Diabetic RetinopathyDRTARESNCT05491746
Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
A study testing Eye4 in people with Diabetic Retinopathy and Low Vision, run by Eyedaptic at 1 site in United States.
Trial summary
Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Low Vision
- What is being tested?
- Eye4
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 1 Oct 2022
- 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
- Best correct visual acuity in the better seeing eye between 20/60 and 20/800
- History of diabetic retinopathy
Who cannot join
- Unable to complete the visit
- Unable to give a reliable measurement of vision
- Unable to comfortably wear the glasses for at least 60 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.
Read the detailed description
In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision.
Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.
- Conditions
- Diabetic Retinopathy, Low Vision
- Being tested
- Eye4, Placebo
- Medical subject headings
- Diabetic Retinopathy, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye4Device
Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity.
PlaceboOther
This is the patient's best corrected vision with or without glasses/contact lenses
| Study group | Role | What they receive |
|---|---|---|
| Eye4 | Experimental | This is the arm with the Eyedaptic Device Receives: Device: Eye4 |
| Baseline | Placebo comparator | This is the placebo arm with the best correction the subject has Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity at distance
Visual acuity at distance using Snellen Visual Acuity Chart
Measured: Day 1
Secondary outcomes (2)
Visual acuity at near
Visual acuity at near tested using Ridgevue Near Vision chart
Measured: Day 1
Contrast sensitivity
Contrast sensitivity measured using the Ridgevue contrast sensitivity scale
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Jul 2022
- Primary completion1 Oct 2022
- Study completion1 Oct 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eyedaptic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitul Mehta, MD, Principal investigator, Eyedaptic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491746
- Sponsor's protocol ID
- 2
- Acronym
- DRTARES
- Status last verified
- Feb 2023
- First submitted
- 1 Aug 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetic Retinopathy Tethered Augmented Reality With Eye4 Study
- ClinicalTrials.gov ID
- NCT05491746
- Acronym / sponsor ID
- DRTARES / 2
- Conditions
- Diabetic Retinopathy, Low Vision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- EyedapticIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 8 Aug 2022 (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.
Diabetes has reached epidemic levels in North America and with it, diabetic retinopathy is increasingly affecting the vision of millions of people. Despite treatment many patients still have vision loss that cannot be improved medically or with prescription eyeglasses. Our study is going to look at an FDA Class 1 Exempted visual aid that uses augmented reality to help people see better.
Detailed description
In this study subjects will have their best corrected visual acuity and contrast sensitivity compared to their best vision and contrast with the Eyedaptic device. The Eyedaptic device is an FDA 510(k) Class 1 Exempt device as it is a visual aid. This is a pilot study to determine whether subjects with diabetic retinopathy associated vision loss obtain a benefit with augmented reality vision.
Subjects will receive a manifest refraction. When subjects have their optimal corrective lenses, the subjects' vision will be tested with their corrective lenses alone and again using the Eyedaptic device. This will be a single visit study, with no follow up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eye4 | Experimental | Device: Eye4This is the arm with the Eyedaptic Device |
| Baseline | Placebo comparator | Other: PlaceboThis is the placebo arm with the best correction the subject has |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Best correct visual acuity in the better seeing eye between 20/60 and 20/800
- History of diabetic retinopathy
Key exclusion criteria (3 listed)
- Unable to complete the visit
- Unable to give a reliable measurement of vision
- Unable to comfortably wear the glasses for at least 60 minutes
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 |
|---|---|---|
| Eye4Patients will see if the device helps them see better at distance and near and if it improves their contrast sensitivity. | Device | Eye4 |
| PlaceboThis is the patient's best corrected vision with or without glasses/contact lenses | Other | Baseline |
Primary outcome
Visual acuity at distance
Time frame: Day 1
Visual acuity at distance using Snellen Visual Acuity Chart
2 secondary outcomes
Visual acuity at near
Time frame: Day 1
Contrast sensitivity
Time frame: Day 1
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 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Mitul Mehta, MD principal investigator
Eyedaptic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye4 in people with Diabetic Retinopathy and Low Vision, run by Eyedaptic 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 3 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 15 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Visual acuity at distance (time frame: Day 1). 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 15 Feb 2023.