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

Myopia Clinical Trial

— APP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03911271
• Other study ID #: Line Kessel, RH-Glostrup
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 30, 2019
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 97
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• 0.1% atropine and 0.01% atropine
0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
• 0.01% atropine
0.01% atropine for 24 months
• 0.9% Sodium-chloride
Placebo for 24 months

Locations

Country	Name	City	State
Denmark	Department of Ophthalmology, Aarhus University Hospital	Aarhus
Denmark	Department of Ophthalmology, Rigshospitalet-Glostrup	Glostrup
Denmark	Department of Ophthalmology, Vejle Hospital	Vejle

Sponsors (3)

Lead Sponsor	Collaborator
Line Kessel	Aarhus University Hospital, Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in axial length	Treatment group comparison of change in axial length elongation from baseline to 36 months, as measured using IOLMaster 700	36 months
Primary	Change in spherical equivalent	Treatment group comparison of change in spherical equivalent from baseline to 36 months, as measured using cycloplegic autorefraction	36 months
Secondary	Adverse effects and reactions	Treatment group comparison of adverse effects and reactions	36 months
Secondary	Change in choroidal thickness	Treatment group comparison of change in choroidal thickness from baseline to 36 months, as measured using optical coherence tomography (OCT)	36 months
Secondary	Change in ocular biometry	Treatment group comparison of change in ocular biometry (i.e. keratometry, anterior chamber depth, lens thickness, vitreous axial distance) from baseline to 36 months	36 months
Secondary	Change in higher-order aberrations	Treatment group comparison of change in higher-order aberrations from baseline to 36 months	36 months