Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2025-08-25
Last updated
2025-08-27
Condition(s) studied
AnisometropiaHyperopia
Investigational drug(s) / intervention(s)
light-blocking lensessingle-vision lenses
light-blocking lenses: The eye with higher hyperopia will be fitted with light-blocking lenses for full-time wear, while the fellow eye with lower hyperopia will be fitted with conventional single-vision lenses for full-time wear, over 12 months
single-vision lenses: Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.
Study summary
To evaluate the effectiveness of light-blocking lenses in promoting emmetropization and reducing anisometropia in children with hyperopic anisometropia, and to assess the impact of light-intercepting lenses on visual function in this population.
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;
* The more hyperopic eye has a spherical refractive error between +3.0 D and +7.5 D; the less hyperopic eye has a spherical refractive error of at least +2.0 D; cylindrical refractive error between -2.0 D and 0 D; interocular difference in spherical power \>=1.5 D and in cylindrical power \<=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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.