CompletedNot Applicable

Additional Long-Term Follow-up for Subjects Implanted With a CyPass® Micro-Stent

United States54 participantsStarted 2020-12-21

Plain-language summary

The purpose of this study is to assess long-term (10 years post-CyPass implantation) status of the corneal endothelium in subjects who were implanted with the CyPass Micro-Stent in the COMPASS trial.

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.

Key Inclusion Criteria: * Implantation with a CyPass Micro-Stent as a participant in the COMPASS trial (NCT01085357) (Transcend Medical, Incorporated, Study Number TMI-09-01). * 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. * Other protocol-defined inclusion criteria may apply. Key Exclusion Criteria: * Inability to comply with the protocol or required follow-up visit/procedures. * Other protocol-defined 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

Percentage of Eyes With Sight-threatening Adverse Events (AEs)

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Percentage of Eyes With Ocular Adverse Events

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)

Timeframe: Month 96 (Year 8) postoperative

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)

Timeframe: Month 108 (Year 9) postoperative

Trial details

NCT IDNCT04629521

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-05

Results submitted2024-03-28

View on ClinicalTrials.gov More Primary Open Angle Glaucoma trials

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.

What they're measuring

Percentage of Eyes With Sight-threatening Adverse Events (AEs)

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Percentage of Eyes With Ocular Adverse Events

Timeframe: Month 96 (Year 8) to Month 120 (Year 10) postoperative

Central Endothelial Cell Density (ECD) Reported by Mean and Standard Deviation

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Central Endothelial Cell Density (ECD) Reported by Mean and 95 Percent Confidence Interval

Timeframe: Month 96 (Year 8), Month 108 (Year 9), Month 120 (Year 10) postoperative

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 96 (Year 8)

Timeframe: Month 96 (Year 8) postoperative

Central Endothelial Cell Density (ECD) Reported by Percentile - Month 108 (Year 9)

Timeframe: Month 108 (Year 9) postoperative