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Completed NCT07687407

Intraoperative Floppy Iris Syndrome in Women

Conditions: Intraoperative Floppy Iris Syndrome

Sex: Female
Ages: 50 Years – N/A
Healthy volunteers: No
Enrollment: 704
Sponsor: Başakşehir Çam & Sakura City Hospital

Location: Başakşehir Çam and Sakura City Hospital Istanbul

Summary

Cataract surgery is one of the most commonly performed surgical procedures worldwide. During this surgery, the pupil needs to be adequately widened (dilated) to allow the surgeon to safely access and remove the clouded lens. In some patients, however, the iris - the colored part of the eye that controls pupil size, behaves unexpectedly during surgery. Instead of remaining stable, it becomes floppy, billows in response to fluid currents inside the eye, and the pupil progressively narrows despite the use of dilating eye drops. This condition is called Intraoperative Floppy Iris Syndrome (IFIS) and can make cataract surgery significantly more difficult, increasing the risk of complications such as iris damage, rupture of the lens capsule, or loss of the lens into the back of the eye. IFIS was first described in men taking alpha-1 adrenergic receptor antagonists (alpha-blockers), most commonly used to treat an enlarged prostate. Over time, other medications have also been linked to IFIS in both sexes. However, women develop IFIS less frequently than men, largely because alpha-blockers are prescribed less often in women. Despite this lower frequency, when IFIS occurs in women, it tends to be more severe and is associated with higher rates of surgical complications. This suggests that additional, as yet unidentified, factors may predispose women to IFIS, particularly those not taking any of the medications known to cause it. This study was designed to identify which factors increase the risk of IFIS in women undergoing routine cataract surgery. We prospectively evaluated female cataract patients at a tertiary eye center. Before surgery, all patients completed a structured questionnaire covering their medical history, current and past medications, prior surgical procedures, and eye health. Standardized pupil size measurements were obtained under different lighting conditions. During surgery, each case was evaluated for the presence and severity of IFIS by two independent senior ophthalmologists reviewing the surgical video recordings. The central hypothesis of this study is that factors beyond medication use, including prior surgical history, may independently contribute to IFIS risk in women.

Eligibility Criteria

Inclusion Criteria: * Female sex * Age 50 years or older * Scheduled for elective phacoemulsification cataract surgery at the study center * Ability to provide reliable responses to the preoperative assessment questionnaire * Written informed consent obtained Exclusion Criteria: * Cataract of non-senile etiology (traumatic, uveitic, or drug-induced) * Iris structural or functional abnormalities including coloboma, iris neovascularization, synechiae, and iridoschisis * History of previous intraocular surgery * Prior iris-related laser procedures including laser iridoplasty or peripheral iridotomy * History of scleral buckle surgery * Inability to complete the preoperative questionnaire reliably * IFIS diagnosis made by an assessor outside the designated review panel * Visual acuity of light perception, light projection, or hand motion only at baseline

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07687407). StuddyBuddy aggregates publicly available trial information.