Focus-out Glasses on Emmetropization in Chinese Children (NCT05689567) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Focus-out Glasses on Emmetropization in Chinese Children
China160 participantsStarted 2023-03-23
Plain-language summary
The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.
Who can participate
Age range6 Years – 8 Years
SexALL
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Inclusion criteria
✓. Age: ≥6 and ≤8 years at enrollment.
✓. At least one parent' s Spherical equivalent refraction≤-3.00D.
✓. Spherical equivalent refractions (SERs) under cycloplegia: +0.50 to +1.50 diopters (D)
✓. Astigmatism ≤1.00 D .
✓. Anisometropia ≤1.00 D.
✓. Best Corrected Visual Acuity (BCVA) : 1.0 or better
✓. Provision of consent written by subject's legal guardian
✓. Willing and able to participate in all required activities of the study
Exclusion criteria
✕. Any of the following abnormalities on the ocular surface, such as trachoma, pemphigoid, chemical injury, heat burn, radiation injury, etc.
✕. Eyelid abnormalities (e.g. entropion, ectropion, tumor, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) ,which affect eyelid function in either eye
✕. Eye diseases such as strabismus, amblyopia, anisometropia, fundus diseases, and accommodation abnormality，etc.
✕. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, low-level red-light therapy, etc.
✕
What they're measuring
1
Overall Changes of Cycloplegic Objective Refraction(spherical equivalent refraction, SER)(D)