Faculty Bibliography

Childhood cataracts have become a leading cause of preventable childhood blindness in many areas of the world. Here we summarize regional focus group discussions from the 4th Annual International Congenital Cataract Symposium on the current situation, challenges, and recommendations for the management of congenital cataracts in sub-Saharan Africa, the Middle East and North Africa, South Asia, Central America, South America, and developed nations. Strategies for managing congenital cataracts must be adapted and developed according to regional conditions. A basic framework for acceptable outcomes must focus on developing systems to address the critical components of education, access, quality care, and good follow-up.

PURPOSE/OBJECTIVE: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/METHODS: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/METHODS: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/METHODS: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/METHODS: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.

PURPOSE/OBJECTIVE:To determine whether stereopsis of infants treated for monocular cataracts varies with the type of optical correction used. DESIGN/METHODS:Randomized prospective clinical trial. METHODS:The Infant Aphakia Treatment Study randomized 114 patients with unilateral cataracts at age 1-7 months to either primary intraocular lens (IOL) or contact lens correction. At 4.5 years of age a masked examiner assessed stereopsis on these patients using 3 different tests: (1) Frisby; (2) Randot Preschool; and (3) Titmus Fly. RESULTS:Twenty-eight patients (25%) had a positive response to at least 1 of the stereopsis tests. There was no statistically significant difference in stereopsis between the 2 treatment groups: Frisby (contact lens, 6 [11%]; IOL, 7 [13%]; P = .99), Randot (contact lens, 3 [6%]; IOL, 1 [2%]; P = .62), or Titmus (contact lens, 8 [15%]; IOL, 13 [23%]; P = .34). The median age at surgery for patients with stereopsis was younger than for those without stereopsis (1.2 vs 2.4 months; P = .002). The median visual acuity for patients with stereopsis was better than for those without stereopsis (20/40 vs 20/252; P = .0003). CONCLUSION/CONCLUSIONS:The type of optical correction did not influence stereopsis outcomes. However, 2 other factors did: age at surgery and visual acuity in the treated eye at age 4.5 years. Early surgery for unilateral congenital cataract and the presence of visual acuity better than or equal to 20/40 appear to be more important than the type of initial optical correction used for the development of stereopsis.

OBJECTIVE:To evaluate the characteristics of strabismus in infants who underwent cataract surgery with and without intraocular lens (IOL) implantation. DESIGN/METHODS:Secondary outcome analysis in a prospective, randomized clinical trial. PARTICIPANTS/METHODS:The Infant Aphakia Treatment Study 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/METHODS:Infants underwent cataract surgery with or without placement of an IOL. MAIN OUTCOME MEASURES/METHODS:The proportion of patients in whom strabismus developed during the first 12 months of follow-up was calculated using the life-table method and was 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 pseudophakic infants (life-table estimate, 66.7%) and 42 infants (life-table estimate, 74.5%) treated with contact lenses (P = 0.59). The younger cohort (<49 days) at the time of surgery demonstrated 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 after congenital cataract surgery. However, strabismus was less likely to develop in infants whose cataract was removed at an earlier age. FINANCIAL DISCLOSURE(S)/BACKGROUND:The author(s) have no proprietary or commercial interest in any materials discussed in this article.

PURPOSE/OBJECTIVE: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/METHODS:Retrospective cost analysis of a prospective, randomized clinical trial based on Georgia Medicaid data and the actual costs of supplies used. PARTICIPANTS/METHODS: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/METHODS:Infants underwent cataract surgery with or without placement of an IOL. MAIN OUTCOME MEASURES/METHODS: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)/BACKGROUND:The author(s) have no proprietary or commercial interest in any materials discussed in this article.

PURPOSE/OBJECTIVE:We describe our experience correcting a cohort of infants with contact lenses in the Infant Aphakia Treatment Study. MATERIALS AND METHODS/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/OBJECTIVE:Achieving good vision in infants born with a unilateral cataract is believed to require early surgery and consistent occlusion of the fellow eye. This article examines the relationship between adherence to patching and grating acuity. METHODS:Data came from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for unilateral congenital cataract. Infants were either left aphakic (n = 53) or had an intraocular lens implanted (n = 55). Patching was prescribed 1 hour per day per month of age until 8 months of age and 50% of waking hours thereafter. Adherence was measured as the mean percentage of prescribed patching reported in a 7-day diary completed 2 months after surgery, and 48-hour recall interviews conducted 3 and 6 months after surgery. Grating visual acuity was measured within 1 month of the infant's first birthday (n = 108) using Teller Acuity Cards by a tester masked to treatment. Nonparametric correlations were used to examine the relationship with grating acuity. RESULTS:On average, caregivers reported patching 84.3% (SD = 31.2%) of prescribed time and adherence did not differ by treatment (t = -1.40, df = 106, p = 0.16). Adherence was associated with grating acuity (r(Spearman) = -0.27, p < 0.01), but more so among pseudophakic (r(Spearman) = -0.41, p < 0.01) than aphakic infants (r(Spearman) = -0.10, p = 0.49). CONCLUSIONS:This study empirically has shown that adherence to patching during the first 6 months after surgery is associated with better grating visual acuity at 12 months of age after treatment for unilateral cataract and that implanting an intraocular lens is not associated with adherence. (ClinicalTrials.gov number, NCT00212134.).

BACKGROUND:Little information is available on factors that predict adherence to patching in infants. We evaluated data from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for infants with unilateral congenital cataracts, to investigate factors associated with successful adherence to patching protocols. METHODS:In the Infant Aphakia Treatment Study, patching was prescribed 1 hour daily per month of age until 8 months of age and 50% of waking hours thereafter. A centrally located staff member inquired about the patient's adherence to patching in a phone interview with the primary caregiver. Analyses used χ(2) tests of independence and logistic regression to identify predictors of reported adherence and of achieving adherence rates of at least 75% ("good") and 90% ("excellent"). RESULTS:A total of 104 caregivers provided data on patching 3 months after surgery, at which time 60% reported patching at least 75% of the prescribed time. Reported adherence was not associated with the type of treatment (P = 0.73) but was better in children with private insurance (P = 0.01) and for children with mothers reporting lower levels of parenting stress (P = 0.03). CONCLUSIONS:Most caregivers reported being able to adhere to prescribed patching shortly after extraction of a unilateral congenital cataract. The type of correction (intraocular lens vs contact lens) was not associated with the amount of patching achieved, whereas family socioeconomic status and maternal stress appeared to play a role.

OBJECTIVES/OBJECTIVE:To report the incidence of glaucoma and glaucoma suspects in the IATS, and to evaluate risk factors for the development of a glaucoma-related adverse event in patients in the IATS in the first year of follow-up. METHODS:A total of 114 infants between 1 and 6 months of age with a unilateral congenital cataract were assigned to undergo cataract surgery either with or without an intraocular lens implant. Standardized definitions of glaucoma and glaucoma suspect were created and used in the IATS. RESULTS:Of these 114 patients, 10 (9%) developed glaucoma and 4 (4%) had glaucoma suspect, for a total of 14 patients (12%) with a glaucoma-related adverse event in the treated eye through the first year of follow-up. Of the 57 patients who underwent lensectomy and anterior vitrectomy, 5 (9%) developed a glaucoma-related adverse event; of the 57 patients who underwent an intraocular lens implant, 9 (16%) developed a glaucoma-related adverse event. The odds of developing a glaucoma-related adverse event were 3.1 times higher for a child with persistent fetal vasculature and 1.6 times higher for each month of age younger at cataract surgery. CONCLUSIONS:Modern surgical techniques do not eliminate the early development of glaucoma following congenital cataract surgery with or without an intraocular lens implant. Younger patients with or without persistent fetal vasculature seem more likely to develop a glaucoma-related adverse event in the first year of follow-up. Vigilance for the early development of glaucoma is needed following congenital cataract surgery, especially when surgery is performed during early infancy or for a child with persistent fetal vasculature. Five-year follow-up data for the IATS will likely reveal more glaucoma-related adverse events. TRIAL REGISTRATION/BACKGROUND:clinicaltrials.gov Identifier: NCT00212134.

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/METHODS: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/BACKGROUND:clinicaltrials.gov Identifier: NCT00212134.