Myopia
Conditions
Brief summary
Evaluate the safety and effectiveness of experimental group by comparing with the control group
Detailed description
Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.
Interventions
DEVICEDefocus Distributed Multi-point lens
Wear DDM lens
DEVICESingle vision lens
Wear single vision lens
Sponsors
Tianjin Eye Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 13 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Objective cycloplegic refractive | baseline, 12 months | Changes in objective cycloplegic refractive from baseline between two groups |
| Changes in Axial Length | baseline, 12 months | Changes in axial length from baseline between two groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Objective cycloplegic refractive | baseline, 6 months，18 months and 24 months | Changes in objective cycloplegic refractive from baseline between two groups |
| Changes in Axial length | baseline, 6 months，18 months and 24 months | Changes in axial length from baseline between two groups |
| Changes in amplitude of accommodation | baseline, 6 months，18 months and 24 months | Changes in amplitude of accommodation between two groups evey 6 months |
| Changes in near point of convergence | baseline, 6 months，18 months and 24 months | Changes in near point of convergence between two groups evey 6 months |
Countries
China
Outcome results
None listed