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The PI wanted to make additional changes to the hand held camera therefore he terminated the study rather than continue with an outdated camera design.
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This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.
We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera | Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher. Scale Image scored as follows
| estimated 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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18 years or older
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Flaum Eye Institute-University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Imaged Subjects | Subjects imaged with hand held device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Imaged Subjects |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera | Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher. Scale Image scored as follows
| Posted | Number | participants | estimated 3 months |
|
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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 | Imaged Subjects |
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It was determined that the project should stop in order for more technical changes to be made on the prototype
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Kleinman, MD | University of Rochester | david_kleinman@urmc.rochester.edu |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Acceptability of Hand Held Fundus Photograph in comparison to traditional photgraph | Scale Image scored as follows
Report number of participants with score of 3 or higher | Number | participants |
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|
|
| 0 |
| 1 |
| 0 |
| 1 |
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