{
  "abstract": "Abstract Objectives To evaluate the efficacy and safety of low concentration atropine eye drops for reducing progression of myopia in children in the UK.Design Multicentre, double masked, superiority, placebo controlled, randomised trial.Setting National Health Service hospital eye services and academic institutions at five UK centres.Participants 289 children aged 6-12 years with myopia between −0.50 and −10.0 dioptres (D). Participants were allocated in ratio of 2:1 to atropine or placebo.Interventions One eye drop of preserved atropine 0.01% or placebo daily for two years.Main outcome measures The primary outcome was spherical equivalent refractive error of both eyes measured by autorefractor under cycloplegia after two years. Secondary outcomes included change in axial length, best corrected distance and near visual acuity, reading speed, pupil diameter, spectacle correction, adverse event rates, quality of life, and tolerability. Outcomes were collected every six months. An electronic monitoring system was used to assess adherence.Results 192 participants were included in the atropine group and 97 in the placebo group, with an average age of 9.3 years (standard deviation (SD) 1.7 years). 207 (72%) reported white ethnicity, 161 (56%) were girls, and the mean level of myopia was −2.87 D (SD 1.71 D). A total of 235 (81%) participants completed the study, with primary outcome data available for 230 (80%) participants: 151 (79%) in the atropine group and 79 (81%) in the placebo group. Atropine eye drops were more effective than placebo in reducing myopia progression (mean difference 0.33 D, 95% confidence interval (CI) 0.17 to 0.49 D, P<0.001). Prespecified subgroup analyses did not show differences according to age, ethnicity, sex, or severity of myopia. Changes in central axial length were significantly less in the atropine group versus placebo group: mean difference 0.14 mm (95% CI 0.07 to 0.21, P<0.001). There were no differences in other secondary outcomes, except pupil diameter, which was greater in the atropine group (0.36 mm, 95% CI 0.17, 0.55, P<0.001), and no differences in frequency of adverse events or in tolerability measures. No serious adverse events were related to the trial drugs.Conclusions Low concentration atropine (0.01%) eye drops significantly reduced progression of myopia and were well tolerated compared with placebo in children in the UK.Trial registration ISRCTN registry ISRCTN99883695, ClinicalTrials.gov NCT03690089.",
  "authors": [
    {
      "affiliations": [
        "Centre for Public Health, Queen’s University Belfast, Belfast, UK"
      ],
      "name": "Augusto Azuara-Blanco"
    },
    {
      "affiliations": [
        "School of Optometry, Aston University, Birmingham, UK"
      ],
      "name": "Nicola S Logan"
    },
    {
      "affiliations": [
        "Northern Ireland Clinical Research Facility, Belfast, Ireland, UK"
      ],
      "name": "Emma McConnell"
    },
    {
      "affiliations": [
        "Department of Vision Sciences, Glasgow Caledonian University, Glasgow, UK"
      ],
      "name": "Stephanie Kearney"
    },
    {
      "affiliations": [
        "Vision and Hearing Sciences Research Centre, Anglia Ruskin University, Cambridge, UK"
      ],
      "name": "Gaynor Kirk"
    },
    {
      "affiliations": [
        "School of Optometry, Aston University, Birmingham, UK"
      ],
      "name": "Susie Jones"
    },
    {
      "affiliations": [
        "Northern Ireland Clinical Trials Unit, Belfast, Ireland, UK"
      ],
      "name": "Cliona McDowell"
    },
    {
      "affiliations": [
        "Northern Ireland Clinical Trials Unit, Belfast, Ireland, UK"
      ],
      "name": "Lynn Murphy"
    },
    {
      "affiliations": [
        "Northern Ireland Clinical Trials Unit, Belfast, Ireland, UK"
      ],
      "name": "Gerard O’Hanlon"
    },
    {
      "affiliations": [
        "Department of Pharmacy, Belfast Health and Social Care Trust, Belfast, Ireland, UK"
      ],
      "name": "Margaret McFarland"
    },
    {
      "affiliations": [
        "Birmingham Women and Children’s NHS Foundation Trust, Birmingham, UK"
      ],
      "name": "Sally Painter"
    },
    {
      "affiliations": [
        "Addenbrooke’s Hospital, Cambridge, UK"
      ],
      "name": "Brinda Muthusamy"
    },
    {
      "affiliations": [
        "NHS Lanarkshire, UK"
      ],
      "name": "Shariar Nabili"
    },
    {
      "affiliations": [
        "Institute of Translational Medicine, University of Liverpool, Liverpool, UK"
      ],
      "name": "Jennifer Preston"
    },
    {
      "affiliations": [
        "Centre for Eye Research Ireland, Technological University Dublin, Dublin, Ireland"
      ],
      "name": "Ian Flitcroft"
    },
    {
      "affiliations": [
        "Optometry School, Technological University Dublin, Dublin, Ireland"
      ],
      "name": "James Loughman"
    },
    {
      "affiliations": [
        "Lions Eye Institute, University of Western Australia, Perth, Australia"
      ],
      "name": "David Mackey"
    },
    {
      "affiliations": [
        "Lions Eye Institute, University of Western Australia, Perth, Australia"
      ],
      "name": "Samantha Lee"
    },
    {
      "affiliations": [
        "NIHR Moorfields Biomedical Research Centre, London, UK"
      ],
      "name": "Annegret Dahlmann-Noor"
    },
    {
      "affiliations": [
        "Centre for Public Health, Queen’s University Belfast, Belfast, UK",
        "Orbis International, New York, USA",
        "Zhongshan Ophthalmic Centre, Sun Yat-sen University, Guangzhou, China"
      ],
      "name": "Nathan Congdon"
    },
    {
      "affiliations": [
        "Centre for Public Health, Queen’s University Belfast, Belfast, UK"
      ],
      "name": "Ruth E Hogg"
    },
    {
      "affiliations": [
        "King’s College London, London, UK"
      ],
      "name": "Chris J Hammond"
    },
    {
      "affiliations": [
        "School of Biomedical Sciences, Ulster University, Coleraine, UK"
      ],
      "name": "Kathryn Saunders"
    },
    {
      "affiliations": [
        "Northern Ireland Clinical Research Facility, Belfast, Ireland, UK"
      ],
      "name": "Peter M Allen"
    },
    {
      "affiliations": [
        "Department of Vision Sciences, Glasgow Caledonian University, Glasgow, UK"
      ],
      "name": "Niall Strang"
    },
    {
      "affiliations": [
        "Centre for Public Health, Queen’s University Belfast, Belfast, UK",
        "Northern Ireland Clinical Trials Unit, Belfast, Ireland, UK"
      ],
      "name": "Mike Clarke"
    }
  ],
  "title": "Low concentration atropine eye drops and progression of myopia in children: multicentre placebo controlled, double masked, randomised trial in the UK (CHAMP-UK)",
  "uid": "058ec4f3-3182-56ff-90b2-99042ec43db5"
}