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NCT Number: NCT07803588

A 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.

Recruiting

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Key information

Age range

22 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Retina Consultants San Diego

San Diego, California, 92101, United States

Location status: Recruiting

Location contact

Nikolas London, MD, FACS

CONTACT

[email protected]

858-451-1911

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects enrolled in the study will be required to meet all the following criteria for both eyes:

  • Male or female between the ages of 22 and 49 (inclusive) at Visit 1
  • ETDRS BCVA letter score of 85 (Snellen equivalent of 20/20) or better at Visit 1
  • Able to communicate well with the Investigator and able to understand and comply with the requirements of the study
  • Informed of the nature of this study and has provided written informed consent in accordance with institutional, local and national regulatory guidelines

Exclusion criteria

  • Unable to follow simple instructions, operate a response button or maintain attention for 20 minutes
  • Diagnosis or history of any ocular disease or disorder
  • 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
  • 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
  • Is non-ambulatory
  • History of drug, alcohol or substance abuse within 3 months prior to Visit 1
  • Has received an investigational drug or treatment with an investigational device within 3 months prior to Visit 1
  • In the opinion of the Investigator, is unlikely to comply with the study protocol

Treatment and study plan

AdaptDx Tabletop vs AdaptDx Pro

Diagnostic Test

Two variations of AdaptDx dark adaptation devices.

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Cindy Croissant VP, Clinical Operations, BS, MBA

CONTACT

[email protected]

858 397 1021

Sponsors and collaborators

Lead sponsor

AdaptDx, Inc.

Industry

Registry information

Official study title

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)

Acronym: FlashBack

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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