Intraoperative Floppy Iris Syndrome in Women: Prevalence, Risk Factors, and Novel Association
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 704
- 试验地点
- 1
- 主要终点
- Prevalence of Intraoperative Floppy Iris Syndrome
研究概览
简要总结
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.
详细描述
Background and Rationale Intraoperative floppy iris syndrome (IFIS) represents a well-recognized surgical challenge during phacoemulsification cataract surgery, historically attributed to alpha-1 adrenergic receptor antagonist (α1-ARA) use, predominantly in men receiving treatment for benign prostatic hyperplasia. Emerging evidence suggests that IFIS in women follows a distinct epidemiological and clinical pattern: lower overall incidence but disproportionately higher severity and complication rates compared to male patients. The pharmacological and non-pharmacological determinants of IFIS in women remain incompletely characterized. This study was designed to prospectively determine the prevalence of IFIS in a female cataract population and identify its independent clinical risk factors, with emphasis on factors operating independently of α1-ARA exposure.
Data Collection Framework
Preoperative data collection is structured around three domains:
Domain 1 - Systemic history: Standardized face-to-face interview documenting comorbidities (diabetes mellitus, hypertension, thyroid dysfunction, rheumatological disease), current medications with duration of use, urinary incontinence status and its treatment, and complete surgical history (cardiovascular, abdominal, gynecologic - specifically myomectomy, hysterectomy, and bilateral salpingo-oophorectomy).
Domain 2 - Ocular parameters: Best-corrected visual acuity, slit-lamp biomicroscopy, intraocular pressure by non-contact tonometry, ocular biometry (axial length, anterior chamber depth), iris morphology (color, pseudoexfoliation, iridodonesis), and pupil diameter under scotopic, mesopic, and photopic conditions via integrated pupillography software.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
Prevalence of Intraoperative Floppy Iris Syndrome
时间窗: Intraoperative (at the time of cataract surgery)
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.
次要结局
- Independent Risk Factors for IFIS(Preoperative assessment and intraoperative period)
- IFIS Severity Grade Distribution(Intraoperative (at the time of cataract surgery))
研究者
İREM ÖNAL
Principal investigator
Başakşehir Çam & Sakura City Hospital