NCT02851147

Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Topcon Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Ocular Images

Interventions

Type	Name	Description
DEVICE	SL-D301	Slit Lamp
DEVICE	DC-4	Digital Camera Attachment
DEVICE	SL-3G	Slit Lamp

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2016-08-01
• Last updated: 2022-06-08

Locations

1 site across 1 country: United States