Observational Study on visual performance of three different myopia control optical lenses for children in China

SightGlass Vision0 个研究点目标入组 48 人开始时间: 2023年6月8日最近更新: 2024年7月29日

适应症

试验速览

Abstract results see attached file ISRCTN50468704_Abstract.pdf (added 16/07/2024)

•1. Myopic children aged 6 to 14 years, with spherical equivalent refraction (SER) -0.75 D to -4.00 D (by cycloplegic autorefraction) in each eye.
•2. Best corrected visual acuity (BCVA) by manifest refraction of +0.10 logMAR (0.8 Snellen equivalent) or better in each eye.
•3. Pass stereopsis and color vision screening.
•4. Ability to comply with all study procedures, including assessments of visual performance with assigned correction.
•5. Willingness to wear assigned spectacles for the duration of the study.
•6. The subject's parent(s) or legal guardian(s) must read, understand and sign the ICF and receive a fully executed copy.

•1. Prior use of any myopia control approaches, such as atropine, multifocal contact lenses, orthokeratology (ortho-K), or other spectacle lenses designed for myopia control including peripheral defocus, bifocal, and progressive addition lenses.
•2. Astigmatism worse than -1.25 DC (by manifest refraction) in either eye.
•3. Anisometropia (SER manifest refraction) greater than 1.00 D.
•4. Amblyopia in either eye.
•5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction.
•6. Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down syndrome, family history of poor night vision (to prevent against enrolling subjects with congenital stationary night blindness).
•7. Participation in any investigational clinical study within 30 days of the Screening visit.

发起方

SightGlass Vision