CompletedPhase 4

Comparing the Efficiency of Two Approaches in Patients at Risk of Developing Intraoperative Floppy Iris Syndrome

Czechia164 participantsStarted 2020-07-01

Plain-language summary

Intraoperative Floppy Iris Syndrome (IFIS) is a potentially serious cataract surgery complication. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. There are a number of guidelines for operative technique modifications with the aim to prevent the development of IFIS. The study focuses on two options for prophylactic strategies: the application of atropine drops and the instillation of intracameral epinephrine.

Who can participate

Age range18 Years

SexMALE

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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 benign prostatic hyperplasia * history of having taken, or currently taking any systemic α1-adrenergic receptor antagonists for low urinary tract symptoms * performing of pre-operative examination before cataract surgery * signed informed consent Exclusion Criteria: * presence of any pupil deformity due to e.g. post-traumatic condition * iris defect of any aetiology * status post anterior uveitis

What they're measuring

Development of IFIS

Timeframe: intraoperative

Severity of IFIS

Timeframe: intraoperative

Incidence of intraoperative complications

Timeframe: intraoperative

Trial details

NCT IDNCT06266962

SponsorUniversity Hospital Olomouc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-09-30

View on ClinicalTrials.gov More Intraoperative Floppy Iris Syndrome trials