Safety and Effectiveness of CARE1.02 Spectacle Lens in My... | NCT05818033

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

NCT05818033

Sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Status

Completed

Last Update Posted

Mar 12, 2026Actual

Enrollment

796Actual

Phase

Not Applicable

Conditions

Myopia

Interventions

CARE1.02
Single-vision spectacle lens

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 25, 2023Actual

Primary Completion Date

Jun 12, 2025Actual

Completion Date

Jun 12, 2025Actual

First Submitted Date

Apr 5, 2023

First Submission Date that Met QC Criteria

Apr 17, 2023

First Posted Date

Apr 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

796Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention group	Experimental	CARE1.02	Device: CARE1.02
Control group	Active Comparator	Single-vision spectacle lens	Device: Single-vision spectacle lens

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CARE1.02	Device	Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.	Intervention group

Outcomes Module

Primary Outcomes

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 Outcomes

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.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Ophthalmic Center, Sun Yat-sen University		Guangzhou	Guangdong	510060	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28746982	Background	Irving EL, Yakobchuk-Stanger C. Myopia progression control lens reverses induced myopia in chicks. Ophthalmic Physiol Opt. 2017 Sep;37(5):576-584. doi: 10.1111/opo.12400. Epub 2017 Jul 26.
26875007	Result	Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11.

ID	Term
D012030	Refractive Errors
D005128	Eye Diseases