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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).
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 plan to enroll 10 healthy adult volunteers and 20 pediatric patients in clinic or undergoing examination under anesthesia. This is an observational study. There are no known risks associated with handheld OCT imaging and no adverse events identified imaging with our prior investigational imaging with the same system. There is a risk of corneal abrasion with the contact imaging system (Theia imaging), however, this system is used in the setting of other contact imaging systems (such as RetCam fundus photography).
Imaging data will be downloaded to a secure server for protocol image processing, segmentation, and analysis per protocol in the Duke Advanced Research in SD/SSOCT Imaging (DARSI) Laboratory.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Healthy adult volunteers | Healthy adult volunteers recruited from the patient population, students or employees of Duke University or Duke Eye Center (n=10) |
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| Pediatric participants | Pediatric patients with eye disease recruited from the patient population of Duke Eye Center (n=20) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational contact OCT system | Device | Theia imaging is developing handheld OCT systems bring state of the art OCT to the infant bedside. The Theia 1 widefield imaging system is a light weight, high speed (300 kHz), wide field of view (110°) OCT system that address the limitations of current commercial OCT systems. The system is cart mounted, enabling portable, bedside imaging. The system uses a 300 kHz swept source laser operating in 1060nm regime. The Theia system follows the same safety standards as all applicable laser safety standards (ANSI z80.36 or ISO 15004) as the currently approved prior OCT devices. This nearly 10-fold increase in acquisition speed dramatically reduces imaging time and enables acquisition of full retinal volumes in infants. The 110° field of view is provided via a re-usable contact lens that can be sterilized between imaging sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Presence of abnormal retinal microanatomy as measured by OCT reading | Single imaging session (day 1) | |
| Severity of abnormal retinal microanatomy as measured by OCT reading | Single imaging session (day 1) | |
| Retinal thickness at the fovea and surrounding optic nerve as measured by OCT analysis | Retinal thickness (microns) at the fovea and surrounding optic nerve. | Single imaging session (day 1) |
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Inclusion Criteria:
Exclusion Criteria:
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Group 1 - Healthy adult volunteers (n=10). Participants over the age of 18 without known ocular issues other than refractive error.
Group 2 - Pediatric participants (n=10). Participants under the age of 18 being seen at Duke Eye Center for ocular abnormailities.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Chen, MD | Contact | (919)684-8434 | xi2.chen@duke.edu | |
| Michelle N McCall, MCAPM, BA | Contact | (919) 684-0544 | michelle.mccall@duke.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Eye Center | Recruiting | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18848317 | Background | Scott AW, Farsiu S, Enyedi LB, Wallace DK, Toth CA. Imaging the infant retina with a hand-held spectral-domain optical coherence tomography device. Am J Ophthalmol. 2009 Feb;147(2):364-373.e2. doi: 10.1016/j.ajo.2008.08.010. Epub 2008 Oct 9. | |
| 19766317 | Background | Chavala SH, Farsiu S, Maldonado R, Wallace DK, Freedman SF, Toth CA. Insights into advanced retinopathy of prematurity using handheld spectral domain optical coherence tomography imaging. Ophthalmology. 2009 Dec;116(12):2448-56. doi: 10.1016/j.ophtha.2009.06.003. Epub 2009 Sep 18. |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005901 | Glaucoma |
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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| Investigational noncontact OCT system: | Device | The investigational noncontact handheld OCT systems in this study is developed at Duke University as the result of collaboration between the Departments of Ophthalmology (Cynthia Toth, MD) and Biomedical Engineering (Joseph Izatt, PhD). This investigational device was previously reviewed and approved for use in adults, children, and neonates in nursery by:
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| 20071674 | Background | Maldonado RS, Izatt JA, Sarin N, Wallace DK, Freedman S, Cotten CM, Toth CA. Optimizing hand-held spectral domain optical coherence tomography imaging for neonates, infants, and children. Invest Ophthalmol Vis Sci. 2010 May;51(5):2678-85. doi: 10.1167/iovs.09-4403. Epub 2010 Jan 13. |
| 21397814 | Background | Maldonado RS, Freedman SF, Cotten CM, Ferranti JM, Toth CA. Reversible retinal edema in an infant with neonatal hemochromatosis and liver failure. J AAPOS. 2011 Feb;15(1):91-3. doi: 10.1016/j.jaapos.2010.11.016. |
| 22232366 | Background | Maldonado RS, O'Connell R, Ascher SB, Sarin N, Freedman SF, Wallace DK, Chiu SJ, Farsiu S, Cotten M, Toth CA. Spectral-domain optical coherence tomographic assessment of severity of cystoid macular edema in retinopathy of prematurity. Arch Ophthalmol. 2012 May;130(5):569-78. doi: 10.1001/archopthalmol.2011.1846. |
| 30506013 | Background | Chen X, Mangalesh S, Dandridge A, Tran-Viet D, Wallace DK, Freedman SF, Toth CA. Spectral-Domain OCT Findings of Retinal Vascular-Avascular Junction in Infants with Retinopathy of Prematurity. Ophthalmol Retina. 2018 Sep;2(9):963-971. doi: 10.1016/j.oret.2018.02.001. Epub 2018 Mar 21. |
| 31774474 | Background | Chen X, Prakalapakorn SG, Freedman SF, Vajzovic L, Toth CA. Differentiating Retinal Detachment and Retinoschisis Using Handheld Optical Coherence Tomography in Stage 4 Retinopathy of Prematurity. JAMA Ophthalmol. 2020 Jan 1;138(1):81-85. doi: 10.1001/jamaophthalmol.2019.4796. |
| 30790072 | Background | Mangalesh S, Bleicher ID, Chen X, Viehland C, LaRocca F, Izatt JA, Freedman SF, Hartnett ME, Toth CA. Three-dimensional pattern of extraretinal neovascular development in retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol. 2019 Apr;257(4):677-688. doi: 10.1007/s00417-019-04274-6. Epub 2019 Feb 21. |
| 33792625 | Background | Mangalesh S, Sarin N, McGeehan B, Prakalapakorn SG, Tran-Viet D, Cotten CM, Freedman SF, Maguire MG, Toth CA; BabySTEPS Group. Preterm Infant Stress During Handheld Optical Coherence Tomography vs Binocular Indirect Ophthalmoscopy Examination for Retinopathy of Prematurity. JAMA Ophthalmol. 2021 May 1;139(5):567-574. doi: 10.1001/jamaophthalmol.2021.0377. |