Assessment of Adherence to Visual Correction and Occlusion Therapy in the Infant Aphakia Treatment Study.
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SUBMITTER: Drews-Botsch C
PROVIDER: S-EPMC5152926 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundLittle 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.MethodsIn 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").ResultsA 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).ConclusionsMost 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.
| S-EPMC3336096 | biostudies-literature
Project description: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.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.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).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.).
| S-EPMC3374623 | biostudies-literature
Project description:PurposeUsing data from the Infant Aphakia Treatment Study, we examined the relationship between adherence to patching and parenting stress.MethodsCaregivers 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.ResultsCaregivers 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.ConclusionsThree 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 relevanceClinicians may wish to provide support to caregivers exhibiting high levels of stress since it may impact their ability to adhere to prescribed patching.
| S-EPMC6322710 | biostudies-literature
Project description:Patching has been a mainstay in treating unilateral congenital cataract. However, its efficacy has not been rigorously assessed.To examine the association between patching and visual acuity in a cohort of children treated for unilateral congenital cataract.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.Cataract extraction and randomization to receipt of an intraocular lens vs being left aphakic for the first 5 years of life.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.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.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.clinicaltrials.gov Identifier: NCT00212134.
| S-EPMC4982828 | biostudies-literature
Project description:PurposeTo evaluate spectacle adherence with impact-resistant lenses among 4-year-old children after unilateral cataract surgery in the Infant Aphakia Treatment Study.DesignRetrospective cohort analysis of randomized clinical trial data.MethodsSetting: Multicenter.PatientsOne hundred and fourteen children randomized to contact lens correction or intraocular lens implantation following unilateral cataract surgery during infancy.InterventionOne-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 measuresSpectacle adherence between ages 4 and 5 years.ResultsChildren 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.ConclusionsThese 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.
| S-EPMC6445735 | biostudies-literature
Project description: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.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.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.Children with unilateral congenital cataract may have delayed motor functioning at 4 years 6 months, which may adversely affect their social and academic functioning.
| S-EPMC4869970 | biostudies-literature
Project description:Importance:Although contact lenses have been used for decades to optically correct eyes in children after cataract surgery, there has never been a prospective study looking at contact lens adherence in children with aphakia, to our knowledge. Objective:To evaluate contact lens adherence and its association with visual outcome in a cohort of children treated for unilateral cataract surgery. Design, Setting, and Participants:Secondary analysis of a multicenter randomized clinical trial of 57 infants born from August 22, 2004, to April 25, 2008, who were randomized to 1 of 2 treatments and followed up to age 5 years. Data analysis was performed from August 9, 2016, to December 7, 2017. Interventions:Unilateral cataract extraction and randomization to implantation of an intraocular lens vs contact lens to correct aphakia. Main Outcomes and Measures:Contact lens adherence was assessed by a 48-hour recall telephone interview that was administered every 3 months starting 3 months after surgery to age 5 years. A traveling examiner assessed visual acuity in patients at aged 4.5 years. Adherence to prescribed contact lens use was estimated as the mean percentage of waking hours as reported in 2 or more interviews for each year of life. Results:Of 57 infants who were randomized to contact lens treatment, 32 (56%) were girls, and 49 (86%) were white. A total of 872 telephone interviews were completed. In year 1, a median of 95% participants wore their contacts lenses nearly all waking hours (interquartile range [IQR], 84%-100%); year 2, 93% (IQR, 85%-99%); year 3, 93% (IQR, 85%-99%); year 4, 93% (IQR, 75%-99%); and year 5, 89% (IQR, 71%-97%). There was a tendency for poorer reported adherence at older ages (F = 3.86, P < .001). No differences were identified when the results were analyzed by sex, insurance coverage, or age at cataract surgery. Using linear regression, children who wore the contact lens for a greater proportion of waking hours during the entire study period tended to have better visual acuity at age 4.5 years, even after accounting for adherence to patching (partial correlation = -0.026; P = .08). Conclusions and Relevance:These results confirm that it is possible to achieve a high level of aphakic contact lens adherence over a 5-year period in children. Trial Registration:clinicaltrials.gov Identifier: NCT00212134.
| S-EPMC5862145 | biostudies-literature
Project description:PurposePrediction of refraction after cataract surgery in children is limited by the variance in rate of refractive growth (RRG3). This study compared RRG3 in aphakic and pseudophakic eyes with their fellow, normal eyes in the Infant Aphakia Treatment Study.SettingTwelve clinical sites in the United States.DesignRandomized clinical trial.MethodsInfants randomized to unilateral cataract extraction had RRG3 calculated based on biometric data (axial length and keratometry) at cataract surgery and at 10 years of age, for both the normal and cataract eyes. Subjects were included if complete biometric data from both eyes were available both at surgery and at 10 years. Variance in RRG3 was compared between the groups with Pitman test for equality of variance between correlated samples.ResultsLongitudinal biometric data were available for 103 of the 114 patients enrolled. RRG3 was -15.00 diopters (D) (3.00 D) for normal eyes (reported as mean [SD]), -17.70 D (6.20 D) for aphakic eyes, and -16.70 D (6.20 D) for pseudophakic eyes (P < .0001 for comparison of variances in RRG3 between normal and all operated eyes). Further analysis found differences in the variance in axial length growth (P < .0001) between operated and normal eyes; the variance in keratometry measurement change did not reach significance.ConclusionsThe standard deviation in the RRG3 of normal eyes in our study was half of that found in eyes that underwent cataract surgery.
| S-EPMC8084894 | biostudies-literature
Project description:To evaluate the characteristics of strabismus in infants who underwent cataract surgery with and without intraocular lens (IOL) implantation.Secondary outcome analysis in a prospective, randomized clinical trial.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.Infants underwent cataract surgery with or without placement of an IOL.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.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).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.The author(s) have no proprietary or commercial interest in any materials discussed in this article.
| S-EPMC4525476 | biostudies-literature
Project description:PurposeTo report outcomes of secondary intraocular lens (IOL) implantation in the Infant Aphakia Treatment Study (IATS).SettingMulticenter clinical practice.DesignSecondary analysis of patients enrolled in a randomized clinical trial.MethodsDetails regarding all secondary IOL surgeries conducted in children enrolled in the IATS were compiled. Visual outcomes, refractive outcomes, and adverse events at the age of 10½ years were evaluated. Comparisons were made with eyes that remained aphakic and with eyes randomized to primary IOL placement.ResultsThe study included 114 infants, 57 in the aphakic group and 57 in the primary IOL group; 55 of 57 patients randomized to aphakia with contact lens correction were seen for the 10½-year study visit; 24 (44%) of 55 eyes had secondary IOL surgery. Median age at IOL surgery was 5.4 years (range 1.7 to 10.3 years). Mean absolute prediction error was 1.00 ± 0.70 diopters (D). At age 10½ years, the median logarithm of the minimum angle of resolution visual acuity (VA) was 0.9 (range 0.2 to 1.7), similar to VA in the 31 eyes still aphakic (0.8, range 0.1 to 2.9); the number of eyes with stable or improved VA scores between the 4½-year and 10½-year study visits was also similar (78% secondary IOL eyes; 84% aphakic eyes). For eyes undergoing IOL implantation after the 4½-year study visit (n = 22), the mean refraction at age 10½ years was -3.20 ± 2.70 D (range -9.90 to 1.10 D), compared with -5.50 ± 6.60 D (n = 53, range -26.50 to 3.00 D) in eyes with primary IOL (P = .03).ConclusionsDelayed IOL implantation allows a more predictable refractive outcome at age 10½ years, although the range of refractive error is still large.
| S-EPMC7936988 | biostudies-literature