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

NCT ID: NCT06266962

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-09-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1% Atropine drops

Group Type: ACTIVE_COMPARATOR

1% Atropine drops

Intervention Type: DRUG

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

Epinephrine

Group Type: ACTIVE_COMPARATOR

Epinephrine

Intervention Type: DRUG

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

Interventions

1% Atropine drops

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

Intervention Type: DRUG

Epinephrine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Palacky University

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: lead

Responsible Party

Zuzana Schreiberova

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miroslava Maluskova, MD, FEBO

Role: PRINCIPAL_INVESTIGATOR

University Hospital Olomouc and Palacky University Olomouc

Locations

Department of Ophthalmology, University Hospital Olomouc

Olomouc, , Czechia

Countries

Czechia

References

Maluskova M, Maresova K, Schreiberova Z, Paskova B, Karhanova M. Comparing the efficiency of two prophylactic approaches in patients at risk of developing Intraoperative Floppy Iris Syndrome. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2025 Sep 19. doi: 10.5507/bp.2025.025. Online ahead of print.

Reference Type: DERIVED

PMID: 40977319 (View on PubMed)

Other Identifiers

3/24

Identifier Type: -

Identifier Source: org_study_id