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NCT05689567
Focus-out Glasses on Emmetropization in Chinese Children
Conditions: Emmetropization, Myopia, Hyperopia
Sex: All
Ages: 6 Years – 8 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 160
Sponsor: Children's Hospital of Fudan University
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.
Eligibility Criteria
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 betterProvision of consent written by subject's legal guardianWilling and able to participate in all required activities of the studyExclusion 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 eyeEye 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.Noncompliance with measurement at enrollment.
Source: ClinicalTrials.gov (NCT05689567). StuddyBuddy aggregates publicly available trial information.