AdaptDx Pro vs AdaptDx: Rod Intercept Time 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 observational study compares two versions of a dark adaptation device to see how closely their measurements align in adults with normal vision. Participants are healthy adults aged 22 to 49 with good visual acuity and no ocular disease. The study uses the AdaptDx Tabletop and the AdaptDx Pro to measure Rod Intercept time in both eyes and assess agreement between the devices. Enrollment requires informed consent and the ability to perform study tasks, while excluding those with ocular disease or significant medical illness. Conducted at Retina Consultants San Diego under AdaptDx, Inc., this study does not involve an intervention beyond device usage.

Why it matters

Who can join: the full rules

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

Where it's running

• Retina Consultants San Diego
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Cindy Croissant VP, Clinical Operations, BS, MBA
• Email: ccroissant@opzira.com
• Phone: 858 397 1021

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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.