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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05340699
• Other study ID #: KY202003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: March 2022
• Source: Tianjin Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 168
• Est. completion date: May 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Defocus Distributed Multi-point lens
Wear DDM lens
• Single vision lens
Wear single vision lens

Locations

Country	Name	City	State
China	Tianjin Eye Hospital	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Objective cycloplegic refractive	Changes in objective cycloplegic refractive from baseline between two groups	baseline, 12 months
Primary	Changes in Axial Length	Changes in axial length from baseline between two groups	baseline, 12 months
Secondary	Changes in Objective cycloplegic refractive	Changes in objective cycloplegic refractive from baseline between two groups	baseline, 6 months,18 months and 24 months
Secondary	Changes in Axial length	Changes in axial length from baseline between two groups	baseline, 6 months,18 months and 24 months
Secondary	Changes in amplitude of accommodation	Changes in amplitude of accommodation between two groups evey 6 months	baseline, 6 months,18 months and 24 months
Secondary	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