Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
Stopped: Pupil measurement methodology determined not appropriate in this population.
Austria, Germany18 participantsStarted 2014-02
Plain-language summary
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.
Who can participate
Age range
18 Years
Sex
MALE
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
. Competent to provide informed consent.
. Voluntarily provide informed consent and HIPAA Authorization in accordance with local regulations and governing IEC/IRB requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
. Indicate they understand and are able, willing, and likely to fully comply with study procedures and restrictions.
. Are male and 18 years of age or older at the time of surgery.
. Are to undergo unilateral primary ILR, under topical anesthesia, with insertion of an intraocular lens.
. Have a best-corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.
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.
. Have an intraocular pressure (IOP) between 5 mm Hg and 22 mm Hg, inclusive, in the study eye.
. Is currently and has been taking tamsulosin (Flomax®) for at least six months.
Exclusion criteria
. Hypersensitivity to phenylephrine, ketoprofen, bromfenac, or other NSAIDs, including aspirin.
. Hypersensitivity to tetracaine, lidocaine, ophthalmic viscoelastic devices (such as hydroxypropylmethylcellulose or hyaluronic acid or latex..
. Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory or other medical condition that could increase the risk to the subject as determined by the Investigator.
. Presence of any connective tissue disorder (e.g., lupus, rheumatoid arthritis, fibromyalgia).
. Presence of systolic blood pressure of greater than 170 mmHg or less than 90 mmHg, or diastolic blood pressure of greater than110 mmHg or less than 40 mmHg at the screening visit.
. Use of phenylephrine in the study eye (other than for the screening ophthalmological examination) within seven days prior to the day of surgery.
. Use of monoamine oxidase inhibitors within 21 days prior to the day of surgery.
. Use of pilocarpine in the study eye within seven days prior to the day of surgery.