Intraoperative Floppy Iris SyndromeNCT07517094
Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome
An observational study of Intraoperative Floppy Iris Syndrome and Cataract, run by University Hospital Olomouc at 1 site in Czechia.
Trial summary
Intraoperative Floppy Iris Syndrome (IFIS) is a potencial complication encountered during cataract surgery in patients treated with α1-adrenergic receptor antagonists (α1-ARAs) for lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 3 Jan 2022to 31 May 2024
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be recruited from patients examined before cataract surgery at the Department of Ophthalmology of University Hospital Olomouc.
Who may be able to join
- Age related cataract
- Age over 18 years
- Men with diagnosed lower urinary tract symptoms
- History of having taken any systemic α1-adrenergic receptor antagonists for lower urinary tract symptoms
- Signed informed consent
- Performing of pre-operative examination before cataract surgery (best-corrected visual acuity, measurement of refraction, slit lamp and biometric examination)
- Measurement on anterior segment optical coherence tomography under photopic (>300 lux) and scotopic conditions (0 lux)
Who cannot join
- Congenital or secondary changes in iris morphology - perforating or blunt eye injuries
- Previous uveitis
- LIRE performer
- History of acute ange-closure glaucoma
- Pigment dispersion syndrome
- Pseudoexfoliation syndrome
Show all 9Show fewer
- Iris tumors
- Previous intraocular surgery
- History of use of miotics, mydriatics and α1-adrenergic agonists
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Ophthalmology, University Hospital Olomouc, Olomouc
Olomouc, 77900
About this study
Official title: Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome: An Anterior Segment Optical Coherence Study
Intraoperative Floppy Iris Syndrome (IFIS) is a potencial complication encountered during cataract surgery in patients treated with α1-adrenergic receptor antagonists (α1-ARAs) for lower urinary tract symptoms. Therefore, careful assessment of pharmacological history is essential during the preoperative biometric evaluation of patients indicated for cataract surgery. In this study, the investigators expand the standart preoperative assessment by incorporating measurements of iris thickness at the level of the dilator and sphincter pupillae muscles, as well as pupil diameter, using anterior segment optical coherence tomography in patients receiving α1-ARAs. The aim of the study was to determine whether these parameters are associated with the intraoperative risk of IFIS development.
Read the detailed description
Intraoperative Floppy Iris Syndrome (IFIS) is an unpredictable complication that may occur during cataract surgery in patients diagnosed with lower urinary tract symptoms (LUTS) undergoing therapy with α1-adrenergic receptor antagonists (α1-ARAs). Of all α1-ARAs, tamsulosin is most strongly associated with the development of IFIS. IFIS is characterized by a fluttering, unstable iris, its prolapse into corneal incisions, and intraoperative progressive miosis despite pharmacologically induced mydriasis in the preoperative period. The use of α1-ARAs reduces the tone of the pupil dilator muscle and subsequently leads to its gradual atrophy, which causes laxity of the iris stroma and the development of IFIS during cataract surgery. Based on the presence of individual signs, the investigators distinguish between mild, moderate, and severe forms of IFIS. IFIS symptoms can complicate cataract surgery and increase the risk of complications during and after surgery. During cataract surgery, posterior capsule rupture with lens masses luxation into the vitreous body, damage the iris by the phacoemulsification probe, or prolapse of the vitreous body into the anterior chamber may occur. In the postoperative period, the patient may experience elevated intraocular pressure, persistent photophobia, endophthalmitis, or cystoid macular edema. Ultimately, IFIS can negatively affect the functional outcome of the surgery and leave the patient dissatisfied with permanently reduced vision quality. Anatomical changes in the iris caused by the use of α1-ARAs can be verified using anterior segment optical coherence tomography (AS-OCT). In this study, the authors used AS-OCT as the main instrument for measuring individual iris parameters prior to cataract surgery in patients undergoing α1-ARAs therapy. The goal was to determine whether there is a correlation between the degree of atrophy of the pupillary dilator muscle and the incidence of IFIS development. Among other things, the investigators also focused on measuring pupil diameter. During the study, the incidence of intraoperative complications and the relationship between the duration of α1-ARA use and the development of IFIS were evaluated. In patients, the parameters of the iris in the first eye scheduled for cataract extraction using AS-OCT Carl Zeiss Visante was measured before cataract surgery. The investigators performed AS-OCT measurements under photopic conditions with maximum artificial lighting (>300 lux) and under scotopic conditions in a dark room with the patient covered with a black non-translucent cloth (0 lux). The thickness of the pupillary dilator muscle at half the distance between the scleral spur and the edge of the pupil, the pupillary sphincter muscle at a distance of 0.75 millimeters from the edge of the pupil and the ratio to compensate for possible variability between subjects were evaluated. The investigators also used AS-OCT to measure the pupil diameter without mydriasis under photopic and scotopic conditions. Under scotopic conditions, the pupil size was assessed 30 minutes after inducing artificial mydriasis using a combination of 1% tropicamide and 10% phenylephrine hydrochloride mydriatics, which were applied three times at 10-minute intervals. The horizontal images were taken in the center of the pupil under both light conditions, performing the measurements three times and averaging the resulting values. In addition to iris and pupil parameters, patients´ age, type, and duration of α1-ARA use were determined. The investigators also monitored the development of IFIS during cataract surgery, determining its severity based on the classification established by Chang and Campbell, and the occurrence of intraoperative complications. The cataract surgeons were informed in advance about the risk group of patients. At the beginning of the cataract surgery, phenylephrine at a dose of 0.2 mg/ml was administered to the anterior chamber to induce more pronounced mydriasis and restore iris rigidity. The surgery was performed by experienced surgeons using a temporal approach with the Alcon Centurion Vision System and Alcon Constellation Vision System.
- Conditions
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Adrenergic Receptor Antagonist Adverse Reaction
- Keywords
- intraoperative floppy iris syndrome, cataract, Age-related Cataract, Benign Prostatic Hyperplasia, Alpha1-adrenergic receptor antagonists, Lower Urinary Tract Symptoms
- Medical subject headings
- Cataract, Prostatic Hyperplasia, Lower Urinary Tract Symptoms
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 |
|---|---|---|
| Patients with lower urinary tract symptoms undergoing therapy with α1-adrenergic receptor antagonist | Patients with lower urinary tract symptoms undergoing therapy with α1-adrenergic receptor antagonists and undergoing cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of pupillary dilator muscle
Thickness of pupillary dilator muscle is measured at half the distance between scleral spur and the edge of the pupil (mm).
Measured: preoperatively
Thickness of pupillary sphincter muscle
Thickness of pupillary sphincter muscle is measured at a distance of 0.75 mm from the edge of the pupil (mm).
Measured: preoperatively
Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle
Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle is a dimensionless quantity.
Measured: preoperatively
Pupil diameter
Measurement of pupil diameter in a horizontal section in the center of the pupil naturally and after the use of mydriatics using Anterior segment optical coherence tomography (mm).
Measured: preoperatively
Development of IFIS during cataract surgery
Development of IFIS - yes/no.
Measured: intraoperative
Severity of IFIS during cataract surgery
Determination of severity of IFIS - mild/moderate/severe.
Measured: intraoperative
Incidence of intraoperative complications
To find out if there are any intraoperative complications in patients and what the complications are (rupture of the posterior capsule, luxation of lens masses into the vitreous body, damage to the iris by surgical instruments, hyphaema…)
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start3 Jan 2022
- Primary completion31 May 2024
- Study completion31 May 2024
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Collaborators
- Palacky University
- Responsible party
- Sponsor
- Investigators
- Miroslava Maluskova, MD, FEBO, Principal investigator, University Hospital Olomouc and Palacky University Olomouc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517094
- Sponsor's protocol ID
- IGA_LF_2022_026
- Status last verified
- Apr 2026
- First submitted
- 25 Jan 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome: An Anterior Segment Optical Coherence Study
- ClinicalTrials.gov ID
- NCT07517094
- Acronym / sponsor ID
- IGA_LF_2022_026
- Conditions
- Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Adrenergic Receptor Antagonist Adverse Reaction
- Keywords
- intraoperative floppy iris syndrome, cataract, Age-related Cataract, Benign Prostatic Hyperplasia, Alpha1-adrenergic receptor antagonists, Lower Urinary Tract Symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Collaborators
- Palacky University
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 8 Apr 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.
Intraoperative Floppy Iris Syndrome (IFIS) is a potencial complication encountered during cataract surgery in patients treated with α1-adrenergic receptor antagonists (α1-ARAs) for lower urinary tract symptoms. Therefore, careful assessment of pharmacological history is essential during the preoperative biometric evaluation of patients indicated for cataract surgery. In this study, the investigators expand the standart preoperative assessment by incorporating measurements of iris thickness at the level of the dilator and sphincter pupillae muscles, as well as pupil diameter, using anterior segment optical coherence tomography in patients receiving α1-ARAs. The aim of the study was to determine whether these parameters are associated with the intraoperative risk of IFIS development.
Detailed description
Intraoperative Floppy Iris Syndrome (IFIS) is an unpredictable complication that may occur during cataract surgery in patients diagnosed with lower urinary tract symptoms (LUTS) undergoing therapy with α1-adrenergic receptor antagonists (α1-ARAs). Of all α1-ARAs, tamsulosin is most strongly associated with the development of IFIS. IFIS is characterized by a fluttering, unstable iris, its prolapse into corneal incisions, and intraoperative progressive miosis despite pharmacologically induced mydriasis in the preoperative period. The use of α1-ARAs reduces the tone of the pupil dilator muscle and subsequently leads to its gradual atrophy, which causes laxity of the iris stroma and the development of IFIS during cataract surgery. Based on the presence of individual signs, the investigators distinguish between mild, moderate, and severe forms of IFIS. IFIS symptoms can complicate cataract surgery and increase the risk of complications during and after surgery. During cataract surgery, posterior capsule rupture with lens masses luxation into the vitreous body, damage the iris by the phacoemulsification probe, or prolapse of the vitreous body into the anterior chamber may occur. In the postoperative period, the patient may experience elevated intraocular pressure, persistent photophobia, endophthalmitis, or cystoid macular edema. Ultimately, IFIS can negatively affect the functional outcome of the surgery and leave the patient dissatisfied with permanently reduced vision quality. Anatomical changes in the iris caused by the use of α1-ARAs can be verified using anterior segment optical coherence tomography (AS-OCT). In this study, the authors used AS-OCT as the main instrument for measuring individual iris parameters prior to cataract surgery in patients undergoing α1-ARAs therapy. The goal was to determine whether there is a correlation between the degree of atrophy of the pupillary dilator muscle and the incidence of IFIS development. Among other things, the investigators also focused on measuring pupil diameter. During the study, the incidence of intraoperative complications and the relationship between the duration of α1-ARA use and the development of IFIS were evaluated. In patients, the parameters of the iris in the first eye scheduled for cataract extraction using AS-OCT Carl Zeiss Visante was measured before cataract surgery. The investigators performed AS-OCT measurements under photopic conditions with maximum artificial lighting (>300 lux) and under scotopic conditions in a dark room with the patient covered with a black non-translucent cloth (0 lux). The thickness of the pupillary dilator muscle at half the distance between the scleral spur and the edge of the pupil, the pupillary sphincter muscle at a distance of 0.75 millimeters from the edge of the pupil and the ratio to compensate for possible variability between subjects were evaluated. The investigators also used AS-OCT to measure the pupil diameter without mydriasis under photopic and scotopic conditions. Under scotopic conditions, the pupil size was assessed 30 minutes after inducing artificial mydriasis using a combination of 1% tropicamide and 10% phenylephrine hydrochloride mydriatics, which were applied three times at 10-minute intervals. The horizontal images were taken in the center of the pupil under both light conditions, performing the measurements three times and averaging the resulting values. In addition to iris and pupil parameters, patients´ age, type, and duration of α1-ARA use were determined. The investigators also monitored the development of IFIS during cataract surgery, determining its severity based on the classification established by Chang and Campbell, and the occurrence of intraoperative complications. The cataract surgeons were informed in advance about the risk group of patients. At the beginning of the cataract surgery, phenylephrine at a dose of 0.2 mg/ml was administered to the anterior chamber to induce more pronounced mydriasis and restore iris rigidity. The surgery was performed by experienced surgeons using a temporal approach with the Alcon Centurion Vision System and Alcon Constellation Vision System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with lower urinary tract symptoms undergoing therapy with α1-adrenergic receptor antagonist | – | –Patients with lower urinary tract symptoms undergoing therapy with α1-adrenergic receptor antagonists and undergoing cataract surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited from patients examined before cataract surgery at the Department of Ophthalmology of University Hospital Olomouc.
Key inclusion criteria (7 listed)
- Age related cataract
- Age over 18 years
- Men with diagnosed lower urinary tract symptoms
- History of having taken any systemic α1-adrenergic receptor antagonists for lower urinary tract symptoms
- Signed informed consent
Key exclusion criteria (9 listed)
- Congenital or secondary changes in iris morphology - perforating or blunt eye injuries
- Previous uveitis
- LIRE performer
- History of acute ange-closure glaucoma
- Pigment dispersion syndrome
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
Thickness of pupillary dilator muscle
Time frame: preoperatively
Thickness of pupillary dilator muscle is measured at half the distance between scleral spur and the edge of the pupil (mm).
Thickness of pupillary sphincter muscle
Time frame: preoperatively
Thickness of pupillary sphincter muscle is measured at a distance of 0.75 mm from the edge of the pupil (mm).
Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle
Time frame: preoperatively
Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle is a dimensionless quantity.
Pupil diameter
Time frame: preoperatively
Measurement of pupil diameter in a horizontal section in the center of the pupil naturally and after the use of mydriatics using Anterior segment optical coherence tomography (mm).
Development of IFIS during cataract surgery
Time frame: intraoperative
Development of IFIS - yes/no.
Severity of IFIS during cataract surgery
Time frame: intraoperative
Determination of severity of IFIS - mild/moderate/severe.
Incidence of intraoperative complications
Time frame: intraoperative
To find out if there are any intraoperative complications in patients and what the complications are (rupture of the posterior capsule, luxation of lens masses into the vitreous body, damage to the iris by surgical instruments, hyphaema…)
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 Apr 2026.
Related trials for Intraoperative Floppy Iris Syndrome
Not yet recruitingPhase 4
Iris Structural Changes With Tamsulosin vs. Silodosin in Benign Prostatic Hyperplasia Patients
Benign Prostatic Hyperplasia, Tamsulosin
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.
Miroslava Maluskova, MD, FEBO principal investigator
University Hospital Olomouc and Palacky University Olomouc
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 and Cataract, run by University Hospital Olomouc at 1 site in Czechia.
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 7 inclusion and 9 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 Apr 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 Czechia. 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?
Thickness of pupillary dilator muscle (time frame: preoperatively). The study lists 7 primary outcomes in all. 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 Apr 2026.