ABSTRACT 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.
Specific Health-Related Quality of Life Concerns in Children with Intermittent Exotropia
ABSTRACT Purpose. The Minnesota Low‐Vision Reading Test (MNREAD) has been developed to measure reading speed. An abbreviated version of the MNREAD test was developed that presented only three large paragraphs and would be easier for children to complete. Methods. Fifty children ages 8 to 18 years, with normal eye examinations or refractive error alone, underwent testing of reading speed using the MNREAD test. All the children read the standard MNREAD paragraphs starting at the 1.0 logarithm of the minimum angle of resolution (logMAR) level until they could no longer read the subsequent paragraph. Each eye was tested separately, using the second MNREAD card for the left eye. The standard MNREAD reading speed was calculated by plotting the speed for each paragraph, determining the critical print size, then taking the median value of all the paragraphs above the cutoff paragraph. The proposed abbreviated test reading speed was calculated from the median of three large paragraphs (logMAR, 1.0, 0.9, and 0.8). At a second site, 25 children with a variety of ocular conditions were similarly tested using an alternative abbreviated test (logMAR, 1.3, 1.2, and 1.1). The standard and abbreviated reading speeds were then compared between tests and between eyes using generalized estimating equation and intraclass correlation coefficients. Results. The mean reading method speeds with the standard and abbreviated tests were almost identical [177 words per minute (wpm) ± 46 wpm vs. 178 ± 46 wpm, p = 0.43 for normal children and 140 ± 29 wpm vs. 141 ± 33 wpm, p = 0.35 in children with a variety of ocular conditions]. Conclusion. The new abbreviated version of the MNREAD reading speed test yields similar results to the standard MNREAD test in children. The new abbreviated MNREAD test is faster to administer and appears to be particularly useful for children.
The Pediatric Eye Disease Investigator Group Report May Be Too Optimistic About Efficacy of Treatment: In Reply