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.
Objective To evaluate the characteristics of strabismus in infants who underwent cataract surgery with and without intraocular lens (IOL) implantation. Design Secondary outcome analysis in a prospective, randomized clinical trial Participants The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter (n = 12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with a unilateral congenital cataract. Intervention Infants underwent cataract surgery with or without placement of an IOL. Main Outcome Measures The proportion of patients who developed strabismus during the first 12 months of follow-up was calculated using the life-table method, and compared across treatment groups and age strata using a log-rank test. Results Strabismus developed within the first 12 months of follow-up in 38 (life table estimate: 66.7%) pseudophakic infants and 42 (life table estimate: 74.5%) infants treated with contact lenses (p=0.59). The younger cohort (< 49 days) at the time of surgery developed less strabismus (29 of 50, life table estimate: 58.0%) than the older cohort (≥ 49 days) (51 of 64, life table estimate: 80.0%) (p<0.01). Conclusions Intraocular lens placement does not prevent the early development of strabismus following congenital cataract surgery. However, strabismus was less likely to develop in infants whose cataract was removed at an earlier age.
Purpose To evaluate sensorimotor outcomes among children in the Infant Aphakia Treatment Study (IATS). Methods Secondary outcome analysis was performed in this randomized, multicenter, clinical trial comparing treatment of unilateral aphakia with a primary intraocular lens (IOL) or contact lens (CL) correction. The alignment characteristics and sensory status of children through age 5 years were evaluated. Results In the IATS study, 91 of 112 children (81%) developed strabismus through age 5 years. Of 34 infants who were orthotropic at near 12 months after cataract surgery, by age 5 years 14 (41%) were orthotropic at distance, and 15 (44%) were orthotropic at near at age 5 years without strabismus surgery. Eight of 56 children (14%) in the CL group and 13 of 56 (23%) in the IOL group were orthotropic at distance (P = 0.33) by 5 years of age and had no history of strabismus surgery. Thirteen of 48 (27%) who underwent cataract surgery prior to 49 days of age compared to 8 of 64 (13%) who had surgery after 49 days were orthotropic (P = 0.085). Median visual acuity in the operative eye was 0.4 logMAR (20/50) for children with orthotropia or microtropia (<10Δ) versus 1.10 logMAR (20/252) for strabismus ≥10Δ (P = 0.0001). Stereopsis was detected in 12 of 21 children (57%) with orthotropia versus 16 of 89 (18%) children with strabismus (P = 0.0006). Conclusions IOL placement does not reduce the development of strabismus after monocular congenital cataract surgery. Improved ocular alignment by age 5 years correlated strongly with improved visual acuity and stereopsis.
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