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.
The Infant Aphakia Treatment Study (IATS) did not find a significant difference in visual acuity for infants with a unilateral congenital cataract <7 months of age who were corrected with a contact lens compared to an intraocular lens (IOL) after cataract surgery. However, there were significantly more intraoperative and postoperative adverse events and additional intraocular surgeries in the IOL group compared to the contact lens group. This outcome prompted the recommendation that IOL implantation be limited to infants at risk of experiencing “significant periods of uncorrected aphakia” if an IOL was not implanted. Some pediatric cataract surgeons have speculated that if the IATS protocol had been designed differently or if more experienced surgeons had performed the cataract surgeries that the high rate of adverse events in the IOL group would have been averted. Some of these critiques have been published as letters-to-the editor and others have been raised in forums, both public and private.3 In this report, we address these issues and, in some areas, we provide additional outcome data from the IATS to help clarify areas where there may have been misunderstandings.
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.
Design: Retrospective cost analysis of a prospective, randomized clinical trial based on Georgia Medicaid data and the actual costs of supplies used.
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 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% ($1,600/patient) in the aphakic group whereas glasses costs only represented 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 ($7,302 vs. $5,357) 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% (about $4000) more expensive than cataract surgery coupled with contact lens correction.
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 29.9D(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 18mm 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
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.)
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.
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.[Figure presented]