CompletedNot Applicable

Trabecular Microbypass IStent in Patients with Glaucoma

Taiwan71 participantsStarted 2022-05-16

Plain-language summary

The goal of this clinical trial is to assess the safety and efficacy of phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone in a Taiwanese population, as well as to investigate any differences in outcomes between patients with primary open angle glaucoma (POAG) and those with normal tension glaucoma (NTG). The main question it aims to answer is: • How much do intraocular pressure (IOP) and the number of antiglaucoma medications change after iStent insertion, with subgroup analyses for POAG and NTG? Researchers will compare phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone to see if IOP and the number of antiglaucoma medications decrease. Participants will receive their regular phacoemulsification and decided whether to receive iStent by themselves.

Who can participate

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: Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts. Exclusion Criteria: * Eyes that have previously undergone vitrectomy or retinal surgery. * Patients with ocular surface inflammation (e.g., corneal ulcers, orbital cellulitis, etc.). * Patients with hypotony (intraocular pressure \<5 mmHg). * Patients with a history of globe rupture.

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

Intraocular pressure (IOP) in mmHg or percentage changes

Timeframe: From enrollment to the end of treatment at 18 months

glaucoma medication changes in number

Timeframe: From enrollment to the end of treatment at 18 months

Visual acuity changes in LogMAR scale

Timeframe: From enrollment to the end of treatment at 18 months

Trial details

NCT IDNCT06630546

SponsorYu-Ting Tsao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-30

View on ClinicalTrials.gov More Primary Open Angle Glaucoma (POAG) trials

Plain-language summary

Who can participate

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

Intraocular pressure (IOP) in mmHg or percentage changes

Timeframe: From enrollment to the end of treatment at 18 months

glaucoma medication changes in number

Timeframe: From enrollment to the end of treatment at 18 months

Visual acuity changes in LogMAR scale

Timeframe: From enrollment to the end of treatment at 18 months