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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| The Hartwell Foundation | OTHER |
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Young children age 6 month to 6 years are often not able to cooperate for advanced OCT eye imaging. The purpose of this study is to investigate the use of a novel long-working distance swept source (SS) optical coherence tomography imaging system with fixation alignment for use first in young adults, older children, and then young children ages 6 months to 6 years. The investigator's future goal is to obtain important retinal and optic nerve information from OCT in clinic in these young children.
The overall objective of this study is to examine the utility of a long-working distance high speed SSOCT system along with technology to identify and use movies, etc. to aid with fixation. This study would be the first testing of such a system, first in adults and then moving to older children who could provide feedback, and then to young children.
This imaging data will be compared to other clinical tests and images collected during regular health care and eye examinations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult | Experimental | Duke Biomedical Engineering's long-working distance OCT system imaging of adult participants ages ≥18 year of age |
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| Teenage minors | Experimental | Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥13-≤17 years of age |
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| Children-pre teen | Experimental | Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥7-≤12 years of age |
|
| Target age group ≥6 months to ≤6 years | Experimental | Duke Biomedical Engineering's long-working distance OCT system imaging of children ≥6 months to ≤6 years of age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duke Biomedical Engineering's Long-working distance OCT | Device | The long-distance SSOCT system designed by Duke University Biomedical Engineering Department allows the user to quickly image an eye at a much greater distance (typically 20-40 cm away but this could be longer or shorter). This could potentially be used while briefly attracting a child's attention to an illuminated image over the imaging lens. With this methodology, young patients would not need to place their eye close to the system and could be rapidly imaged during the short interval while they glance at the image from the correct distance. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of eyes with successful research imaging. | The primary outcome of this study is the percent of eyes with successful research imaging of retinal and optic nerve microanatomy including the following: the inner surface and retinal pigment epithelial (RPE) layers of the macula, a full cross section of optic nerve, identification of either foveal center or severe pathology that obscures foveal depression and the presence or absence of 5 substructures of retina (Inner retinal complex, inner nuclear layer, outer plexiform layer, photoreceptor layer, RPE layer). | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of eyes with 5 substructures of retina capable of being determined as deformed, containing cystoid spaces or abnormal (> 50%) thickening or thinning of layers. | Evaluation of retinal substructure morphology. Five substructures of retina include: Inner retinal complex, inner nuclear layer, outer plexiform layer, photoreceptor layer, RPE layer. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia A Toth, MD | Duke University Health System, Department of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Eye Center, Duke University Health System | Durham | North Carolina | 27710 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25439600 | Background | Rothman AL, Tran-Viet D, Gustafson KE, Goldstein RF, Maguire MG, Tai V, Sarin N, Tong AY, Huang J, Kupper L, Cotten CM, Freedman SF, Toth CA. Poorer neurodevelopmental outcomes associated with cystoid macular edema identified in preterm infants in the intensive care nursery. Ophthalmology. 2015 Mar;122(3):610-9. doi: 10.1016/j.ophtha.2014.09.022. Epub 2014 Nov 4. | |
| 24811961 |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D009901 | Optic Nerve Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
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| Participant feedback, as measured by questionnaire. | Scoring of participant feedback from questionnaire on: longevity of imaging, ease of finding or fixating on a target and comfortability during imaging. Parents and children will complete questionnaire together. | 1 year |
| The time it takes to gather the research images. | The time from start of attempted imaging to imaging of both the macula and optic nerve of each eye. | 1 year |
| Tong AY, El-Dairi M, Maldonado RS, Rothman AL, Yuan EL, Stinnett SS, Kupper L, Cotten CM, Gustafson KE, Goldstein RF, Freedman SF, Toth CA. Evaluation of optic nerve development in preterm and term infants using handheld spectral-domain optical coherence tomography. Ophthalmology. 2014 Sep;121(9):1818-26. doi: 10.1016/j.ophtha.2014.03.020. Epub 2014 May 6. |
| 24691567 | Background | Rothman AL, Folgar FA, Tong AY, Toth CA. Spectral domain optical coherence tomography characterization of pediatric epiretinal membranes. Retina. 2014 Jul;34(7):1323-34. doi: 10.1097/IAE.0000000000000113. |
| 24461542 | Background | Maldonado RS, Yuan E, Tran-Viet D, Rothman AL, Tong AY, Wallace DK, Freedman SF, Toth CA. Three-dimensional assessment of vascular and perivascular characteristics in subjects with retinopathy of prematurity. Ophthalmology. 2014 Jun;121(6):1289-96. doi: 10.1016/j.ophtha.2013.12.004. Epub 2014 Jan 21. |
| 25349032 | Background | Gramatikov BI, Irsch K, Guyton D. Optimal timing of retinal scanning during dark adaptation, in the presence of fixation on a target: the role of pupil size dynamics. J Biomed Opt. 2014;19(10):106014. doi: 10.1117/1.JBO.19.10.106014. |
| 24718173 | Background | Irsch K, Gramatikov BI, Wu YK, Guyton DL. Improved eye-fixation detection using polarization-modulated retinal birefringence scanning, immune to corneal birefringence. Opt Express. 2014 Apr 7;22(7):7972-88. doi: 10.1364/OE.22.007972. |
| 24779618 | Background | Gramatikov BI. Modern technologies for retinal scanning and imaging: an introduction for the biomedical engineer. Biomed Eng Online. 2014 Apr 29;13:52. doi: 10.1186/1475-925X-13-52. |
| 27805643 | Background | Carrasco-Zevallos OM, Qian R, Gahm N, Migacz J, Toth CA, Izatt JA. Long working distance OCT with a compact 2f retinal scanning configuration for pediatric imaging. Opt Lett. 2016 Nov 1;41(21):4891-4894. doi: 10.1364/OL.41.004891. |
| 29057163 | Background | Qian R, Carrasco-Zevallos OM, Mangalesh S, Sarin N, Vajzovic L, Farsiu S, Izatt JA, Toth CA. Characterization of Long Working Distance Optical Coherence Tomography for Imaging of Pediatric Retinal Pathology. Transl Vis Sci Technol. 2017 Oct 16;6(5):12. doi: 10.1167/tvst.6.5.12. eCollection 2017 Oct. |