Multifocal vs Monofocal IOL in Congenital Cataract Surgery

Sponsor
Bambino Gesù Hospital and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04872829
Collaborator
(none)
43
Enrollment
84.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: cataract surgery

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.

Study Design

Study Type:
Observational
Actual Enrollment :
43 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery
Actual Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jun 30, 2015
Actual Study Completion Date :
Jun 30, 2015

Arms and Interventions

ArmIntervention/Treatment
multifocal IOL group

patients with unilateral and bilateral multifocal IOL

Device: cataract surgery
All patients underwent cataract surgery under 1 year of age (mean age 8 months, range 6-12) performed with the same surgical technique: two 1.2 mm clear corneal incision, continuous curvilinear capsulorhexis with a diameter of approximately 6.0 mm and intraocular lens implantation, posterior capsulotomy and anterior vitrectomy. IOL power was calculated using Sanders-Retzlaff-Kraff (SRK)/II formula. Multifocal IOL implantated was Alcon AcrySof ReSTOR SN60D3, while the monofocal one was Alcon AcrySof SN60AT. According to the Infant Aphakia treatment Study, the IOL power was calculated as a function of the child age17, with an undercorrection ranging from 4 to 6 D.

monofocal IOL group

patients with unilateral and bilateral monofocal IOL

Device: cataract surgery
All patients underwent cataract surgery under 1 year of age (mean age 8 months, range 6-12) performed with the same surgical technique: two 1.2 mm clear corneal incision, continuous curvilinear capsulorhexis with a diameter of approximately 6.0 mm and intraocular lens implantation, posterior capsulotomy and anterior vitrectomy. IOL power was calculated using Sanders-Retzlaff-Kraff (SRK)/II formula. Multifocal IOL implantated was Alcon AcrySof ReSTOR SN60D3, while the monofocal one was Alcon AcrySof SN60AT. According to the Infant Aphakia treatment Study, the IOL power was calculated as a function of the child age17, with an undercorrection ranging from 4 to 6 D.

Outcome Measures

Primary Outcome Measures

  1. Mean CDVA [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Bambino Gesù Hospital and Research Institute

Investigators

  • Principal Investigator: Luca Buzzonetti, MD, Bambino Gesù Children's Hospital, Rome, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Luca Buzzonetti, Head of the Ofthalmology Departement, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier:
NCT04872829
Other Study ID Numbers:
  • L121
First Posted:
May 5, 2021
Last Update Posted:
May 5, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2021