A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Imp… (NCT00834223) | Clinical Trial Compass
CompletedNot Applicable
A Prospective, Multicenter, Open-label, Safety and Preliminary Efficacy Study of the Surgical Implantation of OPKO's Glaucoma Drainage Device (AquashuntTM) in Patients With Refractory Chronic Forms of Open Angle Glaucoma (OAG)
Dominican Republic15 participantsStarted 2009-01
Plain-language summary
A prospective, multicenter, open-label, safety and preliminary efficacy study of the surgical implantation of OPKO's glaucoma drainage device (AquashuntTM) in patients with refractory chronic forms of open angle glaucoma (OAG). The primary objective of this study is to evaluate the surgical implantation, safety and preliminary efficacy of the AquashuntTM after implantation in patients with refractory chronic forms of OAG
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
. Patients must be aged 18 years or more.
. Patients must have a diagnosis of chronic forms of open angle glaucoma in the study eye, which is uncontrolled on maximum tolerated medical treatment with ocular hypotensive medications and has failed glaucoma surgery or is not considered a reasonable candidate for traditional surgery.
. The patient's documented IOP must be considered by the treating physician to be too high for their glaucoma status.
. Patients must have BCVA of between 20/400 and Light Perception, or no light perception with pain, in the study eye.
. Patients must have a BCVA in the fellow eye, which is better than that of the study eye.
. Patients must be mentally competent and willing to provide informed consent.
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
Primary efficacy measure: The percentage change in IOP from baseline to 6 months and 12 months post-implantation.
. Patients must be willing to return for all study visits and assessments for at least 3 years after surgery.
Exclusion criteria
. Patients with a diagnosis of glaucoma other than open angle glaucoma including active uveitic, active neovascular or recent traumatic glaucoma.
. Patients with clinically significant corneal disease including corneal dystrophy.
. Patients with iridocorneal endothelial syndrome.
. Any previous ocular surgery other than trabeculectomy, trabeculoplasty or cataract surgery and any surgery (including laser) within previous 3 months.
. Patients with an Anterior Chamber configuration that puts the patient at high risk for the development of angle closure glaucoma.
. Patients with any recent (within previous 30 days), or current, ocular/periocular inflammation or infection.
. Patients with a history of extensive keloid formation.
. Patients who will need ancillary procedures in the study eye at the time of implantation or during the initial one year study period.