Skip to content

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06266962
Enrollment
164
Registered
2024-02-20
Start date
2020-07-01
Completion date
2022-09-30
Last updated
2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Intraoperative Floppy Iris Syndrome, Cataract, Age-related Cataract, Atropine, Epinephrine, Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Alpha1-adrenergic receptor antagonists, Tamsulosin

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.

Interventions

DRUG1% Atropine drops

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

DRUGEpinephrine

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

Sponsors

Palacky University
CollaboratorOTHER
University Hospital Olomouc
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Development of IFISintraoperativeDevelopment of IFIS - yes/no.
Severity of IFISintraoperativeDetermination of severity of IFIS - mild/moderate/severe.
Incidence of intraoperative complicationsintraoperativeTo 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.)

Countries

Czechia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026