Article Text

Download PDFPDF
Clinical science
One-year efficacy of myopia control by the defocus distributed multipoint lens: a multicentric randomised controlled trial
  1. Xiaoqin Chen1,2,3,
  2. Mengdi Li3,
  3. Jun Li1,3,
  4. Min Wu4,
  5. Xiaonan Liu5,
  6. Cui Yu5,
  7. Xingyi Guo3,
  8. Yanbo Wang6,
  9. Yansong Wang7,
  10. Wenli Lu6,
  11. Lihua Li2,3,
  12. Yan Wang1,2
  1. 1 Clinical College of Ophthalmology, Tianjin Medical University, Tianjin, China
  2. 2 Tianjin Eye Hospital, Tianjin Key Lab of Ophthalmology and Visual Science, Tianjin Eye Institute, Nankai University affiliated Eye Institute, Tianjin, China
  3. 3 Tianjin Eye Hospital Optometric Center, Tianjin, China
  4. 4 Tongren Eye Care Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China
  5. 5 He Eye Specialist Hospital, Shenyang, China
  6. 6 Department of Epidemiology and Health Statistics, School of Public Health, Tianjin Medical University, Tianjin, China
  7. 7 Donghua University, Shanghai, China
  1. Correspondence to Professor Yan Wang; wangyan7143{at}vip.sina.com; Professor Lihua Li; lilihua5081{at}vip.sina.com

Abstract

Aims To report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial.

Methods Overall, 168 children aged 6–13 years were recruited and randomly assigned to wear a DDM lens (n=84) or single-vision (SV) lens (n=84) in three centres. Cycloplegic autorefraction (spherical equivalent refraction (SER)) and axial length (AL) were measured. Linear mixed model analysis was performed to compare between-group SER and AL changes. Logistic regression analysis was used to analyse the between-group difference in rapid myopia progression (SER increase≥0.75 D per year or AL growth≥0.40 mm per year).

Results After 1 year, mean changes in SER were significantly lower in the DDM group (−0.47±0.37 D) than in the SV group (−0.71±0.42 D) (p<0.001). Similarly, mean changes in AL were significantly lower in the DDM group (0.21±0.17 mm) than in the SV group (0.34±0.16 mm) (p<0.001). After adjusting for age, sex, daily wearing time and parental myopia, rapid myopia progression risk was higher in the SV group than in the DDM group (OR=3.51, 95% CI: 1.77 to 6.99), especially for children who wore a lens for >12 hours per day, boys and younger children (6–9 years) with ORs (95% CIs) of 10.82 (3.22 to 36.37), 5.34 (1.93 to 14.78) and 8.73 (2.6 to 29.33), respectively.

Conclusions After 1 year, DDM lenses effectively retarded myopia progression in children. Longer daily wearing time of DDM lens improved the efficacy of myopia control. Future long-term studies are needed for validation.

Trial registration number NCT05340699.

  • Clinical Trial
  • Epidemiology
  • Public health
  • Prospective Studies
  • Optics and Refraction

Data availability statement

Data are available upon reasonable request.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Data availability statement

Data are available upon reasonable request.

View Full Text

Footnotes

  • XC and ML are joint first authors.

  • Contributors Concept and design: XC, ML, XG, LL and YanW; data acquisition and research execution: JL, MW, XL and CY; analysis and interpretation: YanboW, YansongW and WL; manuscript preparation and final approval: XC, ML, XG and YanW; and guarantor: LL and YanW.

  • Funding This study was funded by the National Natural Science Foundation of China (82271118) and Tianjin Key Medical Discipline (Specialty) Construction Project (TJYXZDXK-016A).

  • 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.