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

February 19, 2024 updated by: Zuzana Schreiberova, University Hospital Olomouc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intraoperative Floppy Iris Syndrome (IFIS) is a complication that may develop during cataract surgery. IFIS is most commonly associated with the chronic use of tamsulosin and other alpha1-adrenergic receptor antagonists prescribed in low urinary tract symptoms. It is characterised by an unstable iris whose increased elasticity may lead to a number of complications during cataract extraction with a negative impact on vision outcomes. Basic features of IFIS are a 'floppy' iris that 'ripples' in irrigation, insufficiently inducible mydriasis with progressive intraoperative miosis (despite repeated application of mydriatics) and the tendency of the iris to prolapse into the phacoemulsification probe.

IFIS is a complication that makes surgery more difficult for the eye surgeon. There is a risk of intraoperative conditions such as rupture of the posterior capsule with lens masses luxation into the vitreous body, damage to the iris by surgical instruments, damage to the endothelium with washout of endothelial cells, hyphaema, or prolapse of the vitreous body into the anterior chamber.

There are several surgical approaches to prevent the development of IFIS and facilitate easier management of the entire cataract extraction in unstable iris. The investigators recommend patients apply 1% atropine drops twice a day for one week during the pre-operative period. A more elegant method is the administration of epinephrine into the anterior chamber at the beginning of the cataract surgery. The aim of this study is to evaluate the effectiveness of two mydriatic agents - the administration of atropine drops and the instillation of epinephrine into the anterior chamber and to compare their effectiveness in preventing IFIS.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Olomouc, Czechia
        • Department of Ophthalmology, University Hospital Olomouc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1% Atropine drops
Drug: 1% Atropine drops
Patients administered 1% Atropine drops twice a day for a week before the cataract surgery.
Active Comparator: Epinephrine
Drug: Epinephrine
Patients underwent the instillation of epinephrine into the anterior chamber at the beginning of the cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of IFIS
Time Frame: intraoperative
Development of IFIS - yes/no.
intraoperative
Severity of IFIS
Time Frame: intraoperative
Determination of severity of IFIS - mild/moderate/severe.
intraoperative
Incidence of intraoperative complications
Time Frame: intraoperative
To find out if there are any intraoperative complications in either group (%) and what the complications are (rupture of the posterior capsule of the lens, intraoperative hypotonia, iris defect atc.)
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Olomouc

Collaborators

Palacky University

Investigators

  • Principal Investigator: Miroslava Maluskova, MD, FEBO, University Hospital Olomouc and Palacky University Olomouc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2022

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 19, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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