One-year efficacy of myopia control by the defocus distributed multipoint lens : a multicentric randomised controlled trial
© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
The British journal of ophthalmology - (2024) vom: 19. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Chen, Xiaoqin [VerfasserIn] |
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| Links: |
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| Themen: |
Clinical Trial |
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| Anmerkungen: |
Date Revised 19.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT05340699 Citation Status Publisher |
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| doi: |
10.1136/bjo-2023-324243 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369930800 |
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| 100 | 1 | |a Chen, Xiaoqin |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a One-year efficacy of myopia control by the defocus distributed multipoint lens |b a multicentric randomised controlled trial |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT05340699 | ||
| 500 | |a Citation Status Publisher | ||
| 520 | |a © Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ. | ||
| 520 | |a 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 | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a TRIAL REGISTRATION NUMBER: NCT05340699 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Clinical Trial | |
| 650 | 4 | |a Epidemiology | |
| 650 | 4 | |a Optics and Refraction | |
| 650 | 4 | |a Prospective Studies | |
| 650 | 4 | |a Public health | |
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| 700 | 1 | |a Li, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Wu, Min |e verfasserin |4 aut | |
| 700 | 1 | |a Liu, Xiaonan |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Cui |e verfasserin |4 aut | |
| 700 | 1 | |a Guo, Xingyi |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yanbo |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yansong |e verfasserin |4 aut | |
| 700 | 1 | |a Lu, Wenli |e verfasserin |4 aut | |
| 700 | 1 | |a Li, Lihua |e verfasserin |4 aut | |
| 700 | 1 | |a Wang, Yan |e verfasserin |4 aut | |
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