Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
Myopia
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria:
Aged 6-13,with written consent of his/her guardian,regardless of gender; Objective cycloplegic spherical equivalent refractive between -1.00D and -5.00D,and best corrected vision acuity of right and left eyes are better than or equal to 1.0; Astigmatism less than or equal to -1.50D; Voluntarily participate in the clinical trial and sign the informed consent.
Exclusion Criteria:
Those with a history of ocular trauma or intraocular surgery; Clinical significant slit-lamp findings; Abnormal IOP(<10 mmHg , >21 mmHg or difference between two eyes >5mmHg); Patient with other eye diseases,such as uveitis and other inflammation,glaucoma,cataract,fundus disease,eye tumors,eye trauma,strabismus and any lesions that affect vision function; Patient with systemic diseases causing immunosuppression,such as acute or chronic sinusitis,diabetes,Down syndrome,rheumatoid arthritis,psychosis and other conditions that the investigator considers inappropriate for wearing glasses; Those who have participated in other drug clinical trials within 3 months; Only one eye meets the inclusion criteria; Those who cannot have regular eye examinations; Those who have been involved in any myopia control clinical trials,previously used or are using RGP,contact lens and glasses or atropine drugs to control myopia in the past year; The candidates determined by the investigator are not eligible.
Sites / Locations
- Tianjin Eye Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
experimental group
control group
A group of children wearing Xingyouxue Defocus Distributed Multi-point lens
A group of children wearing single vision lens