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Group 1: Healthy adult volunteers for Optic Neuropathy

N/A
Recruiting
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up single imaging session (day 1)
Awards & highlights

Study Summary

Handheld optical coherence tomography (OCT) has become an important imaging modality to evaluate the pediatric retina. The objective of this pilot study is to compare a new contact OCT system (Theia Imaging) with an investigational noncontact OCT system (Duke Biomedical Engineering) to assess their ability to image the pediatric retina. The investigators hypothesize that the contact OCT system is superior in imaging larger areas of the retina (larger field-of-view), while it has similar resolution to image the retina substructures (non-inferior image quality).

Eligible Conditions
  • Optic Neuropathy
  • Glaucoma
  • Retinal Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~single imaging session (day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and single imaging session (day 1) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Presence of abnormal retinal microanatomy as measured by OCT reading
Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis
Severity of abnormal retinal microanatomy as measured by OCT reading

Trial Design

2Treatment groups
Experimental Treatment
Group I: Pediatric participantsExperimental Treatment2 Interventions
Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20)
Group II: Group 1: Healthy adult volunteersExperimental Treatment2 Interventions
Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10)

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,039 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Ophthalmology RetinaJournal
Spectral-domain OCT Findings of Retinal Vascular–avascular Junction in Infants with Retinopathy of Prematurity
Chen, Xi, Shwetha Mangalesh, Alexandria Dandridge, Du Tran-Viet, David K. Wallace, Sharon F. Freedman, and Cynthia A. Toth. 2018. “Spectral-domain OCT Findings of Retinal Vascular–avascular Junction in Infants with Retinopathy of Prematurity”. Ophthalmology Retina. Elsevier BV. doi:10.1016/j.oret.2018.02.001.
Graefe's Archive for Clinical and Experimental OphthalmologyJournal
Three-dimensional Pattern of Extraretinal Neovascular Development in Retinopathy of Prematurity
Mangalesh, Shwetha, Isaac D. Bleicher, Xi Chen, Christian Viehland, Francesco LaRocca, Joseph A. Izatt, Sharon F. Freedman, M. Elizabeth Hartnett, and Cynthia A. Toth. 2019. “Three-dimensional Pattern of Extraretinal Neovascular Development in Retinopathy of Prematurity”. Graefe's Archive for Clinical and Experimental Ophthalmology. Springer Science and Business Media LLC. doi:10.1007/s00417-019-04274-6.
JAMA OphthalmologyJournal
Preterm Infant Stress During Handheld Optical Coherence Tomography Vs Binocular Indirect Ophthalmoscopy Examination for Retinopathy of Prematurity
Mangalesh, Shwetha, Neeru Sarin, Brendan McGeehan, S. Grace Prakalapakorn, Du Tran-Viet, C. Michael Cotten, Sharon F. Freedman, Maureen G. Maguire, Cynthia A. Toth, and BabySTEPS Group. 2021. “Preterm Infant Stress During Handheld Optical Coherence Tomography Vs Binocular Indirect Ophthalmoscopy Examination for Retinopathy of Prematurity”. JAMA Ophthalmology. American Medical Association (AMA). doi:10.1001/jamaophthalmol.2021.0377.
clinicaltrials.govStudy
Optimize Pediatric OCT Imaging
2024. "Optimize Pediatric OCT Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06139523.
All > High Point > Greensboro
~20 spots leftby Jul 2025
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