Trials / Active Not Recruiting
Active Not RecruitingNCT05562622
Assessment of DOT Spectacles in Chinese Children
Clinical Assessment of DOT Spectacle Lenses in Chinese Children
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 195 (actual)
- Sponsor
- SightGlass Vision, Inc. · Industry
- Sex
- All
- Age
- 6 Years – 13 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-02-05
- Primary completion
- 2025-09-30
- Completion
- 2026-03-31
- First posted
- 2022-10-03
- Last updated
- 2024-12-20
Locations
5 sites across 1 country: China
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05562622. Inclusion in this directory is not an endorsement.