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| Name | Class |
|---|---|
| University of North Carolina, Chapel Hill | OTHER |
| Wallace H. Coulter Foundation | OTHER |
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The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT imaging | Experimental | OCT device images retina |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT imaging | Device | imaging of retina using OCT device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Acceptable OCT Image Quality | measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device | day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Central Macular Thickness | compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system | day 1 |
| Total Macular Volume | compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wax, Ph.D. | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina Kittner Eye Center | Chapel Hill | North Carolina | 27517 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | OCT Imaging | All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OCT Imaging | All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Acceptable OCT Image Quality | measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device | Posted | Count of Participants | Participants | day 1 |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCT Imaging | All participants had retinal OCT imaging of both eyes. All participants were first imaged with the commercially available Heidelberg Engineering Spectralis OCT machine. All participants were then imaged with the Low Cost OCT device designed by the study team. |
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Acquiring data for the secondary endpoints was not feasible given the technical limitations of the current low cost OCT system set up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Adam Wax | Duke University | 919-660-5143 | a.wax@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2019 | Oct 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020163 | Ornithine Carbamoyltransferase Deficiency Disease |
| ID | Term |
|---|---|
| D056806 | Urea Cycle Disorders, Inborn |
| D020739 | Brain Diseases, Metabolic, Inborn |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
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| day 1 |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Retinal Pathology | Count of Participants | Participants |
|
|
| Secondary | Central Macular Thickness | compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system | The current version of the low cost OCT device only acquired a single line image on the retina per scan, which did not allow for the pinpointing of the central macula. Therefore, central macular thickness could not be measured. | Posted | day 1 |
|
|
| Secondary | Total Macular Volume | compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system | Volumetric imaging was not achievable with the current version of the low cost OCT device due to the line rate being too slow. Volumetric imaging was possible on the Heidelberg Spectralis OCT, but at a significant increase in acquisition time, which was not feasible for amount of time we had with each subject. | Posted | day 1 |
|
|
| Post-Hoc | Contrast-to-Noise Ratio (CNR) | Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest [i.e., retina] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless. | Participants from whom OCT images of acceptable quality were obtained. | Posted | Mean | Standard Deviation | unitless | day 1 |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
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| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D040181 | Genetic Diseases, X-Linked |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |