Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome
Pupillary Dilator Muscle Thickness as a Potential Predictor of Intraoperative Floppy Iris Syndrome: An Anterior Segment Optical Coherence Study
Study Overview
Status
Status
Conditions
Conditions
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
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-
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Olomouc, Czechia, 77900
- Department of Ophthalmology, University Hospital Olomouc, Olomouc
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Thickness of pupillary dilator muscle
Time Frame: preoperatively
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Thickness of pupillary dilator muscle is measured at half the distance between scleral spur and the edge of the pupil (mm).
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preoperatively
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Thickness of pupillary sphincter muscle
Time Frame: preoperatively
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Thickness of pupillary sphincter muscle is measured at a distance of 0.75 mm from the edge of the pupil (mm).
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preoperatively
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Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle
Time Frame: preoperatively
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Ratio of the thickness of pupillary dilator muscle and pupillary sphincter muscle is a dimensionless quantity.
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preoperatively
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Pupil diameter
Time Frame: preoperatively
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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).
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preoperatively
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Development of IFIS during cataract surgery
Time Frame: intraoperative
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Development of IFIS - yes/no.
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intraoperative
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Severity of IFIS during cataract surgery
Time Frame: intraoperative
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Determination of severity of IFIS - mild/moderate/severe.
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intraoperative
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Incidence of intraoperative complications
Time Frame: intraoperative
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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…)
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intraoperative
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Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Miroslava Maluskova, MD, FEBO, University Hospital Olomouc and Palacky University Olomouc
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IGA_LF_2022_026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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