Eye DiseasesNCT06841575
Advancing Pediatric Retinal Imaging With Auto-aligned OCT
A study testing Auto-aligned OCT in people with Eye Diseases and Retinal Disease, run by Duke University at 1 site in United States.
Trial summary
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases, Retinal Disease, Glaucoma
- What is being tested?
- Auto-aligned OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2026to Sep 2027
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Group 1: Healthy adult volunteers
- Subject is able and willing to consent to study participation
- Subject is more than 18 years of age
- Healthy adult volunteers without known ocular issues other than refractive error
- Group 2: Adult patients in ophthalmology clinics
- Health care provider, knowledgeable of protocol, agrees that study personnel could contact the subject
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- Subject is able and willing to consent to study participation
- Subject is more than 18 years of age and is a patient in the Duke Eye Center ophthalmology clinics
- Group 3: Pediatric participants in ophthalmology clinics
- Health care provider, knowledgeable of protocol, agrees that study personnel could contact the parent/legal guardian
- Parent/legal guardian is able and willing to consent to study participation
- Pediatric patient less than 18 years of age in Duke Eye Center ophthalmology clinics or undergoing clinically-indicated examination under anesthesia at Duke Eye Center
Who cannot join
- Group 1: Healthy adult volunteers
- Students or employees under direct supervision of the investigators
- Subjects with prior problems with pupil dilation
- Pregnant woman if receiving dilating drops
- Group 2: Adult patients in ophthalmology clinics
- Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
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- Group 3: Pediatric participants in ophthalmology clinics
- Parent/legal guardian unwilling or unable to provide consent
- Participant has a health or eye condition that preclude eye examination or retinal imaging (such as corneal opacity or cataract)
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 University Eye Center
Durham, North Carolina, 27710
Michelle N McCall, MCAPM, BA, 919-684-0544, michelle.mccall@duke.edu
Neeru Sarin, MD, (919) 668-5641, neeru.sarin@duke.edu
About this study
The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Read the detailed description
Handheld OCT imaging is an advancement in ophthalmic imaging technology allowing us to image the pediatric retina. lt has tremendous potential to be applied to assess the structure and blood flow of children with retinal vascular diseases or as a screening tool for pediatric retinal diseases. Despite progress in the development of hand-held OCT probes, there remains a critical gap in technology to achieve fast, proper alignment between the imaging device and the infant eye. Even with the most skilled operators, to acquire consistent OCT and OCTA data capture for longitudinal follow up in uncooperative patients at the bedside remains difficult. lmprovements in hand-held OCT probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time, would address this critical gap in handheld OCT technology. Our biomedical engineering team, has developed prior iterations of the handheld OCT devices and successfully imaged the pediatric retina. The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
The investigators plan to enroll 20 healthy adult volunteers, 20 adult patients and 10 pediatric patients from the ophthalmology clinic. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with prior iterations of handheld OCT devices. lmaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SS/SDOCT lmaging (DARSI) laboratory.
- Conditions
- Eye Diseases, Retinal Disease, Glaucoma, Optic Nerve Diseases
- Being tested
- Auto-aligned OCT
- Keywords
- Optical Coherence Tomography (OCT)
- Medical subject headings
- Eye Diseases, Retinal Diseases, Glaucoma, Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-aligned OCTDevice
Swept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Healthy adult volunteers | Experimental | Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20) Receives: Device: Auto-aligned OCT |
| Group 2: Adult patients in ophthalmology clinics | Experimental | Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20) Receives: Device: Auto-aligned OCT |
| Group 3: Pediatric patients in ophthalmology clinics | Experimental | Minor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10) Receives: Device: Auto-aligned OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal retinal microanatomy
Measured by optical coherence tomography (OCT) reading.
Measured: Up to 4 single imaging sessions at clinical visits over 2 years
Severity of abnormal retinal microanatomy
Measured by optical coherence tomography (OCT) reading.
Measured: Up to 4 single imaging sessions at clinical visits over 2 years
Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis
Measured by optical coherence tomography (OCT) analysis.
Measured: Up to 4 single imaging sessions at clinical visits over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start23 Mar 2026
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Xi Chen, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841575
- Sponsor's protocol ID
- Pro00116369
- Other IDs
- R21EY036545
- Status last verified
- Mar 2026
- First submitted
- 19 Feb 2025
- Last updated
- 25 Mar 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 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Pediatric Retinal Imaging With Auto-aligned OCT
- ClinicalTrials.gov ID
- NCT06841575
- Acronym / sponsor ID
- Pro00116369
- Conditions
- Eye Diseases, Retinal Disease, Glaucoma, Optic Nerve Diseases
- Keywords
- Optical Coherence Tomography (OCT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Eye Institute (NEI)
- Study start
- 23 Mar 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Feb 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 goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
Detailed description
Handheld OCT imaging is an advancement in ophthalmic imaging technology allowing us to image the pediatric retina. lt has tremendous potential to be applied to assess the structure and blood flow of children with retinal vascular diseases or as a screening tool for pediatric retinal diseases. Despite progress in the development of hand-held OCT probes, there remains a critical gap in technology to achieve fast, proper alignment between the imaging device and the infant eye. Even with the most skilled operators, to acquire consistent OCT and OCTA data capture for longitudinal follow up in uncooperative patients at the bedside remains difficult. lmprovements in hand-held OCT probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time, would address this critical gap in handheld OCT technology. Our biomedical engineering team, has developed prior iterations of the handheld OCT devices and successfully imaged the pediatric retina. The goal of the current study is to conduct a pilot study to test a new version of the handheld OCT device capable of auto-alignment to image the retina in adult volunteers, and adult and pediatric patients in clinic.
The investigators plan to enroll 20 healthy adult volunteers, 20 adult patients and 10 pediatric patients from the ophthalmology clinic. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with prior iterations of handheld OCT devices. lmaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SS/SDOCT lmaging (DARSI) laboratory.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Healthy adult volunteers | Experimental | Device: Auto-aligned OCTHealthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20) |
| Group 2: Adult patients in ophthalmology clinics | Experimental | Device: Auto-aligned OCTAdult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20) |
| Group 3: Pediatric patients in ophthalmology clinics | Experimental | Device: Auto-aligned OCTMinor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10) |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Group 1: Healthy adult volunteers
- Subject is able and willing to consent to study participation
- Subject is more than 18 years of age
- Healthy adult volunteers without known ocular issues other than refractive error
- Group 2: Adult patients in ophthalmology clinics
Key exclusion criteria (9 listed)
- Group 1: Healthy adult volunteers
- Students or employees under direct supervision of the investigators
- Subjects with prior problems with pupil dilation
- Pregnant woman if receiving dilating drops
- Group 2: Adult patients in ophthalmology clinics
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-aligned OCTSwept Source OCT system with improved hand-held probe technology for auto-alignment to the patient's eye, as well as on-line detection of image quality and auto-saving at the proper time | Device | Group 1: Healthy adult volunteers, Group 2: Adult patients in ophthalmology clinics, Group 3: Pediatric patients in ophthalmology clinics |
Primary outcome
Number of participants with abnormal retinal microanatomy
Time frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) reading.
Severity of abnormal retinal microanatomy
Time frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) reading.
Retinal thickness (microns) at the fovea and surrounding optic nerve as measured by OCT analysis
Time frame: Up to 4 single imaging sessions at clinical visits over 2 years
Measured by optical coherence tomography (OCT) analysis.
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 25 Mar 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.
Xi Chen, MD, PhD 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 Auto-aligned OCT in people with Eye Diseases and Retinal Disease, 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 12 inclusion and 9 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 25 Mar 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 Xi Chen, MD, PhD ((919) 684-8434, xi2.chen@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 with abnormal retinal microanatomy (time frame: Up to 4 single imaging sessions at clinical visits over 2 years). The study lists 3 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 25 Mar 2026.