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.