A randomized trial comparing part-time patching with observation for children 3 to 10 years of age with intermittent exotropia.

OBJECTIVE: To determine the effectiveness of prescribed part-time patching for treatment of intermittent exotropia (IXT) in children. DESIGN: Multicenter, randomized clinical trial. PARTICIPANTS: Three hundred fifty-eight children 3 to <11 years of age with previously untreated (except for refractive correction) IXT and near stereoacuity of 400 seconds of arc or better were enrolled. Intermittent exotropia met the following criteria: (1) IXT at distance OR constant exotropia at distance and either IXT or exophoria at near; (2) exodeviation (tropia or phoria) of at least 15 prism diopters (PD) at distance or near by prism and alternate cover test (PACT); and (3) exodeviation of at least 10 PD at distance by PACT. METHODS: Participants were assigned randomly either to observation (no treatment for 6 months) or to patching for 3 hours daily for 5 months, with a 1-month washout period of no patching before the 6-month primary outcome examination. MAIN OUTCOME MEASURES: The primary outcome was deterioration at either the 3-month or the 6-month follow-up visit, defined as: (1) constant exotropia measuring at least 10 PD at distance and near by simultaneous prism and cover test, and/or (2) near stereoacuity decreased by at least 2 octaves from baseline, both assessed by a masked examiner and confirmed by a retest. Participants who were prescribed any nonrandomized treatment without first meeting either deterioration criteria also were counted as having deteriorated. RESULTS: Of the 324 participants (91%) completing the 6-month primary outcome examination, deterioration occurred in 10 of the 165 participants (6.1%) in the observation group (3 of these 10 started treatment without meeting deterioration criteria) and in 1 of the 159 participants (0.6%) in the part-time patching group (difference, 5.4%; lower limit of 1-sided exact 95% confidence interval, 2.0%; P = 0.004, 1-sided hypothesis test). CONCLUSIONS: Deterioration of previously untreated childhood IXT over a 6-month period is uncommon with or without patching treatment. Although there is a slightly lower deterioration rate with patching, both management approaches are reasonable for treating children 3 to 10 years of age with IXT.

Feasibility of a clinical trial of vision therapy for treatment of amblyopia.

PURPOSE: We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. METHODS: A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. RESULTS: Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. CONCLUSIONS: This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

Parent-provided photographs as an outcome measure for childhood chalazia.

PURPOSE: To determine whether smartphone photographs of children's eyelids are reliable for diagnosing the presence of chalazia. METHODS: In this prospective cross-sectional study, 60 participants, 7 months to 16.5 years of age, at four sites were enrolled; all participants had a chalazion measuring at least 2 mm on at least one eyelid based on an in-person clinical examination by a pediatric eye care professional. Smartphone photographs taken by the parent during the office visit were uploaded to the study website. A masked reader assessed each photograph for the presence or absence of chalazia; results were compared with the gold standard clinical examination results. Sensitivity and specificity for the presence of chalazion by eyelid were calculated. RESULTS: Photographs were available for 240 eyelids; 85 had at least one chalazion and 155 were without a chalazion based on clinical examination. The masked reader correctly classified 68 of 85 eyelids with at least one chalazion and 151 of 155 eyelids without chalazia for a sensitivity of 80% (95% CI, 72%-86%) and a specificity of 97% (95% CI, 94%-99%). Sensitivity improved to 89% for chalazia 5 mm or larger and 94% when superficially located within the eyelid. CONCLUSIONS: Parental smartphone photographs appear to be useful in assessing chalazia in children as an alternative to in-office follow-up examinations. These photographs may be a valuable outcome measure in future clinical trials of chalazia treatment, especially when assessing larger lesions.

Treatment of anisometropic amblyopia in children with refractive correction.

OBJECTIVE: To evaluate the effectiveness of refractive correction alone for the treatment of untreated anisometropic amblyopia in children 3 to <7 years old. DESIGN: Prospective, multicenter, noncomparative intervention. PARTICIPANTS: Eighty-four children 3 to <7 years old with untreated anisometropic amblyopia ranging from 20/40 to 20/250. METHODS: Optimal refractive correction was provided, and visual acuity (VA) was measured with the new spectacle correction at baseline and at 5-week intervals until VA stabilized or amblyopia resolved. MAIN OUTCOME MEASURES: Maximum improvement in best-corrected VA in the amblyopic eye and proportion of children whose amblyopia resolved (interocular difference of < or =1 line) with refractive correction alone. RESULTS: Amblyopia improved with optical correction by > or =2 lines in 77% of the patients and resolved in 27%. Improvement took up to 30 weeks for stabilization criteria to be met. After stabilization, additional improvement occurred with spectacles alone in 21 of 34 patients observed in a control group of a subsequent randomized trial, with amblyopia resolving in 6. Treatment outcome was not related to age, but was related to better baseline VA and lesser amounts of anisometropia. CONCLUSION: Refractive correction alone improves VA in many cases and results in resolution of amblyopia in at least one third of 3- to <7-year-old children with untreated anisometropic amblyopia. Although most cases of resolution occur with moderate (20/40-20/100) amblyopia, the average 3-line improvement in VA resulting from treatment with spectacles may lessen the burden of subsequent amblyopia therapy for those with denser levels of amblyopia.

A randomized trial to evaluate 2 hours of daily patching for strabismic and anisometropic amblyopia in children.

OBJECTIVE: To compare 2 hours of daily patching (combined with 1 hour of concurrent near visual activities) with a control group of spectacle wear alone (if needed) for treatment of moderate to severe amblyopia in children 3 to 7 years old. DESIGN: Prospective randomized multicenter clinical trial (46 sites). PARTICIPANTS: One hundred eighty children 3 to 7 years old with best-corrected amblyopic-eye visual acuity (VA) of 20/40 to 20/400 associated with strabismus, anisometropia, or both who had worn optimal refractive correction (if needed) for at least 16 weeks or for 2 consecutive visits without improvement. INTERVENTION: Randomization either to 2 hours of daily patching with 1 hour of near visual activities or to spectacles alone (if needed). Patients were continued on the randomized treatment (or no treatment) until no further improvement was noted. MAIN OUTCOME MEASURE: Best-corrected VA in the amblyopic eye after 5 weeks. RESULTS: Improvement in VA of the amblyopic eye from baseline to 5 weeks averaged 1.1 lines in the patching group and 0.5 lines in the control group (P = 0.006), and improvement from baseline to best measured VA at any visit averaged 2.2 lines in the patching group and 1.3 lines in the control group (P<0.001). CONCLUSION: After a period of treatment with spectacles, 2 hours of daily patching combined with 1 hour of near visual activities modestly improves moderate to severe amblyopia in children 3 to 7 years old.

A symptom survey and quality of life questionnaire for nasolacrimal duct obstruction in children.

PURPOSE: To develop and validate a new parental questionnaire addressing symptoms and health-related quality of life (HRQL) in childhood nasolacrimal duct obstruction (NLDO). DESIGN: Cross-sectional study. PARTICIPANTS: Children ages 6 to younger than 48 months with and without clinical signs of NLDO. METHODS: A new questionnaire was developed using semistructured interviews with parents of children with NLDO and through discussions with expert clinicians. Questionnaires were completed by parents of children with and without NLDO. Cronbach's alpha was calculated as a measure of internal-consistency reliability. Factor analysis was used to evaluate a priori subscales: symptoms and HRQL. Discriminant construct validity was assessed by comparing questionnaire scores between children with and without NLDO and between affected and unaffected eyes of children with unilateral NLDO. Instrument responsiveness was determined by comparing presurgical and postsurgical intervention scores in a subset of NLDO patients who underwent surgical treatment. MAIN OUTCOME MEASURE: The NLDO questionnaire score. RESULTS: Eighty-seven children were enrolled, 56 with and 31 without NLDO. All but 2 questions on the questionnaire showed a good distribution of responses, a high correlation with the rest of the questionnaire, and excellent discrimination between patients with and without NLDO. Cronbach's alpha values were good for the overall questionnaire (0.95), and for 2 predetermined subscales: symptoms (0.95) and HRQL (0.85). On a 0 to 4 scale, NLDO patients had worse scores compared with non-NLDO patients for both symptoms (mean difference, 2.1; 95% confidence interval [CI], 1.9-2.3) and HRQL (mean difference, 1.2; 95% CI, 0.9-1.5) subscales. The NLDO patients had worse scores before intervention compared with after intervention for both the symptoms (mean difference, 2.2; 95% CI, 1.6-2.9) and HRQL (mean difference, 1.4; 95% CI, 0.8-2.1) subscales. Finally, NLDO patients had worse symptom scores for affected eyes compared with unaffected eyes (mean difference, 2.3; 95% CI, 1.9-2.6). CONCLUSIONS: This novel NLDO questionnaire is useful in quantifying parental perception of symptoms and HRQL in childhood NLDO. The questionnaire may have a role in future clinical studies of NLDO.

Randomized trial of treatment of amblyopia in children aged 7 to 17 years.

OBJECTIVE: To evaluate the effectiveness of treatment of amblyopia in children aged 7 to 17 years. METHODS: At 49 clinical sites, 507 patients with amblyopic eye visual acuity ranging from 20/40 to 20/400 were provided with optimal optical correction and then randomized to a treatment group (2-6 hours per day of prescribed patching combined with near visual activities for all patients plus atropine sulfate for children aged 7 to 12 years) or an optical correction group (optical correction alone). Patients whose amblyopic eye acuity improved 10 or more letters (> or =2 lines) by 24 weeks were considered responders. RESULTS: In the 7- to 12-year-olds (n = 404), 53% of the treatment group were responders compared with 25% of the optical correction group (P<.001). In the 13- to 17-year-olds (n = 103), the responder rates were 25% and 23%, respectively, overall (adjusted P = .22) but 47% and 20%, respectively, among patients not previously treated with patching and/or atropine for amblyopia (adjusted P = .03). Most patients, including responders, were left with a residual visual acuity deficit. CONCLUSIONS: Amblyopia improves with optical correction alone in about one fourth of patients aged 7 to 17 years, although most patients who are initially treated with optical correction alone will require additional treatment for amblyopia. For patients aged 7 to 12 years, prescribing 2 to 6 hours per day of patching with near visual activities and atropine can improve visual acuity even if the amblyopia has been previously treated. For patients 13 to 17 years, prescribing patching 2 to 6 hours per day with near visual activities may improve visual acuity when amblyopia has not been previously treated but appears to be of little benefit if amblyopia was previously treated with patching. We do not yet know whether visual acuity improvement will be sustained once treatment is discontinued; therefore, conclusions regarding the long-term benefit of treatment and the development of treatment recommendations for amblyopia in children 7 years and older await the results of a follow-up study we are conducting on the patients who responded to treatment.

A randomized pilot study of near activities versus non-near activities during patching therapy for amblyopia.

BACKGROUND: To plan a future randomized clinical trial, we conducted a pilot study to determine whether children randomized to near or non-near activities would perform prescribed activities. A secondary aim was to obtain a preliminary estimate of the effect of near versus non-near activities on amblyopic eye visual acuity, when combined with 2 hours of daily patching. METHODS: Sixty-four children, 3 to less than 7 years of age, with anisometropic, strabismic, or combined amblyopia (20/40 to 20/400) were randomly assigned to receive either 2 hours of daily patching with near activities or 2 hours of daily patching without near activities. Parents completed daily calendars for 4 weeks recording the activities performed while patched and received a weekly telephone call in which they were asked to describe the activities performed during the previous 2 hours of patching. Visual acuity was assessed at 4 weeks. RESULTS: The children assigned to near visual activities performed more near activities than those assigned to non-near activities (by calendars, mean 1.6 +/- 0.5 hours versus 0.2 +/- 0.2 hours daily, P < 0.001; by telephone interviews, 1.6 +/- 0.4 hours versus 0.4 +/- 0.5 hours daily, P < 0.001). After 4 weeks of treatment, there was a suggestion of greater improvement in amblyopic eye visual acuity in those assigned to near visual activities (mean 2.6 lines versus 1.6 lines, P = 0.07). The treatment group difference in visual acuity was present for patients with severe amblyopia but not moderate amblyopia. CONCLUSIONS: Children patched and instructed to perform near activities for amblyopia spent more time performing those near activities than children who were instructed to perform non-near activities. Our results suggest that performing near activities while patched may be beneficial in treating amblyopia. Based on our data, a formal randomized amblyopia treatment trial of patching with and without near activities is both feasible and desirable.

A randomized trial of atropine regimens for treatment of moderate amblyopia in children.

OBJECTIVE: To compare daily atropine to weekend atropine as prescribed treatments for moderate amblyopia in children younger than 7 years. DESIGN: Prospective, randomized multicenter clinical trial (30 sites). PARTICIPANTS: One hundred sixty-eight children younger than 7 years with amblyopia in the range of 20/40 to 20/80 associated with strabismus, anisometropia, or both. INTERVENTION: Randomization either to daily atropine or to weekend atropine for 4 months. Partial responders were continued on the randomized treatment until no further improvement was noted. MAIN OUTCOME MEASURE: Visual acuity (VA) in the amblyopic eye after 4 months. RESULTS: The improvement in VA of the amblyopic eye from baseline to 4 months averaged 2.3 lines in each group. The VA of the amblyopic eye at study completion was either (1) at least 20/25 or (2) better than or equal to that of the sound eye in 39 children (47%) in the daily group and 45 children (53%) in the weekend group. The VA of the sound eye at the end of follow-up was reduced by 2 lines in one patient in each group. Stereoacuity outcomes were similar in the 2 groups. CONCLUSIONS: Weekend atropine provides an improvement in VA of a magnitude similar to that of the improvement provided by daily atropine in treating moderate amblyopia in children 3 to 7 years old. This article contains additional online-only material available at http://www.ophsource.com/periodicals/ophtha.

Retinal nerve fiber layer thickness in amblyopic eyes.

PURPOSE: To compare the peripapillary retinal nerve fiber layer (RNFL) thickness of amblyopic and fellow eyes. We hypothesized that the RNFL of the amblyopic eye may be thinner. DESIGN: Prospective, cross-sectional, observational case series. METHODS: Optical coherence tomography of the peripapillary RNFL thickness of amblyopic and fellow eyes was performed in 37 patients 7 to 12 years of age (mean age +/- standard deviation, 9.2 +/- 1.5 years) with unilateral strabismic, anisometropic, or combined-mechanism amblyopia enrolled in a randomized treatment trial. RESULTS: Mean global RNFL thickness of the amblyopic and fellow eyes was 111.4 and 109.6 microm, respectively (mean difference, 1.8 microm thicker in the amblyopic eyes; 95% confidence interval, -0.6 to 4.3 microm). The amblyopic eye was 8 microm or more thicker than the fellow eye in 9 patients (24%); the fellow eye was 8 microm or more thicker than the amblyopic eye in 2 patients (5%); and the difference was within test-retest variability (7 microm) in 26 patients (70%). CONCLUSIONS: Our findings do not indicate that peripapillary RNFL thickness is thinner in eyes with moderate amblyopia compared with their fellow eyes.

Monocular oral reading performance after amblyopia treatment in children.

PURPOSE: To evaluate the monocular oral reading rate, accuracy, fluency, and comprehension in 10-year-old children previously treated for amblyopia. DESIGN: Prospective, observational case series. METHODS: Seventy-nine children (mean age, 10.3 years) previously treated in a multicenter randomized trial comparing patching and atropine were tested at seven sites using a modification of the Gray Oral Reading Test, Fourth Edition (GORT-4). RESULTS: The mean visual acuities (VA) in the amblyopic and fellow eyes at the time of the reading assessment were 0.17 logarithm of the minimum angle of resolution (logMAR) units (approximately 20/32) and -0.03 logMAR units (approximately 20/20), respectively. Compared with the sound eye, amblyopic eye performance was worse when reading orally with respect to rate (P < .001), accuracy (P = .03), and fluency (P < .001). Reading comprehension scores were similar with the amblyopic and fellow eyes (P = .45). Similar results were found with respect to original treatment group assignment (atropine or patching). There was a modest correlation between interocular difference (IOD) of VA at age 10 years and IOD in reading rate (r = 0.37; 95% confidence interval [CI], 0.18 to 0.56) and fluency (r = 0.28; 95% CI, 0.08 to 0.49). There was no correlation between the IOD in VA and IOD in accuracy (r = 0.08; 95% CI, -0.14 to 0.30) or comprehension (r = 0.16; 95% CI, -0.05 to 0.37). CONCLUSIONS: The monocular oral reading ability when measured with the GORT-4 was slightly worse when reading with previously treated amblyopic eyes compared with fellow eyes in terms of rate, accuracy, and fluency, but reading comprehension testing was similar.