No DiseaseFlashForwardNCT07860905
A Study to Test the Repeatability and Reproducibility in Rod Intercept Time Within the AdaptDx Pro in Healthy Subjects With Normal Vision (FlashForward)
An observational study of No Disease, run by AdaptDx, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- No Disease
- What is being tested?
- AdaptDx Pro
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Inclusion Criteria (each eye qualifies for the study independently):
- 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 (each eye qualifies for the study independently):
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Pacific NorthWest Retina (Silverdale)
Silverdale, Washington, 98383
Anna Rogers, 360-307-0300, a.rogers@pnwretina.com
Todd Schneiderman, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- No Disease
- Being tested
- AdaptDx Pro
- Keywords
- Dark adaptation, Rod intercept time, Rod mediated dark adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdaptDx ProDiagnostic test
The AdaptDx device measures changes in dark adaptation via rod intercept time.
| Study group | Role | What they receive |
|---|---|---|
| AdaptDx Pro Wearable | The updated AdaptDx Pro dark adaptation device Receives: Diagnostic Test: AdaptDx Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rod Intercept Time (RIT)
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
Measured: Immediately after test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start18 Sep 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdaptDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860905
- Sponsor's protocol ID
- OPZ003
- Acronym
- FlashForward
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07860905
- Acronym / sponsor ID
- FlashForward / OPZ003
- Conditions
- No Disease
- Keywords
- Dark adaptation, Rod intercept time, Rod mediated dark adaptation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- AdaptDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Sep 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AdaptDx Pro Wearable | – | Diagnostic Test: AdaptDx ProThe updated AdaptDx Pro dark adaptation device |
Who may qualify
- Ages
- 22 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdaptDx ProThe AdaptDx device measures changes in dark adaptation via rod intercept time. | Diagnostic test | AdaptDx Pro Wearable |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of No Disease, run by AdaptDx, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rod Intercept Time (RIT) (time frame: Immediately after test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.