NCT06411717

A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression

A Prospective, Single-center, Randomized, Double-blind, Controlled, Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Suzhou Care-Real Medical Technology Co., Ltd. · Academic / Other
• Sex: All
• Age: 8 Years – 13 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents. A total of 156 subjects meeting the requirements of the study protocol were included. During the study, subjects were required to wear the test product (defocus lens A or defocus lens B) or the control product (aspheric lens) for 12 months, and regular follow-up was required during the wearing process, including various ophthalmological examinations and subjective feelings about wearing the lens. During the study period, the product status, ocular conditions, adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Microstructure lens A	Subjects randomized to Trial Group A will be required to wear microstructural lens A (microstructural design type with low defocus ratio) for 12 months
DEVICE	Microstructure lens B	Subjects randomized to Trial B will be required to wear microstructural lens B (high defocus ratio microstructural design type) for 12 months
OTHER	Control group	Subjects randomized to the control group will be required to wear aspherical single-light lenses for 12 months

Timeline

• Start date: 2024-04-07
• Primary completion: 2025-11-07
• Completion: 2026-03-07
• First posted: 2024-05-13
• Last updated: 2024-05-14

Locations

1 site across 1 country: China