Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial
We investigated the two-year safety and efficacy of 0.1% loading dose and 0.01% low-dose atropine eye drops in Danish children for reduction in myopia progression in an investigator-initiated, placebo-controlled, double-masked, randomized clinical trial. Ninety-seven six- to twelve-year old myopic p...
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MDPI AG
2024-02-01
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| Series: | Journal of Personalized Medicine |
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| Online Access: | https://www.mdpi.com/2075-4426/14/2/175 |
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| author | Niklas Cyril Hansen Anders Hvid-Hansen Flemming Møller Toke Bek Dorte Ancher Larsen Nina Jacobsen Line Kessel |
| author_facet | Niklas Cyril Hansen Anders Hvid-Hansen Flemming Møller Toke Bek Dorte Ancher Larsen Nina Jacobsen Line Kessel |
| author_sort | Niklas Cyril Hansen |
| collection | DOAJ |
| description | We investigated the two-year safety and efficacy of 0.1% loading dose and 0.01% low-dose atropine eye drops in Danish children for reduction in myopia progression in an investigator-initiated, placebo-controlled, double-masked, randomized clinical trial. Ninety-seven six- to twelve-year old myopic participants were randomized to 0.1% loading dose for six months and then 0.01% for eighteen months (loading dose group, N = 33), 0.01% for two years (0.01% group, N = 32) or placebo for two years (placebo, N = 32). Axial length (AL) and spherical equivalent refraction (SER) were primary outcomes. Secondary outcomes included adverse events and reactions, choroidal thickness, and other ocular biometrical measures. Outcomes were measured from baseline and at six-month intervals. Individual eyes nested by participant ID were analyzed with linear-mixed model analysis. Data were analyzed with intention-to-treat. Mean AL was 0.08 mm less (95% confidence interval (CI): −0.01; 0.17, <i>p</i>-value = 0.08) in the 0.1% loading dose and 0.10 mm less (95% CI: 0.01; 0.19, <i>p</i>-value = 0.02) in the 0.01% group after two years of treatment compared to placebo. Mean SER progression was 0.12 D (95% CI: −0.10; 0.33) less in the loading dose and 0.26 D (95% CI: 0.04; 0.48) less in the 0.01% groups after two years of treatment compared to placebo (<i>p</i>-value = 0.30 and 0.02, respectively). In total, 17 adverse events were reported in the second-year follow-up, and all were rated as mild. Adjusting for iris color did not affect treatment effect estimates. Intra-ocular pressure increased over two years comparably between all groups but remained within normal limits. Two-year treatment with 0.01% low-dose atropine eye drops is a safe and moderately efficacious intervention in Danish children for reducing myopia progression. |
| first_indexed | 2024-03-07T22:25:08Z |
| format | Article |
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| institution | Directory Open Access Journal |
| issn | 2075-4426 |
| language | English |
| last_indexed | 2024-03-07T22:25:08Z |
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| spelling | doaj.art-cca49c7fe0da4182ab6e331c00a4fccc2024-02-23T15:23:46ZengMDPI AGJournal of Personalized Medicine2075-44262024-02-0114217510.3390/jpm14020175Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical TrialNiklas Cyril Hansen0Anders Hvid-Hansen1Flemming Møller2Toke Bek3Dorte Ancher Larsen4Nina Jacobsen5Line Kessel6Department of Ophthalmology, Copenhagen University Hospital—Rigshospitalet-Glostrup, DK-2600 Glostrup, DenmarkDepartment of Ophthalmology, Copenhagen University Hospital—Rigshospitalet-Glostrup, DK-2600 Glostrup, DenmarkDepartment of Ophthalmology, University Hospital of Southern Denmark—Vejle Hospital, DK-7100 Vejle, DenmarkDepartment of Ophthalmology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Ophthalmology, Aarhus University Hospital, DK-8200 Aarhus N, DenmarkDepartment of Ophthalmology, Copenhagen University Hospital—Rigshospitalet-Glostrup, DK-2600 Glostrup, DenmarkDepartment of Ophthalmology, Copenhagen University Hospital—Rigshospitalet-Glostrup, DK-2600 Glostrup, DenmarkWe investigated the two-year safety and efficacy of 0.1% loading dose and 0.01% low-dose atropine eye drops in Danish children for reduction in myopia progression in an investigator-initiated, placebo-controlled, double-masked, randomized clinical trial. Ninety-seven six- to twelve-year old myopic participants were randomized to 0.1% loading dose for six months and then 0.01% for eighteen months (loading dose group, N = 33), 0.01% for two years (0.01% group, N = 32) or placebo for two years (placebo, N = 32). Axial length (AL) and spherical equivalent refraction (SER) were primary outcomes. Secondary outcomes included adverse events and reactions, choroidal thickness, and other ocular biometrical measures. Outcomes were measured from baseline and at six-month intervals. Individual eyes nested by participant ID were analyzed with linear-mixed model analysis. Data were analyzed with intention-to-treat. Mean AL was 0.08 mm less (95% confidence interval (CI): −0.01; 0.17, <i>p</i>-value = 0.08) in the 0.1% loading dose and 0.10 mm less (95% CI: 0.01; 0.19, <i>p</i>-value = 0.02) in the 0.01% group after two years of treatment compared to placebo. Mean SER progression was 0.12 D (95% CI: −0.10; 0.33) less in the loading dose and 0.26 D (95% CI: 0.04; 0.48) less in the 0.01% groups after two years of treatment compared to placebo (<i>p</i>-value = 0.30 and 0.02, respectively). In total, 17 adverse events were reported in the second-year follow-up, and all were rated as mild. Adjusting for iris color did not affect treatment effect estimates. Intra-ocular pressure increased over two years comparably between all groups but remained within normal limits. Two-year treatment with 0.01% low-dose atropine eye drops is a safe and moderately efficacious intervention in Danish children for reducing myopia progression.https://www.mdpi.com/2075-4426/14/2/175myopiamyopia controllow-dose atropineaxial lengthspherical equivalent |
| spellingShingle | Niklas Cyril Hansen Anders Hvid-Hansen Flemming Møller Toke Bek Dorte Ancher Larsen Nina Jacobsen Line Kessel Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial Journal of Personalized Medicine myopia myopia control low-dose atropine axial length spherical equivalent |
| title | Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial |
| title_full | Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial |
| title_fullStr | Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial |
| title_full_unstemmed | Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial |
| title_short | Two-Year Results of 0.01% Atropine Eye Drops and 0.1% Loading Dose for Myopia Progression Reduction in Danish Children: A Placebo-Controlled, Randomized Clinical Trial |
| title_sort | two year results of 0 01 atropine eye drops and 0 1 loading dose for myopia progression reduction in danish children a placebo controlled randomized clinical trial |
| topic | myopia myopia control low-dose atropine axial length spherical equivalent |
| url | https://www.mdpi.com/2075-4426/14/2/175 |
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