NCT06927388

Myopia Progression With Freeform Myopia Control Spectacles

Myopia Progression With Freeform Open Ring Myopia Control Spectacles Versus a Commercial Peripheral Plus Myopia Control Spectacle in Chinese Children

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, randomized clinical trial. There will be a total of 180 participants randomized into three groups, Group 1 - 60 participants will wear the commercial peripheral plus myopia control lens (CML). Group 2 - 60 participants will wear the Open Ring 1 (OR1) lens design. Group 3 - 60 participants will wear the Open Ring 2 (OR2) lens design. For each group, an equal balance of gender will be recruited and 50% of children will be aged between 6- 9 years old and 50% aged 10-12 years old. All groups will be required to wear spectacles for all waking hours for 12 months. After 12 months, the control group participants wearing CML will be randomised to wear either OR1 or OR2 lens designs; the Group 2 participants will continue wearing the OR1 lens for a further 12 months. The Group 3 participants will wear OR2 or OR3 (a modified design of OR2) based on their risk of myopia progression for a further 12 months.

Conditions

• Myopia, Progressive

Interventions

Type	Name	Description
DEVICE	freeform myopia control spectacles	The open ring freeform myopia control spectacle lens designs incorporate positively powered cylindrical annular refractive elements (CARE) on the back surface with a superiorly positioned opening in each CARE. The CARE provides an effective optical myopic defocus signal for myopia control and the ring opening facilitates a defocus free zone to aid a smoother visual free transition from downgaze through to upgaze (far) vision for the wearer. The OR designs provide a difference in area and strength of myopia defocus by altering design parameters i.e. zone widths and zone powers. The OR2 and OR3 designs have wider zones and/or higher zone powers than OR1.
DEVICE	Commercial myopia control spectacle lens (CML)	Myoless freeform peripheral plus myopia control spectacle lens by IOT

Timeline

• Start date: 2025-05-17
• Primary completion: 2027-09-30
• Completion: 2027-09-30
• First posted: 2025-04-15
• Last updated: 2025-12-08

Locations

1 site across 1 country: China