50 Participants Needed

Auto-aligned OCT for Eye Disorders

XC
MN
Overseen ByMichelle N McCall, MCAPM, BA
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Auto-aligned OCT for eye disorders?

Research shows that aligning and averaging multiple OCT scans can improve the quality of retinal images, making it easier to diagnose and monitor eye conditions. This suggests that Auto-aligned OCT, which likely uses similar techniques, could be effective in providing clearer images for better eye disorder management.12345

Is Auto-aligned OCT safe for use in humans?

A study on the second-generation frequency-domain optical coherence tomography (FD-OCT) system assessed its safety, indicating that this type of OCT technology is generally safe for use in humans.46789

How does the Auto-aligned OCT treatment differ from other treatments for eye disorders?

Auto-aligned OCT is unique because it uses advanced imaging techniques to automatically align and register images from different devices, providing more accurate and comprehensive information about the eye's structure. This approach enhances the precision of diagnosis and monitoring compared to traditional OCT methods, which may not integrate data from multiple sources as effectively.110111213

Research Team

XC

Xi Chen, MD, PhD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Group 3: Pediatric patients in ophthalmology clinicsExperimental Treatment1 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 clinicsExperimental Treatment1 Intervention
Adult participants recruited from the patient population of Duke Eye Center undergoing clinical examination (n=20)
Group III: Group 1: Healthy adult volunteersExperimental Treatment1 Intervention
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=20)

Find a Clinic Near You

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+

References

Enhanced optical coherence tomography imaging by multiple scan averaging. [2022]
Helvacioglu reproducibility index: a new algorithm to evaluate the effects of misalignments on the measurements of retinal nerve fiber layer by spectral-domain OCT. [2022]
Enhancing the signal-to-noise ratio in ophthalmic optical coherence tomography by image registration--method and clinical examples. [2022]
Segmentation error in Stratus optical coherence tomography for neovascular age-related macular degeneration. [2009]
Self-examination low-cost full-field OCT (SELFF-OCT) for patients with various macular diseases. [2023]
Repeatability and reproducibility of automatic segmentation of retinal layers in healthy subjects using Spectralis optical coherence tomography. [2018]
Feasibility and safety of the second-generation, frequency domain optical coherence tomography (FD-OCT): a multicenter study. [2016]
Motion artefact correction in retinal optical coherence tomography using local symmetry. [2019]
Prevalences of segmentation errors and motion artifacts in OCT-angiography differ among retinal diseases. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Training Deep Learning Models to Work on Multiple Devices by Cross-Domain Learning with No Additional Annotations. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Automated inter-device 3D OCT image registration using deep learning and retinal layer segmentation. [2023]
Agreement between time-domain and spectral-domain optical coherence tomography in the assessment of macular thickness in patients with idiopathic macular telangiectasia type 2. [2014]
13.United Statespubmed.ncbi.nlm.nih.gov
Integrated adaptive optics optical coherence tomography and adaptive optics scanning laser ophthalmoscope system for simultaneous cellular resolution in vivo retinal imaging. [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security