A Study to Test the AdaptDx Pro Agreement in Rod Intercept Time With the AdaptDx in Healthy Subjects With Normal Vision (FlashBack)
Purpose
The purpose of this study is to test the AdaptDx Pro agreement in Rod Intercept (RI) time with the AdaptDx tabletop (AdaptDx) in healthy subjects with normal vision.
Condition
- Healthy Adult Participants
Eligibility
- Eligible Ages
- Between 22 Years and 49 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
Subjects enrolled in the study will be required to meet all the following criteria for both eyes: 1. Male or female between the ages of 22 and 49 (inclusive) at Visit 1 2. ETDRS BCVA letter score of 85 (Snellen equivalent of 20/20) or better at Visit 1 3. Able to communicate well with the Investigator and able to understand and comply with the requirements of the study 4. Informed of the nature of this study and has provided written informed consent in accordance with institutional, local and national regulatory guidelines
Exclusion Criteria
- Unable to follow simple instructions, operate a response button or maintain attention for 20 minutes 2. Diagnosis or history of any ocular disease or disorder 3. Serious medical illness that will prevent the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic, or hematologic disease) or, in the judgement of the Investigator, is likely to require surgical intervention or hospitalization at any point during the study 4. Presence of or history of malignancy within the past year of Visit 1 other than non-melanoma skin or squamous cell cancer or cervical carcinoma in-situ 5. Is non-ambulatory 6. History of drug, alcohol or substance abuse within 3 months prior to Visit 1 7. Has received an investigational drug or treatment with an investigational device within 3 months prior to Visit 1 8. In the opinion of the Investigator, is unlikely to comply with the study protocol
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| AdaptDx Tabletop | Rod intercept time will be measured using the AdaptDx Tabletop device |
|
| AdaptDx Pro Wearable | Rod intercept time will be measured using the AdaptDx Pro device |
|
Recruiting Locations
Retina Consultants San Diego
San Diego, California 92101
San Diego, California 92101
More Details
- Status
- Recruiting
- Sponsor
- AdaptDx, Inc.