Personalized versus standardized dosing strategies for the treatment of childhood amblyopia: study protocol for a randomized controlled trial

Background: Amblyopia is the commonest visual disorder of childhood in Western societies, affecting, predominantly, spatial visual function. Treatment typically requires a period of refractive correction (‘optical treatment’) followed by occlusion: covering the nonamblyopic eye with a fabric patch for varying daily durations. Recent studies have provided insight into the optimal amount of patching (‘dose’), leading to the adoption of standardized dosing strategies, which, though an advance on previous ad-hoc regimens, take little account of individual patient characteristics. This trial compares the effectiveness of a standardized dosing strategy (that is, a fixed daily occlusion dose based on disease severity) with a personalized dosing strategy (derived from known treatment dose-response functions), in which an initially prescribed occlusion dose is modulated, in a systematic manner, dependent on treatment compliance. Methods/design: A total of 120 children aged between 3 and 8 years of age diagnosed with amblyopia in association with either anisometropia or strabismus, or both, will be randomized to receive either a standardized or a personalized occlusion dose regimen. To avoid confounding by the known benefits of refractive correction, participants will not be randomized until they have completed an optical treatment phase. The primary study objective is to determine whether, at trial endpoint, participants receiving a personalized dosing strategy require fewer hours of occlusion than those in receipt of a standardized dosing strategy. Secondary objectives are to quantify the relationship between observed changes in visual acuity (logMAR, logarithm of the Minimum Angle of Resolution) with age, amblyopia type, and severity of amblyopic visual acuity deficit. Discussion: This is the first randomized controlled trial of occlusion therapy for amblyopia to compare a treatment arm representative of current best practice with an arm representative of an entirely novel treatment regimen based on statistical modelling of previous trial outcome data. Should the personalized dosing strategy demonstrate superiority over the standardized dosing strategy, then its adoption into routine practice could bring practical benefits in reducing the duration of treatment needed to achieve an optimal outcome

The effect of amblyopia treatment on stereoacuity

Purpose: To explore how stereoacuity changes in patients while they are being treated for amblyopia. Methods: The Monitored Occlusion Treatment for Amblyopia Study (MOTAS) comprised 3 distinct phases. In the first phase, baseline, assessments of visual function were made to confirm the initial visual and binocular visual deficit. The second phase, refractive adaptation, now commonly termed “optical treatment,” was an 18-week period of spectacle wear with measurements of logMAR visual acuity and stereoacuity with the Frisby test at weeks 0, 6, 12, and 18. In the third phase, occlusion, participants were prescribed 6 hours of patching per day. Results: A total of 85 children were enrolled (mean age, 5.1 ± 1.5 years). In 21 children amblyopia was associated with anisometropia; in 29, with strabismus; and in 35, with both. At study entry, poor stereoacuity was associated with poor visual acuity (P < 0.001) in the amblyopic eye and greater angle of strabismus (P < 0.001). Of 66 participants, 25 (38%) who received refractive adaptation and 19 (29%) who received occlusion improved by at least one octave in stereoacuity, exceeding test–retest variability. Overall, 38 (45%) improved one or more octaves across both treatment phases. Unmeasureable stereoacuity was observed in 56 participants (66%) at study entry and in 37 (43%) at study exit. Conclusions: Stereoacuity improved for almost one half of the study participants. Improvement was observed in both treatment phases. Factors associated with poor or nil stereoacuity at study entry and exit were poor visual acuity of the amblyopic eye and large-angle strabismus

The further refinement of ROP treatment. Commentary on the Early Treatment of Retinopathy of Prematurity study: structural findings at 2 years of age

Reaching the goal of early ROP treatment by recent advances in ROP managemen

Objectively monitored patching regimens for treatment of amblyopia: randomised trial

Objectives To compare visual outcome in response to two prescribed rates of occlusion (six hours a day and 12 hours a day)

Cost-effectiveness of digital photographic screening for retinopathy of prematurity in the United Kingdom.

OBJECTIVES: To compare the cost-effectiveness of alternative methods of screening for retinopathy of prematurity (ROP) in the United Kingdom, including the existing method of indirect ophthalmoscopy by ophthalmologists and digital photographic screening by nurses. METHODS: A decision tree model was used to compare five screening modalities for the UK population of preterm babies, using a health service perspective. Data were taken from published sources, observation at a neonatal intensive care unit (NICU), and expert judgment. RESULTS: We estimated that use of standard digital cameras by nurses in NICUs would cost more than current methods (pound 371 compared with pound 321 per baby screened). However, a specialist nurse visiting units with a portable camera would be cheaper (pound 172 per baby). These estimates rely on nurses capturing and interpreting the images, with suitable training and supervision. Alternatively, nurses could capture the images then transmit them to a central unit for interpretation by ophthalmologists, although we estimate that this would be rather more expensive (pound 390 and pound 201, respectively, for NICU and visiting nurses). Sensitivity analysis was used to examine the robustness of estimates. CONCLUSIONS: It is likely that there is an opportunity to improve the efficiency of the ROP screening program. We estimate that screening by specialist nurses trained in image capture and interpretation using portable digital cameras is a cost-effective alternative to the current program of direct visualization by ophthalmologists. This option would require the development of a suitable portable machine. Direct comparative research is strongly needed to establish the accuracy of the various screening options