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)

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 Disease	Intervention/Treatment	Phase
Cataract Congenital	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

Arm	Intervention/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.

Arm

Intervention/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

Outcome Measures

Primary Outcome Measures

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:

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:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of May 5, 2021