Surgical Treatment of Refractory Open Angle Glaucoma (NCT01212861) | Clinical Trial Compass
CompletedNot Applicable
Surgical Treatment of Refractory Open Angle Glaucoma
United States4 participantsStarted 2010-08
Plain-language summary
The primary objective of this study is to evaluate the safety, efficacy, and performance of the Suprachoroidal Dissection Instrument in creating a fistula between Schlemm's canal and the suprachoroidal space in refractory, open angle glaucoma subjects.
Who can participate
Age range
18 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:
* Available for up to 3 years follow-up.
* Diagnosed with primary open-angle, pseudoexfoliative, or pigmentary glaucoma or more than one glaucoma diagnosis of these types.
* Subject scheduled to undergo glaucoma surgery with the Suprachoroidal Dissection Instrument involving creation of fistula between Schlemm's canal and the suprachoroidal space without combined cataract surgery.
* Subject has failed at least one incisional glaucoma surgery (trabeculectomy, tube shunt, deep sclerectomy, viscocanalostomy, canaloplasty) or angle surgery (Trabectome) OR Is not a candidate for conventional glaucoma surgery due to reasons such as the presence of scleral buckle or compromised conjunctiva.
* Subject has IOP ≥ 16 mm Hg on maximally tolerated medications within the six week (-42 days) period prior to surgery.
* Visual field defect defined as mean deviation (MD) score worse than or equal to -10 dB on the Swedish Interactive Threshold Algorithm \[SITA\] Standard 24-2 Humphrey Analysis during the 6 month period prior to surgery. OR Subject has vertical cup-to-disk ratio ≥ 0.75 during the 6 month period prior to surgery.
Exclusion Criteria:
* Significant lens opacities or patient is candidate for cataract surgery during the duration of the study.
* The patient had developmental glaucoma or a secondary glaucoma including steroid-induced, uveitic, or neovascular glaucoma (with the exception of pigmentary and pseudoexfoliative glaucoma).
* The patient has narrow angle…
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
Postoperative intraocular pressure, glaucoma medication usage, and visual acuity