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. 2023 Feb 16;2023(2):CD014758. doi: 10.1002/14651858.CD014758.pub2

NCT04699357.

Study name The effect and safety of different doses of atropine on myopic progression of highly myopic children: multi‐centered randomized clinical trial
Methods Randomised parallel‐group design
Participants Inclusion criteria: age 6‐12 years, BCVA of distant vision is at least 0.5, near vision is at least 1.0, Titmus stereo vision is < 80 seconds, far exotropia is < 10 prism degrees, far esotropia is < 6‐8 prism degrees, and astigmatism ≤ −2.50 D; myopia progressed > 0.5D in the past year
Exclusion criteria: diseases of the study eye: keratitis, keratoconus, congenital cataract, glaucoma, fundus diseases; present situation with anterior segment or posterior segment inflammation, such as acute conjunctivitis, iridocyclitis, systemic diseases affecting drug use: albinism, epilepsy, serious mental and neurological diseases, congenital heart disease, arrhythmia, atropine allergy, very low‐birthweight infants with birthweight < 1500 g, receiving other treatment to control the development of myopia, including anticholinergic drugs such as atropine, or participated in other functional frame lens, MFl soft lens in the past year
Interventions Intervention: 0.01% atropine eye drops
Intervention: 0.04% atropine eye drops
Intervention: 0.1% atropine eye drops
Outcomes Primary outcome: changes of spherical equivalent, changes of AL
Maximum follow up: not reported
Starting date July 2021
Estimated end date: August 2025
Contact information clinicaltrials.gov/ct2/show/NCT04699357
Notes