Auto-aligned OCT for Eye Disorders

Overseen By Michelle N McCall, MCAPM, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Pregnancy, Corneal opacity, Cataract, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new handheld device called Auto-aligned OCT, which automatically aligns to capture images of the retina, the part of the eye responsible for vision. The study includes healthy adults and both adult and pediatric patients visiting eye clinics. Suitable participants are healthy adults without eye issues other than needing glasses or contacts, adults being examined at Duke Eye Center, and children receiving eye check-ups there. As an unphased trial, this study allows participants to contribute to the development of innovative eye care technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your healthcare provider.

What prior data suggests that this OCT device is safe for imaging the retina?

Research has shown that optical coherence tomography (OCT) is generally safe for patients. Studies have found no major side effects or harm from using this technology. Eye clinics commonly use OCT to diagnose and manage eye issues. The version tested in this trial can automatically focus on the eye, potentially making it easier and quicker to use. However, specific safety information for this new feature isn't widely available yet. Overall, based on the use of similar OCT devices in the past, it appears well-tolerated with few reported risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auto-aligned OCT because it could revolutionize how we diagnose and manage eye disorders. Unlike traditional optical coherence tomography (OCT), which requires skilled technicians to manually align the device, auto-aligned OCT automates this process. This innovation could lead to faster, more accurate eye exams, making it easier to detect issues early. By reducing human error and improving efficiency, this technology has the potential to enhance patient care significantly.

What evidence suggests that this auto-aligned OCT device is effective for imaging the retina?

Research has shown that a new version of eye scan technology, called auto-aligned optical coherence tomography (OCT), makes images clearer and more stable. Studies have found that features like gaze tracking and aiming enhance focus on specific parts of the eye. This improvement can lead to better management of eye disorders by providing clearer images. OCT has already transformed the diagnosis and treatment of retinal diseases by offering detailed images of the retina. The new auto-aligned version, currently tested in this trial, could make these scans even more precise, aiding doctors in identifying and managing eye conditions more effectively. ^{1 4 6 7 8}

Who Is on the Research Team?

Xi Chen, MD, PhD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for both adults and children with various eye conditions such as Purtscher Retinopathy, optic nerve issues, neuro-ophthalmological disorders, glaucoma, and other retinal diseases. It aims to include volunteers who can undergo imaging with a new handheld device in a clinical setting.

Exclusion Criteria

Group 1: Healthy adult volunteers must not be students or employees under direct supervision of the investigators, must not have prior problems with pupil dilation, and pregnant women receiving dilating drops are excluded

I don't have any health issues that prevent eye exams or imaging.

My child can undergo an eye exam and does not have conditions like corneal opacity or cataract.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Sessions

Participants undergo handheld OCT imaging to assess retinal microanatomy and thickness

2 years

Up to 4 single imaging sessions at clinical visits

Follow-up

Participants are monitored for any changes in retinal microanatomy and thickness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auto-aligned OCT

Trial Overview The study is testing an advanced version of a handheld OCT (Optical Coherence Tomography) device that automatically aligns itself to capture images of the retina. This pilot study will assess its effectiveness in real-world clinic settings on adult and pediatric patients.

How Is the Trial Designed?

Group I: Group 3: Pediatric patients in ophthalmology clinics Experimental Treatment 1 Intervention

Minor participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=10)

Group II: Group 2: Adult patients in ophthalmology clinics Experimental Treatment 1 Intervention

Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)

Group III: Group 1: Healthy adult volunteers Experimental Treatment 1 Intervention

Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20)

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8713666/

Robotically aligned optical coherence tomography with 5 ... Our results demonstrate that the system stabilized images and that the addition of gaze tracking and aiming allowed for region-of-interest specific alignment at ...

2. withpower.com withpower.com/trial/phase-retinal-diseases-1-2025-18b86

Auto-aligned OCT for Eye Disorders · Info for Participants This suggests that Auto-aligned OCT, which likely uses similar techniques, could be effective in providing clearer images for better eye disorder management.

3. nature.com nature.com/articles/s41433-020-01263-6

Optical coherence tomography in the 2020s—outside ... In this review, we discuss the major milestones in OCT hardware development to reach those beyond the eye clinic.

4. mdpi.com mdpi.com/2306-5354/12/5/441

Recent Optical Coherence Tomography (OCT) Innovations ... Optical Coherence Tomography (OCT) has revolutionized the diagnosis and management of retinal diseases, offering high-resolution, cross-sectional imaging ...

5. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1442758/full

Home-monitoring/remote optical coherence tomography in ... This systematic review summarized the available data on the clinical usage, feasibility and diagnostic accuracy (sensitivity and specificity) of ...

6. opg.optica.org opg.optica.org/abstract.cfm?uri=boe-15-6-3993

Large area robotically assisted optical coherence ... We demonstrate large-area robotically assisted optical coherence tomography (LARA-OCT), utilizing a seven-degree-of-freedom robotic arm.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26992420/

Safety of optical coherence tomography in daily practice No major adverse events, prolongation of hospital stay, or permanent patient harm was observed. Conclusion: FD-OCT is safe in an unselected and ...

8. bmjophth.bmj.com bmjophth.bmj.com/content/4/1/e000187

Impact of automated OCT in a high-volume eye urgent care ... Optical coherence tomography (OCT) has become standard of care of diagnosis and management of retinal and optic nerve pathology. What are ...