Mingguang He1, Fan Xiang2, Yangfa Zeng3, Jincheng Mai4, Qianyun Chen3, Jian Zhang3, Wayne Smith5, Kathryn Rose6, Ian G Morgan7. 1. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China2Centre for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, East Melbourne. 2. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China3National Centre for Epidemiology and Population Health, Australian National University, Canberra. 3. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. 4. Guangzhou Student's Health Care Institute of the Guangdong City Department of Education, Guangzhou, China. 5. Environmental Health Branch, NSW Department of Health, Sydney, Australia. 6. Discipline of Orthoptics, Faculty of Health Sciences, University of Sydney, Sydney, Australia7Discipline of Orthoptics, Graduate School of Health, University of Technology Sydney, Sydney, Australia. 7. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China8Research School of Biology, Australian National University, Canberra.
Abstract
IMPORTANCE: Myopia has reached epidemic levels in parts of East and Southeast Asia. However, there is no effective intervention to prevent the development of myopia. OBJECTIVE: To assess the efficacy of increasing time spent outdoors at school in preventing incident myopia. DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized trial of children in grade 1 from 12 primary schools in Guangzhou, China, conducted between October 2010 and October 2013. INTERVENTIONS:For 6 intervention schools (n = 952 students), 1 additional 40-minute class of outdoor activities was added to each school day, and parents were encouraged to engage their children in outdoor activities after school hours, especially during weekends and holidays. Children and parents in the 6 control schools (n = 951 students) continued their usual pattern of activity. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the 3-year cumulative incidence rate of myopia (defined using the Refractive Error Study in Children spherical equivalent refractive error standard of ≤-0.5 diopters [D]) among the students without established myopia at baseline. Secondary outcome measures were changes in spherical equivalent refraction and axial length among all students, analyzed using mixed linear models and intention-to-treat principles. Data from the right eyes were used for the analysis. RESULTS: There were 952 children in the intervention group and 951 in the control group with a mean (SD) age of 6.6 (0.34) years. The cumulative incidence rate of myopia was 30.4% in the intervention group (259 incident cases among 853 eligible participants) and 39.5% (287 incident cases among 726 eligible participants) in the control group (difference of -9.1% [95% CI, -14.1% to -4.1%]; P < .001). There was also a significant difference in the 3-year change in spherical equivalent refraction for the intervention group (-1.42 D) compared with the control group (-1.59 D) (difference of 0.17 D [95% CI, 0.01 to 0.33 D]; P = .04). Elongation of axial length was not significantly different between the intervention group (0.95 mm) and the control group (0.98 mm) (difference of -0.03 mm [95% CI, -0.07 to 0.003 mm]; P = .07). CONCLUSIONS AND RELEVANCE: Among 6-year-old children in Guangzhou, China, the addition of 40 minutes of outdoor activity at school compared with usual activity resulted in a reduced incidence rate of myopia over the next 3 years. Further studies are needed to assess long-term follow-up of these children and the generalizability of these findings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00848900.
RCT Entities:
IMPORTANCE: Myopia has reached epidemic levels in parts of East and Southeast Asia. However, there is no effective intervention to prevent the development of myopia. OBJECTIVE: To assess the efficacy of increasing time spent outdoors at school in preventing incident myopia. DESIGN, SETTING, AND PARTICIPANTS: Cluster randomized trial of children in grade 1 from 12 primary schools in Guangzhou, China, conducted between October 2010 and October 2013. INTERVENTIONS: For 6 intervention schools (n = 952 students), 1 additional 40-minute class of outdoor activities was added to each school day, and parents were encouraged to engage their children in outdoor activities after school hours, especially during weekends and holidays. Children and parents in the 6 control schools (n = 951 students) continued their usual pattern of activity. MAIN OUTCOMES AND MEASURES: The primary outcome measure was the 3-year cumulative incidence rate of myopia (defined using the Refractive Error Study in Children spherical equivalent refractive error standard of ≤-0.5 diopters [D]) among the students without established myopia at baseline. Secondary outcome measures were changes in spherical equivalent refraction and axial length among all students, analyzed using mixed linear models and intention-to-treat principles. Data from the right eyes were used for the analysis. RESULTS: There were 952 children in the intervention group and 951 in the control group with a mean (SD) age of 6.6 (0.34) years. The cumulative incidence rate of myopia was 30.4% in the intervention group (259 incident cases among 853 eligible participants) and 39.5% (287 incident cases among 726 eligible participants) in the control group (difference of -9.1% [95% CI, -14.1% to -4.1%]; P < .001). There was also a significant difference in the 3-year change in spherical equivalent refraction for the intervention group (-1.42 D) compared with the control group (-1.59 D) (difference of 0.17 D [95% CI, 0.01 to 0.33 D]; P = .04). Elongation of axial length was not significantly different between the intervention group (0.95 mm) and the control group (0.98 mm) (difference of -0.03 mm [95% CI, -0.07 to 0.003 mm]; P = .07). CONCLUSIONS AND RELEVANCE: Among 6-year-old children in Guangzhou, China, the addition of 40 minutes of outdoor activity at school compared with usual activity resulted in a reduced incidence rate of myopia over the next 3 years. Further studies are needed to assess long-term follow-up of these children and the generalizability of these findings. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00848900.