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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: Defocus Distributed Multi-point lens; Device: Single vision lens

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Tianjin, China
    • Tianjin Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Tianjin Eye Hospital
• Investigators: Principal Investigator: Xiaoqin Chen, MD, Tianjin Eye Hospital, Tianjin,China

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): February 20, 2023
• Study Completion (Anticipated): May 20, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 22, 2022

Study Record Updates

• Last Update Posted (Estimate): December 7, 2022
• Last Update Submitted That Met QC Criteria: December 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: KY202003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No