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

Primary Purpose

Myopia

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Defocus Distributed Multi-point lens
Single vision lens
Sponsored by
Tianjin Eye Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

6 Years - 13 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Tianjin Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

experimental group

control group

Arm Description

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

A group of children wearing single vision lens

Outcomes

Primary Outcome Measures

Changes in Objective cycloplegic refractive
Changes in objective cycloplegic refractive from baseline between two groups
Changes in Axial Length
Changes in axial length from baseline between two groups

Secondary Outcome Measures

Changes in Objective cycloplegic refractive
Changes in objective cycloplegic refractive from baseline between two groups
Changes in Axial length
Changes in axial length from baseline between two groups
Changes in amplitude of accommodation
Changes in amplitude of accommodation between two groups evey 6 months
Changes in near point of convergence
Changes in near point of convergence between two groups evey 6 months

Full Information

First Posted
March 22, 2022
Last Updated
December 5, 2022
Sponsor
Tianjin Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05340699
Brief Title
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
Official Title
Safety and Efficacy of Defocus Distributed Multi-point Lens in Myopia Control
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
February 20, 2023 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Eye Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
A group of children wearing Xingyouxue Defocus Distributed Multi-point lens
Arm Title
control group
Arm Type
Active Comparator
Arm Description
A group of children wearing single vision lens
Intervention Type
Device
Intervention Name(s)
Defocus Distributed Multi-point lens
Intervention Description
Wear DDM lens
Intervention Type
Device
Intervention Name(s)
Single vision lens
Intervention Description
Wear single vision lens
Primary Outcome Measure Information:
Title
Changes in Objective cycloplegic refractive
Description
Changes in objective cycloplegic refractive from baseline between two groups
Time Frame
baseline, 12 months
Title
Changes in Axial Length
Description
Changes in axial length from baseline between two groups
Time Frame
baseline, 12 months
Secondary Outcome Measure Information:
Title
Changes in Objective cycloplegic refractive
Description
Changes in objective cycloplegic refractive from baseline between two groups
Time Frame
baseline, 6 months,18 months and 24 months
Title
Changes in Axial length
Description
Changes in axial length from baseline between two groups
Time Frame
baseline, 6 months,18 months and 24 months
Title
Changes in amplitude of accommodation
Description
Changes in amplitude of accommodation between two groups evey 6 months
Time Frame
baseline, 6 months,18 months and 24 months
Title
Changes in near point of convergence
Description
Changes in near point of convergence between two groups evey 6 months
Time Frame
baseline, 6 months,18 months and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoqin Chen, MD
Organizational Affiliation
Tianjin Eye Hospital, Tianjin,China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Eye Hospital
City
Tianjin
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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