A randomized, controlled, 3-period crossover study to evaluate short-term effects of blue light stimulation of the optic nerve head with the device MyopiaX on the clinical biomarkers choroidal thickness and axial length in children and adolescents with myopia

Dopavision GmbH0 个研究点目标入组 18 人开始时间: 2023年8月29日最近更新: 2023年11月20日

适应症

试验速览

暂无简介。

•Male or female volunteers aged between 6 and 16 years.
•Documented diagnosis of myopia as characterized by spherical equivalent refraction ranging from -0.5 to -6.0 D inclusive.
•Corrected visual acuity of at least 0.2 logMAR in each eye.
•Good tolerability of test session with the VR system.
•Binocular adequacy as tested with VR.
•Ability to understand and give assent.

•Not habitually corrected for myopia.
•Concomitant therapies for control of myopia progression.
•Former myopia interventions within the following washout periods:
•- Low-dose atropine eyedrops within the last 3 months.
•- Orthokeratology contact lenses within the last 3 months.
•Eye diseases/conditions such as
•- Anisometropia of at least 1.5 D
•- Astigmatism of at least 3 D
•- Ophthalmological comorbidities
•- Optic nerve abnormalities
•- Suspicion of syndromic or monogenetic myopia
•Systemic illnesses affecting eye health.
•Any illnesses affecting dopamine function (such as sleep disorder, ADHD, Parkinson’s Disease, and autism spectrum disorders).
•Medication affecting dopamine function, accommodation, pupil size, or having an impact on the ocular surface (topical ocular medications).
•Participation in other clinical studies.
•Medical history (or family history) of photosensitive epilepsy.

发起方