NCT06266962

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (actual)
• Sponsor: University Hospital Olomouc · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-07-01
• Primary completion: 2022-09-30
• Completion: 2022-09-30
• First posted: 2024-02-20
• Last updated: 2024-02-20

Locations

1 site across 1 country: Czechia