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 |