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NCT Number: NCT06266962

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1% Atropine drops

Drug

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

Epinephrine

Drug

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

Primary outcomes

  1. Development of IFIS

    Time frame: intraoperative

    Development of IFIS - yes/no.

  2. Severity of IFIS

    Time frame: intraoperative

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

  3. Incidence of intraoperative complications

    Time frame: intraoperative

    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.)

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Collaborators

  • Palacky University

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 20, 2024
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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