Healthy Adult Participants
Conditions
Keywords
Dark adaptation, rod-mediated dark adaptation
Brief summary
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.
Interventions
DIAGNOSTIC_TESTAdaptDx Tabletop vs AdaptDx Pro
Two variations of AdaptDx dark adaptation devices.
Sponsors
AdaptDx, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to 49 Years
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
1. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rod Intercept Time | Immediately after the dark adaptation test | the time in minutes it takes for the eye's rod photoreceptors to recover sensitivity after a bright flash of light |
Countries
United States
Contacts
CONTACTCindy Croissant VP, Clinical Operations, BS, MBA
Outcome results
None listed