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

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

  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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
AdaptDx Tabletop Rod intercept time will be measured using the AdaptDx Tabletop device
  • Diagnostic Test: AdaptDx Tabletop vs AdaptDx Pro
    Two variations of AdaptDx dark adaptation devices.
AdaptDx Pro Wearable Rod intercept time will be measured using the AdaptDx Pro device
  • Diagnostic Test: AdaptDx Tabletop vs AdaptDx Pro
    Two variations of AdaptDx dark adaptation devices.

Recruiting Locations

Retina Consultants San Diego
San Diego, California 92101
Contact:
Nikolas London, MD, FACS
858-451-1911
london@rcsd.com

More Details

Status
Recruiting
Sponsor
AdaptDx, Inc.

Study Contact

Cindy Croissant VP, Clinical Operations, BS, MBA
858 397 1021
ccroissant@opzira.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.