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OpenTrials
Completed

NCT Number: NCT02851147

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

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.

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Key information

Conditions

Ocular Images

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glassman Eye Associates

Teaneck, New Jersey, 07766, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any Willing Subject

Exclusion criteria

  • Subjects unwilling to participate

Treatment and study plan

SL-D301

Device

Slit Lamp

DC-4

Device

Digital Camera Attachment

SL-3G

Device

Slit Lamp

Primary outcomes

  1. Image Comparison of DC-4 to the SL-D301

    Time frame: 1 Hour

Sponsors and collaborators

Lead sponsor

Topcon Medical Systems, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2016
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.