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

Study Overview
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Brief Summary
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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.

Official Title
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Safety and Effectiveness of CARE1.02 Spectacle Lens Versus Single-vision Spectacle Lens in Myopia Control: a Randomised Controlled Trial

Conditions
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Myopia

Intervention / Treatment
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* Device: CARE1.02
* Device: Single-vision spectacle lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>CARE1.02 | Device: CARE1.02<br>* Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.<br>|
| Active Comparator: Control group<br>Single-vision spectacle lens | Device: Single-vision spectacle lens<br>* Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of spherical equivalent refraction (SER) at one year | The difference of SER at one year from baseline. SER will be measured after cycloplegia | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of axial length (AL) at one year | The difference of AL at one year from baseline. | 1 year | 
| Change of anterior chamber depth (ACD) at one year | The difference of ACD at one year from baseline. | 1 year | 
| Change of lens thickness (LT) at one year | The difference of LT at one year from baseline. | 1 year | 
| Change of corneal curvature (CR) at one year | The difference of CR at one year from baseline. | 1 year | 
| Best corrected visual acuity at one year | Best corrected visual acuity | 1 year | 
| Binocular visual function at one year | Binocular visual function | 1 year | 
| Choroidal thickness at one year | The difference of Choroidal thickness at one year from baseline. | 1 year | 
| Visual scale score at 1 year | Visual scale score measured by the Chinese version of the pediatric refractive error profile2 (PREP2) | 1 year | 
| Time length of wearing spectcales at one year | Time length of wearing spectcales collected every half year | 1 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia control