Effect of Light-Blocking Lenses on Pediatric Hyperopia

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Hyperopia

Treatments: Other: light-blocking lenses; Other: single-vision lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT07142915

2025KYPJ081

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

Subjects will be instructed to wear light-blocking lenses full-time for 12 months. Scheduled follow-up examinations will be conducted at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Replacement of the lenses will be arranged if a refractive change greater than 0.50 diopters is observed, or in cases of severe lens damage.

Treatment:

Other: light-blocking lenses

Control Group

Placebo Comparator group

Description:

Subjects will be instructed to wear single-vision lenses full-time for 12 months. Scheduled follow-up examinations will be conducted at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Replacement of the lenses will be arranged if a refractive change greater than 0.50 diopters is observed, or in cases of severe lens damage.

Treatment:

Other: single-vision lenses