Refractive Accuracy and Visual Outcome by Self-Refraction Using Adjustable-Focus Spectacles in Young Children: A Randomized Clinical Trial.

Importance: Uncorrected refractive error is the most common cause of vision impairment in children. Most children 12 years or older can achieve visual acuity (VA) of 20/25 or better by self-refraction using adjustable-focus spectacles, but data on younger children are lacking. Objective: To assess refractive accuracy, corrected VA, and factors associated with not achieving VA of 20/25 or better among children aged 5 to 11 years performing self-refraction with Adspecs adjustable-focus spectacles (Adaptive Eyecare), compared with noncycloplegic autorefraction and cycloplegic refraction. Design, Setting, and Participants: This was a cross-sectional noninferiority trial conducted from September 2, 2015, to December 14, 2017. The study setting was an academic pediatric eye clinic. Children aged 5 to 11 years with uncorrected VA of 20/40 or worse in 1 or both eyes and without systemic or ocular conditions preventing best-corrected VA of 20/25 or better were enrolled. Children who had best-corrected VA worse than 20/25 were excluded. Study data were analyzed from September 2017 to June 2023. Exposures: Children were taught to self-refract with adjustable-focus spectacles. Main Outcomes and Measures: Spherical equivalent refractive error (using self-refraction, noncycloplegic autorefraction, and cycloplegic refraction) and VA (uncorrected and using self-refraction, noncycloplegic autorefraction, and cycloplegic refraction) for study eyes were evaluated. Potential predictors of failure to achieve VA of 20/25 or better with self-refraction were assessed using logistic regression. Results: A total of 127 consecutive children were enrolled. After exclusions, 112 children (median [IQR] age, 9.0 [8.0-10.3] years; 52 boys [46.4%]) were included in the study. Mean (SD) spherical equivalent refractive power was -2.00 (1.52) diopters (D) for self-refraction, -2.32 (1.43) D for noncycloplegic autorefraction, and -1.67 (1.49) D for cycloplegic refraction. Mean (SD) difference in refractive power between self-refraction and noncycloplegic autorefraction was 0.32 (1.11) D (97.5% 1-sided CI, 0.11 to ∞ D; P < .001) and between self-refraction and cycloplegic refraction was -0.33 (1.15) D (97.5% 1-sided CI, -0.54 to ∞ D; P = .77). The proportion of children with corrected VA of 20/25 or better was 79.5% (89 of 112) with self-refraction, 85.7% (96 of 112) with noncycloplegic autorefraction, and 79.5% (89 of 112) with cycloplegic refraction (self-refraction vs noncycloplegic autorefraction: McNemar P value = .27; self-refraction vs cycloplegic refraction: McNemar P value > .99). Those failing to achieve best-corrected VA of 20/25 or better with self-refraction had higher astigmatism (odds ratio [OR], 10.6; 95% CI, 3.1-36.4; P < .001) and younger age (OR, 1.5; 95% CI, 1.1-2.2; P = .02). Conclusions and Relevance: Self-refraction among children aged 5 to 11 years may result in more myopic power than cycloplegic refraction but not necessarily to a clinically relevant degree. Although the proportion of children achieving VA of 20/25 or better with self-refraction using adjustable-focus spectacles did not differ from cycloplegic refraction, it was less likely among younger children and those with higher astigmatism.

A Randomized Noninferiority Trial of Wearing Adjustable Glasses versus Standard and Ready-made Spectacles among Chinese Schoolchildren: Wearability and Evaluation of Adjustable Refraction III.

PURPOSE: To compare wear of standard, adjustable, and ready-made glasses among children. DESIGN: Randomized, controlled, open-label, noninferiority trial. PARTICIPANTS: Students aged 11 to 16 years with presenting visual acuity (VA) ≤6/12 in both eyes, correctable to ≥6/7.5, subjective spherical equivalent refractive error (SER) ≤-1.0 diopters (D), astigmatism and anisometropia both <2.00 D, and no other ocular abnormalities. METHODS: Participants were randomly allocated (1:1:1) to standard glasses, ready-made glasses, or adjustable glasses based on self-refraction. We recorded glasses wear on twice-weekly covert evaluation by head teachers (primary outcome), self-reported and investigator-observed wear, best-corrected visual acuity (BCVA) (not prespecified), children's satisfaction, and value attributed to glasses. MAIN OUTCOME MEASURE: Proportion of glasses wear on twice-weekly covert evaluation by head teachers over 2 months. RESULTS: Among 379 eligible participants, 127 were allocated to standard glasses (mean age, 13.7 years; standard deviation [SD], 1.0 years; 54.3% were male), 125 to ready-made (mean age, 13.6; SD, 0.83; 45.6%), and 127 to adjustable (mean age, 13.4 years; SD, 0.85; 54.3%). Mean wear proportion of adjustable glasses was significantly lower than for standard glasses (45% vs. 58%; P = 0.01), although the adjusted difference (90% confidence interval [CI], -19.0% to -3.0%) did not meet the prespecified inferiority threshold of 20%. Self-reported (90.2% vs. 84.8%, P = 0.64) and investigator-observed (44.1% vs. 33.9%, P = 0.89) wear did not differ between standard and adjustable glasses, nor did satisfaction with (P = 0.97) or value attributed to study glasses (P = 0.55) or increase in quality of life (5.53 [SD, 4.47] vs. 5.68 [SD, 4.34] on a 100-point scale, P > 0.30). Best-corrected visual acuity with adjustable glasses was better (P < 0.001) than with standard glasses. Change in power of study lenses at the end of the study (adjustable: 0.65 D, 95% CI, 0.52-0.79; standard, 0.01 D; 95% CI, -0.006 to 0.03, P < 0.001) was greater for adjustable glasses, although interobserver variation in power measurements may explain this. Lens scratches and frame damage were more common with adjustable glasses, whereas lens breakage was less common than for standard glasses. CONCLUSIONS: Proportion of wear was lower with adjustable glasses, although VA was better and measures of satisfaction and quality of life were not inferior to standard glasses.

Self correction of refractive error among young people in rural China: results of cross sectional investigation.

OBJECTIVE: To compare outcomes between adjustable spectacles and conventional methods for refraction in young people. DESIGN: Cross sectional study. SETTING: Rural southern China. PARTICIPANTS: 648 young people aged 12-18 (mean 14.9 (SD 0.98)), with uncorrected visual acuity ≤ 6/12 in either eye. INTERVENTIONS: All participants underwent self refraction without cycloplegia (paralysis of near focusing ability with topical eye drops), automated refraction without cycloplegia, and subjective refraction by an ophthalmologist with cycloplegia. MAIN OUTCOME MEASURES: Uncorrected and corrected vision, improvement of vision (lines on a chart), and refractive error. RESULTS: Among the participants, 59% (384) were girls, 44% (288) wore spectacles, and 61% (393/648) had 2.00 dioptres or more of myopia in the right eye. All completed self refraction. The proportion with visual acuity ≥ 6/7.5 in the better eye was 5.2% (95% confidence interval 3.6% to 6.9%) for uncorrected vision, 30.2% (25.7% to 34.8%) for currently worn spectacles, 96.9% (95.5% to 98.3%) for self refraction, 98.4% (97.4% to 99.5%) for automated refraction, and 99.1% (98.3% to 99.9%) for subjective refraction (P = 0.033 for self refraction v automated refraction, P = 0.001 for self refraction v subjective refraction). Improvements over uncorrected vision in the better eye with self refraction and subjective refraction were within one line on the eye chart in 98% of participants. In logistic regression models, failure to achieve maximum recorded visual acuity of 6/7.5 in right eyes with self refraction was associated with greater absolute value of myopia/hyperopia (P<0.001), greater astigmatism (P = 0.001), and not having previously worn spectacles (P = 0.002), but not age or sex. Significant inaccuracies in power (≥ 1.00 dioptre) were less common in right eyes with self refraction than with automated refraction (5% v 11%, P<0.001). CONCLUSIONS: Though visual acuity was slightly worse with self refraction than automated or subjective refraction, acuity was excellent in nearly all these young people with inadequately corrected refractive error at baseline. Inaccurate power was less common with self refraction than automated refraction. Self refraction could decrease the requirement for scarce trained personnel, expensive devices, and cycloplegia in children's vision programmes in rural China.

The child self-refraction study results from urban Chinese children in Guangzhou.

OBJECTIVE: To compare visual and refractive outcomes between self-refracting spectacles (Adaptive Eyecare, Ltd, Oxford, UK), noncycloplegic autorefraction, and cycloplegic subjective refraction. DESIGN: Cross-sectional study. PARTICIPANTS: Chinese school-children aged 12 to 17 years. METHODS: Children with uncorrected visual acuity ≤ 6/12 in either eye underwent measurement of the logarithm of the minimum angle of resolution visual acuity, habitual correction, self-refraction without cycloplegia, autorefraction with and without cycloplegia, and subjective refraction with cycloplegia. MAIN OUTCOME MEASURES: Proportion of children achieving corrected visual acuity ≥ 6/7.5 with each modality; difference in spherical equivalent refractive error between each of the modalities and cycloplegic subjective refractive error. RESULTS: Among 556 eligible children of consenting parents, 554 (99.6%) completed self-refraction (mean age, 13.8 years; 59.7% girls; 54.0% currently wearing glasses). The proportion of children with visual acuity ≥ 6/7.5 in the better eye with habitual correction, self-refraction, noncycloplegic autorefraction, and cycloplegic subjective refraction were 34.8%, 92.4%, 99.5% and 99.8%, respectively (self-refraction versus cycloplegic subjective refraction, P<0.001). The mean difference between cycloplegic subjective refraction and noncycloplegic autorefraction (which was more myopic) was significant (-0.328 diopter [D]; Wilcoxon signed-rank test P<0.001), whereas cycloplegic subjective refraction and self-refraction did not differ significantly (-0.009 D; Wilcoxon signed-rank test P = 0.33). Spherical equivalent differed by ≥ 1.0 D in either direction from cycloplegic subjective refraction more frequently among right eyes for self-refraction (11.2%) than noncycloplegic autorefraction (6.0%; P = 0.002). Self-refraction power that differed by ≥ 1.0 D from cycloplegic subjective refractive error (11.2%) was significantly associated with presenting without spectacles (P = 0.011) and with greater absolute power of both spherical (P = 0.025) and cylindrical (P = 0.022) refractive error. CONCLUSIONS: Self-refraction seems to be less prone to accommodative inaccuracy than noncycloplegic autorefraction, another modality appropriate for use in areas where access to eye care providers is limited. Visual results seem to be comparable. Greater cylindrical power is associated with less accurate results; the adjustable glasses used in this study cannot correct astigmatism. Further studies of the practical applications of this modality are warranted. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.