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Enrolling by invitation NCT07425106

Comparative Study of High Performance Low-Cost Optical Coherence Tomography (Stage 1B, 2 and 3)

No phase Interventional Optical Coherence Tomography of Retina Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: retinal imaging with low-cost OCT-a/LCI device.
Who it may be relevant to
Registry conditions: Optical Coherence Tomography of Retina, Alzheimer Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Study of High Performance Low-Cost Optical Coherence Tomography

Overview

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.

Interventions

  • Device retinal imaging with low-cost OCT-a/LCI device
    retinal imaging with low-cost OCT-a/LCI device

Primary outcome measures

  • Number of Participants with Acceptable OCT Image Quality as Measured by Low-Cost OCT Device [Time frame: during study procedures (30 minutes)]
  • RNFL Thickness [Time frame: during study procedures (30 minutes)]
  • GCL Thickness [Time frame: during study procedures (30 minutes)]
Secondary outcome measures (1)
  • Contrast-to-Noise Ratio (CNR) [Time frame: during study procedures (30 minutes)]

Eligibility criteria

All Participants:

Inclusion criteria

  • able to provide informed consent

Exclusion criteria

  • 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:

Inclusion:

\- mild cognitive impairment (MCI) or dementia due to Alzheimer's disease, confirmed by A/T/N classification

Healthy Controls:

Exclusion:

\- 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Duke University Medical Center — Durham

Identifiers

NCT: NCT07425106 · Pro00111488_1 · R01AG072732

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗