Effect of Light-Blocking Lenses on Pediatric Hyperopia

NCT ID: NCT07142915

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2027-06-30

Brief 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.

Conditions

Hyperopia

Study Design

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

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

light-blocking lenses

Intervention Type: OTHER

Subjects will be instructed to wear light-blocking lenses full-time for 12 months.

Control Group

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.

Group Type: PLACEBO_COMPARATOR

single-vision lenses

Intervention Type: OTHER

Subjects will be instructed to wear single-vision lenses full-time for 12 months.

Interventions

light-blocking lenses

Subjects will be instructed to wear light-blocking lenses full-time for 12 months.

Intervention Type: OTHER

single-vision lenses

Subjects will be instructed to wear single-vision lenses full-time for 12 months.

Intervention Type: OTHER

Eligibility Criteria

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;

• 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

2025KYPJ081

Identifier Type: -

Identifier Source: org_study_id