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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06266962
Other study ID # 3/24
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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