Status:
UNKNOWN
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
Lead Sponsor:
Tianjin Eye Hospital
Conditions:
Myopia
Eligibility:
All Genders
6-13 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2023
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05340699
Start Date
May 1 2022
End Date
May 20 2023
Last Update
December 7 2022
Active Locations (1)
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1
Tianjin Eye Hospital
Tianjin, China