Efficacy and Mechanisms of Low Dose Atropine in the Control of Myopia in Children Trial name: Myopia Outcome Study of Atropine in Children (MOSAIC) - MOSAIC

Technological University Dublin0 个研究点目标入组 250 人开始时间: 2018年7月3日最近更新: 2024年3月12日

适应症

试验速览

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•To be eligible for inclusion, each child must have spherical equivalent refractive error of -1.0D or worsewith myopia progression of at least -0.50DS over the last year, based on refractive or clinical evidence. They must have astigmatism less than or equal to -2.50D and an intraocular difference in spherical equivalent <= 1D. Their corrected visual acuity must be better or equal to logMAR 0.2in both eyes and ifference between non-cycloplegic and cycloplegic spherical refraction of less than 1.00 D. Participants must have normal IOP (<= 21mmHg), normal ocular health and good general health with no history of cardiac/respiratory diseases. Participants must have willingness to commit to the 2 year clinical trial as well as randomisation to the placebo.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 250
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Any child meeting any of the exclusion criteria at the baseline visit will be excluded from study participation:
•Ocular/systemic diseases/conditions affecting vision or refractive error
•Any ocular/systemic condition wherein atropine is contraindicated
•Known allergy to atropine, cyclopentolate hydrochloride and/or proxymetacaine hydrochloride
•Defective binocular vision, amblyopia or strabismus
•Any other conditions precluding adherence to the protocol including allergy to study eye drops (active agent or preservative)
•Previous pharmaceutical or optical myopia control interventions
•Subjects (or parent/guardian) unable to provide written informed consent Subjects (or parent/guardian) unable to provide written informed consent

发起方