UnknownNot Applicable

The Effect of Anterior Corneal Incisions on Intraoperative Floppy Iris Syndrome (IFIS) Incidence and Severity in Tamsulosin Treated Cataract Patients

Israel40 participantsStarted 2010-07

Plain-language summary

Intraoperative Floppy Iris Syndrome (IFIS) may occur during cataract surgeries in patients treated with alpha 1 blockers. IFIS related to alpha 1 blocker Tamsulosin (used for prostate hypertrophy) was reported in 50-90% of patients. IFIS during surgery make the surgery more difficult and raise complication rate. Using anterior corneal incisions was reported briefly in literature as a prophylactic means but was not studied prospectively. we believe (according to our clinical experience) that these anterior incisions do help to reduce the incidence and severity of IFIS signs and complications rate during surgeries.

Who can participate

Age range

55 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

. cataract candidates treated (in the present or in the past) with tamsulosin
. aged 55 or more
. candidates for topical anesthesia
. no allergy to anticholinergic or adrenergic drugs
. able to understand and sign an informed consent

Exclusion criteria

. history of uveitis
. iris neovascularization

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

the number of IFIS cases observed during operation.

Timeframe: during the operations

Trial details

NCT IDNCT01070602

SponsorMeir Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Intraoperative Floppy Iris Syndrome trials