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

Phase 4

Completed

• Conditions: Intraoperative Floppy Iris Syndrome; Age-related Cataract; Adrenergic Receptor Antagonist Adverse Reaction; Cataract
• Interventions: Drug: 1% Atropine drops; Drug: Epinephrine

• Registration Number: NCT06266962
• Lead Sponsor: University Hospital Olomouc

Brief 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.

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 Timeline

• Study Start: 2020-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2024-02
• Study First Submitted: 2024-02-07
• Study First Submitted QC: 2024-02-19
• Last Update Submitted: 2024-02-19
• Study First Posted: 2024-02-20
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 164

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% Atropine drops	1% Atropine drops	-
Epinephrine	Epinephrine	-

Primary Outcome Measures

Name	Time	Method
Development of IFIS	intraoperative	Development of IFIS - yes/no.
Incidence of intraoperative complications	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.)
Severity of IFIS	intraoperative	Determination of severity of IFIS - mild/moderate/severe.

Trial Locations

Locations (1)

Department of Ophthalmology, University Hospital Olomouc; 🇨🇿 Olomouc, Czechia