Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control

Study Overview
=================
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.

Official Title
-----------------
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Defocus Distributed Multi-point lens
* Device: Single vision lens


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental group<br>A group of children wearing Xingyouxue Defocus Distributed Multi-point lens | Device: Defocus Distributed Multi-point lens<br>* Wear DDM lens<br>|
| Active Comparator: control group<br>A group of children wearing single vision lens | Device: Single vision lens<br>* Wear single vision lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Objective cycloplegic refractive | Changes in objective cycloplegic refractive from baseline between two groups | baseline, 12 months | 
| Changes in Axial Length | Changes in axial length from baseline between two groups | baseline, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Objective cycloplegic refractive | Changes in objective cycloplegic refractive from baseline between two groups | baseline, 6 months，18 months and 24 months | 
| Changes in Axial length | Changes in axial length from baseline between two groups | baseline, 6 months，18 months and 24 months | 
| Changes in amplitude of accommodation | Changes in amplitude of accommodation between two groups evey 6 months | baseline, 6 months，18 months and 24 months | 
| Changes in near point of convergence | Changes in near point of convergence between two groups evey 6 months | baseline, 6 months，18 months and 24 months |