Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

NCT07142928 | Not Yet Recruiting

• 1 other identifier: 2025KYPJ092
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Anisometropia; Hyperopia; light-blocking lenses; emmetropization

Outcome Measures

Primary Outcomes (1)

• Axial length

  measured by optical biometer

  At baseline, 6 months, and 12 months

Secondary Outcomes (8)

• Refractive error

  At baseline, 6 months, and 12 months

• Best-corrected visual acuity

  At baseline, 6 months, and 12 months

• Intraocular pressure

  At baseline, 6 months, and 12 months

• Angle of deviation

  At baseline, 6 months, and 12 months

• Contrast sensitivity

  At baseline, 6 months, and 12 months

Other Outcomes (3)

• Height

  At baseline, 6 months, and 12 months

• Weight

  At baseline, 6 months, and 12 months

• Choroidal thickness (optional)

  At baseline, 6 months, and 12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Other: light-blocking lenses

Control group

PLACEBO COMPARATOR

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.

Other: single-vision lenses

Interventions

light-blocking lenses 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

Intervention Group

single-vision lenses OTHER

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

Control group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Anisometropia; Hyperopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Jinrong Li, MD PhD

CONTACT

86-020-87330351; lijingr3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 27, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)