The Myopic Shift in Aphakic Eyes in the Infant Aphakia Treatment Study After 10 Years of Follow-up.

OBJECTIVES: To report the myopic shift in the aphakic eyes of a cohort of children who underwent unilateral cataract surgery during infancy and were then followed longitudinally for 10.5 years. METHODS: One-half of the children enrolled in the Infant Aphakia Treatment Study (IATS) were randomized to aphakia and contact lens correction after unilateral cataract surgery. They then underwent ocular examinations using standardized protocols at prescribed time intervals until age 10.5 years. RESULTS: Thirty of 57 children randomized to aphakia remained aphakic at age 10.5, having undergone unilateral cataract surgery at a median age of 1.6 (IQR: 1.1-3.1) months. The median refractive error (RE) in the 57 eyes randomized to aphakia immediately after cataract surgery was 19.01 D (IQR: 16.98-20.49) compared to 10.38 D (IQR: 7.50-14.00) for the 30 eyes that remained aphakic at age 10.5 years. The mean change in RE in aphakic eyes was -2.11 D/year up to age 1.5 years, -0.68 D/year from 1.5 to 5.0 years, and -0.35 D/year from age 5 to 10.5 years. At age 10.5 years, 18 patients continued to wear a contact lens correction (silicone elastomer, n=6; gas permeable, n=6; hydrogel, n=5; and silicone hydrogel, n=1) (median RE, 12.50 D), 9 wore only spectacles (median RE, 4.00 D), and 4 wore no correction (median RE, 11.25 D) to correct their aphakic eye. CONCLUSIONS: The RE in aphakic eyes decreased by 44% from infancy to age 10.5 years. About two-thirds of children who remained aphakic at age 10.5 years continued to wear a contact lens.

Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial.

Importance: 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. Objective: 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. 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, 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. Trial Registration: ClinicalTrials.gov Identifier: NCT00212134.

Parenting Stress and Adherence to Occlusion Therapy in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial.

PURPOSE: Using data from the Infant Aphakia Treatment Study, we examined the relationship between adherence to patching and parenting stress. METHODS: Caregivers completed the Parenting Stress Index 3 months after surgery (n = 106), after a visual acuity assessment at 12 months of age (n = 97), and at 4.25 (n = 96) years of age. Patching was reported in quarterly telephone interviews and annual 7-day patching diaries, and averaged across all assessments prior to and in the 6 months following the first stress assessment, and for 6 months before and after the other two stress assessments. The association was assessed using linear regression. RESULTS: Caregivers reporting the highest stress levels 3 months after surgery (i.e., 75th percentile) subsequently reported approximately three-quarters (0.87, 95% confidence interval -1.3 to -0.34) of an hour a day less patching than caregivers reporting the least stress (i.e., the 25th percentile) after controlling for prior patching and other confounders. The association was in the same direction, but not statistically significant, after the second stress assessment and was not apparent at 4.25 years of age. In contrast to our hypothesis, we did not find evidence that higher levels of patching were associated with subsequent increases in parenting stress. CONCLUSIONS: Three months after surgery, higher levels of parenting stress are associated with poorer adherence to patching, and thus stress may contribute to early adherence to patching. TRANSLATIONAL RELEVANCE: Clinicians may wish to provide support to caregivers exhibiting high levels of stress since it may impact their ability to adhere to prescribed patching.

Spectacle Adherence Among Four-Year-Old Children in the Infant Aphakia Treatment Study.

PURPOSE: To evaluate spectacle adherence with impact-resistant lenses among 4-year-old children after unilateral cataract surgery in the Infant Aphakia Treatment Study. DESIGN: Retrospective cohort analysis of randomized clinical trial data. METHODS: Setting: Multicenter. PATIENTS: One hundred and fourteen children randomized to contact lens correction or intraocular lens implantation following unilateral cataract surgery during infancy. INTERVENTION: One-week diaries completed annually and retrospective telephone interviews conducted every 3 months to age 5 years to assess spectacle adherence with impact-resistant lenses. Visual acuity was assessed by a traveling examiner at age 4.5 years. MAIN OUTCOME MEASURES: Spectacle adherence between ages 4 and 5 years. RESULTS: Children with 20/40 or better vision in their treated eye were more likely to wear spectacles ≥80% of their waking hours than children with vision worse than 20/40 (66% vs 42%, P = .034). Reported adherence to spectacle wear correlated with reported patching (r = 0.30, P = .002). Spectacle adherence did not correlate with sex, type of healthcare insurance, or the refractive error in the treated or fellow eye. Seven patients with reduced vision in their treated eye reported <10% spectacle adherence. CONCLUSIONS: These results confirm that it is possible to achieve high levels of spectacle adherence among 4-year-old children after unilateral cataract surgery during infancy. However, children with vision worse than 20/40 in their worse eye, who needed eye protection the most, had the worst adherence.

Correlation of monocular grating acuity at age 12 months with recognition acuity at age 4.5 years: findings from the Infant Aphakia Treatment Study.

PURPOSE: To determine whether grating acuity at age 12 months can be used to predict recognition acuity at age 4.5 years in children treated for unilateral congenital cataract enrolled in the Infant Aphakia Treatment Study (IATS). METHODS: Traveling testers assessed monocular grating acuity at 12 months of age (Teller Acuity Card Test [TACT]) and recognition acuity at 4.5 years of age (Amblyopia Treatment Study Electronic Visual Acuity Testing, HOTV) in children treated for visually significant monocular cataract in the IATS. Spearman rank correlation was used to evaluate the relationship between visual acuities at the two ages in the treated eyes. RESULTS: Visual acuity data at both ages were available for 109 of 114 children (96%). Grating acuity at 12 months of age and recognition acuity at 4.5 years of age were significantly correlated for the treated eyes (rspearman = 0.45; P = 0.001). At age 4.5 years, 67% of the subjects who had grating acuity at 12 months of age within the 95% predictive limits in their treated eye demonstrated recognition acuity better than 20/200. Similarly, at age 4.5 years 67% of the subjects who had grating acuity at age 12 months below the 95% predictive limits in their treated eye demonstrated recognition acuity of 20/200 or worse. CONCLUSIONS: A single grating acuity assessment at age 12 months predicts recognition acuity in a child treated for unilateral congenital cataract in only two-thirds of cases. Clinicians should consider other factors, such as patching compliance and age at surgery, when using an early grating acuity assessment to modify treatment.

Myopic Shift 5 Years after Intraocular Lens Implantation in the Infant Aphakia Treatment Study.

PURPOSE: To report the myopic shift at 5 years of age after cataract surgery with intraocular lens (IOL) implantation for infants enrolled in the Infant Aphakia Treatment Study (IATS). METHODS: Refractions were performed at 1 month and every 3 months postoperatively until age 4 years 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: Intraocular lens implantation was completed in 56 eyes; 43 were analyzed (median age, 2.4 months; range, 1.0-6.8 months). Exclusions included 11 patients with glaucoma, 1 patient with Stickler syndrome, and 1 patient with an IOL exchange at 8 months postoperatively. The mean rate of change in a myopic direction from 1 month after cataract surgery to age 1.5 years was 0.35 diopters (D)/month (95% confidence interval [CI], 0.29-0.40 D/month); after age 1.5 years, the mean rate of change in a myopic direction was 0.97 D/year (95% CI, 0.66-1.28 D/year). The mean refractive change was 8.97 D (95% CI, 7.25-10.68 D) at age 5 years for children 1 month of age at surgery and 7.22 D (95% CI, 5.54-8.91 D) for children 6 months of age at surgery. The mean refractive error at age 5 years was -2.53 D (95% CI, -4.05 to -1.02). CONCLUSIONS: After IOL implantation during infancy, the rate of myopic shift occurs most rapidly during the first 1.5 years of life. Myopic shift varies substantially among patients. If the goal is emmetropia at age 5 years, then the immediate postoperative hypermetropic targets should be +10.5 D 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 will require additional refractive correction given the high variability of refractive outcomes.

The Infant Aphakia Treatment Study Contact Lens Experience to Age 5 Years.

PURPOSE: To describe our experience treating a cohort of unilateral aphakic infants with contact lenses in the Infant Aphakia Treatment Study (IATS). MATERIALS AND METHODS: Fifty-seven of the 114 infants in the IATS were randomized to contact lens wear; all were followed until age 5 years, although a few had lapses in care. An examination under anesthesia, including keratometry, was performed at the time of enrollment and at approximately 1 year of age; keratometry was performed again at 5 years of age. A traveling examiner assessed visual acuity at approximately 1 year of age and again at 4.5 years of age. RESULTS: Twenty-four treated eyes (46%) wore silicone elastomer (SE) contact lenses, 11 eyes (19%) rigid gas permeable (GP) contact lenses and 17 eyes (29%) wore both lens types at various points of time. Median logMAR visual acuity was +0.70 (interquartile range (IQR), +0.30 to 1.20) in the SE group and 2.03 (IQR, +0.20 to 2.28) in the GP group at age 4.5 years. The mean (±SD) keratometric power of the treated eyes was 46.3±2.8 diopter (D) at baseline, 44.6±2.3 D at 1 year of age, and 44.3±1.7 D at 5 years of age. Keratometric astigmatism of treated eyes was 1.98±1.37 D at baseline, 1.62±0.98 D at 1 year of age, and 2.00±1.00 D at 5 years of age. Thirteen contact lens-related adverse events occurred among 7 patients after age 1 year. CONCLUSIONS: A cohort of infants with unilateral aphakia successfully wore contact lenses with relatively few adverse events.

Comparison of the rate of refractive growth in aphakic eyes versus pseudophakic eyes in the Infant Aphakia Treatment Study.

PURPOSE: To compare the rate of refractive growth (RRG) between aphakic eyes and pseudophakic eyes in the Infant Aphakia Treatment Study (IATS). SETTING: Twelve clinical sites across the United States. DESIGN: Randomized clinical trial. METHODS: Patients randomized to unilateral cataract extraction with contact lens correction versus intraocular lens (IOL) implantation in the IATS had their rate of refractive growth (RRG3) calculated based on the change in refraction from the 1-month postoperative examination to age 5 years. The RRG3 is a logarithmic formula designed to calculate the RRG in children. Two-group t tests were used to compare the mean refractive growth between the contact lens group and IOL group and outcomes based on age at surgery and visual acuity. RESULTS: Longitudinal refractive data were studied for 108 of 114 patients enrolled in the IATS (contact lens group, n = 54; IOL group, n = 54). The mean RRG3 was similar in the contact lens group (-18.0 diopter [D] ± 11.0 [SD]) and the IOL group (-19.0 ± 9.0 D) (P = .49). The RRG3 value was not correlated with age at cataract surgery, glaucoma status, or visual outcome in the IOL group. In the aphakia group, only visual outcome was correlated with refractive growth (P = .01). CONCLUSIONS: Infants' eyes had a similar rate of refractive growth after unilateral cataract surgery whether or not an IOL was implanted. A worse visual outcome was associated with a higher RRG in aphakic, but not pseudophakic, eyes. FINANCIAL DISCLOSURE: None of the authors has a financial or proprietary interest in any material or method mentioned.

Motor skills of children with unilateral visual impairment in the Infant Aphakia Treatment Study.

AIM: To assess motor functioning in children aged 4 years 6 months enrolled in the Infant Aphakia Treatment Study, and to determine contributions of visual acuity and stereopsis to measured motor skills. METHOD: One hundred and four children (53% female) with unilateral aphakia randomized to intraocular lens or contact lens treatment were evaluated at 4 years 6 months (age range 4y 6mo-4y 11mo) for monocular recognition visual acuity, motor skills, and stereopsis by a traveling examiner masked to treatment condition. Motor skills were assessed with the Movement Assessment Battery for Children--Second Edition (MABC-2). Visual acuity was operationalized as log10 of the minimum angle of resolution (logMAR) value for treated eye, best logMAR value for either eye, and intraocular logMAR difference. RESULTS: Student's t-tests showed no significant differences in MABC-2 scores between the intraocular lens and contact lens groups. The mean total score was low (6.43; 18th centile) compared with the normative reference group. Motor functioning was not related to visual acuity in the treated eye or to intraocular logMAR difference, but was predicted in a regression model by the better visual acuity of either eye (usually the fellow eye), even after accounting for the influence of age at surgery, examiner, orthotropic ocular alignment, and stereopsis. INTERPRETATION: Children with unilateral congenital cataract may have delayed motor functioning at 4 years 6 months, which may adversely affect their social and academic functioning.

Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery in the infant aphakia treatment study at age 5 years.

PURPOSE: To analyze differences in the cost of treatment for infants randomized to primary intraocular lens (IOL) implantation versus optical correction with a contact lens (CL) after unilateral cataract surgery in the Infant Aphakia Treatment Study (IATS). DESIGN: Retrospective cost analysis of a prospective, randomized clinical trial based on Georgia Medicaid reimbursement data as well as actual costs of supplies used during the study, adjusted for inflation. PARTICIPANTS: The IATS is a multicenter (n = 12), randomized clinical trial comparing the optical treatment of aphakia with either primary IOL implantation (n = 57) or CL correction (n = 57) in 114 infants with unilateral congenital cataract. INTERVENTION: One hundred fourteen infants underwent unilateral cataract surgery and were either corrected optically by primary IOL implantation at the time of surgery or were corrected with a CL after surgery. MAIN OUTCOME MEASURES: The mean cost of cataract surgery and all additional surgeries, examinations, and supplies used up to 5 years of age. RESULTS: The 5-year treatment cost of an infant with a unilateral congenital cataract corrected optically with an IOL was $27 090 versus $25 331 for a patient treated with a CL after initial cataract surgery. The total cost of supplies was $3204 in the IOL group versus $7728 in the CL group. CONCLUSIONS: Unilateral cataract surgery in infancy coupled with primary IOL implantation is approximately 7% more expensive than aphakia and CL correction. Patient costs are more than double with CL versus IOL treatment.

Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years.

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 PARTICIPANTS: The 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. RESULTS: The 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 RELEVANCE: There 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

Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery: retrospective analysis at age 1 year.

PURPOSE: To describe the differences in treatment costs for infants randomized to contact lens correction versus primary intraocular lens (IOL) implantation after unilateral cataract surgery in the Infant Aphakia Treatment Study (IATS). DESIGN: Retrospective cost analysis of a prospective, randomized clinical trial based on Georgia Medicaid data and the actual costs of supplies used. PARTICIPANTS: The IATS is a randomized, multicenter (n=12) clinical trial comparing treatment of aphakia with a primary IOL or contact lens in 114 infants with unilateral congenital cataract. INTERVENTION: Infants underwent cataract surgery with or without placement of an IOL. MAIN OUTCOME MEASURES: The mean cost of cataract surgery and all additional surgeries, examinations, and supplies used up to 12 months of age. RESULTS: The mean cost of treatment for a unilateral congenital cataract with primary IOL implantation was $14 752 versus $10 726 with contact lens correction. The initial cataract surgery accounted for approximately 50% of the treatment costs for both groups. Contact lens costs accounted for 15% ($1600/patient) in the aphakic group, whereas glasses costs represented only 4% ($535/patient) in the IOL group. The increased costs in the IOL group were primarily due to the higher cost of cataract surgery in this group ($7302 vs. $5357) and the cost of additional operations. CONCLUSIONS: For IATS patients up to 12 months of age, cataract surgery coupled with IOL implantation and spectacle correction was 37.5% (∼$4000) more expensive than cataract surgery coupled with contact lens correction. FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Axial elongation following cataract surgery during the first year of life in the infant Aphakia Treatment Study.

PURPOSE: To compare ocular axial elongation in infants after unilateral cataract surgery corrected with a contact lens (CL) or primary intraocular lens (IOL) implantation. METHODS: Baseline axial length (AL) was measured at the time of cataract surgery (1-6 months) and at age 1 year. AL at baseline and age 1 year and the change in length/mo were analyzed in relation to treatment modality, cataractous versus fellow eye, and age at surgery using linear mixed models. RESULTS: Mean baseline AL did not differ between the CL and IOL groups for either cataractous or fellow eyes. Eyes with cataracts were shorter than fellow eyes by an average of 0.6 mm (95% confidence interval [CI], 0.4-0.8 mm; P < 0.0001). For the operated eyes, the mean change in AL/mo was smaller in the CL group (0.17 mm/mo) than in the IOL group (0.24 mm/mo) (P = 0.0006) and was independent of age at surgery (P = 0.19). In contrast, the change in AL/mo for fellow eyes decreased with older age at surgery (P < 0.0001). At age 1 year, operated eyes treated with a CL were 0.6 mm shorter on average than operated eyes treated with an IOL (P = 0.009). CONCLUSIONS: At baseline, eyes with cataracts were shorter than fellow eyes. The change in AL/mo was smaller in operated eyes treated with a CL than in operated eyes treated with an IOL, but was not significantly related to age at surgery. (ClinicalTrials.gov number, NCT00212134.).

The infant aphakia treatment study contact lens experience: one-year outcomes.

PURPOSE: We describe our experience correcting a cohort of infants with contact lenses in the Infant Aphakia Treatment Study. MATERIALS AND METHODS: Fifty-seven infants 1-6 months of age were randomized to contact lens wear. An examination under anesthesia was performed at the time of enrollment and at approximately 1 year of age. A traveling examiner assessed visual acuity at approximately 1 year of age. RESULTS: Forty-two treated eyes (74 %) were fitted with silicone elastomer (SE) contact lenses; 12 eyes (21 %) with rigid gas permeable (RGP) contact lenses, and 3 eyes (5%) wore both lens types. Median visual acuity was +0.80 logMAR in both lens type-wearing groups. The mean (± SD) keratometric power of the treated eyes was 46.3±2.8 D at baseline and 44.6±2.3 D at 1 year of age for a mean decrease of 0.2±0.2 D/mo. Keratometric astigmatism of treated eyes was 1.98±1.37 D at baseline and 1.62±0.98 D at 1 year of age for a mean decrease of 0.05±0.2 D/mo. The mean RGP lens base curve at baseline was 47.62 D±2.62 D versus 47.00 D±3.50 D at 12 months after surgery. Children wearing SE lenses required a mean of 10.9 replacements (range 2-24) compared to 16.8 replacements (range 8-32) for children wearing RGP lenses. Three adverse events occurred. CONCLUSIONS: Contact lenses were worn successfully with relatively few adverse events by a cohort of infants with unilateral aphakia. The visual acuity results were identical independent of the contact lens material or modality. RGP lenses needed replacement more often than SE lenses.

Predictability of intraocular lens calculation and early refractive status: the Infant Aphakia Treatment Study.

OBJECTIVE: To report the accuracy of intraocular lens (IOL) power calculations and the early refractive status in pseudophakic eyes of infants in the Infant Aphakia Treatment Study. METHODS: Eyes randomized to receive primary IOL implantation were targeted for a postoperative refraction of +8.0 diopters (D) for infants 28 to 48 days old at surgery and +6.0 D for those 49 days or older to younger than 7 months at surgery using the Holladay 1 formula. Refraction 1 month after surgery was converted to spherical equivalent, and prediction error (PE; defined as the calculated refraction minus the actual refraction) and absolute PE were calculated. Baseline eye and surgery characteristics and A-scan quality were analyzed to compare their effect on PE. MAIN OUTCOME MEASURES: Prediction error. RESULTS: Fifty-six eyes underwent primary IOL implantation; 7 were excluded for lack of postoperative refraction (n = 5) or incorrect technique in refraction (n = 1) or biometry (n = 1). Overall mean (SD) absolute PE was 1.8 (1.3) D and mean (SD) PE was +1.0 (2.0) D. Absolute PE was less than 1 D in 41% of eyes but greater than 2 D in 41% of eyes. Mean IOL power implanted was 29.9 D (range, 11.5-40.0 D); most eyes (88%) implanted with an IOL of 30.0 D or greater had less postoperative hyperopia than planned. Multivariate analysis revealed that only short axial length (<18 mm) was significant for higher PE. CONCLUSIONS: Short axial length correlates with higher PE after IOL placement in infants. Less hyperopia than anticipated occurs with axial lengths of less than 18 mm or high-power IOLs. Application to Clinical Practice Quality A-scans are essential and higher PE is common, with a tendency for less hyperopia than expected. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00212134.

A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy: grating acuity and adverse events at age 1 year.

OBJECTIVE: To compare the visual outcomes and adverse events of contact lens with 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 MEASURE: Grating visual acuity at 1 year of age. RESULTS: The median logMAR visual acuity was not significantly different between the treated eyes in the 2 groups (contact lens group, 0.80; IOL group, 0.97; P = .19). More patients in the IOL group underwent 1 or more additional intraocular operations than patients in the contact lens group (63% vs 12%; P < .001). Most of these additional operations 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 contact lens groups; however, additional intraocular operations 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 aged 6 months or younger given the higher incidence of adverse events and the absence of an improved short-term visual outcome compared with contact lens use.

The infant aphakia treatment study: design and clinical measures at enrollment.

OBJECTIVE: To compare the use of 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 unilateral congenital cataracts were assigned to undergo cataract surgery with or without IOL implantation. Children randomized to IOL treatment had their residual refractive error corrected with spectacles. Children randomized to no IOL treatment had their aphakia treated with a contact lens. MAIN OUTCOME MEASURES: Grating acuity at 12 months of age and HOTV visual acuity at 4 1/2 years of age. APPLICATION TO CLINICAL PRACTICE: This study should determine whether either treatment for an infant with a visually significant unilateral congenital cataract results in a better visual outcome. RESULTS: Enrollment began December 23, 2004, and was completed January 16, 2009. The median age at the time of cataract surgery was 1.8 months. Fifty patients were 4 to 6 weeks of age at the time of enrollment; 32, 7 weeks to 3 months of age; and the remaining 32, more than 3 to less than 7 months of age. Fifty-seven children were randomized to each treatment group. 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. However, the Infant Aphakia Treatment Study was designed to provide empirical evidence of whether optical treatment with an IOL or a contact lens after unilateral cataract surgery during infancy is associated with a better visual outcome.

Intraocular lens implantation during infancy: perceptions of parents and the American Association for Pediatric Ophthalmology and Strabismus members.

BACKGROUND: To determine whether a randomized clinical trial, the Infant Aphakia Treatment Study, comparing intraocular lens (IOL) implantation with contact lens (CL) correction for infants with a unilateral congenital cataract (UCC), is feasible by (1) ascertaining whether American Association for Pediatric Ophthalmology and Strabismus (AAPOS) members have equipoise regarding these two treatments and (2) evaluating the willingness of parents to agree to randomization. METHODS: All AAPOS members were surveyed in August 1997 and again in June 2001 regarding their use of CLs and IOL implants to correct infants vision after unilateral cataract surgery. In addition, a pilot study was begun in March 2002 to evaluate the safety of IOL implantation during infancy and the willingness of parents to randomize their children with a UCC to either IOL implantation or CL correction. RESULTS: In 1997, 89% of the 260 respondents reported that in the previous year they had treated at least one infant with a UCC, but only 4% had implanted an IOL in an infant <7 months old. Silsoft (Bausch & Lomb, Rochester, NY) CL correction was the preferred treatment choice for 84% of the respondents. In 2001, 21% of the 279 respondents had implanted an IOL in an infant. On a scale from 1 to 10 with 1 strongly favoring an IOL implant and 10 strongly favoring a CL, the median score was 7.5. Sixty-one percent of the respondents indicated that they would be willing to randomize children with a UCC to one of these two treatments. The main concerns about IOL implantation were poor predictability of power changes, postoperative complications, inflammation, and technical difficulty of surgery. The main concerns about CL correction were poor compliance, high lens loss rate, high cost, and keratitis. In our pilot study, 30 infants <7 months of age were evaluated at nine clinical centers for a visually significant UCC. Of 24 infants eligible for randomization, the parents of 17 (71%) agreed to randomization. CONCLUSIONS: Although most AAPOS members still favor CL correction after cataract surgery for a UCC, five times as many had implanted an IOL in an infant in 2001 compared with the number in 1997. Parents were almost equally divided in their preference for IOL implant versus CL correction. Given the relative equipoise of AAPOS members regarding these treatments and the willingness of more than two thirds of parents to agree to randomization, it seems likely that a randomized clinical trial comparing these two treatments could indeed be conducted.