Diabetic RetinopathyNCT03343730
RetinaVue Diabetic Screening
A study testing Non-mydriatic color fundus photography with the RetinaVue camera and Referral for dilated eye exam with an eye care professional in people with Diabetic Retinopathy, run by Bassett Healthcare at 1 site in United States.
Trial summary
the purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Non-mydriatic color fundus photography with the RetinaVue camera and Referral for dilated eye exam with an eye care professional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 1 Oct 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Type II diabetes without documented diabetic retinopathy
Who cannot join
- Documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract)
- Macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy)
- Inability to attain analyzable RetinaVue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image)
- Acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the RetinaVue camera interpretation report
- Seen within the last 11 months for a diabetic eye exam.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Bassett Medical Center
Cooperstown, New York, 13326
jennifer Victory, RN, 607-547-6965, jennifer.victory@bassett.org
james dalton, MD
About this study
Official title: Diabetic Retinopathy Screening With Non-mydriatic Color Fundus Camera in the Primary Care Clinic
the purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low.
Read the detailed description
The Centers for Disease Control and Prevention (CDC) have estimated that 25.6 million Americans aged 20 years or older have either been diagnosed or undiagnosed with diabetes mellitus. As such, it is crucial for patients to receive routine eye exams during their annual health assessment or diabetes follow-up visit with their primary care physician to check for diabetic retinopathy (DR). Of those Type 2 patients with a known duration of diabetes of less than 5 years, DR was diagnosed in 40% of patients taking insulin and 24% of patients not taking insulin. These percentages are especially concerning since data presented by Schoenfeld and colleagues indicates that approximately 35% of Americans with diabetes mellitus do not receive timely and recommended eye care to detect and treat their DR.10 Reasons for noncompliance include transfer to a retinal specialist, limited personal mobility, and insurance. In addition, patients regularly fail to follow-up with their ophthalmologist or optometrist due to the lack of visual symptoms-the lack of symptoms does not exclude the possibility of early diabetic retinopathy. Per the American Diabetes Association (ADA) guidelines, it is recommended that all Type 2 patients receive annual dilated eye exams. These eye exams must be completed by a knowledgeable and experienced eye care professional (i.e. ophthalmologist or optometrist). Early detection of DR and the preventative effects of therapy is an important aspect for long term vision outcomes.
The long-term goal is to improve the detection of diabetic retinopathy through better-quality measures of patient compliance and screening protocols in the prime care clinic. It is hypothesized that in type II diabetic patients without documented retinal pathology, a hand-held non-mydriatic fundus camera is superior to a referred dilated eye exams for the screening and detection of DR.
- Conditions
- Diabetic Retinopathy
- Being tested
- Non-mydriatic color fundus photography with the RetinaVue camera, Referral for dilated eye exam with an eye care professional
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-mydriatic color fundus photography with the RetinaVue cameraDiagnostic test
This hand-held device allows the primary care physician to capture an image of the patient's retina and transmit the image to a board-certified ophthalmologist for interpretation.
Referral for dilated eye exam with an eye care professionalDiagnostic test
All patients will be given a referral to an eye care professional for a routine, dilated, diabetic eye exam.
| Study group | Role | What they receive |
|---|---|---|
| Non-mydriatic color fundus photography | Experimental | All participants will receive Non-mydriatic color fundus photography with the RetinaVue camera at an already scheduled annual physical exam or follow up clinic visit with their primary care provider (PCP). Receives: Diagnostic Test: Non-mydriatic color fundus photography with the RetinaVue camera |
| Standard of Care (Control) | Active comparator | All patients will also receive a referral for a dilated eye exam with an eye care professional. A yearly dilated exam as referred by the PCP. Receives: Diagnostic Test: Referral for dilated eye exam with an eye care professional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Diabetic Retinopathy Detection
This study will examine the rate of detection of diabetic retinopathy using an in-clinic retinal camera and standard referral to eye care professional for dilated eye exam
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start27 Feb 2018
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Dalton, Bassett Healthcare
- Investigators
- james Dalton, MD, Principal investigator, Bassett Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343730
- Sponsor's protocol ID
- 2078
- Status last verified
- Jul 2018
- First submitted
- 13 Nov 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy Screening With Non-mydriatic Color Fundus Camera in the Primary Care Clinic
- ClinicalTrials.gov ID
- NCT03343730
- Acronym / sponsor ID
- 2078
- Conditions
- Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 17 Nov 2017 (actual)
- 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 purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low.
Detailed description
The Centers for Disease Control and Prevention (CDC) have estimated that 25.6 million Americans aged 20 years or older have either been diagnosed or undiagnosed with diabetes mellitus. As such, it is crucial for patients to receive routine eye exams during their annual health assessment or diabetes follow-up visit with their primary care physician to check for diabetic retinopathy (DR). Of those Type 2 patients with a known duration of diabetes of less than 5 years, DR was diagnosed in 40% of patients taking insulin and 24% of patients not taking insulin. These percentages are especially concerning since data presented by Schoenfeld and colleagues indicates that approximately 35% of Americans with diabetes mellitus do not receive timely and recommended eye care to detect and treat their DR.10 Reasons for noncompliance include transfer to a retinal specialist, limited personal mobility, and insurance. In addition, patients regularly fail to follow-up with their ophthalmologist or optometrist due to the lack of visual symptoms-the lack of symptoms does not exclude the possibility of early diabetic retinopathy. Per the American Diabetes Association (ADA) guidelines, it is recommended that all Type 2 patients receive annual dilated eye exams. These eye exams must be completed by a knowledgeable and experienced eye care professional (i.e. ophthalmologist or optometrist). Early detection of DR and the preventative effects of therapy is an important aspect for long term vision outcomes.
The long-term goal is to improve the detection of diabetic retinopathy through better-quality measures of patient compliance and screening protocols in the prime care clinic. It is hypothesized that in type II diabetic patients without documented retinal pathology, a hand-held non-mydriatic fundus camera is superior to a referred dilated eye exams for the screening and detection of DR.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-mydriatic color fundus photography | Experimental | Diagnostic Test: Non-mydriatic color fundus photography with the RetinaVue cameraAll participants will receive Non-mydriatic color fundus photography with the RetinaVue camera at an already scheduled annual physical exam or follow up clinic visit with their primary care provider (PCP). |
| Standard of Care (Control) | Active comparator | Diagnostic Test: Referral for dilated eye exam with an eye care professionalAll patients will also receive a referral for a dilated eye exam with an eye care professional. A yearly dilated exam as referred by the PCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Type II diabetes without documented diabetic retinopathy
Key exclusion criteria (5 listed)
- Documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract)
- Macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy)
- Inability to attain analyzable RetinaVue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image)
- Acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the RetinaVue camera interpretation report
- Seen within the last 11 months for a diabetic eye exam.
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 |
|---|---|---|
| Non-mydriatic color fundus photography with the RetinaVue cameraThis hand-held device allows the primary care physician to capture an image of the patient's retina and transmit the image to a board-certified ophthalmologist for interpretation. | Diagnostic test | Non-mydriatic color fundus photography |
| Referral for dilated eye exam with an eye care professionalAll patients will be given a referral to an eye care professional for a routine, dilated, diabetic eye exam. | Diagnostic test | Standard of Care (Control) |
Primary outcome
Rate of Diabetic Retinopathy Detection
Time frame: 3 months
This study will examine the rate of detection of diabetic retinopathy using an in-clinic retinal camera and standard referral to eye care professional for dilated eye exam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
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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.
james Dalton, MD principal investigator
Bassett Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-mydriatic color fundus photography with the RetinaVue camera and Referral for dilated eye exam with an eye care professional in people with Diabetic Retinopathy, run by Bassett Healthcare 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 5 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: status not confirmed, as of the sponsor's last update on 11 Jul 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jennifer Victory, RN (6075476965, jennifer.victory@bassett.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Diabetic Retinopathy Detection (time frame: 3 months). 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 11 Jul 2018.