MD score)
- written consent
- available for up to 24 months follow-up
You may not qualify if…
- either eye with VA worse than count fingers
- recent angle closure glaucoma episode
- uveitic glaucoma, iridocorneal endothelial (ICE) syndrome, traumatic glaucoma, or neovascular 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
- North Bay Eye Associates — Petaluma, California, United States
- Glaucoma Consultants of Colorado — Littleton, Colorado, United States
- International Eye Care — Tampa, Florida, United States
- Price Vision Group — Indianapolis, Indiana, United States
- University of Medicine and Dentistry of New Jersey — Newark, New Jersey, United States
- Glaucoma Associates of New York — New York, New York, United States
- Eagle Mountain Vision — Tulsa, Oklahoma, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- University of Tennessee / Hamilton Eye Institute — Memphis, Tennessee, United States
- Credit Valley EyeCare — Mississauga, Ontario, Canada
- Institut du Glaucome de Montréal — Montreal, Quebec, Canada
- Bombay City Eye Institute & Research Centre — Mumbai, Maharashtra, India
- Vision Research Foundation / Sankara Nethralaya — Chennai, Tamil Nadu, India
- Chaim Sheba Medical Center — Tel Litwinsky, Israel
- Military Institute of the Health Services — Warsaw, Poland
Full record on ClinicalTrials.gov
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