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APP: Low-dose Atropine for the Prevention of Myopia Progression in Danish Children

Sponsor
Line Kessel (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03911271
Collaborator
Aarhus University Hospital (Other), Vejle Hospital (Other)
97
Enrollment
3
Locations
3
Arms
66.1
Anticipated Duration (Months)
32.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Myopia (nearsightedness) is increasing in prevalence throughout the world. It is associated with a risk of potentially blinding complications such as retinal detachment and myopic maculopathy. There is a direct association between the degree of myopia and the risk of complications. Myopia develops in childhood and during adolescence. To prevent higher degrees of myopia, we need to halt disease progression in children and teenagers. Low-dose atropine eye drops have been shown to reduce myopia progression by 50% in Asian populations but its effect in non-Asian populations is unknown. The aim of this study is to investigate if low-dose atropine can reduce myopia progression in Danish children and teenagers. The study is an investigator initiated randomized clinical trial conducted as a collaboration between three Danish Eye Departments covering all of Denmark.

Condition or Disease Intervention/Treatment Phase
  • Drug: 0.1% atropine and 0.01% atropine
  • Drug: 0.01% atropine
  • Drug: 0.9% Sodium-chloride
 Phase 2

Detailed Description

The main hypotheses tested in this study are:

  • 0.01% atropine one drop nightly reduces the progression of childhood myopia in Danish children.

  • 0.01% atropine one drop nightly is safe and with no significant side effects.

  • A 6-month loading dose of 0.1% atropine followed by a 0.01% atropine maintenance dose is superior to single 0.01% atropine.

  • 0.1% atropine one drop nightly is safe and has tolerable side effects.

  • The rebound effect after stopping both atropine regimens is limited.

  • Choroidal thickness is a predictor for the progression of childhood myopia.

Study Design

Study Type:
Interventional
Actual Enrollment :
97 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Low-dose Atropine for the Prevention of Myopia Progression in Danish Children - a Randomized, Double-masked, Multicenter, 36-month Prospective 1:1:1 Study of Safety and Efficacy of 0.1% Atropine Loading Dose to Single 0.01% Atropine and Placebo
Actual Study Start Date :
May 30, 2019
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Loading dose

In phase 1 (treatment phase), the participants (n=50) will receive 0.1% atropine loading dose for 6 months followed by 0.01 % atropine for 18 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

Drug: 0.1% atropine and 0.01% atropine
0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
Other Names:
  • Loading dose

    		•
    Experimental: Low dose

    In phase 1 (treatment phase), the participants (n=50) will receive 0.01 % atropine for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

    Drug: 0.01% atropine
    0.01% atropine for 24 months
    Other Names:
  • Low-dose

    		•
    Placebo Comparator: Placebo

    In phase 1 (treatment phase), the participants (n=50) will receive placebo eye drops for 24 months. The eye drops are administered as one eye drop daily in each eye at bedtime. In phase 2 (washout phase), treatment will be stopped and the participants monitored for 12 months.

    Drug: 0.9% Sodium-chloride
    Placebo for 24 months
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in axial length [36 months]

      Treatment group comparison of change in axial length elongation from baseline to 36 months, as measured using IOLMaster 700

    2. Change in spherical equivalent [36 months]

      Treatment group comparison of change in spherical equivalent from baseline to 36 months, as measured using cycloplegic autorefraction

    Secondary Outcome Measures

    1. Adverse effects and reactions [36 months]

      Treatment group comparison of adverse effects and reactions

    2. Change in choroidal thickness [36 months]

      Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)

    3. Change in ocular biometry [36 months]

      Treatment group comparison of change in ocular biometry (i.e. keratometry, anterior chamber depth, lens thickness, vitreous axial distance) from baseline to 36 months

    4. Change in higher-order aberrations [36 months]

      Treatment group comparison of change in higher-order aberrations from baseline to 36 months

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Children aged ≥6-<9 years: myopia ≤-1 (spherical power) in at least one eye

    • Children aged ≥9-≤12 years: myopia ≤-2 (spherical power) in at least one eye

    • Cylinder less than 1.5 diopters

    Exclusion Criteria:

    • Myopia related to retinal dystrophies

    • Collagen syndroms (Ehlers-Danlos syndrome, Marfan syndrome and Stickler syndrome)

    • Other ocular pathology (e.g., amblyopia, strabismus)

    • Previous eye surgery

    • Previous use of agents thought to affect myopia progression, e.g. atropine, pirenzepine or 7-methylxanthine (metabolite of caffeine and theobromine) and orthokeratology contact lenses

    • Known allergy to atropine or any of the contents of the trial medication (active and in-active ingredients) used in the study

    • Non-compliance to eye examinations

    • Serious systemic health troubles (e.g., cardiac or respiratory illness) and developmental disorders and delays

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, Aarhus University Hospital Aarhus Denmark DK-8000
    2 Department of Ophthalmology, Rigshospitalet-Glostrup Glostrup Denmark DK-2600
    3 Department of Ophthalmology, Vejle Hospital Vejle Denmark DK-7100

    Sponsors and Collaborators

    • Line Kessel
    • Aarhus University Hospital
    • Vejle Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Line Kessel, Consultant ophthalmologist, Associate Professor, MD, Ph.D., FEBO, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT03911271
    Other Study ID Numbers:
    • Line Kessel, RH-Glostrup
    First Posted:
    Apr 11, 2019
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Myopia
    Atropine

    Study Results

    No Results Posted as of Jul 7, 2021