Effect of Light-Blocking Lenses on Hyperopic Anisometropic Children

Not Applicable

Not yet recruiting

• Conditions: Anisometropia; Hyperopia

• Registration Number: NCT07142928
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study Start: 2025-08-25
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial length	At baseline, 6 months, and 12 months	measured by optical biometer

Secondary Outcome Measures

Name	Time	Method
Refractive error	At baseline, 6 months, and 12 months	measured by cycloplegic refraction
Best-corrected visual acuity	At baseline, 6 months, and 12 months	measured by visual acuity chart
Intraocular pressure	At baseline, 6 months, and 12 months	measured by non-contact tonometer
Angle of deviation	At baseline, 6 months, and 12 months	measured by alternate cover test with prism
Contrast sensitivity	At baseline, 6 months, and 12 months	measured by quick contrast sensitivity function test
Stereopsis	At baseline, 6 months, and 12 months	measured by stereotest booklet
Accommodative function	At baseline, 6 months, and 12 months	measured by phoropter
Intervention questionnaire	At baseline, 6 months, and 12 months	measured by questionnaire

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China