Diabetic RetinopathyNCT03078231
Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
An observational study of Diabetic Retinopathy, run by Eyenuk, Inc. at 1 site in United States.
Trial summary
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. 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?
- Color fundus photography and Mydriatic Agent
- Type of treatment
- Surgery or procedure
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2017to 24 Apr 2017
- 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
- Adult, Older adult
Study population: The study subjects will be enrolled at a primary care center
Who may be able to join
- 18 years of age or older;
- a diagnosis of diabetes mellitus; and
- understanding of study and provision of written informed consent.
Who cannot join
- Persistent visual impairment or sudden vision loss in one or both eyes;
- History of uncorrected media opacity in one or both eyes;
- History of retinal vascular disease other than diabetic eye disease;
- History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
- Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
- Subject is currently enrolled in an interventional study of an investigational device/drug; or
- Subject has a condition or is in a situation which in the opinion of the Investigator, might confound study results, may interfere significantly with the subject's participation in the study, or result in ungradable 4-wide field stereoscopic mydriatic fundus photographs.
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC+USC Medical Center
Los Angeles, California, 90033
About this study
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.
- Conditions
- Diabetic Retinopathy
- Being tested
- Color fundus photography, Mydriatic Agent
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Color fundus photographyProcedure or surgery
Subjects will undergo fundus photography before and after administration of mydriatic agent.
Mydriatic AgentDrug
Subjects will be administered mydriatic medication to dilate their pupils.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study start17 Feb 2017
- Primary completion24 Apr 2017
- Study completion24 Apr 2017
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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenuk, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03078231
- Sponsor's protocol ID
- EN-01p
- Other IDs
- 9SB1EY027241, 2R44EY026864
- Status last verified
- Jul 2018
- First submitted
- 2 Mar 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool
- ClinicalTrials.gov ID
- NCT03078231
- Acronym / sponsor ID
- EN-01p
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Eyenuk, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Eye Institute (NEI)
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- 24 Apr 2017 (actual)
- Study completion
- 24 Apr 2017 (actual)
- First posted
- 13 Mar 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.
More than 29 million people in the US are living with diabetes, many of whom will develop diabetic retinopathy (DR) or diabetic eye disease (DED), the leading cause of vision loss and blindness in working-age adults. Annual eye screening is recommended for all diabetic patients since vision loss can be prevented with laser photocoagulation and anti-VEGF injections if DR is diagnosed in its early stages. Currently, the number of clinical personnel trained for DR screening is orders of magnitude smaller than that needed to screen the large, growing diabetic population. Therefore, to meet this large unmet need for DR screening, a fully-automated computerized DR screening system is necessary. This study is designed to assess the performance of EyeArt, an automated DR screening tool.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study subjects will be enrolled at a primary care center
Key inclusion criteria (3 listed)
- 18 years of age or older;
- a diagnosis of diabetes mellitus; and
- understanding of study and provision of written informed consent.
Key exclusion criteria (7 listed)
- Persistent visual impairment or sudden vision loss in one or both eyes;
- History of uncorrected media opacity in one or both eyes;
- History of retinal vascular disease other than diabetic eye disease;
- History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract;
- Subject has contraindications for mydriatic medications or is unwilling or unable to dilate;
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 |
|---|---|---|
| Color fundus photographySubjects will undergo fundus photography before and after administration of mydriatic agent. | Procedure or surgery | – |
| Mydriatic AgentSubjects will be administered mydriatic medication to dilate their pupils. | Drug | – |
Primary outcome
Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
Time frame: 1 visit
The performance of EyeArt will be evaluated using overall accuracy, sensitivity, and specificity measures.
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 30 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetic Retinopathy, run by Eyenuk, 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 3 inclusion and 7 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 30 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?
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?
Number of subjects whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME). (time frame: 1 visit). 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 30 Jul 2018.