Objective To evaluate the association of subretinal hyper-reflective material (SHRM) with visual acuity (VA), geographic atrophy (GA) and scar in the Comparison of Age related Macular Degeneration Treatments Trials (CATT) Design Prospective cohort study within a randomized clinical trial. Participants The 1185 participants in CATT. Methods Participants were randomly assigned to ranibizumab or bevacizumab treatment monthly or as-needed. Masked readers graded scar and GA on fundus photography and fluorescein angiography images, SHRM on time domain (TD) and spectral domain (SD) optical coherence tomography (OCT) throughout 104 weeks. Measurements of SHRM height and width in the fovea, within the center 1mm2, or outside the center 1mm2 were obtained on SD-OCT images at 56 (n=76) and 104 (n=66) weeks. VA was measured by certified examiners. Main Outcome Measures SHRM presence, location and size, and associations with VA, scar, and GA. Results Among all CATT participants, the percentage with SHRM at enrollment was 77%, decreasing to 68% at 4 weeks after treatment and 54% at 104 weeks. At 104 weeks, scar was present more often in eyes with persistent SHRM than eyes with SHRM that resolved (64% vs. 31%; p<0.0001). Among eyes with detailed evaluation of SHRM at weeks 56 (n=76) and 104 (n=66), mean [SE] VA letter score was 73.5 [2.8], 73.1 [3.4], 65.3 [3.5], and 63.9 [3.7] when SHRM was absent, present outside the central 1mm2, present within the central 1mm2 but not the foveal center, or present at the foveal center (p=0.02). SHRM was present at the foveal center in 43 (30%), within the central 1mm2 in 21 (15%) and outside the central 1mm2 in 19 (13%). When SHRM was present, the median maximum height in microns under the fovea, within the central 1 mm2 including the fovea and anywhere within the scan was 86; 120; and 122, respectively. VA was decreased with greater SHRM height and width (p<0.05). Conclusions SHRM is common in eyes with NVAMD and often persists after anti-VEGF treatment. At 2 years, eyes with scar were more likely to have SHRM than other eyes. Greater SHRM height and width were associated with worse VA. SHRM is an important morphological biomarker in eyes with NVAMD.

The Infant Aphakia Treatment Study Group IMPORTANCE The efficacy and safety of primary intraocular lens (IOL) implantation during early infancy is unknown.OBJECTIVE To compare the visual outcomes of patients optically corrected with contact lenses vs IOLs following unilateral cataract surgery during early infancy. DESIGN, SETTING, AND PARTICIPANTSThe Infant Aphakia Treatment Study is a randomized clinical trial with 5 years of follow-up that involved 114 infants with unilateral congenital cataracts at 12 sites. A traveling examiner assessed visual acuity at age 4.5 years.INTERVENTIONS Cataract surgery with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Treatment was determined through random assignment.MAIN OUTCOMES AND MEASURES HOTV optotype visual acuity at 4.5 years of age. RESULTSThe median logMAR visual acuity was not significantly different between the treated eyes in the 2 treatment groups (both, 0.90 [20/159]; P = .54). About 50% of treated eyes in both groups had visual acuity less than or equal to 20/200. Significantly more patients in the IOL group had at least 1 adverse event after cataract surgery (contact lens, 56%; IOL, 81%; P = .02). The most common adverse events in the IOL group were lens reproliferation into the visual axis, pupillary membranes, and corectopia. Glaucoma/glaucoma suspect occurred in 35% of treated eyes in the contact lens group vs 28% of eyes in the IOL group (P = .55). Since the initial cataract surgery, significantly more patients in the IOL group have had at least 1 additional intraocular surgery (contact lens, 21%; IOL, 72%; P < .001). CONCLUSIONS AND RELEVANCEThere was no significant difference between the median visual acuity of operated eyes in children who underwent primary IOL implantation and those left aphakic. However, there were significantly more adverse events and additional intraoperative procedures in the IOL group. When operating on an infant younger than 7 months of age with a unilateral cataract, we recommend leaving the eye aphakic and focusing the eye with a contact lens. Primary IOL implantation should be reserved for those infants where, in the opinion of the surgeon, the cost and handling of a contact lens would be so burdensome as to result in significant periods of uncorrected aphakia. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00212134

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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.

Objective-To compare the visual outcomes and adverse events of contact lens to primary intraocular lens (IOL) correction of monocular 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 between 1 to 6 months of age either with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Grating visual acuity was tested at 1 year of age by a masked traveling examiner Main Outcome Measures-Grating visual acuity at 1 year of age.Results-The median logMAR visual acuity was not significantly different between the treated eyes in the two groups (CL = 0.80, IOL = 0.97, p =.20). More patients in the IOL group underwent one or more additional intraocular surgeries than patients in the CL group (63% vs 12%; p <. 0001). Most of these additional surgeries were performed to clear lens reproliferation and pupillary membranes from the visual axis.Conclusions-There was no statistically significant difference in grating visual acuity at age 1 year between the IOL and CL groups; however, additional intraocular surgeries were performed more frequently in the IOL group.Application to Clinical Practice-Until longer term follow-up data are available, caution should be exercised when performing IOL implantation in children 6 months of age or younger given the higher incidence of adverse events and the absence of an improved short-term visual outcome compared to contact lens use.

Purpose To report the myopic shift at 5 years of age after cataract surgery with IOL implantation for infants enrolled in the Infant Aphakia Treatment Study. Methods Refractions were performed at 1 month and every 3 months postoperatively until age 4 and then at ages 4.25, 4.5 and 5 years. The change in refraction over time was estimated by linear mixed model analysis. Results IOL implantation was completed in 56 eyes; 43 were analyzed (median age = 2.4 mo, range = 1.0 – 6.8 mo). Exclusions included 11 patients with glaucoma, one patient with Stickler syndrome and one patient with an IOL exchange at 8 months postoperatively. The mean rate of change in a myopic direction from 1 month after cataract surgery up until age 1.5 years was 0.35 D/mo (95% CI = 0.29,0.40 D/mo); after age 1.5 years the mean rate of change in a myopic direction was 0.97 D/yr (95% CI = 0.66, 1.28 D/yr). The mean refractive change at age 5 years for children 1 month of age at surgery was 8.97 D (95% CI, 7.25, 10.68 D) and for children 6 months of age at surgery was 7.22 D (95% CI, 5.54, 8.91 D). The mean refractive error at age 5 years was −2.53 D (95% CI, −4.05, −1.02) Conclusion After IOL implantation during infancy, the rate of myopic shift occurs most rapidly during the first one and one-half years of life. Myopic shift varies significantly amongst patients. If the goal is emmetropia at age 5 years, then the immediate postoperative hypermetropic targets should be +10.5D at 4 to 6 weeks and 8.50 D from 7 weeks to 6 months. However, even using these targets it is likely that many children with require additional refractive correction given the high variability of refractive outcomes.

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