Test of repeatability of rod intercept time with two AdaptDx Pro devices in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center observational study enrolling 16 healthy participants to evaluate the repeatability and reproducibility of Rod Intercept time using two AdaptDx Pro devices. Each eye is evaluated independently to assess consistency over repeated measurements. Participants must have normal vision (20/20) and no ocular disease, and all procedures are performed within one center. The study provides insights into measurement reliability for dark adaptation testing in a normal-vision population.

Why it matters

Who can join: the full rules

Inclusion Criteria (each eye qualifies for the study independently):

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 (each eye qualifies for the study independently):

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

Where it's running

• Pacific NorthWest Retina (Silverdale)
  Silverdale, Washington, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.