NCT06266962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 20, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

February 7, 2024

Last Update Submit

February 19, 2024

Conditions

Intraoperative Floppy Iris SyndromeCataractAge-related CataractAdrenergic Receptor Antagonist Adverse Reaction

Keywords

Intraoperative Floppy Iris SyndromeCataractAge-related CataractAtropineEpinephrineBenign Prostatic HyperplasiaLower Urinary Tract SymptomsAlpha1-adrenergic receptor antagonistsTamsulosin

Outcome Measures

Primary Outcomes (3)

  • Development of IFIS

    Development of IFIS - yes/no.

    intraoperative

  • Severity of IFIS

    Determination of severity of IFIS - mild/moderate/severe.

    intraoperative

  • 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

Study Arms (2)

1% Atropine drops

ACTIVE COMPARATOR
Drug: 1% Atropine drops

Epinephrine

ACTIVE COMPARATOR
Drug: Epinephrine

Interventions

1% Atropine dropsDRUG

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

1% Atropine drops
EpinephrineDRUG

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

Epinephrine

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • presence of any pupil deformity due to e.g. post-traumatic condition
  • iris defect of any aetiology
  • status post anterior uveitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Hospital Olomouc

Olomouc, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 40977319DERIVED

MeSH Terms

Conditions

CataractProstatic HyperplasiaLower Urinary Tract Symptoms

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesProstatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Miroslava Maluskova, MD, FEBO

    University Hospital Olomouc and Palacky University Olomouc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 7, 2024

First Posted

February 20, 2024

Study Start

July 1, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

February 20, 2024

Record last verified: 2024-02

Locations

CZ(1)