A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) and a Predicate Device.
Public ClinicalTrials.gov record NCT05783583. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Comparison of the Diagnostic Confidence and Image Quality Between the Eyoto Theia (RDSL) Remote Digital Slit Lamp and a the Topcon SL-D2 With DC-4 Digital Attachment (Predicate Device).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
A clinical study has been identified as a requirement for the RDSL (Theia). This study involves a clinical comparison of the imaging from the RDSL with that of a predicate device. The clinical evaluation showed that there remains some residual risk in the practitioner's ability to use the imaging from the RDSL to detect pathologies at the same level as when using the imaging function on a predicate device. The aim of this comparative study is to determine the degree, if any, of difference in using images captured from the RDSL for clinical inspection of pathologies, when compared to images captured from a predicate device. Due to the involvement of real patients during the study, ethics approval was sought prior to commencement. This study is limited to the clinical benefits of the device. An additional Human factors study has been conducted to assess the useability of the device Images were taken of healthy eyes and eyes with pathology (with images of several pathologies from each major pathology group to give a full range) on both the predicate device, and the RDSL.
Study identification
- NCT ID
- NCT05783583
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 49 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 99 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2022
- Primary completion
- Jan 4, 2023
- Completion
- Jan 19, 2023
- Last update posted
- Apr 6, 2023
2022 – 2023
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Vision Inc Corporate Office | Atlanta | Georgia | 300096 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05783583, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 6, 2023 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05783583 live on ClinicalTrials.gov.