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Hidden risks for Women's eye surgery: floppy iris syndrome under the microscope

NCT ID NCT07687407

Knowledge-focused Sponsor: Başakşehir Çam & Sakura City Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study looks at why some women develop a condition called Intraoperative Floppy Iris Syndrome (IFIS) during cataract surgery. IFIS makes the iris unstable, complicating surgery and raising risks. Researchers are examining factors beyond medication—such as medical history and prior surgeries—that may increase risk in women aged 50 and older. The goal is to better predict and prevent this complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify women at higher risk for floppy iris during cataract surgery, allowing surgeons to take extra precautions.
What could go wrong
This is an observational study, not a treatment trial. It may find associations but cannot prove cause and effect.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

704 people

The number who actually took part.

Started

Jan 2025

Finished

Jun 2025

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

50 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

cataract intraoperative floppy iris syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intraoperative floppy iris syndrome

Contacts and locations

Locations

  • Başakşehir Çam and Sakura City Hospital

    Istanbul, 34, Turkey (Türkiye)

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