Healthy Adult ParticipantsFlashBackNCT07803588
A Study to Test the AdaptDx Pro Agreement in Rod Intercept Time With the AdaptDx in Healthy Subjects With Normal Vision (FlashBack)
An observational study of Healthy Adult Participants, run by AdaptDx, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- AdaptDx Tabletop vs AdaptDx Pro
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2026to 1 Mar 2027
- 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: Healthy adult individuals with no ocular disorder or disease.
Who may be able to join
- 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
Who cannot join
- 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
Retina Consultants San Diego
San Diego, California, 92101
Nikolas London, MD, FACS, 858-451-1911, london@rcsd.com
About this study
Official 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)
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.
- Conditions
- Healthy Adult Participants
- Being tested
- AdaptDx Tabletop vs AdaptDx Pro
- Keywords
- Dark adaptation, rod-mediated dark adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdaptDx Tabletop vs AdaptDx ProDiagnostic test
Two variations of AdaptDx dark adaptation devices.
| Study group | Role | What they receive |
|---|---|---|
| AdaptDx Tabletop | Rod intercept time will be measured using the AdaptDx Tabletop device Receives: Diagnostic Test: AdaptDx Tabletop vs AdaptDx Pro | |
| AdaptDx Pro Wearable | Rod intercept time will be measured using the AdaptDx Pro device Receives: Diagnostic Test: AdaptDx Tabletop vs AdaptDx Pro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rod Intercept Time
the time in minutes it takes for the eye's rod photoreceptors to recover sensitivity after a bright flash of light
Measured: Immediately after the dark adaptation test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies 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
- 24 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
- NCT07803588
- Sponsor's protocol ID
- OPZ002
- Acronym
- FlashBack
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2026
- Last updated
- 3 Sep 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 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07803588
- Acronym / sponsor ID
- FlashBack / OPZ002
- Conditions
- Healthy Adult Participants
- Keywords
- Dark adaptation, rod-mediated dark adaptation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- AdaptDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 3 Sep 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 AdaptDx Pro agreement in Rod Intercept (RI) time with the AdaptDx tabletop (AdaptDx) in healthy subjects with normal vision.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AdaptDx Tabletop | – | Diagnostic Test: AdaptDx Tabletop vs AdaptDx ProRod intercept time will be measured using the AdaptDx Tabletop device |
| AdaptDx Pro Wearable | – | Diagnostic Test: AdaptDx Tabletop vs AdaptDx ProRod intercept time will be measured using the AdaptDx Pro device |
Who may qualify
- Ages
- 22 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult individuals with no ocular disorder or disease.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 Tabletop vs AdaptDx ProTwo variations of AdaptDx dark adaptation devices. | Diagnostic test | AdaptDx Pro Wearable, AdaptDx Tabletop |
Primary outcome
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
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 3 Sep 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 Healthy Adult Participants, 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?
The sponsor lists 5 inclusion and 8 exclusion criteria. 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 3 Sep 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?
Contact Cindy Croissant VP, Clinical Operations, BS, MBA (858 397 1021, ccroissant@opzira.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rod Intercept Time (time frame: Immediately after the dark adaptation 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 3 Sep 2026.