Clinical Evaluation of Morcher Artificial Iris Diaphragms
United States72 participantsStarted 2003-04-09
Plain-language summary
The purpose of this study is to determine the safety and efficacy of Morcher iris diaphragms in the treatment of congenital and acquired aniridia. Morcher iris diaphragms are intraocular devices that are designed to provide an artificial pupil for patients suffering from partial or complete aniridia. These devices are constructed from clinical quality, ultraviolet light-absorbing, opaque black polymethylmethacrylate (PMMA). After surgical implantation, patients are monitored over the course of 1 year to measure any changes to visual acuity and improvements in light and glare sensitivity.
Who can participate
Age range
18 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:
* Patient must be 18 years old and have partial or complete aniridia.
* Be willing and able to comply with all follow-up requirements.
* Must have increased light and/or glare sensitivity or complete aniridia.
* Patients may be phakic, aphakic, or pseudophakic.
* Phakic patients will require simultaneous cataract surgery.
* Aphakic patients will require secondary intraocular lens implantation.
Exclusion Criteria:
* The presence of any ocular condition that may cause complications from the surgical procedure
* Active ocular infection or inflammation
* Patients with allergies to operative and/or postoperative medications
* Pregnant or lactating women
* Persons who, in the determination of the investigator, are not competent to understand the procedure or the actions asked of them as research subjects
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
Change in Light and Glare Sensitivity as Determined by a Clinical Glare Test (Primary Efficacy Measure)
Timeframe: Preoperatively and 1 year postoperatively
2
Change in Best Corrected Visual Acuity (Primary Safety Measure)
Timeframe: Preoperatively and 1 year postoperatively