Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control

Sun Yat-sen University

Status

Active, not recruiting

Conditions

Myopia

Treatments

Device: CARE1.02

Device: Single-vision spectacle lens

Study type

Interventional

Funder types

Other

Identifiers

NCT05818033

2023KYPJ005

Details and patient eligibility

About

China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, The researchers plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.

Enrollment

760 estimated patients

Sex

All

Ages

12 to 17 years old

Volunteers

No Healthy Volunteers

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.