Effect of Light-Blocking Lenses on Pediatric Hyperopia

NCT07142915 — Not applicable, Not yet recruiting, 156 participants, Zhongshan Ophthalmic Center, Sun Yat-sen University

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Prospective Randomized Controlled Trial on the Effect of Light-Blocking Lenses on Emmetropization in Hyperopic Children

Registry	NCT07142915
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	156 (Estimated)
Sponsor	Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
Conditions	Hyperopia
Interventions	light-blocking lenses, single-vision lenses (Other)
Dates	start 2025-08-25 (estimated), primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2025-08-27, last updated 2025-08-27
Locations	1 site in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Intervention Group	Experimental	Other: light-blocking lenses	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.
Control Group	Placebo comparator	Other: single-vision lenses	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.

light-blocking lenses (Other): Subjects will be instructed to wear light-blocking lenses full-time for 12 months.
single-vision lenses (Other): Subjects will be instructed to wear single-vision lenses full-time for 12 months.

+Outcome measures

Primary outcomes

Axial length [At baseline, 6 months, and 12 months]: measured by optical biometer

Secondary outcomes

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

Other outcomes

Height [At baseline, 6 months, and 12 months]: measured by ruler
Weight [At baseline, 6 months, and 12 months]: measured by weighing scale
Choroidal thickness (optional) [At baseline, 6 months, and 12 months]: measured by OCT, optional

+Eligibility

Sex: All, ages: 6 Years to 12 Years

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;

+Locations (1)

Facility	City	Country	Status
Zhongshan Ophthalmic Center	Guangzhou, Guangdong	China