United States, Brazil, Canada116 participantsStarted 2011-01
Plain-language summary
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.
Who can participate
Age range
21 Years
Sex
ALL
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 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use