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

NCT06266962 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Intraoperative Floppy Iris Syndrome
  • Cataract
  • Age-related Cataract
  • Adrenergic Receptor Antagonist Adverse Reaction

Interventions

DRUG

1% Atropine drops

Patients administered 1% Atropine drops twice a day for a week before the cataract surgery.

DRUG

Epinephrine

Patients underwent the instillation of epinephrine into the anterior chamber at the beginning of the cataract surgery.

Sponsors & Collaborators

  • Palacky University

    collaborator OTHER

  • University Hospital Olomouc

    lead OTHER

Principal Investigators

  • Miroslava Maluskova, MD, FEBO · University Hospital Olomouc and Palacky University Olomouc

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266962 on ClinicalTrials.gov