A Study to Test the AdaptDx Pro Agreement in Rod Intercept Time With the AdaptDx in Healthy Subjects With Normal Vision (FlashBack) (FlashBack)

September 2, 2026 updated by: AdaptDx, Inc.

A Prospective, Single-Center Study to Test the AdaptDx Pro Agreement in Rod Intercept Time With the AdaptDx in Healthy Subjects With Normal Vision (FlashBack)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

24

Contacts and Locations

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

Study Contact

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

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92101
        • Recruiting
        • Retina Consultants San Diego
        • Contact:
          • Nikolas London, MD, FACS
          • Phone Number: 858-451-1911
          • Email: london@rcsd.com

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy adult individuals with no ocular disorder or disease.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AdaptDx Tabletop
Rod intercept time will be measured using the AdaptDx Tabletop device
Diagnostic test: AdaptDx Tabletop vs AdaptDx Pro
Two variations of AdaptDx dark adaptation devices.
AdaptDx Pro Wearable
Rod intercept time will be measured using the AdaptDx Pro device
Diagnostic test: AdaptDx Tabletop vs AdaptDx Pro
Two variations of AdaptDx dark adaptation devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rod Intercept Time
Time Frame: Immediately after the dark adaptation test
the time in minutes it takes for the eye's rod photoreceptors to recover sensitivity after a bright flash of light
Immediately after the dark adaptation 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 (Estimated)

September 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

August 18, 2026

First Submitted That Met QC Criteria

September 2, 2026

First Posted (Actual)

September 3, 2026

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 2, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPZ002

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

product manufactured in and exported from the U.S.

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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