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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06266962
• Other study ID #: 3/24
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2020
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2024
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age-related cataract

• age over 18 years

• men with diagnosed benign prostatic hyperplasia

• history of having taken, or currently taking any systemic a1-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

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract
• Intraoperative Floppy Iris Syndrome
• Syndrome

Intervention

Drug:
• 1% Atropine drops
Patients administered 1% Atropine drops twice a day for a week before the cataract surgery.
• Epinephrine
Patients underwent the instillation of epinephrine into the anterior chamber at the beginning of the cataract surgery.

Locations

Country	Name	City	State
Czechia	Department of Ophthalmology, University Hospital Olomouc	Olomouc

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Olomouc	Palacky University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of IFIS	Development of IFIS - yes/no.	intraoperative
Primary	Severity of IFIS	Determination of severity of IFIS - mild/moderate/severe.	intraoperative
Primary	Incidence of intraoperative complications	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