Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety
Abstract Background To investigate the efficacy and safety of 0.1% and 0.01% low-dose atropine eye drops in reducing myopia progression in Danish children. Methods Investigator-initiated, placebo-controlled, double-masked, randomized clinical trial. Ninety-seven six- to twelve-year old myopic partic...
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| Format: | Article |
| Language: | English |
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BMC
2023-10-01
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| Series: | BMC Ophthalmology |
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| Online Access: | https://doi.org/10.1186/s12886-023-03177-9 |
| _version_ | 1827770652676849664 |
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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 | Abstract Background To investigate the efficacy and safety of 0.1% and 0.01% low-dose atropine eye drops in reducing myopia progression in Danish children. Methods 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 followed by 0.01% for six months (loading dose group, Number (N) = 33), 0.01% for twelve months (0.01% group, N = 32) or vehicle for twelve months (placebo, N = 32). Primary outcomes were axial length and spherical equivalent refraction. Secondary outcomes included adverse events and reactions, choroidal thickness and ocular biometry. Outcomes were measured at baseline and three-month intervals. Data was analyzed with linear-mixed model analysis according to intention-to-treat. Results Mean axial elongation was 0.10 mm less (95% confidence interval (CI): 0.17; 0.02, adjusted-p = 0.06) in the 0.1% loading dose and 0.07 mm less (95% CI: 0.15; 0.00, adjusted-p = 0.16) in the 0.01% group at twelve months compared to placebo. Mean spherical equivalent refraction progression was 0.24 D (95% CI: 0.05; 0.42) less in the loading dose and 0.19 D (95% CI: 0.00; 0.38) less in the 0.01% groups at twelve months, compared to placebo (adjusted-p = 0.06 and 0.14, respectively). A total of 108 adverse events were reported during the initial six-month loading dose period, primarily in the loading dose group, and 14 were reported in the six months following dose switching, all deemed mild except two serious adverse events, unrelated to the intervention. Conclusions Low-dose atropine eye drops are safe over twelve months in otherwise healthy children. There may be a modest but clinically relevant reduction in myopia progression in Danish children after twelve months treatment, but the effect was statistically non-significant after multiple comparisons adjustment. After dose-switching at six months the loading dose group approached the 0.01% group, potentially indicating an early “rebound-effect”. Trial registration this study was registered in the European Clinical Trials Database (EudraCT, number: 2018-001286-16) 05/11/2018 and first posted at www.clinicaltrials.gov (NCT03911271) 11/04/2019, prior to initiation. |
| first_indexed | 2024-03-11T12:42:39Z |
| format | Article |
| id | doaj.art-58b9611826a84707ae3063c70a06a537 |
| institution | Directory Open Access Journal |
| issn | 1471-2415 |
| language | English |
| last_indexed | 2024-03-11T12:42:39Z |
| publishDate | 2023-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Ophthalmology |
| spelling | doaj.art-58b9611826a84707ae3063c70a06a5372023-11-05T12:10:54ZengBMCBMC Ophthalmology1471-24152023-10-0123111110.1186/s12886-023-03177-9Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safetyNiklas Cyril Hansen0Anders Hvid-Hansen1Flemming Møller2Toke Bek3Dorte Ancher Larsen4Nina Jacobsen5Line Kessel6Department of Ophthalmology, Copenhagen University Hospital - Rigshospitalet-GlostrupDepartment of Ophthalmology, Copenhagen University Hospital - Rigshospitalet-GlostrupDepartment of Ophthalmology, University Hospital of Southern Denmark – Vejle HospitalDepartment of Ophthalmology, Aarhus University HospitalDepartment of Ophthalmology, Aarhus University HospitalDepartment of Ophthalmology, Copenhagen University Hospital - Rigshospitalet-GlostrupDepartment of Ophthalmology, Copenhagen University Hospital - Rigshospitalet-GlostrupAbstract Background To investigate the efficacy and safety of 0.1% and 0.01% low-dose atropine eye drops in reducing myopia progression in Danish children. Methods 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 followed by 0.01% for six months (loading dose group, Number (N) = 33), 0.01% for twelve months (0.01% group, N = 32) or vehicle for twelve months (placebo, N = 32). Primary outcomes were axial length and spherical equivalent refraction. Secondary outcomes included adverse events and reactions, choroidal thickness and ocular biometry. Outcomes were measured at baseline and three-month intervals. Data was analyzed with linear-mixed model analysis according to intention-to-treat. Results Mean axial elongation was 0.10 mm less (95% confidence interval (CI): 0.17; 0.02, adjusted-p = 0.06) in the 0.1% loading dose and 0.07 mm less (95% CI: 0.15; 0.00, adjusted-p = 0.16) in the 0.01% group at twelve months compared to placebo. Mean spherical equivalent refraction progression was 0.24 D (95% CI: 0.05; 0.42) less in the loading dose and 0.19 D (95% CI: 0.00; 0.38) less in the 0.01% groups at twelve months, compared to placebo (adjusted-p = 0.06 and 0.14, respectively). A total of 108 adverse events were reported during the initial six-month loading dose period, primarily in the loading dose group, and 14 were reported in the six months following dose switching, all deemed mild except two serious adverse events, unrelated to the intervention. Conclusions Low-dose atropine eye drops are safe over twelve months in otherwise healthy children. There may be a modest but clinically relevant reduction in myopia progression in Danish children after twelve months treatment, but the effect was statistically non-significant after multiple comparisons adjustment. After dose-switching at six months the loading dose group approached the 0.01% group, potentially indicating an early “rebound-effect”. Trial registration this study was registered in the European Clinical Trials Database (EudraCT, number: 2018-001286-16) 05/11/2018 and first posted at www.clinicaltrials.gov (NCT03911271) 11/04/2019, prior to initiation.https://doi.org/10.1186/s12886-023-03177-9AtropineMyopia controlSpherical equivalent refractionAxial lengthMyopiaEye drops |
| spellingShingle | Niklas Cyril Hansen Anders Hvid-Hansen Flemming Møller Toke Bek Dorte Ancher Larsen Nina Jacobsen Line Kessel Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety BMC Ophthalmology Atropine Myopia control Spherical equivalent refraction Axial length Myopia Eye drops |
| title | Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety |
| title_full | Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety |
| title_fullStr | Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety |
| title_full_unstemmed | Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety |
| title_short | Safety and efficacy of 0.01% and 0.1% low-dose atropine eye drop regimens for reduction of myopia progression in Danish children: a randomized clinical trial examining one-year effect and safety |
| title_sort | safety and efficacy of 0 01 and 0 1 low dose atropine eye drop regimens for reduction of myopia progression in danish children a randomized clinical trial examining one year effect and safety |
| topic | Atropine Myopia control Spherical equivalent refraction Axial length Myopia Eye drops |
| url | https://doi.org/10.1186/s12886-023-03177-9 |
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