Recruiting

Observational Study

Sponsor:

AdaptDx, Inc.

Code:

NCT07860905

Conditions

No Disease

Eligibility Criteria

Sex: All

Age: 22 - 49

Healthy Volunteers: Accepted

Interventions

AdaptDx Pro

Study Details

Brief summary:

The purpose of this study is to test the repeatability and reproducibility in Rod Intercept (RI) time with two AdaptDx Pro devices in healthy subjects with normal vision.

Conditions

No Disease

Study ID

NCT07860905

Start date

Sep 18, 2026

Status verified date

Oct, 2026

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 49

Healthy Volunteers: Accepted

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

Study Design

Enrollment

16 participants

Anticipated

Interventions and Outcome Measures

Arms

AdaptDx Pro Wearable

The updated AdaptDx Pro dark adaptation device

Interventions

AdaptDx Pro

The AdaptDx device measures changes in dark adaptation via rod intercept time.

Primary outcome measure

  • Rod Intercept Time (RIT) [ Time Frame: Immediately after test ]

Central Contacts and Locations

Locations

Pacific NorthWest Retina (Silverdale)

Recruiting

Silverdale, Washington, United States, 98383

Contacts

Principal Investigator:

Todd Schneiderman, MD

More Information

Sponsor

AdaptDx, Inc.

Last update posted

Oct 6, 2026

Last verified

Oct, 2026

Keywords

  • Dark adaptation
  • Rod intercept time
  • Rod mediated dark adaptation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by AdaptDx, Inc. on 2026-10-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.