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Clinical Trials/NCT04872829
NCT04872829
Completed
Not Applicable

Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery

Bambino Gesù Hospital and Research Institute0 sites43 target enrollmentJune 1, 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract Congenital
Sponsor
Bambino Gesù Hospital and Research Institute
Enrollment
43
Primary Endpoint
Mean CDVA
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.

Detailed Description

PURPOSE: To assess the impact on visual development of multifocal versus monofocal intraocular lenses (IOLs) implantation in children following congenital cataract surgery. DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.

Registry
clinicaltrials.gov
Start Date
June 1, 2008
End Date
June 30, 2015
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Bambino Gesù Hospital and Research Institute
Responsible Party
Principal Investigator
Principal Investigator

Luca Buzzonetti

Head of the Ofthalmology Departement

Bambino Gesù Hospital and Research Institute

Eligibility Criteria

Inclusion Criteria

  • unilateral congenital cataract
  • bilateral congenital cataract

Exclusion Criteria

  • other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts)
  • systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)

Outcomes

Primary Outcomes

Mean CDVA

Time Frame: CDVA was evaluated after 4 years of age.

Corrected distance visual acuity (CDVA), calculated in logarithm of the minimum angle of resolution (logMAR), using standard Snellen charts

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