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Can a handheld eye test replace a lab machine?

NCT ID NCT07803588

Diagnosis Sponsor: AdaptDx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

Researchers are testing whether a portable device called the AdaptDx Pro gives the same measurements as the standard tabletop AdaptDx. Both devices measure rod intercept time, which is how long the eye's rod cells take to recover after a bright flash. The study enrolls healthy adults aged 22 to 49 with normal vision. If the two devices agree, the portable version could offer a more convenient way to assess dark adaptation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two versions of a dark adaptation diagnostic device: the AdaptDx tabletop and the AdaptDx Pro
What this could lead to
If the portable AdaptDx Pro matches the tabletop device, it could make dark adaptation testing easier and more accessible for detecting early eye disease.
What could go wrong
This is a small study in healthy adults, so results may not apply to people with eye conditions. The two devices might not agree closely enough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy adult individuals with no ocular disorder or disease.

Ages

22 to 49 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy adult participants

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Retina Consultants San Diego

    RECRUITING

    San Diego, California, 92101, United States

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