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The purpose of the evaluation is to confirm operability and usability of the SL-D301 Slit Lamp and the DC-4 digital camera attachment by conducting a usability evaluation and subsequently submitting a questionnaire and hold an interview with the operator.
Of special interest for the study is to confirm whether the illumination level of SL-D301 is enough to perform an eye exam since the maximum illumination level on the SL-D301 is lower than other existing Topcon digital ready slit lamps due to regulations that limit the maximum light intensity on the human eye. The SL-D301 will be compared against the predicate device SL-3G.
An eye care professional familiar with the use of slit lamps and experienced with other Topcon and other manufacturer's slit lamps will evaluate operability and usability of SL-D301 and DC-4 digital camera attachment instrument performing routine eye examinations and image capture on volunteer subjects using above mentioned instruments. Similar evaluations will be performed with the SL-3G Slit Lamp and a comparative evaluation will be drawn between the two instruments. At the end of the evaluation, the evaluator will be presented with a questionnaire on specific points regarding the performance and features of the instruments and interviewed. The responses will then be evaluated by Topcon.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Any Willing and Able Person for Ocular Imaging | Any Willing and Able Person for Ocular Imaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SL-D301 | Device | Slit Lamp |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Image Comparison of DC-4 to the SL-D301 | 1 Hour |
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Inclusion Criteria:
Exclusion Criteria:
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The subject population will consist of a maximum number of 30 volunteer subjects consenting to undergo a slit lamp eye exam and to have digital images of their eyes obtained with the DC-4 and the SL-D301.
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| Name | Affiliation | Role |
|---|---|---|
| Ricardo Almiron | Topcon Corporation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glassman Eye Associates | Teaneck | New Jersey | 07766 | United States |
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| DC-4 |
| Device |
Digital Camera Attachment |
|
| SL-3G | Device | Slit Lamp |
|