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

Completed

• Conditions: Ocular Images
• Interventions: Device: SL-D301; Device: DC-4; Device: SL-3G

• Registration Number: NCT02851147
• Lead Sponsor: Topcon Medical Systems, Inc.

Brief 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.

Study Timeline

• Study Start: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-06
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-06
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Any Willing Subject

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Exclusion Criteria

• Subjects unwilling to participate

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Any Willing and Able Person for Ocular Imaging	SL-D301	Any Willing and Able Person for Ocular Imaging
Any Willing and Able Person for Ocular Imaging	DC-4	Any Willing and Able Person for Ocular Imaging
Any Willing and Able Person for Ocular Imaging	SL-3G	Any Willing and Able Person for Ocular Imaging

Primary Outcome Measures

Name	Time	Method
Image Comparison of DC-4 to the SL-D301	1 Hour

Trial Locations

Locations (1)

Glassman Eye Associates; 🇺🇸 Teaneck, New Jersey, United States