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

NCT05818033 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 796

Last updated 2026-03-12

No results posted yet for this study

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.

Conditions

  • Myopia

Interventions

DEVICE

CARE1.02

Participants in the intervention group will wear CARE1.02 and receive the follow-up checks.

DEVICE

Single-vision spectacle lens

Participants in the control group will wear single-vision spectacle lens and receive the follow-up checks.

Sponsors & Collaborators

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2025-06-12
Completion
2025-06-12

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05818033 on ClinicalTrials.gov