Status:

NOT_YET_RECRUITING

Effect of Light-Blocking Lenses on Pediatric Hyperopia

Lead Sponsor:

Zhongshan Ophthalmic Center, Sun Yat-sen University

Conditions:

Hyperopia

Eligibility:

All Genders

6-12 years

Phase:

NA

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.

Eligibility Criteria

Inclusion

  • 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

  • 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;

Key Trial Info

Start Date :

August 25 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 30 2027

Estimated Enrollment :

156 Patients enrolled

Trial Details

Trial ID

NCT07142915

Start Date

August 25 2025

End Date

June 30 2027

Last Update

August 27 2025

Active Locations (1)

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1

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China, 510060