Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome (NCT07517094) | Clinical Trial Compass
CompletedNot Applicable
Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome
Czechia30 participantsStarted 2022-01-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Thickness of pupillary dilator muscle
Timeframe: preoperatively
2
Thickness of pupillary sphincter muscle
Timeframe: preoperatively
3
Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle