Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Anisometropia; Hyperopia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07142928

2025KYPJ092

Details and patient eligibility

About

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.

Enrollment: 90 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;
• 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

Intervention Group

Experimental group

Description:

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. Follow-up visits will be scheduled at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Lens replacement will be arranged if a refractive change greater than 0.50 diopters occurs or if the lenses become severely damaged

Treatment:

Other: light-blocking lenses

Control group

Placebo Comparator group

Description:

Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12-months. Follow-up visits will be scheduled at 6 months (±15 days) and 12 months (±15 days) after lens fitting. Lens replacement will be arranged if a refractive change greater than 0.50 diopters is detected or if the lenses become severely damaged.

Treatment:

Other: single-vision lenses