Is primary intraocular lens implantation associated with improvements in the long-term visual outcome for infants undergoing unilateral congenital cataract surgery?
This randomized clinical trial of 114 patients who underwent treatment for unilateral congenital cataract, with or without intraocular lens implantation, between ages 1 and 6 months found that visual acuity at age 10.5 years was not significantly different between the 2 treatment groups.
Results of this randomized clinical trial showed that implanting an intraocular lens at the time of cataract surgery extraction was neither beneficial nor detrimental to the visual outcome in children with unilateral congenital cataract.
Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy.
To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy.
Design, Setting, and Participants
This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019.
Intraocular lens implantation at the time of cataract surgery.
Main Outcomes and Measures
Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis.
Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was −0.54 to 0.47).
Conclusions and Relevance
As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome.
ClinicalTrials.gov Identifier: NCT00212134
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Lambert SR, Cotsonis G, DuBois L, et al. Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial. JAMA Ophthalmol. 2020;138(4):365–372. doi:10.1001/jamaophthalmol.2020.0006
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