Patching in Children With Unilateral Congenital Cataract and Child Functioning and Parenting Stress.

Importance: Parents may be concerned about the adverse outcomes of occlusion therapy in children treated for unilateral congenital cataract (UCC). Objective: To determine whether occlusion therapy in children treated for UCC with poor visual outcomes is negatively associated with poorer child and/or family functioning. Design, Setting, and Participants: This cohort study was conducted in 2023 using data collected between 2006 and 2016 in the Infant Aphakia Treatment Study (IATS). IATS participants with a visual acuity (VA) of 20/200 or worse were included. Statistical analysis was performed from July 2022 to October 2023. Exposure: Caregivers reported the mean daily minutes of patching during the 12 months prior to the VA assessment at 4.5 years of age. Patching was categorized as minimal (<15 minutes per day), moderate (15 to <120 minutes per day), or extensive (≥120 minutes per day). Main Outcome Measures: At 4.25 and 10.5 years of age, caregivers reported stress associated with the parenting role using the Parenting Stress Index and the Ocular Treatment Index and child behavior problems using the Achenbach Child Behavior Checklist. Motor skills were assessed at age 54 months using the Movement Assessment Battery for Children-Second Edition. Children completed the Harter Self-Perception Profile for Children at age 10.5 years. One-way analysis of variance and χ2 tests were used to compare outcomes by amount of patching. Results: Patching data were available for 47 of 53 children (88.7%) with a VA of 20/200 or worse. Among these 47 children with patching data included in the study, 20 (42.5%) were female, 27 (57.5%) were male, 12 (25.5%) were reported to have been patched fewer than 15 minutes per day, 11 (23.4%) were patched 16 to 119 minutes per day, and 24 (51.1%) were patched at least 120 minutes per day. Parenting stress, child behavior problems, motor functioning, and child self-perception were similar in all groups. For example, after adjusting for gender and insurance status, there was a nonsignificant difference between mean stress scores of 11.0 (95% CI, -4.5 to 26.5) points for parents who reported minimal patching vs parents who reported patching at least 120 minutes per day, and there was no significant difference in children's report of their global self-worth (0.0 [95% CI, -0.4 to 0.3] points). Conclusions and Relevance: Occlusion therapy was not negatively associated with family or child functioning. Although the sample size was limited, these results do not support changes to the current practice guidelines.

Association of Sociodemographic Characteristics with Pediatric Vision Screening and Eye Care: An Analysis of the 2021 National Survey of Children's Health.

PURPOSE: Vision screening and regular eye care can help detect and treat potentially irreversible vision impairment. This study aims to investigate the associations between sociodemographic and health characteristics and the receipt of eye care among children aged 17 years and younger in the United States. DESIGN: This cross-sectional study used data from the National Survey of Children's Health (NSCH), a nationally representative and population-based survey of randomly sampled households. PARTICIPANTS: Participants were children aged 0 to 17 years, residing in all 50 states and the District of Columbia, whose caregivers or parents answered an address-based survey by mail or online. METHODS: Weighted prevalence calculations were applied to analyze the data, and logistic regression was performed to explore associations between reported eye care and demographic, health, and parent-related variables. MAIN OUTCOME MEASURES: Caregiver-reported vision screenings, referral to an eye doctor after vision screening, eye doctor visits, and prescription of corrective lenses. RESULTS: Caregivers reported that 53.2% of children had a vision screening at least once (if child ≤ 5 years) or within the past 2 years (if child > 5 years). Of those screened, 26.9% were referred to an eye doctor. Overall, 38.6% of all children had a previous eye doctor visit, and among them, 55.4% were prescribed corrective lenses during the visit. Factors associated with decreased odds of vision screening included younger age, lack of health care visits, no insurance coverage, parent education high school or less, and lower household income. Non-White ethnicities, households with a non-English primary language, and lower incomes were more likely to be referred to an eye doctor after vision screening. Lower rates of eye doctor visits were associated with younger age, lack of insurance coverage, and primary household languages other than English. CONCLUSIONS: Children from disadvantaged backgrounds are less likely to receive vision screening and eye care. Targeted strategies are needed to increase vision screening and access to eye care services in these vulnerable groups. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.

Rate of ocular trauma in children operated on for unilateral cataract in infancy-data from the Infant Aphakia Treatment Study.

To determine whether the fellow eye of children who have undergone unilateral cataract extraction in the first year of life are at increased risk of injury and vision loss, the 10.5-year data on 109 of 114 children enrolled in the Infant Aphakia Treatment Study were examined. Based on this limited data, it was estimated that the fellow eye is at greater risk of injury than the operated eye. Our data do not support the risk being higher in children with the worst vision in the treated eye.

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.

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.

Behaviors of children with unilateral vision impairment in the Infant Aphakia Treatment Study.

PURPOSE: To determine whether behavioral functioning of 4.5-year-olds differs between two treatments for unilateral cataract and whether behavioral functioning is predicted by visual acuity in the treated eye. METHODS: The Infant Aphakia Treatment Study is a multicenter clinical trial in which 114 infants with unilateral congenital cataracts were randomized to undergo cataract extraction with contact lens correction or implantation of an intraocular lens. Patching data were collected during the year preceding a visit at age 4.5 years, when both visual acuity and caregiver-reported behavioral functioning were assessed for 109 participants. Caregiver stress was assessed with the Parenting Stress Index at 4.25 years. RESULTS: There were no treatment group differences in behavioral functioning as measured by the Child Behavior Checklist. Poorer visual acuity was associated with more externalizing behavior problems (attention problems and aggressive behavior) and total behavior problems in regression models that did not include caregiver stress. Both caregiver stress and dichotomized visual acuity significantly predicted externalizing problems. CONCLUSIONS: Treatment assignment did not affect caregiver-reported behavior. Poor visual acuity may confer risk for problems with attention and aggressive behavior in preschoolers treated for unilateral cataract.

Association Between Occlusion Therapy and Optotype Visual Acuity in Children Using Data From the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial.

IMPORTANCE: Patching has been a mainstay in treating unilateral congenital cataract. However, its efficacy has not been rigorously assessed. OBJECTIVE: To examine the association between patching and visual acuity in a cohort of children treated for unilateral congenital cataract. DESIGN, SETTING, AND PARTICIPANTS: This study was a secondary analysis of a randomized clinical trial (Infant Aphakia Treatment Study) of infants born from August 1, 2004, through December 31, 2008, who were treated with 1 of 2 treatments for unilateral congenital cataract and followed up to 5 years of age. Data analysis was performed from March 1, 2013, to March 1, 2016. INTERVENTIONS: Cataract extraction and randomization to receipt of an intraocular lens vs being left aphakic for the first 5 years of life. MAIN OUTCOMES AND MEASURES: Caregivers reported patching in the previous 48 hours in quarterly semistructured telephone interviews. The mean number of hours of patching per day was calculated from surgery to the first birthday (n = 92) and between 12 and 48 months of age (n = 102). Monocular optotype acuity was assessed at 4½ years of age by a traveling examiner using the Aphakia Treatment Study HOTV protocol. RESULTS: The Infant Aphakia Treatment Study enrolled 114 children; 57 were randomized to each treatment group. At 4½ years of age, optotype visual acuity was assessed in 112 children. The current analyses exclude an additional 3 children (2 who had adverse events that limited visual potential and 1 who had Stickler syndrome), leaving 109 total children analyzed (59 female [54.1%] and 92 white [84.4%]). Caregivers reported patching their children a mean (SD) of 3.73 (1.47) hours per day in the first year of life and 3.43 (2.04) hours per day thereafter. An association between reported patching and treatment was not identified (mean difference in first year, -0.29 hours per day; 95% CI, -0.90 to 0.33 hours per day; mean difference between 12 and 48 months of age, -0.40 hours per day; 95% CI, -1.20 to 0.40 hours per day). Visual acuity was associated with reported hours of patching in the first year of life (r = -0.32; 95% CI, -0.49 to -0.13) and between 12 and 48 months of age (r = -0.36; 95% CI, -0.52 to -0.18). However, patching accounted for less than 15% of the variance in logMAR acuity at 4½ years of age. CONCLUSIONS AND RELEVANCE: These results support the association of occlusion throughout the preschool years with improved visual acuity in infants treated for unilateral congenital cataract. However, similar visual outcomes were achieved with varying amounts of patching. These conclusions should be interpreted in the context of limitations related to generalizability from incomplete data collected in a clinical trial. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00212134.

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.

Vision and eye health in children 36 to <72 months: proposed data system.

PURPOSE: This article provides a rationale for developing an integrated data system for recording vision screening and eye care follow-up outcomes in preschool-aged children. The recommendations were developed by the National Expert Panel to the National Center for Children's Vision and Eye Health at Prevent Blindness and funded by the Maternal and Child Health Bureau of the Health Resources and Services Administration, US Department of Health and Human Services. Guidance is provided regarding specific elements to be included, as well as the characteristics and architecture of such a data system. Vision screening for preschool-aged children is endorsed by many organizations concerned with children's health issues. Currently, there is a lack of data on the proportion of children screened and no effective system to ensure that children who fail screenings access appropriate comprehensive eye examinations and follow-up care. RESULTS: The expansion of currently existing, or developing integrated health information systems, which would include child-level vision screening data, as well as referral records and follow-up diagnosis and treatment, is consistent with the proposed national approach to an integrated health information system (National Health Information Infrastructure). Development of an integrated vision data system will enhance eye health for young children at three different levels: (1) the child level, (2) the health care provider level, and (3) an epidemiological level. CONCLUSIONS: It is critical that the end users, the professionals who screen children and the professionals who provide eye care, be involved in the development and implementation of the proposed integrated data systems. As essential stakeholders invested in ensuring quality eye care for children, this community of professionals should find increasing need and opportunities at local, state, and national levels to contribute to cooperative guidance for data system development.

Stereopsis results at 4.5 years of age in the infant aphakia treatment study.

PURPOSE: To determine whether stereopsis of infants treated for monocular cataracts varies with the type of optical correction used. DESIGN: 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: 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.

Baseline characteristics of the infant aphakia treatment study population: predicting recognition acuity at 4.5 years of age.

PURPOSE: To identify patient baseline characteristics that predict recognition acuity at 4.5 years of age in the Infant Aphakia Treatment Study, a study of patients with monocular infantile cataracts. METHODS: We analyzed baseline characteristics of the 114 infants enrolled in the Infant Aphakia Treatment Study to determine which were most predictive of visual outcome at 4.5 years of age. All infants underwent cataract surgery between 1 and 7 months of age. Monocular acuity was assessed at 4.5 years of age by a traveling examiner using the Amblyopia Treatment Study HOTV protocol. RESULTS: Age at cataract surgery was weakly associated with visual acuity (Spearman rank correlation coefficient = 0.19, P = 0.041) with median visual acuity better among the younger patients (28-48 days: 0.50 logMAR, 49-210 days: 1.10 logMAR, P = 0.046). Patients from families with private insurance had significantly better median visual acuity (0.60 vs. 1.40 logMAR, P = 0.0004). No other baseline characteristic revealed a significant bivariate relationship with visual acuity. A multiple linear regression relating visual acuity to all baseline characteristics demonstrated that only the availability of private insurance was statistically significant, accounting for 12% of the variance. CONCLUSIONS: This analysis concurs with previous studies that early surgery is important for good visual outcomes in patients with unilateral infantile cataracts. The fact that only one baseline variable (private insurance) contributed to the multivariate analysis, accounting for 12% of the variance, suggests that predicting visual outcome for these patients is complicated at best, and cannot be estimated from baseline characteristics alone. (ClinicalTrials.gov number, NCT00212134.).

Nystagmus and related fixation instabilities following extraction of unilateral infantile cataract in the Infant Aphakia Treatment Study (IATS).

PURPOSE: To study eye movements in a large group of children after the removal of unilateral infantile cataract, and to compare fixation instabilities between treatment groups with or without IOL implantation. METHODS: The Infant Aphakia Treatment Study (IATS) is a randomized, multicenter clinical trial comparing IOL to contact lens (CL) treatment with a unilateral infantile cataract in participants who underwent cataract surgery at 1 to 6 months of age. At age 4.5 years, eye movements were recorded in 103 participants, using a high-speed video camera while the child performed a fixation task. The recordings were inspected by masked readers for the presence of fixation instabilities (nystagmus and saccadic oscillations). RESULTS: Overall, fixation instabilities were observed in 50 (60%) of 83 children who had evaluable recordings, with no differences between treatment groups (27 [64%] of 42 in the IOL group, 23 [56%] of 41 in the CL group; P = 0.51). Nystagmus was seen in 38% and saccadic oscillations in 31%, with no differences between treatment groups (P > 0.33). Children without a fixation instability had better visual acuity (P = 0.04). CONCLUSIONS: Nystagmus and saccadic oscillations are well-known consequences of infantile cataracts, presumably the result of visual deprivation during the critical period of visual development. After early cataract extraction, successful optical correction may reduce further form deprivation and minimize the incidence of these fixation instabilities. In this study, no differences in the presence of fixation instabilities were found between the two treatment strategies (CL or IOL) for optical correction after cataract removal. (ClinicalTrials.gov number, NCT00212134.).

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

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.).

Predictors of adherence to occlusion therapy 3 months after cataract extraction in the Infant Aphakia Treatment Study.

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.

Adherence to occlusion therapy in the first six months of follow-up and visual acuity among participants in the Infant Aphakia Treatment Study (IATS).

PURPOSE: 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.).

The effects of nicotine on the human electroretinogram.

PURPOSE: To examine the effects of nicotine on responses from the human retina measured electrophysiologically. METHODS: Electroretinogram (ERG) responses were obtained from ten healthy, visually normal adults who were nonsmokers. Nicotine (2 and 4 mg) and a placebo were administered in the form of gum 30 minutes before testing in two separate experiments. ERG responses were collected and analyzed using a full-field ERG system. Responses were recorded from one eye of each subject using a bipolar contact-lens electrode. Intensity-response curves were obtained under both dark- and light-adapted conditions. In experiment 1, both dark- and light-adapted tests were completed sequentially. In experiment 2, only light-adapted testing was performed. Intensity-response functions were analyzed using the Naka-Rushton equation. RESULTS: In experiment 1, compared with placebo, dark-adapted b-wave amplitude responses decreased significantly after chewing gum containing both 2 and 4 mg of nicotine. Under light-adapted conditions, the peak b-wave amplitude was significantly decreased after chewing gum containing 4 mg of nicotine. In experiment 2, light-adapted b-wave amplitudes were increased after 4 mg nicotine. Oscillatory potentials were measured but no significant effects under nicotine were observed. CONCLUSIONS: To the knowledge of the authors, this is the first demonstration that nicotine by itself affects responses in the human retina. These data support reports of the expression of nicotinic acetylcholine receptors in rabbit and nonhuman primate retina.