Trials / Unknown
UnknownNCT05425108
Binocular Peripheral Myopic Defocus Using a Clinical Prototype Device
Effectiveness of Binocular Peripheral Myopic Projected Defocus on Ocular Biometrics Using a Clinical Prototype Device
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Kubota Vision Inc. · Industry
- Sex
- All
- Age
- 7 Years – 12 Years
- Healthy volunteers
- Not accepted
Summary
Kubota Vision Inc. has developed a spectacle-like prototype device which is designed to be used as a light-based therapy to reduce myopia progression. In this study, we aim to observe the ocular biometric and refractive changes following binocular part-time wear of the clinical prototype device over a course of 12 months and compare that to 12 months of no clinical prototype device use (control).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Binocular CP1 | Binocular active projection of defocused image in the peripheral visual field |
Timeline
- Start date
- 2022-06-23
- Primary completion
- 2023-08-01
- Completion
- 2023-08-01
- First posted
- 2022-06-21
- Last updated
- 2022-07-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05425108. Inclusion in this directory is not an endorsement.