Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control
Myopia
About this trial
This is an interventional prevention trial for Myopia focused on measuring Myopia control
Eligibility Criteria
Inclusion Criteria: Aged 12 to 17 years; Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D; Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen). The intraocular pressure of 10 to 21mmHg. Volunteer to participate in this clinical trial with signature of the informed consent form. Exclusion Criteria: History of eye injury or intraocular surgery; Clinically abnormal slit-lamp findings; Abnormal fundus examination; Ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function; Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); Participation of the drug clinical trial within three month and the device clinical trial within one month; Only one eye meets the inclusion criteria; Unable to have regular follow-up; Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.
Sites / Locations
- Zhongshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention group
Control group
CARE1.02
Single-vision spectacle lens