Develop and Test Robotically Assisted Imaging System for the Front of the EyeNCT06566339
Robotic OCT for ER Anterior Eye Exams
A study testing Robotically Aligned Eye Imaging System in people with Develop and Test Robotically Assisted Imaging System for the Front of the Eye, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Develop and Test Robotically Assisted Imaging System for the Front of the Eye
- What is being tested?
- Robotically Aligned Eye Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2026to 30 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients 18 years of age and older
- Presenting with ocular complaints potentially indicative of an anterior segment pathology (e.g., foreign body sensation, red eye, pain)
Who cannot join
- Hemodynamically unstable patients (e.g., undergoing active resuscitation efforts)
- Patients with potential penetrating trauma to the eye who may need immediate surgical care
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
Duke Eye Center
Durham, North Carolina, 27705
Teresa Hawks, 919-681-1569, teresa.hawks@duke.edu
About this study
Official title: Robotically Assisted Anterior Eye Examinations for Acute Eye Care
The purpose of this study is to develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.
- Being tested
- Robotically Aligned Eye Imaging System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotically Aligned Eye Imaging SystemDevice
Also called Robot OCT
Robotically Aligned Eye Imaging System is a non-contact, micrometer scale imaging technique that provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop hardware systems and software algorithms necessary for acquiring ocular anterior segment images for those seeking eye care in emergency department settings.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Imaging patients | Experimental | Participants eyes will be imaged with a Robotically aligned eye imaging system to help eye care through the emergency department Receives: Device: Robotically Aligned Eye Imaging System |
| Standard of care exam | No intervention | ED providers' standard of care exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard.
Measured: Day 1
Specificity
Specificity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start29 Jun 2026
- 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 Develop and Test Robotically Assisted Imaging System for the Front of the EyeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 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
- NCT06566339
- Sponsor's protocol ID
- Pro00115313
- Status last verified
- Jan 2026
- First submitted
- 20 Aug 2024
- Last updated
- 6 Aug 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 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotically Assisted Anterior Eye Examinations for Acute Eye Care
- ClinicalTrials.gov ID
- NCT06566339
- Acronym / sponsor ID
- Pro00115313
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 93 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 29 Jun 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Aug 2024 (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 develop and test a robotically assisted imaging system for the front of the eye with a goal of helping eye care through the emergency department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Imaging patients | Experimental | Device: Robotically Aligned Eye Imaging SystemParticipants eyes will be imaged with a Robotically aligned eye imaging system to help eye care through the emergency department |
| Standard of care exam | No intervention | –ED providers' standard of care exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients 18 years of age and older
- Presenting with ocular complaints potentially indicative of an anterior segment pathology (e.g., foreign body sensation, red eye, pain)
Key exclusion criteria (2 listed)
- Hemodynamically unstable patients (e.g., undergoing active resuscitation efforts)
- Patients with potential penetrating trauma to the eye who may need immediate surgical care
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 |
|---|---|---|
| Robotically Aligned Eye Imaging SystemAlso: Robot OCTRobotically Aligned Eye Imaging System is a non-contact, micrometer scale imaging technique that provides clinicians and researchers with high resolution in vivo images sufficient to visualize layered microanatomy in 3D. The study team will develop hardware systems and software algorithms necessary for acquiring ocular anterior segment images for those seeking eye care in emergency department settings. | Device | Experimental: Imaging patients |
Primary outcome
Sensitivity
Time frame: Day 1
Sensitivity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard.
Specificity
Time frame: Day 1
Specificity of the ED providers' 1. standard of care exam and 2. assessment of robotically acquired ocular imaging to detect referable ocular pathology in the study participants will be compared. The on-duty ophthalmologist exam will serve as the gold standard.
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 Aug 2026.
- Individual participant dataSharing planned: No
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?
A study testing Robotically Aligned Eye Imaging System in people with Develop and Test Robotically Assisted Imaging System for the Front of the Eye, 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 2 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 6 Aug 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 Terry H. Coordinator (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?
Sensitivity (time frame: Day 1). The study lists 2 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 6 Aug 2026.