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

Not Applicable

• Conditions: Myopia
• Interventions: Device: Defocus Distributed Multi-point lens; Device: Single vision lens

• Registration Number: NCT05340699
• Lead Sponsor: Tianjin Eye Hospital

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.

Study Timeline

• Status Verified: 2022-03
• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-22
• Study Start: 2022-05-01
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07
• Primary Completion: 2023-02-20
• Study Completion: 2023-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental group	Defocus Distributed Multi-point lens	A group of children wearing Xingyouxue Defocus Distributed Multi-point lens
control group	Single vision lens	A group of children wearing single vision lens

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tianjin Eye Hospital; 🇨🇳 Tianjin, China