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Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control

Primary Purpose

Myopia

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CARE1.02
Single-vision spectacle lens
Sponsored by
Zhongshan Ophthalmic Center, Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Myopia focused on measuring Myopia control

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged 12 to 17 years; Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D; Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen). The intraocular pressure of 10 to 21mmHg. Volunteer to participate in this clinical trial with signature of the informed consent form. Exclusion Criteria: History of eye injury or intraocular surgery; Clinically abnormal slit-lamp findings; Abnormal fundus examination; Ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function; Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); Participation of the drug clinical trial within three month and the device clinical trial within one month; Only one eye meets the inclusion criteria; Unable to have regular follow-up; Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.

Sites / Locations

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

CARE1.02

Single-vision spectacle lens

Outcomes

Primary Outcome Measures

Changes of spherical equivalent refraction (SER) at one year
The difference of SER at one year from baseline. SER will be measured after cycloplegia

Secondary Outcome Measures

Changes of axial length (AL) at one year
The difference of AL at one year from baseline.
Change of anterior chamber depth (ACD) at one year
The difference of ACD at one year from baseline.
Change of lens thickness (LT) at one year
The difference of LT at one year from baseline.
Change of corneal curvature (CR) at one year
The difference of CR at one year from baseline.
Best corrected visual acuity at one year
Best corrected visual acuity
Binocular visual function at one year
Binocular visual function
Choroidal thickness at one year
The difference of Choroidal thickness at one year from baseline.
Visual scale score at 1 year
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)
Time length of wearing spectcales at one year
Time length of wearing spectcales collected every half year
Safty of wearing the spectacle lens
Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations through symptoms and signs, intraocular pressure#slit lamp and ocular fundus checks.

Full Information

First Posted
April 5, 2023
Last Updated
April 17, 2023
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05818033
Brief Title
Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control
Official Title
Safety and Effectiveness of CARE1.02 Spectacle Lens Versus Single-vision Spectacle Lens in Myopia Control: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 20, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University

4. Oversight

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

5. Study Description

Brief Summary
China is a major country in myopia, with the highest number of teenagers suffering from myopia. Controlling the progression of myopia and the related complications caused by axial elongation have clinical significance and social value. Currently. There is a lack of researches on the impact of specially designed myopia control spectacle lens in adolescents aged 12 and above. Therefore, we plan to conduct a randomized controlled trial among myopia adolescents aged 12-17 in middle and high schools in Guangzhou, to test and verify the safety and effectiveness of CARE1.02 on myopia control compared with single-vision spectacle lens.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
760 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
CARE1.02
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Single-vision spectacle lens
Intervention Type
Device
Intervention Name(s)
CARE1.02
Intervention Description
Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.
Intervention Type
Device
Intervention Name(s)
Single-vision spectacle lens
Intervention Description
Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.
Primary Outcome Measure Information:
Title
Changes of spherical equivalent refraction (SER) at one year
Description
The difference of SER at one year from baseline. SER will be measured after cycloplegia
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Changes of axial length (AL) at one year
Description
The difference of AL at one year from baseline.
Time Frame
1 year
Title
Change of anterior chamber depth (ACD) at one year
Description
The difference of ACD at one year from baseline.
Time Frame
1 year
Title
Change of lens thickness (LT) at one year
Description
The difference of LT at one year from baseline.
Time Frame
1 year
Title
Change of corneal curvature (CR) at one year
Description
The difference of CR at one year from baseline.
Time Frame
1 year
Title
Best corrected visual acuity at one year
Description
Best corrected visual acuity
Time Frame
1 year
Title
Binocular visual function at one year
Description
Binocular visual function
Time Frame
1 year
Title
Choroidal thickness at one year
Description
The difference of Choroidal thickness at one year from baseline.
Time Frame
1 year
Title
Visual scale score at 1 year
Description
Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2)
Time Frame
1 year
Title
Time length of wearing spectcales at one year
Description
Time length of wearing spectcales collected every half year
Time Frame
1 year
Title
Safty of wearing the spectacle lens
Description
Safty of wearing the spectacle lens which is a qualitative outcome will be evaluated every half year by prespecified measures and definations through symptoms and signs, intraocular pressure#slit lamp and ocular fundus checks.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 12 to 17 years; Under the condition of bilateral cycloplegic autorefraction, the spherical refractive error of -0.50 to -8.00 D in each eye and astigmatism of not more than 1.50 D and anisometropia of not more than 1.50 D; Best-corrected visual acuity of equal or better than 0.00 LogMAR (>= 1.0 as Snellen). The intraocular pressure of 10 to 21mmHg. Volunteer to participate in this clinical trial with signature of the informed consent form. Exclusion Criteria: History of eye injury or intraocular surgery; Clinically abnormal slit-lamp findings; Abnormal fundus examination; Ocular disease, such as uveitis and other inflammatory diseases,glaucoma, cataract, fundus diseases, eye tumors, dominant strabismus, and any eye diseases that affect visual function; Systemic diseases causing low immunity (such as diabetes, Down's syndrome, rheumatoid arthritis, psychotic patients or other diseases that researchers think are not suitable for wearing glasses); Participation of the drug clinical trial within three month and the device clinical trial within one month; Only one eye meets the inclusion criteria; Unable to have regular follow-up; Participation of any myopia control clinical research trial within three months, and currently using rigid contact lenses (including nursing products), multifocal contact lenses, progressive multifocal lenses and other specially designed myopia control lenses, atropine drugs, etc.
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The researchs will share the IPD as request in future.
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Safety and Effectiveness of CARE1.02 Spectacle Lens in Myopia Control

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