Ocular PathologiesNCT07218835
Compact Auto-Aligning Multi-Modal Eye Imaging to Diagnose Traumatic Eye Injury
An observational study of Ocular Pathologies, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test an investigational eye imaging device by taking pictures of participants eyes with a single image capture that takes only seconds. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Pathologies
- What is being tested?
- Auto-aligning Ocular imaging instrument
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to 30 Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Duke Eye Center patients will be drawn from the Eye Center clinics and from Duke Emergency Department consulted by ophthalmologist in the Emergency Department.
Who may be able to join
- Ocular complaints potentially indicating anterior segment pathology (e.g., corneal abrasions, corneal edema, corneal scars)
- Ocular complaints potentially indicating posterior segment pathology (e.g., macular edema, neovascular, macular degeneration)
Who cannot join
- Participant is unable to be imaged for any reason
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Compact Auto-Aligning Multi -Modal Eye Imaging
The purpose of this study is to test an investigational eye imaging device by taking pictures of participants eyes with a single image capture that takes only seconds.
- Conditions
- Ocular Pathologies
- Being tested
- Auto-aligning Ocular imaging instrument
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-aligning Ocular imaging instrumentDevice
Develop a tri-modality, auto-aligning ocular imaging instrument incorporating gross color photography, anterior and posterior segment OCT in a compact, handheld form factor.
| Study group | Role | What they receive |
|---|---|---|
| Tri-Modality, auto-aligning ocular imaging with compact handheld instrument | Color photography, anterior and posterior segment OCT images with the investigational eye imaging system will be taken of consented participant's eyes presenting within Duke Eye Center and Duke University emergency room Receives: Device: Auto-aligning Ocular imaging instrument |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who found the eye imaging device easy to use
Measured: up to 2 years
Number of participants who found the eye imaging device mobile
Measured: up to 2 years
Number of participants who found the eye imaging device reliable
Measured: up to 2 years
Image quality as measured by the number of eye condition diagnoses that match official diagnoses
Diagnoses made from the eye imaging device will be compared to the official diagnoses the patients received from a full eye exam in the clinic or emergency department.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study startSep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PathologiesStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Kuo, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218835
- Sponsor's protocol ID
- Pro00117676
- Other IDs
- HT9425-24-1-0870
- Status last verified
- Oct 2025
- First submitted
- 16 Oct 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compact Auto-Aligning Multi -Modal Eye Imaging
- ClinicalTrials.gov ID
- NCT07218835
- Acronym / sponsor ID
- Pro00117676
- Conditions
- Ocular Pathologies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Oct 2025 (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 an investigational eye imaging device by taking pictures of participants eyes with a single image capture that takes only seconds.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tri-Modality, auto-aligning ocular imaging with compact handheld instrument | – | Device: Auto-aligning Ocular imaging instrumentColor photography, anterior and posterior segment OCT images with the investigational eye imaging system will be taken of consented participant's eyes presenting within Duke Eye Center and Duke University emergency room |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Duke Eye Center patients will be drawn from the Eye Center clinics and from Duke Emergency Department consulted by ophthalmologist in the Emergency Department.
Key inclusion criteria (2 listed)
- Ocular complaints potentially indicating anterior segment pathology (e.g., corneal abrasions, corneal edema, corneal scars)
- Ocular complaints potentially indicating posterior segment pathology (e.g., macular edema, neovascular, macular degeneration)
Key exclusion criteria (1 listed)
- Participant is unable to be imaged for any reason
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 |
|---|---|---|
| Auto-aligning Ocular imaging instrumentDevelop a tri-modality, auto-aligning ocular imaging instrument incorporating gross color photography, anterior and posterior segment OCT in a compact, handheld form factor. | Device | Tri-Modality, auto-aligning ocular imaging with compact handheld instrument |
Primary outcome
Number of participants who found the eye imaging device easy to use
Time frame: up to 2 years
Number of participants who found the eye imaging device mobile
Time frame: up to 2 years
Number of participants who found the eye imaging device reliable
Time frame: up to 2 years
Image quality as measured by the number of eye condition diagnoses that match official diagnoses
Time frame: up to 2 years
Diagnoses made from the eye imaging device will be compared to the official diagnoses the patients received from a full eye exam in the clinic or emergency department.
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 24 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Anthony Kuo, MD principal investigator
Duke University
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 Ocular Pathologies, run by Duke University 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 24 Feb 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 Teresa Hawks (919-681-1569, teresa.hawks@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who found the eye imaging device easy to use (time frame: up to 2 years). The study lists 4 primary outcomes in all. 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 24 Feb 2026.