SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma (NCT00382395) | Clinical Trial Compass
SuspendedPhase 3
SOLX Gold Shunt Versus Control Implant: Randomized Trial for Refractory Glaucoma
United States180 participantsStarted 2005-11
Plain-language summary
Study Objective:
To establish the substantial equivalence of the SOLX Gold Shunt to commercially available aqueous shunts, specifically the Ahmedâ„¢ 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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Percentage reduction in IOP at both 12 and 24 months after implant