Optical Coherence Tomography of RetinaNCT07425106
Comparative Study of High Performance Low-Cost Optical Coherence Tomography (Stage 1B, 2 and 3)
A study testing retinal imaging with low-cost OCT-a/LCI device in people with Optical Coherence Tomography of Retina and Alzheimer Disease, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Optical Coherence Tomography of Retina, Alzheimer Disease
- What is being tested?
- retinal imaging with low-cost OCT-a/LCI device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to Feb 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- able to provide informed consent
- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A/T/N classification
- Healthy Controls:
Who cannot join
- potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
- eyes that have had intraocular surgery or retinal surgery, other than cataract surgery
- Participants with Alzheimer's Disease:
- has a memory or other neurodegenerative diagnosis (including mild cognitive impairment, Parkinson's disease, Alzheimer's disease, traumatic brain injury, post-traumatic stress disorder)
- If two eyes satisfy the inclusion / exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.
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
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Comparative Study of High Performance Low-Cost Optical Coherence Tomography
The purpose of this study is to complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device. We will then add an angle-resolved low coherence interferometry (a/LCI module) to the device to make measurements of retinal tissue structure.
Read the detailed description
There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a/LCI) to make light scattering measurements of retinal tissue structure. The first objective of this study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, the second objective will be to use the custom OCT-a/LCI device to identify retinal structure changes that could be possible AD biomarkers.
For this study, the team will recruit volunteers to attend one study visit that is about 30 minutes long. For arm 1A (registered under NCT05530460), this visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system. For arms 1B and 2/3, the visit will include examination with the custom OCT-a/LCI instrument.
This study will recruit participants with Alzheimer's disease and healthy controls.
- Being tested
- retinal imaging with low-cost OCT-a/LCI device
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinal imaging with low-cost OCT-a/LCI deviceDevice
retinal imaging with low-cost OCT-a/LCI device
| Study group | Role | What they receive |
|---|---|---|
| Performance Testing of OCT-a/LCI (1B) | Experimental | Performance testing of custom OCT-a/LCI device. Receives: Device: retinal imaging with low-cost OCT-a/LCI device |
| Retinal Morphology (2/3) | Experimental | examination with OCT-a/LCI device to examine retinal morphology characteristics of participants with Alzheimer's disease and healthy controls Receives: Device: retinal imaging with low-cost OCT-a/LCI device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device
measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device.
Measured: during study procedures (30 minutes)
RNFL Thickness
Thickness of retinal nerve fiber layer, measured in microns
Measured: during study procedures (30 minutes)
GCL Thickness
Thickness of ganglion cell layer, measured in microns.
Measured: during study procedures (30 minutes)
Secondary outcomes (1)
Contrast-to-Noise Ratio (CNR)
Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest [i.e., retina] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless.
Measured: during study procedures (30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start13 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence Tomography of RetinaStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Adam Wax, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425106
- Sponsor's protocol ID
- Pro00111488_1
- Other IDs
- R01AG072732
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- 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 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of High Performance Low-Cost Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT07425106
- Acronym / sponsor ID
- Pro00111488_1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 20 Feb 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 complete performance testing of our custom optical coherence tomography (OCT) device to verify it can deliver retinal images of similar quality to a commercial OCT device. We will then add an angle-resolved low coherence interferometry (a/LCI module) to the device to make measurements of retinal tissue structure.
Detailed description
There is some evidence that certain changes in retinal structures could be an indicator of Alzheimer's disease (AD). We are developing a new technology that combines optical coherence tomography (OCT) and angle-resolved low coherence interferometry (a/LCI) to make light scattering measurements of retinal tissue structure. The first objective of this study is to compare performance characteristics of our custom OCT instrument to a commercial OCT instrument. Once we have optimized our device, the second objective will be to use the custom OCT-a/LCI device to identify retinal structure changes that could be possible AD biomarkers.
For this study, the team will recruit volunteers to attend one study visit that is about 30 minutes long. For arm 1A (registered under NCT05530460), this visit will include examination with our custom OCT instrument, followed by examination with a commercial OCT system. For arms 1B and 2/3, the visit will include examination with the custom OCT-a/LCI instrument.
This study will recruit participants with Alzheimer's disease and healthy controls.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Performance Testing of OCT-a/LCI (1B) | Experimental | Device: retinal imaging with low-cost OCT-a/LCI devicePerformance testing of custom OCT-a/LCI device. |
| Retinal Morphology (2/3) | Experimental | Device: retinal imaging with low-cost OCT-a/LCI deviceexamination with OCT-a/LCI device to examine retinal morphology characteristics of participants with Alzheimer's disease and healthy controls |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- able to provide informed consent
- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A/T/N classification
Key exclusion criteria (5 listed)
- potentially confounding ocular conditions, such as: glaucoma, current corneal injury, retinal damage, diabetes, corrected distance visual acuity worse than 20/40
- eyes that have had intraocular surgery or retinal surgery, other than cataract surgery
- has a memory or other neurodegenerative diagnosis (including mild cognitive impairment, Parkinson's disease, Alzheimer's disease, traumatic brain injury, post-traumatic stress disorder)
- If two eyes satisfy the inclusion / exclusion criteria, both eyes will be included in the study. If only one eye satisfies the criteria, only the qualifying eye will be included in the study.
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 |
|---|---|---|
| retinal imaging with low-cost OCT-a/LCI deviceretinal imaging with low-cost OCT-a/LCI device | Device | Performance Testing of OCT-a/LCI (1B), Retinal Morphology (2/3) |
Primary outcome
Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device
Time frame: during study procedures (30 minutes)
measured by: ability to see clearly defined and recognizable structures of the retina with the low-cost OCT device.
RNFL Thickness
Time frame: during study procedures (30 minutes)
Thickness of retinal nerve fiber layer, measured in microns
GCL Thickness
Time frame: during study procedures (30 minutes)
Thickness of ganglion cell layer, measured in microns.
1 secondary outcome
Contrast-to-Noise Ratio (CNR)
Time frame: during study procedures (30 minutes)
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 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Optical Coherence Tomography of Retina
RecruitingObservational study
The Value of Measuring Retinal Vascular Density by Optical Coherence Tomography-Angiography (OCT-A) in Patients With Microvascular Angina Confirmed by Myocardial Microcirculatory Resistance Index (MRI).
Microvascular Angina
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
RecruitingObservational study
Imaging Retinal Vasculature in Infant Eyes
Retinopathy of Prematurity
RecruitingObservational study
Retinal and Choroidal Microcirculation in Preeclampsia: An OCTA Study
Preeclampsia (PE), Hypertension ,Pregnancy
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.
Adam Wax, Ph.D. 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 retinal imaging with low-cost OCT-a/LCI device in people with Optical Coherence Tomography of Retina and Alzheimer 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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 25 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device (time frame: during study procedures (30 minutes)). 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 Feb 2026.