Intraoperative Floppy Iris Syndrome in Women

NCT07687407 | Completed

• 1 other identifier: KAEK-11/29.01.2025.33
• Study Type: observational
• Target: 704
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraoperative Floppy Iris Syndrome

Keywords

Intraoperative Floppy Iris Syndrome; cataract surgery; Alpha-1 adrenergic receptor; Gynecologic surgery

Outcome Measures

Primary Outcomes (1)

• Prevalence of Intraoperative Floppy Iris Syndrome

  Proportion of female cataract patients in whom IFIS was diagnosed during phacoemulsification surgery, based on the presence of the classic triad described by Chang and Campbell (iris billowing, iris prolapse tendency, and progressive intraoperative miosis), confirmed by consensus between two independent senior ophthalmologist reviewers.

  Intraoperative (at the time of cataract surgery)

Secondary Outcomes (2)

• Independent Risk Factors for IFIS

  Preoperative assessment and intraoperative period

• IFIS Severity Grade Distribution

  Intraoperative (at the time of cataract surgery)

Other Outcomes (1)

• Intraoperative Complication Rate

  Intraoperative (at the time of cataract surgery)

Study Arms (1)

Female Cataract Surgery Patients

Female patients aged 50 years and older who underwent elective phacoemulsification cataract surgery at a tertiary ophthalmology clinic between January 2025 and June 2025. All participants completed a structured preoperative questionnaire documenting systemic comorbidities, medication use, and surgical history, including gynecologic procedures. Comprehensive ophthalmological examination, ocular biometry, and pupillometry under scotopic, mesopic, and photopic conditions were performed preoperatively. Surgery was performed by four senior surgeons using a standardized phacoemulsification technique. All cases were prospectively evaluated for the presence and severity of IFIS by two independent senior ophthalmologists with diagnosis requiring consensus between both assessors. IFIS was identified in 37 of 704 patients. No experimental intervention was administered; this cohort represents an observational prospective study of naturally occurring IFIS during routine cataract surgery.

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Only female participants are eligible for this study. The study was specifically designed to investigate the prevalence and risk factors of IFIS in women, a population that has been understudied relative to male patients. Eligibility is restricted to individuals who self-identify as female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female patients aged 50 years and older presenting for elective phacoemulsification cataract surgery at a tertiary ophthalmology clinic. The study population represents a consecutive clinical sample drawn from the routine surgical caseload of the center, reflecting a diverse urban and semi-urban patient population referred from both primary and secondary care settings.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, 34, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 7, 2026
• Study Start: January 29, 2025
• Primary Completion: June 27, 2025
• Study Completion: June 30, 2025
• Last Updated: July 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)