Post Approval Study of the CyPass System (NCT03273907) | Clinical Trial Compass
TerminatedNot Applicable
Post Approval Study of the CyPass System
Stopped: Voluntary market withdrawal
United States79 participantsStarted 2017-10-12
Plain-language summary
The purpose of this study is to demonstrate that the rate of clinically relevant complications associated with CyPass Micro-Stent placement and stability using the CyPass 241-S applier, as determined at 36 months in the postmarket setting, is less than the pre-specified performance target, which is based on experience with the CyPass Model E applier in COMPASS trial TMI-09-01 (NCT01085357).
Who can participate
Age range
45 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:
* Able to understand the requirements of the study and willing to follow study instructions, provide written informed consent, and agree to comply with all study requirements, including the required study follow-up visits
* Diagnosis of primary open angle glaucoma (POAG)
* Medicated intraocular pressure (IOP) of ≥10 millimeters mercury (mmHg) and ≤25 mmHg, or an unmedicated IOP of ≥21 mmHg and ≤33 mmHg
* An operable age-related cataract eligible for phacoemulsification
* Visual acuity as specified in the protocol
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Inability to complete a visual field test prior to surgery
* Use of ocular hypotensive medication/s, as specified in the protocol
* Diagnosis of glaucoma other than POAG, as specified in the protocol
* Other medical conditions, as specified in the protocol
* Proliferative diabetic retinopathy
* Previous surgery for retinal detachment
* Previous corneal surgery
* Wet age-related macular degeneration
* Poor vision in the non-study eye not due to cataract
* Significant ocular inflammation or infection within 30 days of screening visit
* Uncontrolled systemic diseases that may put the subject's health at risk and/or prevent the subject from completing all study visits
* Women who are pregnant or nursing
* Other protocol-specified exclusion criteria may apply.
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
Percentage of Eyes With Clinically Relevant Complications Associated With CyPass Micro-Stent Placement and Stability as Determined at Month 36