Myopa
Conditions
Interventions
Experimental Group:MyoCtrl Fractal Lenses
Control Group:Essilor Aspherical Crizal Forte UV Lenses
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Age: 8 years (inclusive) to 12 years (inclusive), any gender; (2) After cycloplegic subjective refraction, the spherical equivalent of myopia in both eyes ranges from -0.75D to -4.00D (inclusive); astigmatism <= 2.00D, and anisometropia in spherical equivalent <= 1.50D; (3) Best corrected visual acuity with spectacles reaches 0.0 LogMAR or better in both eyes; (4) During the study period, able to comply with spectacle wear requirements (wearing for at least 10 hours daily). Any interruption must be reported to the investigator; (5) The subject and their guardian are able to understand the purpose of the trial, willing to complete the visits, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Any active ocular disease or systemic disease affecting the eyes. (2) Use of myopia progression control products within the past month or currently using such products, including specially designed myopia control lenses (such as spectacles, orthokeratology lenses, RGP lenses, multifocal contact lenses, progressive addition lenses, etc.), atropine, or red light therapy. (3) Current use or anticipated need during the follow-up study period for medications that may cause dry eye or affect vision (such as penicillin, streptomycin, chloramphenicol, sulfonamides, isoniazid, etc.). (4) Known allergy to oxybuprocaine, proparacaine, or tropicamide. (5) Manifest strabismus or significant binocular vision abnormalities. (6) Concurrent participation in other clinical trials. (7) Abnormal and clinically significant findings on slit-lamp examination, fundus examination, or intraocular pressure measurement. (8) Ocular or systemic abnormalities that may affect visual function or refractive development. (9) Any other conditions deemed by the investigator as unsuitable for participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial Length;Cycloplegic refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Corrected Visual Acuity;Visual Function;Subjective Visual Quality; | — |
Countries
China
Contacts
Public ContactKai Wang
Peking University People's Hospital
Outcome results
None listed