Willing and Able Subjects for Ocular ImagingNCT02432898
Non-Invasive Imaging of the Human Eye
An observational study of Willing and Able Subjects for Ocular Imaging, run by Topcon Medical Systems, Inc. at 1 site in United States.
Trial summary
Evaluate the clinical information obtained from the use of the machines. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Willing and Able Subjects for Ocular Imaging
- What is being tested?
- 3D OCT-1, 3D OCT-2000 and DRI OCT-1
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2015
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal subjects will be recruited from Topcon Medical Systems.
Who may be able to join
- Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.
Who cannot join
- History of ocular pathology.
- History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
- History of systemic disease
- fixation problems which may prevent obtaining good quality images in the eye.
Trial locations and contacts
1 site in 1 country.
United States1 site
Topcon Medical Systems, Inc.
Oakland, New Jersey, 07436
About this study
Evaluate the clinical information obtained from the use of the machines.
Read the detailed description
Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.
- Being tested
- 3D OCT-1, 3D OCT-2000, DRI OCT-1, NW-300, CT-1P
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D OCT-1Device
Spectral Domain OCT Device
3D OCT-2000Device
Spectral Domain OCT Device
DRI OCT-1Device
Swept Source OCT Device
NW-300Device
Fundus Camera
CT-1PDevice
Tonometry
TRK-2PDevice
Tonometry, Corneal Topography
SP-1PDevice
Specular Microscopy
SL-D701Device
Slit Lamp Imaging
MC-4SDevice
Visual Acuity Testing
| Study group | Role | What they receive |
|---|---|---|
| Normal Healthy Eyes | Normal healthy eyes with no known ocular diseases Receives: Device: 3D OCT-1; Device: 3D OCT-2000; Device: DRI OCT-1; Device: NW-300; Device: CT-1P; Device: TRK-2P; Device: SP-1P; Device: SL-D701; Device: MC-4S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Evaluation
Determine Clinical Utility, Efficacy, and Safety
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 posted4 May 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionApr 2015
Why it stopped: No subjects were enrolled in this protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Willing and Able Subjects 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
- 0 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
- NCT02432898
- Sponsor's protocol ID
- Topcon-001-2014
- Status last verified
- Jun 2022
- First submitted
- 20 Nov 2014
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Non-Invasive Imaging of the Human Eye
- ClinicalTrials.gov ID
- NCT02432898
- Acronym / sponsor ID
- Topcon-001-2014
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subjects were enrolled in this protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Topcon Medical Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 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.
Evaluate the clinical information obtained from the use of the machines.
Detailed description
Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Eyes | – | Device: 3D OCT-1, Device: 3D OCT-2000, Device: DRI OCT-1, Device: NW-300, Device: CT-1P, Device: TRK-2P, Device: SP-1P, Device: SL-D701, Device: MC-4SNormal healthy eyes with no known ocular diseases |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal subjects will be recruited from Topcon Medical Systems.
Key inclusion criteria (2 listed)
- Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed.
- Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date.
Key exclusion criteria (4 listed)
- History of ocular pathology.
- History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device.
- History of systemic disease
- fixation problems which may prevent obtaining good quality images in the eye.
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 |
|---|---|---|
| 3D OCT-1Spectral Domain OCT Device | Device | Normal Healthy Eyes |
| 3D OCT-2000Spectral Domain OCT Device | Device | Normal Healthy Eyes |
| DRI OCT-1Swept Source OCT Device | Device | Normal Healthy Eyes |
| NW-300Fundus Camera | Device | Normal Healthy Eyes |
| CT-1PTonometry | Device | Normal Healthy Eyes |
| TRK-2PTonometry, Corneal Topography | Device | Normal Healthy Eyes |
| SP-1PSpecular Microscopy | Device | Normal Healthy Eyes |
| SL-D701Slit Lamp Imaging | Device | Normal Healthy Eyes |
| MC-4SVisual Acuity Testing | Device | Normal Healthy Eyes |
Primary outcome
Device Evaluation
Time frame: 1 Hour
Determine Clinical Utility, Efficacy, and Safety
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: Undecided
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 Willing and Able Subjects 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 2 inclusion and 4 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: withdrawn, 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 was withdrawn before enrolling participants, so there are no results.
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?
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.