Naked-Eye 3-Dimensional Vision Training for Myopia Control: A Randomized Clinical Trial.

Importance: Early onset of myopia increases the risk of high myopia, which can lead to irreversible retinal damage and even loss of central vision. Objective: To investigate the efficacy and safety of naked-eye 3-dimensional vision training (NVT) in preventing the progression of myopia in children. Design, Setting, and Participants: This randomized clinical trial was conducted in 3 hospitals from May 25, 2022, to February 24, 2023. Participants were children (aged 6-18 years) who had a diagnosis of myopia with a spherical equivalent refraction of -0.75 to -6.00 diopters (D). Intervention: Children in the intervention group received 20 minutes of NVT treatment every day, whereas children in the control group lived as usual without vision training. Main Outcome and Measure: The primary outcome was the change in axial length at 6 months. Spherical equivalent refraction (SER) was included as a secondary outcome. Results: Among 263 participants, 125 (47.5%) were male and 138 (52.5%) were female; the mean (SD) age was 10.3 (1.9) years (range, 6.1-15.6 years). A total of 227 patients (86.3%) completed the 6-month follow-up, including 102 in the intervention group and 125 in the control group. In the intervention group, the changes in axial length and SER at 6 months were 0.18 mm (95% CI, 0.16 to 0.20 mm) and -0.25 D (95% CI, -0.31 to -0.19 D), respectively. In the control group, the changes in axial length and SER at 6 months were 0.23 mm (95% CI, 0.21 to 0.25 mm) and -0.35 D (95% CI, -0.41 to -0.30 D), respectively. The differences in AL and SER between the 2 groups were significant (AL difference: -0.06 mm; 95% CI, -0.09 to -0.03; P < .001; SER difference: 0.10 D; 95% CI, 0.02 to 0.19; P = .02). No study-related adverse reactions were reported during follow-up. Conclusions and Relevance: NVT is a safe and promising means to control myopia progression in children with good adherence. Trial Registration: ClinicalTrials.gov Identifier: NCT05468775.

The Clouclip, a wearable device for measuring near-work and outdoor time: validation and comparison of objective measures with questionnaire estimates.

PURPOSE: To validate a novel wearable device that can measure both viewing distance and light exposure, Clouclip, and compare questionnaire estimates regarding near-work and outdoor time with the objective measures obtained using Clouclip. METHODS: Fifteen Clouclips were selected to measure different distances and levels of illuminance. With each Clouclip, five measurements at different distances and light intensities were measured and recorded. Eighty participants wore Clouclips for a week and completed an activity questionnaire afterwards. RESULTS: The intra- and inter-Clouclip coefficients were 1.00 and 0.99 for measuring distance and 1.00 and 1.00 for illuminance, respectively. Within the measurement limit, the maximum relative error was 2.07% for distance and 2.23% for illuminance. Assuming that <30 cm was the typical distance for near-work activities and >1000 Lux was the typical cut-off for outdoor environments, the questionnaire showed a trend of overestimation for both. The greatest overestimation of near-work occurred during the school period [Questionnaire: 4.73 hr (4.73, 5.07) versus Clouclip: 2.16 hr (1.74, 2.78); p < 0.01]. The greatest overestimation of outdoor activity also occurred during the school period [Questionnaire: 1.60 hr (1.33, 1.85) versus Clouclip: 1.21 hr (0.96, 1.50); p < 0.01]. Based on Clouclip, the total time spent outdoors was estimated to be 1.55 hr on school days, of which 0.34 hr occurred after school. For weekend days, however, the duration was only 0.17 hr. CONCLUSIONS: Clouclip had excellent precision and accuracy. Although the agreement between the questionnaire and Clouclip was relatively poor, they were able to complement each other to provide a more logical and feasible assessment of exposure to near-work and outdoor activity. Indoor-oriented lifestyles were found to predominate in Chinese children.

Objectively measured near work, outdoor exposure and myopia in children.

AIM: To reassess the association between near work, outdoor exposure and myopia in children through an objective approach. METHODS: Eighty-six children (10.13±0.48 years) were asked to wear Clouclip, a newly developed wearable device that is able to measure working distance and eye-level illuminance, for a complete week to obtain information on near work and outdoor exposure. The mean daily Clouclip wearing time was 11.72±1.14 hour. The spherical equivalent refraction was determined by cycloplegic autorefraction. RESULTS: The myopic children were found to be exposed to light intensities >3000 lux (0.68±0.50 hour vs 1.02±0.53 hour, p=0.012) and >5000 lux (0.42±0.35 hour vs 0.63±0.31 hour, p=0.004) for shorter durations on average each day than the non-myopic children. Additionally, the myopic children spent more time on average each day on activities at a distance of <20 cm than non-myopic children (1.89±0.61 hour vs 1.52±0.77 hour, p=0.019). In the multivariate logistic analysis, the time spent with a higher light intensity (>3000 lux (OR=0.27, 95% CI: 0.10 to 0.72, p=0.009); >5000 lux (OR=0.11, 95% CI: 0.02 to 0.56, p=0.008)) and a working distance of <20 cm (in a circumstance of >3000 lux (OR=1.17, 95% CI: 1.09 to 1.86, p=0.038) or in that of >5000 lux (OR=1.12, 95% CI: 1.03 to 1.77, p=0.046)) were the independent protective factors and risk factors, respectively. CONCLUSION: The current study provides novel evidence, based on objective data, to support the association between the intensity of near work, light intensity and myopia. However, the causality and the dose-effect relationship need to be investigated further.

An effectiveness study of a wearable device (Clouclip) intervention in unhealthy visual behaviors among school-age children: A pilot study.

INTRODUCTION: The study aimed to determine the effectiveness of an intervention for unhealthy visual behaviors of school-age children using a wearable device (Clouclip). METHOD: The design was a self-controlled prospective study. Clouclip, with the vibration alert disabled, was first applied to measure baseline near-work behaviors in the first week. The vibration alert was then enabled to signal unhealthy visual behaviors (near-work distance < 30 cm and >5 seconds, or near-work distance <60 cm for >45 minutes) for 3 weeks. Near-work behaviors were measured again at the first week and the first month after intervention, respectively. The changes in behaviors between the baseline and the first week and the first month after intervention were analyzed. RESULTS: Sixty-seven subjects were eligible for this experiment (the mean age 10.45 ±â€Š0.50 years, 34 boys). Children who logged sufficient wearing time (12.30 ±â€Š0.18 hours on weekdays and 12.16 ±â€Š0.23 hours on weekends) were included for analysis. The average daily near-work distance was significantly increased after the vibration intervention. The time ratio of near-work activity <30 cm to the total <60 cm and the frequency of continuous near-work (distance <60 cm and continuous time >30 minutes) were significantly decreased after the intervention. Although some of the effects were reversed with time following the intervention, some were observed to be maintained until the end of the observation period, and the improvement of the behaviors was more prominent in children who had a shorter near-work distance (<30 cm) at baseline. CONCLUSIONS: In conclusion, Clouclip can significantly modify near-work behaviors in school-age children and it can last a certain period of time. If these behaviors are causes of myopia development and progression, Clouclip might provide a strategy for managing myopia.

An Objective Comparison of Light Intensity and Near-Visual Tasks Between Rural and Urban School Children in China by a Wearable Device Clouclip.

PURPOSE: To compare light intensity and near-visual tasks objectively between rural and urban children. METHODS: Clouclip, a wearable device, was applied to assess metrics of these two factors in 78 fifth-grade students from an urban and from a rural school. RESULTS: The light intensity experienced by urban students was found significantly lower both in the school period (614.05 ± 178.77 vs. 918.41 ± 257.81 lux, P < 0.001) and on the weekend (444.53 ± 216.65 vs. 882.21 ± 536.67 lux, P < 0.001). The duration of exposure to bright light (>1000 lux) was also substantially shorter for urban students. Although no significant difference was found in near work-related behaviors during the school period and the weekend, for the after-school period the urban students had a shorter average viewing distance (30.94 ± 4.14 vs. 34.81 ± 3.93 cm, P < 0.001), a longer accumulated duration of near work (2.25 ± 0.53 vs. 1.95 ± 0.46 hours, P = 0.010), a greater time ratio of near work (56% ± 14% vs. 49% ± 14%, P = 0.045), and a greater time ratio of excessively close near work (49% ± 13% vs. 40% ± 12%, P = 0.001). CONCLUSIONS: Our data indicate there were substantial differences in light exposure and near-work metrics between the two regions. The correlation between these differences and the discrepancy in regional myopia prevalence needs further investigation. TRANSLATIONAL RELEVANCE: The objective quantification of these metrics might help explain the varied myopia prevalence among regions.