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

Sponsor

Topcon Medical Systems, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02851147

Collaborator

(none)

Enrollment

Location

Duration (Months)

29.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Images	Device: SL-D301 Device: DC-4 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 Design

Study Type:

Observational

Actual Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Any Willing and Able Person for Ocular Imaging Any Willing and Able Person for Ocular Imaging	Device: SL-D301 Slit Lamp Device: DC-4 Digital Camera Attachment Device: SL-3G Slit Lamp

Arm

Intervention/Treatment

Any Willing and Able Person for Ocular Imaging

Device: SL-D301

Slit Lamp

Device: DC-4

Digital Camera Attachment

Device: SL-3G

Slit Lamp

Outcome Measures

Primary Outcome Measures

Image Comparison of DC-4 to the SL-D301 [1 Hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Any Willing Subject

Exclusion Criteria:

Subjects unwilling to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glassman Eye Associates	Teaneck	New Jersey	United States	07766

Sponsors and Collaborators

Topcon Medical Systems, Inc.

Investigators

Study Chair: Ricardo Almiron, Topcon Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Topcon Medical Systems, Inc.

ClinicalTrials.gov Identifier:

NCT02851147

Other Study ID Numbers:

TOPCON-007-2016

First Posted:

Aug 1, 2016

Last Update Posted:

Jun 8, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Study Results

No Results Posted as of Jun 8, 2022