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

Topcon logo

Topcon

Status

Completed

Conditions

Ocular Images

Treatments

Device: SL-D301
Device: DC-4
Device: SL-3G

Study type

Observational

Funder types

Industry

Identifiers

NCT02851147
TOPCON-007-2016

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Any Willing Subject

Exclusion criteria

  • Subjects unwilling to participate

Trial design

30 participants in 1 patient group

Any Willing and Able Person for Ocular Imaging
Description:
Any Willing and Able Person for Ocular Imaging
Treatment:
Device: SL-D301
Device: SL-3G
Device: DC-4

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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