Multifocal vs Monofocal IOL in Congenital Cataract Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cataract Congenital

Intervention / Treatment
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* Device: cataract surgery


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| multifocal IOL group<br>patients with unilateral and bilateral multifocal IOL | Device: cataract surgery<br>* 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.<br>|
| monofocal IOL group<br>patients with unilateral and bilateral monofocal IOL | Device: cataract surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean CDVA | Corrected distance visual acuity (CDVA), calculated in logarithm of the minimum angle of resolution (logMAR), using standard Snellen charts | CDVA was evaluated after 4 years of age. |