Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

NCT ID: NCT07142928

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Anisometropia; Hyperopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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

Group Type: EXPERIMENTAL

light-blocking lenses

Intervention Type: OTHER

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

Control group

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.

Group Type: PLACEBO_COMPARATOR

single-vision lenses

Intervention Type: OTHER

Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.

Interventions

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

Intervention Type: OTHER

single-vision lenses

Both eyes of the subjects will be fitted with conventional single-vision lenses for full-time wear over 12 months.

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jingrong Li

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Countries

China

Central Contacts

Jinrong Li, MD PhD

Role: CONTACT

lijingr3@mail.sysu.edu.cn

86-020-87330351

Facility Contacts

Jinrong Li, MD PhD

Role: primary

lijingr3@mail.sysu.edu.cn

86-020-87330351

Other Identifiers

2025KYPJ092

Identifier Type: -

Identifier Source: org_study_id