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

Line Kessel

Status and phase: Completed; Phase 2

Conditions: Myopia

Treatments: Drug: 0.9% Sodium-chloride; Drug: 0.01% atropine; Drug: 0.1% atropine and 0.01% atropine

Study type: Interventional

Funder types: Other

Identifiers

NCT03911271

Line Kessel, RH-Glostrup

Details and patient eligibility

About

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.

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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97 participants in 3 patient groups, including a placebo group

Loading dose

Experimental group

Description:

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.

Treatment:

Drug: 0.1% atropine and 0.01% atropine

Low dose

Experimental group

Description:

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.

Treatment:

Drug: 0.01% atropine

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: 0.9% Sodium-chloride