Trials / Completed
CompletedNCT04169802
Study Evaluating Retinal Health Monitoring System Visual Acuity Module.
An Observational, Non-Significant Risk Study Of The Retinal Health Monitoring System (RHMS) - Visual Acuity Module - In Normal Patients And Patients With Neovascular Age-Related Macular Degeneration (AMD)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 25 (actual)
- Sponsor
- Kubota Vision Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
Summary
Assess the performance and usability of the RHMS Visual Acuity Module.
Detailed description
This 510(k)-enabling study is designed to assess the performance and usability of the RHMS Visual Acuity Module in normal patients and patients with neovascular AMD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Retinal Health Monitoring System Visual Acuity Module | Assessment of corrected near visual acuity |
| DIAGNOSTIC_TEST | Sloan letter, logarithmic near visual acuity chart (Reference Chart) | Assessment of corrected near visual acuity |
Timeline
- Start date
- 2019-11-20
- Primary completion
- 2020-04-15
- Completion
- 2020-04-15
- First posted
- 2019-11-20
- Last updated
- 2021-02-21
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04169802. Inclusion in this directory is not an endorsement.