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

NCT ID: NCT02851147

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Ocular Images

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Any Willing and Able Person for Ocular Imaging

Any Willing and Able Person for Ocular Imaging

SL-D301

Intervention Type DEVICE

Slit Lamp

DC-4

Intervention Type DEVICE

Digital Camera Attachment

SL-3G

Intervention Type DEVICE

Slit Lamp

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SL-D301

Slit Lamp

Intervention Type DEVICE

DC-4

Digital Camera Attachment

Intervention Type DEVICE

SL-3G

Slit Lamp

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Any Willing Subject

Exclusion Criteria

* Subjects unwilling to participate
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Topcon Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ricardo Almiron

Role: STUDY_CHAIR

Topcon Corporation

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Glassman Eye Associates

Teaneck, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TOPCON-007-2016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Smartphone Screening for Eye Diseases
NCT03076697 ENROLLING_BY_INVITATION
Comparing 3 Imaging Systems
NCT05022615 COMPLETED