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.
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.
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 χ2tests 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, whe reas family socioeconomic status and maternal stress appeared to play a role.
Occlusion therapy throughout early childhood is believed to be efficacious in treating deprivation amblyopia but has not been rigorously assessed in clinical trials. Further, tools to assess adherence to such therapy over an extended period of time are lacking. Using data from the Infant Aphakia Treatment Study, a randomized clinical trial of treatment for unilateral congenital cataract, we examined the use of quarterly 48-h recall interviews and annual 7-day prospective diaries to assess reported hours of patching in 114 children throughout the first 5 years of life. Consistency of data reported was assessed using correlation coefficients and intraclass correlation coefficients. Both interview and diary data showed excellent consistency with Cronbach's Alpha's ranging from 0.69 to 0.88 for hours of patching and 0.60 to 0.73 for hours of sleep. However, caregivers reported somewhat more adherence in prospective diaries than retrospective interviews. Completion rates, on the other hand, were substantially higher for telephone interviews than prospective diaries. For example, four years after surgery response rates to telephone interviews exceeded 75% versus completion rates of only 54% for diaries. In situations where occlusion dose monitors cannot be used for assessing adherence to occlusion therapy, such as in infants or over an extended period of time, quantitative assessments of occlusion therapy can be obtained by parental report, either as a series of prospective diaries or a series of recall interviews.
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.(figure missing)
Objective: To examine the reliability and validity of the Family Asthma Management System Scale for low-income African-American children with poor asthma control and caregivers under stress. The FAMSS assesses eight aspects of asthma management from a family systems perspective.
Methods: Forty-three children, ages 8–13, and caregivers were interviewed with the FAMSS; caregivers completed measures of primary care quality, family functioning, parenting stress, and psychological distress. Children rated their relatedness with the caregiver, and demonstrated inhaler technique. Medical records were reviewed for dates of outpatient visits for asthma.
Results: The FAMSS demonstrated good internal consistency. Higher scores were associated with adequate inhaler technique, recent outpatient care, less parenting stress and better family functioning. Higher scores on the Collaborative Relationship with Provider subscale were associated with greater perceived primary care quality.
Conclusions: The FAMSS demonstrated relevant associations with asthma management criteria and family functioning for a low-income, African-American sample.
Objective To evaluate parenting stress following infants’ cataract extraction surgery, and to determine if levels of stress differ between 2 treatments for unilateral congenital cataract in a randomized clinical trial. Methods At surgery, an intraocular lens (IOL) was implanted or children were left aphakic, treated with contact lens (CL). Stress measures were administered 3 months after surgery and at the first visit after the visual acuity (VA) assessment done at 12 months of age. Results Caregivers in the IOL group reported higher levels of stress than those in the CL group 3 months after surgery, but there were no group differences in stress scores at the post-VA assessment. Stress scores did not change differentially for participants assigned to IOL versus CL treatments. Conclusions Treatment assignment did not have a significant impact on caregiver stress during infancy or on the change in stress during the child’s first 2 years of life.
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.