Investigator led, double-masked, multicenter, randomized clinical trial for the comparison of Atropine 0.5% versus Atropine 0.05% eye drops for the prevention of myopia progression in Dutch children.

Investigator led, double-masked, multicenter, randomized clinical trial for the comparison of Atropine 0.5% versus Atropine 0.05% eye drops for the prevention of myopia progression in Dutch children. - MAD trial: Myopia Atropine Dose

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55937

Enrollment

550

Registered

2022-07-07

Start date

2022-12-08

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia nearsightedness

Interventions

Intervention: Comparison of 0.05% Atropine to 0.5% Atropine in a multicentre study with a 3 year duration, followed by a 2 year observational period.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to =4 years of age Spherical Equivalent Refraction (SER) of at least -1.00 D and no greater than -6.00 D in each eye Intraocular pressure

Exclusion criteria

Exclusion criteria: Allergy to Atropine History of amblopya or strabismus History of retinal dystrophy or systemic order Prior myopia control treatment (Atropine, ortho-keratology, multifocal contact lenses). Glaucoma

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of AL in children with progressive myopia.	—

Secondary

Measure	Time frame
Secondary study parameters/outcome: • To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of SER (Spherical Equivalent of Refraction) in children with progressive myopia. • To evaluate the safety, adherence, and reasons for nonresponse of atropine 0.05% compared to atropine 0.5% treatment. • To create an online BIG DATA registry for myopia treatment in the Netherlands which can be used for evaluation of myopia progression in the long term. • To evaluate the rebound effect after treatment-stop.	—

Measure

Time frame

Secondary study parameters/outcome: • To compare the efficacy of atropine 0.05% to atropine 0.5% treatment against progression of SER (Spherical Equivalent of Refraction) in children with progressive myopia. • To evaluate the safety, adherence, and reasons for nonresponse of atropine 0.05% compared to atropine 0.5% treatment. • To create an online BIG DATA registry for myopia treatment in the Netherlands which can be used for evaluation of myopia progression in the long term. • To evaluate the rebound effect after treatment-stop.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)