NCT05288335

Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

Muti-center Clinical Trial to Evaluate the Safety and Efficacy of Two Types of Circular Column Modulated Lenses for Delaying the Progression of Myopia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Tianjin Eye Hospital · Academic / Other
• Sex: All
• Age: 6 Years – 13 Years
• Healthy volunteers: Accepted

Summary

Clinical trial to evaluate the safety and effectiveness of two kinds of ring band cylindrical lens in delaying the progression of myopia

Detailed description

Two-hundered and forty children aged 6-13 will be recruited and allocated to three groups. Subjects that were randomized to receive Circular cylindrical mirror modulated frame glasses (compact), Circular cylindrical mirror modulated frame glasses (strong defocus) or single vision frame glasses, respectively. Primary outcome measure ocular axial length and the secondary indicator is spherical equivalent after cycloplegia.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Circular cylindrical mirror modulated frame glasses (compact)	Circular cylindrical mirror modulated frame glasses (compact)
DEVICE	Circular cylindrical mirror modulated frame glasses (strong defocus)	Circular cylindrical mirror modulated frame glasses (strong defocus)
DEVICE	single vision frame glasses	single vision frame glasses

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-10-15
• Completion: 2024-12-31
• First posted: 2022-03-21
• Last updated: 2022-12-28

Locations

1 site across 1 country: China