Active — Not RecruitingNot Applicable

Anterior Segment Optical Coherence Tomography Microstent Positioning

United States116 participantsStarted 2024-04-09

Plain-language summary

The goal of this observational study is to learn about the long-term results of glaucoma stent surgery in men and women 18 or older who have had cataract and microstent surgery in the past 2 years at the Moran Eye Center. The main questions the study aims to answer are: 1. How often are microstents mispositioned? 2. What effect does microstent positioning have on intraocular pressure after surgery? Participants will have a one-time clinic visit for an eye exam and Optical Coherence Tomography (OCT) . From the eye exam and OCT, Researchers will assess and categorize the position of the microstents and assess the Schlemm's canal dilation. Researchers will review the participants' medical records to acquire 2-year data for the following: 1. Surgeon type and level of experience (resident, fellow, attending ophthalmologist) 2. Proportions of proper gonioscopic placement intraoperatively for each surgeon group 3. Effectiveness of surgery, based on change in intraocular pressure (IOP) from baseline medicated IOP, number of IOP-lowering medications the patient was able to discontinue, and rate of need for additional glaucoma surgery.

Who can participate

Age range

18 Years – 100 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: * Any adult glaucoma patient (age 18+) who underwent Hydrus microstent or iStent Inject placement at the Moran Eye Center. Exclusion Criteria: * Any patient who subsequently had to have their stent removed for any reason, any patient with a history of trauma to the anterior segment or reconstruction altering typical anatomy.

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

Difference in percentage of mispositioned stents between Hydrus microstent and iStent groups

Timeframe: Two years post stent placement

Trial details

NCT IDNCT06666751

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04-30

View on ClinicalTrials.gov More Glaucoma trials