Multifocal vs Monofocal IOL in Congenital Cataract Surgery

NCT04872829 | Completed

• 1 other identifier: L121
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract Congenital

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

multifocal IOL group

patients with unilateral and bilateral multifocal IOL

Device: cataract surgery

monofocal IOL group

patients with unilateral and bilateral monofocal IOL

Device: cataract surgery

Interventions

cataract surgery DEVICE

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; multifocal IOL group

Eligibility Criteria

• Age: 6 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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. All patients were directed to our hospital from primary care ophthalmologists or pediatricians

You may qualify if:

• unilateral congenital cataract
• bilateral congenital cataract

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Related Publications (1)

• Buzzonetti L, Petroni S, De Sanctis CM, Valente P, Federici M, Benassi C, Iarossi G. Comparative analysis of visual outcomes of multifocal and monofocal intraocular lenses in congenital cataract surgery. J Cataract Refract Surg. 2022 Jan 1;48(1):56-60. doi: 10.1097/j.jcrs.0000000000000705.

  PMID: 34054076 DERIVED

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Luca Buzzonetti, MD

  Bambino Gesù Children's Hospital, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Ofthalmology Departement

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 5, 2021
• Study Start: June 1, 2008
• Primary Completion: June 30, 2015
• Study Completion: June 30, 2015
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share