Intraoperative Floppy Iris SyndromeNCT07687407
Intraoperative Floppy Iris Syndrome in Women
An observational study of Intraoperative Floppy Iris Syndrome, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Intraoperative Floppy Iris Syndrome
- How many people
- 704 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2025to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, 34
About this study
Official title: Intraoperative Floppy Iris Syndrome in Women: Prevalence, Risk Factors, and Novel Association
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.
Read the detailed description
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.
Domain 3 - Pharmacological mydriasis response: Rather than a fixed time-based protocol, adequacy of dilation is confirmed by functional assessment - absence of the direct pupillary light reflex upon penlight examination by a single designated investigator. Dilated pupil diameter is recorded upon confirmed dilation. This approach was selected to capture inter-individual variability in mydriatic response, particularly relevant in patients with potential iris dilator dysfunction.
Outcome Ascertainment The primary outcome - IFIS diagnosis and grading - is determined through dual independent review. The operating surgeon provides the initial intraoperative assessment; a second senior ophthalmologist, blinded to clinical data, independently reviews the surgical video recording. IFIS classification requires consensus between both reviewers; discordant cases are not classified as IFIS. This two-reviewer consensus model minimizes ascertainment bias and ensures diagnostic consistency across the study period.
IFIS severity is graded on a four-point scale (Chang and Campbell, 2005): Grade 0 (stable iris); Grade 1 (iris billowing, no prolapse or significant miosis); Grade 2 (billowing with prolapse or ≥2 mm pupil reduction); Grade 3 (billowing with both prolapse and ≥2 mm pupil reduction).
Surgical Standardization To minimize surgeon-related confounding, all procedures are performed by three designated senior surgeons using an identical phacoemulsification platform, standardized incision architecture (2.2 mm temporal clear corneal), and uniform fluidic parameters. Intracameral epinephrine (1:10,000) is administered routinely in all cases following side-port construction. Intraoperative adjuncts - capsular tension rings, iris hooks, pupil expansion devices, and corneal sutures - are recorded as secondary outcome variables reflecting surgical complexity attributable to IFIS.
Quality Assurance Data are entered prospectively into a dedicated case record form at each patient encounter. Questionnaire responses are verified against available medical records where possible. Surgical video recordings are archived for all cases to enable post-hoc independent review and audit. IFIS grading discordances between the two reviewers are documented and adjudicated by a third senior ophthalmologist.
- Conditions
- Intraoperative Floppy Iris Syndrome
- Keywords
- Intraoperative Floppy Iris Syndrome, cataract surgery, Alpha-1 adrenergic receptor, Gynecologic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (at the time of cataract surgery)
Secondary outcomes (2)
Independent Risk Factors for IFIS
Identification of clinical variables independently associated with IFIS development through multivariable binary logistic regression analysis, including medication use, systemic comorbidities, surgical history, iris color, and preoperative pupil diameter measurements.
Measured: Preoperative assessment and intraoperative period
IFIS Severity Grade Distribution
Distribution of IFIS severity among affected patients according to the Chang and Campbell grading system (Grade 1: mild; Grade 2: moderate; Grade 3: severe).
Measured: Intraoperative (at the time of cataract surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start29 Jan 2025
- Primary completion27 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperative Floppy Iris SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 704 participants (actual)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İREM ÖNAL, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687407
- Sponsor's protocol ID
- KAEK-11/29.01.2025.33
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to the retrospective nature of the surgical history questionnaire and the sensitive personal health information collected, including gynecologic and systemic surgical history. Patient confidentiality and data protection regulations preclude public sharing of individual-level data. Aggregate de-identified summary data supporting the findings of this study will be available upon reasonable request to the corresponding author following publication.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Floppy Iris Syndrome in Women: Prevalence, Risk Factors, and Novel Association
- ClinicalTrials.gov ID
- NCT07687407
- Acronym / sponsor ID
- KAEK-11/29.01.2025.33
- Conditions
- Intraoperative Floppy Iris Syndrome
- Keywords
- Intraoperative Floppy Iris Syndrome, cataract surgery, Alpha-1 adrenergic receptor, Gynecologic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 704 participants (actual)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Domain 3 - Pharmacological mydriasis response: Rather than a fixed time-based protocol, adequacy of dilation is confirmed by functional assessment - absence of the direct pupillary light reflex upon penlight examination by a single designated investigator. Dilated pupil diameter is recorded upon confirmed dilation. This approach was selected to capture inter-individual variability in mydriatic response, particularly relevant in patients with potential iris dilator dysfunction.
Outcome Ascertainment The primary outcome - IFIS diagnosis and grading - is determined through dual independent review. The operating surgeon provides the initial intraoperative assessment; a second senior ophthalmologist, blinded to clinical data, independently reviews the surgical video recording. IFIS classification requires consensus between both reviewers; discordant cases are not classified as IFIS. This two-reviewer consensus model minimizes ascertainment bias and ensures diagnostic consistency across the study period.
IFIS severity is graded on a four-point scale (Chang and Campbell, 2005): Grade 0 (stable iris); Grade 1 (iris billowing, no prolapse or significant miosis); Grade 2 (billowing with prolapse or ≥2 mm pupil reduction); Grade 3 (billowing with both prolapse and ≥2 mm pupil reduction).
Surgical Standardization To minimize surgeon-related confounding, all procedures are performed by three designated senior surgeons using an identical phacoemulsification platform, standardized incision architecture (2.2 mm temporal clear corneal), and uniform fluidic parameters. Intracameral epinephrine (1:10,000) is administered routinely in all cases following side-port construction. Intraoperative adjuncts - capsular tension rings, iris hooks, pupil expansion devices, and corneal sutures - are recorded as secondary outcome variables reflecting surgical complexity attributable to IFIS.
Quality Assurance Data are entered prospectively into a dedicated case record form at each patient encounter. Questionnaire responses are verified against available medical records where possible. Surgical video recordings are archived for all cases to enable post-hoc independent review and audit. IFIS grading discordances between the two reviewers are documented and adjudicated by a third senior ophthalmologist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Intraoperative Floppy Iris Syndrome
Time frame: 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.
2 secondary outcomes
Independent Risk Factors for IFIS
Time frame: Preoperative assessment and intraoperative period
IFIS Severity Grade Distribution
Time frame: Intraoperative (at the time of cataract surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to the retrospective nature of the surgical history questionnaire and the sensitive personal health information collected, including gynecologic and systemic surgical history. Patient confidentiality and data protection regulations preclude public sharing of individual-level data. Aggregate de-identified summary data supporting the findings of this study will be available upon reasonable request to the corresponding author following publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraoperative Floppy Iris Syndrome, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Intraoperative Floppy Iris Syndrome (time frame: Intraoperative (at the time of cataract surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.