Recruiting

AdaptDx Pro

Sponsor:

AdaptDx, Inc.

Code:

NCT07803588

Conditions

Healthy Adult Participants

Eligibility Criteria

Sex: All

Age: 22 - 49

Healthy Volunteers: Accepted

Interventions

AdaptDx Tabletop vs AdaptDx Pro

Study Details

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.

Conditions

Healthy Adult Participants

Study ID

NCT07803588

Start date

Sep 15, 2026

Status verified date

Sep, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 49

Healthy Volunteers: Accepted

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

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

AdaptDx Tabletop vs AdaptDx Pro

Two variations of AdaptDx dark adaptation devices.

Primary outcome measure

  • Rod Intercept Time [ Time Frame: Immediately after the dark adaptation test ]

Central Contacts and Locations

Central contacts

Cindy Croissant VP, Clinical Operations, BS, MBA

858 397 1021ccroissant@opzira.com

Locations

Retina Consultants San Diego

Recruiting

San Diego, California, United States, 92101

Contacts

Nikolas London, MD, FACS

858-451-1911london@rcsd.com

More Information

Sponsor

AdaptDx, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Dark adaptation
  • rod-mediated dark adaptation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdaptDx, Inc. on 2026-09-03.