Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2025-08-25
Last updated
2025-08-27
Condition(s) studied
Hyperopia
Investigational drug(s) / intervention(s)
light-blocking lensessingle-vision lenses
light-blocking lenses: Subjects will be instructed to wear light-blocking lenses full-time for 12 months.
single-vision lenses: Subjects will be instructed to wear single-vision lenses full-time for 12 months.
Study summary
This study aims to assess the efficacy of light-blocking lenses in facilitating emmetropization in children with hyperopia and to explore their influence on various aspects of visual function.
Eligibility
Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria:
* Aged 6 years or older and 12 years or younger;
* Spherical refractive error in both eyes between +3.0 D and +7.5 D, cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power less than 1.5 D and in cylindrical power no greater than 1.0 D;
* Best-corrected visual acuity of 0.0 logMAR or better in both eyes;
* Ocular deviation with spectacles less than 10 prism diopters;
* Has been wearing standard single-vision spectacles regularly for more than six months;
* In good general health, capable of receiving the study intervention, and willing to comply with the study protocol;
* Written informed consent obtained from both the parent/guardian and the child, with agreement to comply with all study procedures and maintain follow-up availability throughout the study period;
Exclusion Criteria:
* History of ocular trauma or eye surgery;
* Presence of pathological abnormalities on anterior or posterior segment examination, or a history of organic ocular diseases such as cataract, glaucoma, corneal disease, or fundus disorders;
* Intraocular pressure greater than 21 mmHg;
* Presence of systemic diseases or other conditions deemed unsuitable for study participation;
* Any other condition deemed inappropriate for participation in the clinical trial by the investigator;
Primary outcome measure(s)
Axial length — At baseline, 6 months, and 12 months measured by optical biometer
Trial sites (1)
Facility
City
Region
Status
Zhongshan Ophthalmic Center
Guangzhou
Guangdong
More Zhongshan Ophthalmic Center, Sun Yat-sen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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