CompletedNot Applicable

Evaluation of the Safety and Effectiveness of the Bimatoprost Implant System / IOL Combination in Patients With Ocular Hypertension or Mild to Moderate Open-angle Glaucoma

Honduras24 participantsStarted 2022-04-21

Plain-language summary

The goal of this clinical trial is to learn if the SpyGlass Pharma Bimatoprost Implant System / IOL Combination works to treat cataracts and either ocular hypertension or glaucoma. It will also learn about the safety of the Bimatoprost Implant System / IOL Combination. The main questions it aims to answer are: * Does the Bimatoprost Implant System / IOL Combination lower the pressure inside the eye to treat ocular hypertension or glaucoma? * Does the Bimatoprost Implant System / IOL Combination correct vision after cataract surgery? * What medical problems do participants have when treated with the Bimatoprost Implant System / IOL Combination? Participants will: * Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated. * Complete a baseline visit to further evaluate eligibility in the study eye. * Undergo standard of care cataract surgery followed by implantation of the Bimatoprost Implant System / IOL Combination. Only one eye of each participant will be treated. * Complete post-operative follow-up visits for evaluation at Day 1, Week 1, Month 1, Month 3, and Month 6 (last study visit).

Who can participate

Age range

22 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: * Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension * Planned removal of cataract * Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension Exclusion Criteria: * Pregnant women as confirmed via urine pregnancy test for women of child-bearing age at screening * History of incisional/refractive corneal surgery * Pseudoexfoliation, pigmentary glaucoma, traumatic, uveitic, neovascular, or angle-closure glaucoma, or glaucoma associated with vascular disorders * Other ocular diseases, pathology, or conditions

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

Unmedicated eyes with IOP reduction of ≥20% from Baseline to the Month 6

Timeframe: From Baseline until the end of post-operative follow-up at Month 6

Trial details

NCT IDNCT07154797

SponsorSpyGlass Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-12-13

View on ClinicalTrials.gov More Cataract trials