NCT04872829|Completed
Multifocal vs Monofocal IOL in Congenital Cataract Surgery
Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery
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Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery
Sponsor study identifier
observational
43
0 countries
N/A
Study Start
June 1, 2008
Actual (reported)Primary Completion
June 30, 2015
Actual (reported)Study Completion
June 30, 2015
Actual (reported)The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2008
Actual (reported)June 30, 2015
Actual (reported)June 30, 2015
Actual (reported)April 26, 2021
Actual (reported)May 5, 2021
Actual (reported)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.
patients with unilateral and bilateral multifocal IOL
patients with unilateral and bilateral monofocal IOL
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
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.
Luca Buzzonetti, MD
Bambino Gesù Children's Hospital, Rome, Italy
43 participants (actual enrollment reported by the registry).
First Submitted
April 26, 2021
First Posted
May 5, 2021
Study Start
June 1, 2008
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
June 30, 2015
Actual (reported)Study Completion
June 30, 2015
Actual (reported)Last Updated
May 5, 2021
Record last verified: 2021-04
All the data are stored in the Bambino Gesù Children's Hospital data base
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Source: ClinicalTrials.gov.
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