A Study to Test the Repeatability and Reproducibility in Rod Intercept Time Within the AdaptDx Pro in Healthy Subjects With Normal Vision (FlashForward) (FlashForward)

October 1, 2026 updated by: AdaptDx, Inc.

A Prospective, Single-Center Study to Test the Repeatability and Reproducibility in Rod Intercept Time Within the AdaptDx Pro in Healthy Subjects With Normal Vision (FlashForward)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, single-center study to test the repeatability and reproducibility in Rod Intercept (RI) time with two AdaptDx Pro devices in healthy subjects with normal vision. Sixteen subjects will be enrolled. Both eyes will be evaluated.

Study Type

Observational

Enrollment (Estimated)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Silverdale, Washington, United States, 98383
        • Recruiting
        • Pacific NorthWest Retina (Silverdale)
        • Principal Investigator:
          • Todd Schneiderman, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects who will be permitted into the study include those who meet all the inclusion criteria and have none of the exclusion criteria for both eyes at Visit 1 and confirmed at Visit 2.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: COHORT
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AdaptDx Pro Wearable

The updated AdaptDx Pro dark adaptation device
Diagnostic test: AdaptDx Pro

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rod Intercept Time (RIT)
Time Frame: Immediately after test

Rod intercept time is the measure of time it takes for the human eye's rod photoreceptors to recover sensitivity and adjust from bright light to darkness
Immediately after test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdaptDx, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

October 1, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

October 1, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPZ003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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