DiabetesNCT02783807
Clinical Equivalency Validation Protocol Clinical Equivalency Eyenez Retina Camera v200 and Optomed Smartscope M5 EY3
A study testing Eyenez Retinal Camera v200 and Volk Pictor Ret 1 in people with Diabetes, run by Eyenez LLC.
Trial summary
This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Eyenez Retinal Camera v200 and Volk Pictor Ret 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to May 2016
- Phase
- Interventional
- 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
Healthy subjects Inclusion Criteria:
- Written Informed Consent
- Male or female
- Age ≥ 18 years and ≤80 years
- Normal Retina
Healthy subjects Exclusion Criteria:
- Glaucoma
- Limited Ability for Agreement
- Spectrum of retinal diseases
- Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
Diseased subjects Inclusion Criteria:
- Written Informed Consent
- Male or female
- Age ≥ 18 years and ≤80 years
- Spectrum of retinal diseases
Diseased subjects Exclusion Criteria:
- Normal Retina
- Limited Ability for Agreement
- Subjects that may have been exposed to retinal photography in the past 24 hours prior to the study visit or plan to have retinal photography in the 24 hours after the study visit
About this study
Official title: Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1
This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. The study includes healthy patients and patients with a spectrum of retinal diseases. The study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the OC and OP. The pictures will be reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is equivalent to the OP, based on the quality of the images
Read the detailed description
Subjects (patients) will be recruited via word of mouth.
The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. The images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow.
In the Study Environment setting (Foothill Medical Offices), the User Interface will be evaluated by comparing retinal pictures taken with subject device OC and predicate device OP.
Patient subjects will be given an Information and Consent Form to complete prior to the study
The technicians employed by Foothill Eye Clinic will operate the device on patient participants by taking a retinal picture using OC.
The technicians will use the predicate device OP to take retinal pictures.
The Ophthalmologist will compare the results with the pictures taken by OC and OP. The Ophthalmologist will be blinded to what picture was taken by which camera and record his assessment of the quality for each picture.
Patient subjects will receive a standard of care exam with or without dilation.
- Conditions
- Diabetes
- Being tested
- Eyenez Retinal Camera v200, Volk Pictor Ret 1
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyenez Retinal Camera v200Device
Volk Pictor Ret 1Device
Also called Optimed Smartscope M5 EY3
| Study group | Role | What they receive |
|---|---|---|
| Eyenez Retinal Camera v200 | Experimental | Retinal images from Eyenez Retinal Camera v200 of healthy and diseased subjects Receives: Device: Eyenez Retinal Camera v200 |
| Volk Pictor Ret 1 | Active comparator | Retinal images from Volk Pictor Ret 1 of healthy and diseased subjects Receives: Device: Volk Pictor Ret 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects
At least 90% of retinal camera images from both retinal cameras will be equivalent
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenez LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Kislinger, PhD MD, Principal investigator, Eyenez LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783807
- Sponsor's protocol ID
- 101
- Status last verified
- May 2016
- First submitted
- 18 May 2016
- Last updated
- 26 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 510k Submission
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Equivalency Validation Protocol Eyenez v200 and Volk Pictor Ret1
- ClinicalTrials.gov ID
- NCT02783807
- Acronym / sponsor ID
- 101
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Eyenez LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 26 May 2016 (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.
This prospective equivalency study compares the performance of two Ophthalmic Cameras, the Eyenez Retina Ophthalmic Camera v200 (OC) and the Optomed Smartscope M5 EY3 (OP). Trained technicians will take pictures of the same patients' retinas and the quality of the photos will be evaluated. The study includes healthy patients and patients with a spectrum of retinal diseases. The study requires that technicians take pictures of the retinas of adult patients between 18 and 80 years of age using both the OC and OP. The pictures will be reviewed and compared by a central reader/Ophthalmologist, who will determine if the OC is equivalent to the OP, based on the quality of the images
Detailed description
Subjects (patients) will be recruited via word of mouth.
The study duration will be approximately 1-2 weeks, assuming a recruitment rate of 15 subjects per week. The images will be recorded within 15 minutes and will involve minimal disruption to the clinical workflow.
In the Study Environment setting (Foothill Medical Offices), the User Interface will be evaluated by comparing retinal pictures taken with subject device OC and predicate device OP.
Patient subjects will be given an Information and Consent Form to complete prior to the study
The technicians employed by Foothill Eye Clinic will operate the device on patient participants by taking a retinal picture using OC.
The technicians will use the predicate device OP to take retinal pictures.
The Ophthalmologist will compare the results with the pictures taken by OC and OP. The Ophthalmologist will be blinded to what picture was taken by which camera and record his assessment of the quality for each picture.
Patient subjects will receive a standard of care exam with or without dilation.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyenez Retinal Camera v200 | Experimental | Device: Eyenez Retinal Camera v200Retinal images from Eyenez Retinal Camera v200 of healthy and diseased subjects |
| Volk Pictor Ret 1 | Active comparator | Device: Volk Pictor Ret 1Retinal images from Volk Pictor Ret 1 of healthy and diseased subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Eyenez Retinal Camera v200 | Device | Eyenez Retinal Camera v200 |
| Volk Pictor Ret 1Also: Optimed Smartscope M5 EY3 | Device | Volk Pictor Ret 1 |
Primary outcome
Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects
Time frame: up to 1 week
At least 90% of retinal camera images from both retinal cameras will be equivalent
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 26 May 2016.
- Individual participant dataSharing planned: Yes. 510k Submission
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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.
Mark Kislinger, PhD MD principal investigator
Eyenez LLC
Questions about this trial
What is this clinical trial studying?
A study testing Eyenez Retinal Camera v200 and Volk Pictor Ret 1 in people with Diabetes, run by Eyenez LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 26 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Clinical Evaluation of Retina Camera Images from both Healthy and Diseased Subjects (time frame: up to 1 week). 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 26 May 2016.