NCT05818033

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 796 (actual)
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-04-25
• Primary completion: 2025-06-12
• Completion: 2025-06-12
• First posted: 2023-04-18
• Last updated: 2026-03-12

Locations

1 site across 1 country: China