Diabetic RetinopathyNCT04984200
Assessment of EyeArt Performance With Retinal Cameras
An observational study of Diabetic Retinopathy, run by Eyenuk, Inc. at 1 site in United States.
Trial summary
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- Retinal imaging and Mydriatic Agent
- Type of treatment
- Surgery or procedure
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 19 Aug 2022
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study subjects will be enrolled at primary care and/or eye care centers
Who may be able to join
- A diagnosis of diabetes mellitus;
- Understanding of study and provision of written informed consent; and
- 22 years of age or older.
Who cannot join
- Persistent visual impairment in one or both eyes;
- History of retinal vascular (vein or artery) occlusion;
- History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- Subject is contraindicated for fundus photography (for example, has light sensitivity);
- 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 or 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 may result in ungradable dilated fundus photographs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rocky Mountain Diabetes Center
Idaho Falls, Idaho, 83404
About this study
The study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.
- Conditions
- Diabetic Retinopathy
- Being tested
- Retinal imaging, 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.
Retinal imagingProcedure or surgery
Subjects will undergo retinal imaging before and/or after administration of mydriatic agent
Mydriatic AgentDrug
Subjects will be administered mydriatic medication to dilate their pupils.
| Study group | Role | What they receive |
|---|---|---|
| AB | Not described Receives: Procedure: Retinal imaging; Drug: Mydriatic Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall agreement between the results from multiple EyeArt operations
Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other.
Measured: 1 visit (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start13 Jul 2021
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
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
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyenuk, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984200
- Sponsor's protocol ID
- EN-01b
- Status last verified
- Nov 2022
- First submitted
- 16 Jul 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of EyeArt Performance With Retinal Cameras
- ClinicalTrials.gov ID
- NCT04984200
- Acronym / sponsor ID
- EN-01b
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Eyenuk, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 30 Jul 2021 (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 study evaluates the performance of the EyeArt system for detecting diabetic retinopathy from images captured using retinal cameras and operators.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AB | – | Procedure: Retinal imaging, Drug: Mydriatic Agent |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects will be enrolled at primary care and/or eye care centers
Key inclusion criteria (3 listed)
- A diagnosis of diabetes mellitus;
- Understanding of study and provision of written informed consent; and
- 22 years of age or older.
Key exclusion criteria (7 listed)
- Persistent visual impairment in one or both eyes;
- History of retinal vascular (vein or artery) occlusion;
- History of ocular injections, laser treatment of the retina, or intraocular surgery other than cataract surgery without complications;
- Subject is contraindicated for fundus photography (for example, has light sensitivity);
- 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 |
|---|---|---|
| Retinal imagingSubjects will undergo retinal imaging before and/or after administration of mydriatic agent | Procedure or surgery | AB |
| Mydriatic AgentSubjects will be administered mydriatic medication to dilate their pupils. | Drug | AB |
Primary outcome
Overall agreement between the results from multiple EyeArt operations
Time frame: 1 visit (1 day)
Overall agreement is defined as the fraction of cases where the multiple EyeArt operation results agree with each other.
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 9 Nov 2022.
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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 9 Nov 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?
Overall agreement between the results from multiple EyeArt operations (time frame: 1 visit (1 day)). 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 9 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.