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Introduction Little is known about the optimum timing of surgery for dense congenital bilateral cataracts. We examined the critical period for deprivation amblyopia in a cohort of patients with dense bilateral congenital cataracts. Methods Thirty-seven infants with dense bilateral congenital cataracts extracted by 31 weeks of age were enrolled prospectively. Visual acuity outcome was assessed at ≥5 years of age. We statistically evaluated which of 4 models provided the best fit to the data: 1) no change in visual acuity outcome with delay in surgery, 2) linear decline of outcome with delay, 3) a bilinear model in which there is a critical age after which outcome depends on delay, and 4) a bilinear model in which there is a critical age before which outcome depends on delay. In addition, we reviewed medical records for associated adverse outcomes, including strabismus, nystagmus, secondary membrane formation, and glaucoma. Results A bilinear model with a critical age of 14 weeks fit the data better than a linear model (χ2=14.7; p<0.0006). During weeks 0-14, mean visual acuity decreased by 1 line with each 3 weeks delay in surgery. From 14-31 weeks, visual acuity was independent of age at surgery, averaging 20/80. Surgery after 4 weeks was associated with a higher prevalence of strabismus and nystagmus than surgery before 4 weeks while surgery during the first 4 weeks was associated with a higher prevalence of secondary membrane formation and glaucoma. Conclusion We did not find a latent period for treatment of children with dense bilateral congenital cataracts. Deprivation amblyopia may be minimized with early surgery for bilateral cataracts.

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Objective-To compare contact lenses and intraocular lenses (IOLs) for the optical correction of unilateral aphakia during infancy.Methods-In a randomized, multicenter (12 sites) clinical trial, 114 infants with a unilateral congenital cataract were assigned to undergo cataract surgery either with or without IOL implantation. Children randomized to IOL treatment had their residual refractive error corrected with spectacles. Children randomized to no IOL had their aphakia treated with a contact lens Main Outcome Measures-Grating acuity at 12 months of age and HOTV visual acuity at 4.5 years of age Results-Enrollment began in December 2004 and was completed in January 2009. The median age at the time of cataract surgery was 1.8 months. Fifty patients were 4-6 weeks of age at the time of enrollment, 32 patients were between 49 days and 3 months of age and the remaining 32 children were 3 to 7 months of age. Fifty-seven children were randomized to each treatment group with either IOL placement or aphakia. The eyes with cataracts had shorter axial lengths and steeper corneas on average than the fellow eyes.Conclusions-The optimal optical treatment of aphakia in infants is unknown. IATS was designed to provide empirical evidence whether optical treatment with an IOL or a contact lens following unilateral cataract surgery during infancy is associated with a better visual outcome.

IMPORTANCEAlthough 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.OBJECTIVE To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy. DESIGN, SETTING, AND PARTICIPANTSThis 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. INTERVENTIONS 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.RESULTS 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, 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 RELEVANCEAs 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.