Danielle L. Chandler

A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol.

PURPOSE To develop a computerized method of visual acuity testing for clinical research as an alternative to the standard Early Treatment for Diabetic Retinopathy Study (ETDRS) testing protocol, and to evaluate its test-retest reliability and concordance with standard ETDRS testing. DESIGN Test-retest reliability study. METHODS Multicenter setting of a study population of 265 patients at three clinical sites. Visual acuity was measured with both the electronic visual acuity testing algorithm (E-ETDRS) and standard ETDRS protocol (S-ETDRS) twice on one eye of each patient. E-ETDRS testing was conducted using the electronic visual acuity tester (EVA), which utilizes a programmed Palm (Palm, Inc, Santa Clara, California, USA) hand-held device communicating with a personal computer and 17-inch monitor at a test distance of 3 meters. RESULTS For the E-ETDRS protocol, test-retest reliability was high (r = 0.99; with 89% and 98% of retests within 0.1 logMAR and 0.2 logMAR of initial tests, respectively) and comparable with that of S-ETDRS testing (r = 0.99; with 87% and 98% of retests within 0.1 logMAR and 0.2 logMAR of initial test, respectively). The E-ETDRS and S-ETDRS scores were highly correlated (r = 0.96 for initial tests and r = 0.97 for repeat tests). Based on estimates of 95% confidence intervals, a change in visual acuity of 0.2 logMAR (10 letters) from a baseline level is unlikely to be related to measurement variability using either the E-ETDRS or the S-ETDRS visual acuity testing protocol. CONCLUSIONS The E-ETDRS protocol has high test-retest reliability and good concordance with S-ETDRS testing. The computerized method has advantages over the S-ETDRS testing in electronically capturing the data for each tested letter, requiring only a single distance for testing from 20/12 to 20/800, potentially reducing testing time, and potentially decreasing technician-related bias.

Interferon β‐1a for early multiple sclerosis: CHAMPS trial subgroup analyses

The objective of this work was to assess the effect of interferon β‐1a (Avonex®) on the rate of development of clinically definite multiple sclerosis and brain magnetic resonance imaging changes in subgroups based on type of presenting event, baseline brain magnetic resonance imaging parameters, and demographic factors in the Controlled High‐Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS) trial. After the onset of a first demyelinating event, 383 patients with brain magnetic resonance imaging evidence of subclinical demyelination were treated with corticosteroids and randomly assigned to receive weekly intramuscular injections of 30μg interferon β‐1a or placebo. The treatment effect within subgroups was assessed in proportional hazards models both for the development of clinically definite multiple sclerosis and for a combined outcome of development of clinically definite multiple sclerosis or >1 new or enlarging T2 lesions on brain magnetic resonance imaging. A beneficial effect of treatment was noted in all subgroups evaluated. Adjusted rate ratios for the development of clinically definite multiple sclerosis in the optic neuritis, brainstem–cerebellar, and spinal cord syndrome subgroups were 0.58 (p = 0.05), 0.40 (p = 0.03), and 0.30 (p = 0.01) and for the development of the combined clinically definite multiple sclerosis/magnetic resonance imaging outcome were 0.50 (p < 0.001), 0.41 (p = 0.001), and 0.40 (p = 0.004), respectively. A treatment benefit on both outcome measures also was seen in subgroups based on baseline brain magnetic resonance imaging parameters, gender, and age. Interferon β‐1a is beneficial when initiated at the first clinical demyelinating event in patients with brain magnetic resonance imaging evidence of subclinical demyelination. The beneficial effect is present for optic neuritis, brainstem–cerebellar syndromes, and spinal cord syndromes.

A randomized trial of atropine vs patching for treatment of moderate amblyopia: Follow-up at age 10 years

OBJECTIVE To determine the visual acuity outcome at age 10 years for children younger than 7 years when enrolled in a treatment trial for moderate amblyopia. METHODS In a multicenter clinical trial, 419 children with amblyopia (visual acuity, 20/40-20/100) were randomized to patching or atropine eyedrops for 6 months. Two years after enrollment, a subgroup of 188 children entered long-term follow-up. Treatment after 6 months was at the discretion of the investigator; 89% of children were treated. MAIN OUTCOME MEASURE Visual acuity at age 10 years with the electronic Early Treatment Diabetic Retinopathy Study test. APPLICATION TO CLINICAL PRACTICE Patching and atropine eyedrops produce comparable improvement in visual acuity that is maintained through age 10 years. RESULTS The mean amblyopic eye acuity, measured in 169 patients, at age 10 years was 0.17 logMAR (logarithm of the minimum angle of resolution) (approximately 20/32), and 46% of amblyopic eyes had an acuity of 20/25 or better. Age younger than 5 years at entry into the randomized trial was associated with a better visual acuity outcome (P < .001). Mean amblyopic and sound eye visual acuities at age 10 years were similar in the original treatment groups (P = .56 and P = .80, respectively). CONCLUSIONS At age 10 years, the improvement of the amblyopic eye is maintained, although residual amblyopia is common after treatment initiated at age 3 years to younger than 7 years. The outcome is similar regardless of initial treatment with atropine or patching.

Primary treatment of nasolacrimal duct obstruction with nasolacrimal duct intubation in children younger than 4 years of age.

PURPOSE To report the outcome of nasolacrimal duct intubation as the primary treatment of congenital nasolacrimal duct obstruction (NLDO) in children younger than 4 years of age. METHODS A total of 182 eyes of 139 children receiving intubation with planned tube retention for 2 to 5 months were enrolled in a prospective, nonrandomized observational multicenter study (19 sites). Children were ages 6 months to <45 months at the time of surgery, with no previous nasolacrimal surgical procedures and had at least one of the following clinical signs of NLDO: epiphora, mucous discharge, and/or increased tear lake. RESULTS Treatment success was defined as absence of epiphora, mucous discharge, and increased tear lake at the outcome visit, 1 month after tube removal. The surgical outcome was assessed in 150 eyes (82% of cohort). The proportion of eyes treated successfully was 91% (95% CI: 86%-95%). The outcome dye disappearance test was normal in 125 (86%) eyes, indeterminate in 13 (9%), and abnormal in 7 (5%) of the 145 eyes tested. Monocanalicular tubes were used in 74% of cases. The tube was removed before the planned minimum retention time of 2 months in 61 eyes (41%). For 23 eyes, the early removal was attributed to inadvertent displacement by the patient. CONCLUSIONS In children 6 months to <45 months of age, nasolacrimal duct intubation in a nonrandomized and noncomparative trial was a successful primary treatment of NLDO in about 90% of cases not lost to follow-up.

Balloon catheter dilation and nasolacrimal duct intubation for treatment of nasolacrimal duct obstruction after failed probing.

OBJECTIVE To compare the outcomes of balloon catheter dilation and nasolacrimal intubation as treatment for congenital nasolacrimal duct obstruction after failed probing in children younger than 4 years. METHODS We conducted a prospective, nonrandomized, multicenter study that enrolled 159 children aged 6 months to younger than 48 months who had a history of a single failed nasolacrimal duct probing and at least 1 of the following clinical signs of nasolacrimal duct obstruction: epiphora, mucous discharge, or increased tear lake. One hundred ninety-nine eyes underwent either balloon catheter nasolacrimal duct dilation or nasolacrimal duct intubation. Treatment success was defined as absence of epiphora, mucous discharge, or increased tear lake at the outcome visit 6 months after surgery. RESULTS Treatment success was reported in 65 of 84 eyes (77%; 95% confidence interval, 65%-85%) in the balloon catheter dilation group compared with 72 of 88 eyes (84% after adjustment for intereye correlation; 74%-91%) in the nasolacrimal intubation group (risk ratio for success for intubation vs balloon dilation, 1.08; 0.95-1.22). CONCLUSION Both balloon catheter dilation and nasolacrimal duct intubation alleviate the clinical signs of persistent nasolacrimal duct obstruction in a similar percentage of patients.

Interobserver reliability of the prism and alternate cover test in children with esotropia

OBJECTIVE To determine 95% limits of agreement on a measurement and on a difference between 2 measurements for the prism and alternate cover test (PACT) at distance and at near fixation. METHODS In a test-retest reliability study, 143 children aged 60 months or younger with esotropia were examined by 2 masked examiners on 1 or 2 occasions yielding 199 test-retest pairs for PACT at distance fixation and 239 test-retest pairs for PACT at near fixation. RESULTS For angles greater than 20 prism diopters (PD), the 95% limits of agreement on a measurement and on a difference between 2 measurements were +/-7.3 PD and +/-10.4 PD, respectively, for PACT at distance and +/-8.3 PD and +/-11.7 PD, respectively, for PACT at near. For angles of 10 to 20 PD, the 95% limits of agreement on a measurement and on a difference between 2 measurements were +/-4.1 PD and +/-5.8 PD, respectively, for PACT at distance and +/-3.3 PD and +/-4.7 PD, respectively, for PACT at near. CONCLUSION In childhood esotropia, differences of 12 PD or more for angles greater than 20 PD and differences of 6 PD or more for angles between 10 PD and 20 PD are likely to indicate real change. Smaller differences could be real change but could also be due to measurement error.

Resolution of congenital nasolacrimal duct obstruction with nonsurgical management

OBJECTIVE To determine how often nasolacrimal duct obstruction (NLDO) resolves with 6 months of nonsurgical management in infants aged 6 to less than 10 months. METHODS As part of a randomized trial evaluating the cost-effectiveness of immediate office probing vs observation with deferred probing for unresolved cases, 107 infants aged 6 to less than 10 months who had NLDO and no history of nasolacrimal duct surgery were prescribed 6 months of nasolacrimal duct massage and topical antibiotics as needed. Resolution of the NLDO was assessed 6 months after study entry and was defined as the absence of all clinical signs of NLDO (epiphora, increased tear lake, or mucous discharge) and not having undergone NLDO surgery. Exploratory analyses assessed whether baseline characteristics, including age, sex, laterality, and prior treatment, were associated with the probability of NLDO resolving without surgery. RESULTS At the 6-month examination, which was completed for 117 of the 133 eyes (88%), the NLDO had resolved without surgery in 77 eyes (66% [95% CI, 56%-74%]). None of the baseline characteristics we evaluated were found to be associated with resolution. CONCLUSIONS In infants 6 to less than 10 months of age, more than half of eyes with NLDO will resolve within 6 months with nonsurgical management. Knowledge of the rate of NLDO resolution in infancy without surgery will help clinicians and parents effectively discuss treatment options.

Evaluating the burden of amblyopia treatment from the parent and child’s perspective

PURPOSE To evaluate the psychometric properties of the original Parent and new Child Amblyopia Treatment Index (ATI), questionnaires that assess the burden of amblyopia treatment in children and families, and to compare scores between children treated with atropine or patching. METHODS Parent ATI and Child ATI were administered to 233 children 7 to <13 years old and their parents as part of a randomized trial comparing patching and atropine for amblyopia treatment. For each ATI version, construct validity was assessed using factor analysis; internal consistency reliability was assessed using Cronbachs alpha. Data from the Parent ATI and Child ATI were correlated and scores for each version were compared between treatment groups. RESULTS We analyzed the 3 subscales found in prior Parent ATI studies in younger children and confirmed subscales for adverse effects and treatment compliance, but not for social stigma, in both parent and child versions. Overall and subscale scores on the Parent ATI and Child ATI were moderately to well correlated except for the social stigma subscale. For both the Parent ATI and the Child ATI, children treated with atropine had better scores than those treated with patching, both overall and on treatment compliance and social stigma subscales (all p values ≤ 0.01). CONCLUSIONS When used for children 7 to <13 years old, the Parent ATI and Child ATI have similar factor structures to each other and to the Parent ATI for children 3 to <7 years old. Atropine treatment was found to have less negative impact than patching.

Primary treatment of nasolacrimal duct obstruction with balloon catheter dilation in children younger than 4 years of age.

PURPOSE To report the outcome of nasolacrimal duct balloon catheter dilation as the primary treatment of congenital nasolacrimal duct obstruction (NLDO) in children younger than 4 years of age. METHODS One hundred two children (151 eyes) ages 12 to <48 months (mean, 23 months) at the time of surgery, who previously had not undergone a nasolacrimal surgical procedure and who presented with at least one of the following clinical signs of NLDO--epiphora, increased tear lake, and/or mucous discharge--were enrolled in a prospective, nonrandomized observational multicenter study (20 sites). All children received balloon catheter dilation of the nasolacrimal system of the affected eye(s). RESULTS Treatment success was defined as no epiphora, increased tear lake, and/or mucous discharge present at the outcome visit at 1 month after surgery. The proportion of eyes treated successfully was 82% (95% CI: 74%-88%). The dye disappearance test at outcome was normal in 105 (73%), indeterminate in 15 (10%), and abnormal in 23 (16%) of the 143 eyes tested. CONCLUSIONS In children 12 to <48 months of age, balloon catheter dilation as a primary treatment of NLDO was successful in approximately 80% of cases. Because we did not perform a randomized trial with a comparison group, we were unable to determine how this procedures success rate compares with that of simple probing or nasolacrimal intubation in this age group.

Accommodative lag by autorefraction and two dynamic retinoscopy methods.

Purpose. To evaluate two clinical procedures, Monocular Estimate Method (MEM) and Nott retinoscopy, for detecting accommodative lags 1.00 diopter (D) or greater in children as identified by an open-field autorefractor. Methods. One hundred sixty-eight children 8 to <12 years old with low myopia, normal visual acuity, and no strabismus participated as part of an ancillary study within the screening process for a randomized trial. Accommodative response to a 3.00 D demand was first assessed by MEM and Nott retinoscopy, viewing binocularly with spherocylindrical refractive error corrected, with testing order randomized and each performed by a different masked examiner. The response was then determined viewing monocularly with spherical equivalent refractive error corrected, using an open-field autorefractor, which was the gold standard used for eligibility for the clinical trial. Sensitivity and specificity for accommodative lags of 1.00 D or more were calculated for each retinoscopy method compared to the autorefractor. Results. One hundred sixteen (69%) of the 168 children had accommodative lag of 1.00 D or more by autorefraction. MEM identified 66 children identified by autorefraction for a sensitivity of 57% (95% CI = 47 to 66%) and a specificity of 63% (95% CI = 49 to 76%). Nott retinoscopy identified 35 children for a sensitivity of 30% (95% CI = 22 to 39%) and a specificity of 81% (95% CI = 67 to 90%). Analysis of receiver operating characteristic curves constructed for MEM and for Nott retinoscopy failed to reveal alternate cut points that would improve the combination of sensitivity and specificity for identifying accommodative lag ≥1.00 D as defined by autorefraction. Conclusions. Neither MEM nor Nott retinoscopy provided adequate sensitivity and specificity to identify myopic children with accommodative lag ≥1.00 D as determined by autorefraction. A variety of methodological differences between the techniques may contribute to the modest to poor agreement.