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Effect of atropine, orthokeratology and combined treatments for myopia control: a 2-year stratified randomised clinical trial
  1. Shengsong Xu1,
  2. Zhouyue Li1,
  3. Wenchen Zhao1,
  4. Bingru Zheng1,
  5. Jinyun Jiang1,
  6. Guitong Ye1,
  7. Zhibin Feng1,
  8. Wen Long1,
  9. Liying He1,
  10. Mingguang He1,2,
  11. Yin Hu1,
  12. Xiao Yang1
  1. 1State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, Guangdong, China
  2. 2Department of Surgery, Centre for Eye Research Australia, University of Melbourne, Melbourne, Victoria, Australia
  1. Correspondence to Dr Xiao Yang, Sun Yat-Sen University Zhongshan Ophthalmic Center State Key Laboratory of Ophthalmology, Guangzhou, Guangdong, 510000, China; Yangx_zoc{at}163.com; Dr Yin Hu; 18664783831{at}163.com

Abstract

Purpose To investigate the 2-year efficacy of atropine, orthokeratology (ortho-k) and combined treatment on myopia. To explore the factors influencing the efficacy.

Methods An age-stratified randomised controlled trial. Children (n=164) aged 8–12 years with spherical equivalent refraction of −1.00 to −6.00 D were stratified into two age subgroups and randomly assigned to receive placebo drops+spectacles (control), 0.01% atropine+spectacles (atropine), ortho-k+placebo (ortho-k) or combined treatment. Axial length was measured at baseline and visits at 6, 12, 18 and 24 months. The primary analysis was done following the criteria of intention to treat, which included all randomised subjects.

Results All interventions can significantly reduce axial elongation at all visits (all p<0.05). Overall, the 2-year axial elongation was significantly reduced in combined treatment than in monotherapies (all p<0.05). After stratification by age, in the subgroup aged 8–10, the difference between combined treatment and ortho-k became insignificant (p=0.106), while in the subgroup aged 10–12, the difference between combined treatment and atropine became insignificant (p=0.121). A significant age-dependent effect existed in the ortho-k group versus the control group (p for interaction=0.013), and a significant age-dependent effect existed in the ortho-k group versus the atropine group (p for interaction=0.035), which indicated that ortho-k can achieve better efficacy in younger children.

Conclusions Atropine combined with ortho-k treatment can improve the efficacy of myopia control compared with monotherapy in children aged 8–12. Younger children might benefit more from ortho-k.

Trial registration number ChiCTR1800015541.

  • Optics and Refraction
  • Contact lens
  • Child health (paediatrics)

Data availability statement

Data are available upon reasonable request. Data are available upon reasonable request. The full study protocol and study data can be obtained upon request from the corresponding author.

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Data availability statement

Data are available upon reasonable request. Data are available upon reasonable request. The full study protocol and study data can be obtained upon request from the corresponding author.

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Footnotes

  • SX, ZL and WZ contributed equally.

  • Contributors SX: manuscript drafting; SX, ZL and WZ: data analysis and interpretation; BZ, JJ, GY, ZF, LH and WL: data acquisition and material provision; ZL, WZ, YH and XY: study design; MH, YH and XY: manuscript revision. XY is guarantor.

  • Funding This work was supported by the National Natural Science Foundation of China (82070994) and the National Natural Science Foundation of China (81900899).

  • Disclaimer The funders had no role in the study design, data collection, data analysis, data interpretation or writing of the report.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.