Imaging the infant retina with a hand-held spectral-domain optical coherence tomography device.
Adrienne W Scott, Sina Farsiu, Laura B Enyedi...
https://pubmed.ncbi.nlm.nih.gov/18848317Actively Recruiting
All Genders
Healthy Volunteers
ID06139523
Optimize Pediatric OCT (Optical Coherence Tomography) Imaging: a Pilot Study
Led by Duke University · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two handheld optical coherence tomography (OCT) imaging systems to study the pediatric retina. This pilot observational study compares a new contact OCT device by Theia Imaging with an investigational noncontact OCT system developed by Duke Biomedical Engineering. The goal is to assess their ability to capture retinal images, with the hypothesis that the contact system can image larger retinal areas while maintaining similar image quality for retinal substructures. The study involves two groups: 10 healthy adult volunteers and 20 pediatric patients either visiting clinics or undergoing examination under anesthesia. Theia Imaging's contact OCT system uses a sterilizable lens and high-speed laser technology to provide wide-field retinal imaging, while the Duke noncontact OCT system is designed collaboratively by ophthalmology and biomedical engineering departments. Imaging data from both devices will be securely processed and analyzed in specialized research labs. Participants will undergo a single imaging session during which retinal images will be captured. Researchers will evaluate the presence and severity of abnormal retinal microanatomy and measure retinal thickness at key locations. There are no known risks with handheld OCT imaging, though the contact system carries a small risk of corneal abrasion. Data will be stored securely for detailed image processing, and the study is expected to continue until December 2026.
CONDITIONS
Brief Title
Optimize Pediatric OCT Imaging
Who Can Participate
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy adult volunteers able and willing to consent to study participation
- Adults more than 18 years of age
- Healthy adults without known eye issues other than refractive error
- Women of childbearing potential evaluated to reasonably exclude pregnancy
- Pediatric patients less than 18 years of age in Duke Eye Center clinics or undergoing clinically-indicated examination under anesthesia
- Parent or legal guardian able and willing to consent for pediatric participants
- Health care provider agrees study personnel may contact parent or guardian for pediatric participants
You will not qualify if you...
- Students or employees under direct supervision of the investigators
- Adults with prior problems with pupil dilation
- Pregnant women if receiving dilating eye drops
- Parent or legal guardian unwilling or unable to provide consent for pediatric participant
- Pediatric participants with health or eye conditions that prevent eye examination or retinal imaging, such as corneal opacity or cataract
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants undergo imaging sessions using two investigational handheld OCT systems to evaluate the pediatric retina.
1 imaging session (in-person)
Trial Site Locations
Total: 1 location
1
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
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Research Team
X
Xi Chen, MD
M
Michelle N McCall, MCAPM, BA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Insights into advanced retinopathy of prematurity using handheld spectral domain optical coherence tomography imaging.
Sai H Chavala, Sina Farsiu, Ramiro Maldonado...
https://pubmed.ncbi.nlm.nih.gov/19766317Optimizing hand-held spectral domain optical coherence tomography imaging for neonates, infants, and children.
Ramiro S Maldonado, Joseph A Izatt, Neeru Sarin...
https://pubmed.ncbi.nlm.nih.gov/20071674Reversible retinal edema in an infant with neonatal hemochromatosis and liver failure.
Ramiro S Maldonado, Sharon F Freedman, C Michael Cotten...
https://pubmed.ncbi.nlm.nih.gov/21397814Spectral-domain optical coherence tomographic assessment of severity of cystoid macular edema in retinopathy of prematurity.
Ramiro S Maldonado, Rachelle O'Connell, Simon B Ascher...
https://pubmed.ncbi.nlm.nih.gov/22232366Spectral-Domain OCT Findings of Retinal Vascular-Avascular Junction in Infants with Retinopathy of Prematurity.
Xi Chen, Shwetha Mangalesh, Alexandria Dandridge...
https://pubmed.ncbi.nlm.nih.gov/30506013Differentiating Retinal Detachment and Retinoschisis Using Handheld Optical Coherence Tomography in Stage 4 Retinopathy of Prematurity.
Xi Chen, S Grace Prakalapakorn, Sharon F Freedman...
https://pubmed.ncbi.nlm.nih.gov/31774474Three-dimensional pattern of extraretinal neovascular development in retinopathy of prematurity.
Shwetha Mangalesh, Isaac D Bleicher, Xi Chen...
https://pubmed.ncbi.nlm.nih.gov/30790072Preterm Infant Stress During Handheld Optical Coherence Tomography vs Binocular Indirect Ophthalmoscopy Examination for Retinopathy of Prematurity.
Shwetha Mangalesh, Neeru Sarin, Brendan McGeehan...
https://pubmed.ncbi.nlm.nih.gov/33792625