Assessment of DOT Spectacles in Chinese Children
NCT05562622 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 195
Last updated 2026-05-05
Summary
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.
Conditions
- Myopia
- Juvenile Myopia
Interventions
- DEVICE
-
Novel spectacle lens design
Use of lenses may reduce the rate of progression of juvenile myopia
- DEVICE
-
Spectacle lenses
Use of lenses may reduce the rate of progression of juvenile myopia
Sponsors & Collaborators
-
SightGlass Vision, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Years
- Max Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-02-05
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- China
Study Locations
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