Any Willing and Able Person for Ocular ImagingNCT02444039
Slit Lamp and Digital Camera Attachment
An observational study of Any Willing and Able Person for Ocular Imaging, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Any Willing and Able Person for Ocular Imaging
- What is being tested?
- SL-D301, DC-4 and SL-3G
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any Willing and able subjects will be recruited from Topcon Medical Systems.
Who may be able to join
- Any willing subject
Who cannot join
- Subjects unwilling to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Medical Systems, Inc.
Oakland, New Jersey, 07436
About this study
Official title: Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment
The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.
Read the detailed description
The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon and ascertain that the changes and new features incorporated do not interfere with the normal use and application of the device.
- Being tested
- SL-D301, DC-4, SL-3G
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SL-D301Device
Slit Lamp
DC-4Device
Digital Camera Attachment
SL-3GDevice
Slit Lamp
| Study group | Role | What they receive |
|---|---|---|
| Any Willing and Able Person for Ocular Imaging | Any Willing and Able Person for Ocular Imaging Receives: Device: SL-D301; Device: DC-4; Device: SL-3G |
What is being measured
The primary outcome is the main question the study is designed to answer.
Instrument and Device Evaluation
Measured: 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Willing and Able Person for Ocular ImagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Topcon Medical Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Danny Leung, Principal investigator, Topcon Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444039
- Sponsor's protocol ID
- TOPCON-004-2014
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2014
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slit Lamp Model SL-D-301 and DC-4 Digital Camera Attachment
- ClinicalTrials.gov ID
- NCT02444039
- Acronym / sponsor ID
- TOPCON-004-2014
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon.
Detailed description
The objective of the study is to compare the ease of use and performance of the SL-D301 with the DC-4 with other existing slit lamps imaging systems (SL-3G) from Topcon and ascertain that the changes and new features incorporated do not interfere with the normal use and application of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Any Willing and Able Person for Ocular Imaging | – | Device: SL-D301, Device: DC-4, Device: SL-3GAny Willing and Able Person for Ocular Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any Willing and able subjects will be recruited from Topcon Medical Systems.
Key inclusion criteria (1 listed)
- Any willing subject
Key exclusion criteria (1 listed)
- Subjects unwilling to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SL-D301Slit Lamp | Device | Any Willing and Able Person for Ocular Imaging |
| DC-4Digital Camera Attachment | Device | Any Willing and Able Person for Ocular Imaging |
| SL-3GSlit Lamp | Device | Any Willing and Able Person for Ocular Imaging |
Primary outcome
Instrument and Device Evaluation
Time frame: 1 Hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Leung principal investigator
Topcon Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Willing and Able Person for Ocular Imaging, run by Topcon Medical Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Instrument and Device Evaluation (time frame: 1 Hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.