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

Not Applicable

Active, not recruiting

• Conditions: Myopia
• Interventions: Device: CARE1.02; Device: Single-vision spectacle lens

• Registration Number: NCT05818033
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

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, The researchers 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-05
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-18
• Study Start: 2023-04-25
• Status Verified: 2024-03
• Primary Completion: 2024-05-16
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 760

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	CARE1.02	CARE1.02
Control group	Single-vision spectacle lens	Single-vision spectacle lens

Primary Outcome Measures

Name	Time	Method
Changes of spherical equivalent refraction (SER) at one year	1 year	The difference of SER at one year from baseline. SER will be measured after cycloplegia

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China