NCT06860737

A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children

A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 388 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.

Detailed description

Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.

Conditions

• Myopic Children

Interventions

Type	Name	Description
DEVICE	Novel plano spectacle lenses	Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.

Timeline

• Start date: 2025-03-15
• Primary completion: 2026-04-01
• Completion: 2026-06-01
• First posted: 2025-03-06
• Last updated: 2025-12-08

Locations

1 site across 1 country: China