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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-05-20

Brief Summary

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Evaluate the safety and effectiveness of experimental group by comparing with the control group

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Detailed Description

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Compared the experimental group with the control group,the safety and effectiveness of DDM lens in mtopia control will be evaluated.

Conditions

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Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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experimental group

A group of children wearing Xingyouxue Defocus Distributed Multi-point lens

Group Type EXPERIMENTAL

Defocus Distributed Multi-point lens

Intervention Type DEVICE

Wear DDM lens

control group

A group of children wearing single vision lens

Group Type ACTIVE_COMPARATOR

Single vision lens

Intervention Type DEVICE

Wear single vision lens

Interventions

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Defocus Distributed Multi-point lens

Wear DDM lens

Intervention Type DEVICE

Single vision lens

Wear single vision lens

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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.

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;

Minimum Eligible Age

6 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes