Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome

NCT07517094 | Completed

• 1 other identifier: IGA_LF_2022_026
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (7)

• 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).

  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).

  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.

  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).

  preoperatively

• Development of IFIS during cataract surgery

  Development of IFIS - yes/no.

  intraoperative

• Severity of IFIS during cataract surgery

  Determination of severity of IFIS - mild/moderate/severe.

  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…)

  intraoperative

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from patients examined before cataract surgery at the Department of Ophthalmology of University Hospital Olomouc.

You may qualify if:

• 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)

You may not qualify if:

• 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
• Iris tumors
• Previous intraocular surgery
• History of use of miotics, mydriatics and α1-adrenergic agonists

Sponsors & Collaborators

• University Hospital Olomouc: lead
• Palacky University: collaborator

Study Sites (1)

Department of Ophthalmology, University Hospital Olomouc, Olomouc

Olomouc, 77900, Czechia

Location

MeSH Terms

Conditions

Cataract; Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Miroslava Maluskova, MD, FEBO

  University Hospital Olomouc and Palacky University Olomouc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2026
• First Posted: April 8, 2026
• Study Start: January 3, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CZ (1)