Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two H… (NCT02873806) | Clinical Trial Compass
CompletedPhase 4
Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents
Armenia53 participantsStarted 2013-03
Plain-language summary
The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.
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:
Screening Exam Inclusion Criteria:
* Phakic patients or pseudophakic patients with posterior chamber intraocular lenses (PC-IOLs)
* Primary open-angle glaucoma (including pigmentary or pseudoexfoliative)
* C/D ratio ≤ 0.9
* Visual field defects, or nerve abnormality characteristic of glaucoma
* Two topical hypotensive medications at time of screening exam
* IOP \> 18 mmHg and ≤ 30 mmHg (medicated) at screening exam
* Study eye BCVA 20/100 or better
* Normal angle anatomy as determined by gonioscopy
* Absence of peripheral anterior synechia (PAS), rubeosis or other angle abnormalities that could impair proper placement of stent
Baseline Exam Inclusion Criteria:
* Subject has completed appropriate medication washout
* Mean IOP \> 22 mmHg and ≤ 38 mmHg after anti-glaucoma medication washout period
* A 3mmHg IOP increase over screening mean IOP
Exclusion Criteria:
Screening Exam Exclusion Criteria:
* Aphakic patients or pseudophakic patients with anterior chamber IOLs (AC-IOLs)
* Prior stent implantations (study eye)
* Traumatic, uveitic, neovascular, or angle-closure glaucoma; or glaucoma associated with vascular disorders
* Functionally significant visual field loss, including severe nerve fiber bundle defects
* Prior incisional glaucoma surgery
* Prior SLT within 90 days prior to screening
* Prior ALT
* Iridectomy or laser iridotomy
* Ineligibility for ocular hypotensive medication washout period as determined by the investigator.
* Any active cornea…
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
Mean intraocular pressure reduction of 20% or more versus baseline with reduction of 1 medication