Macular Degeneration, Age-RelatedEvergazeNCT03794752
Visual Enhancement Device in Low Vision Patients
A study testing Head-Mounted Visual Enhancement Device in people with Macular Degeneration, Age-Related and Diabetic Retinopathy, run by University of Texas Southwestern Medical Center.
Trial summary
This study will be a prospective, non-randomized study of low-vision individuals diagnosed with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern (UTSW) Medical Center at Dallas. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Degeneration, Age-Related, Diabetic Retinopathy
- What is being tested?
- Head-Mounted Visual Enhancement Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to 28 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient of any sex, race, or ethnicity who are 18 years of age or older. Spanish speaking patients will be encouraged to participate, Spanish forms will be available to review and execute.
- Patient willing to review, understand and sign written informed consent. Parents or legal guardians will consent on behalf of minors.
- Written authorization for use or release of health and research study information.
- Patient who volunteers is suffering from a posterior segment ophthalmic disorder including AMD and/or Diabetic Retinopathy and visual acuity from 20/60 to 20/400 in the better seeing eye.
Who cannot join
- Subjects will be excluded if they are less than 18 years of age.
- Subjects will not be considered for this research study if they will not review and execute the informed consent form.
- During the screening process, subjects will be excluded from further consideration if they are identified with having a potential ophthalmic diagnosis other than age-related macular degeneration or diabetic macular edema that could be negatively affecting the visual testing.
- ETDRS Visual Acuity better than 20/60 or worse than 20/400
- During screening, subjects will be disqualified from further assessment if it is determined that their refractive error is outside of the -5.00 to +5.00 D corrective range.
About this study
Official title: Evaluation of a Head Mounted Electronic Visual Enhancement Device in Low Vision Patients
This study will be a prospective, non-randomized study of low-vision individuals diagnosed with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern (UTSW) Medical Center at Dallas. Specifically, the primary objective of this testing is to establish the benefits of a wide field-of-view (FOV) monocular head-mounted visual enhancement device display (HMD), aiding the most degraded eye, as compared to best corrected visual acuity with glasses. It should be noted that in this approach, the HMD incorporates a camera, mounted coaxially with the visual axis of the eye with worse vision, and also image-enhancing or correction algorithms. Following review and execution of the informed consent, each subject will undergo an examination of their eyes, including: 1) ETDRS Best-corrected distance visual acuity; 2) Best-corrected near visual acuity; 3) Tests based on questions 5,6,7 and 11 of the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25).
Read the detailed description
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. All testing will be used for research purposes. There will be an 1) Early Treatment Diabetic Retinopathy Study visual acuity test, 2) near vision test, 3) Testing based on questions 5,6,7, and 11 of the National Eye Institute 25 item visual function questionnaire, (NEI VFQ-25) which includes a speed reading test, identifying objects, physically taking them and returning the items to correct original placement, once with glasses only, once with the head mounted visual device placed over the worst eye visually. There will also be an video tracks showing a conversation between 2 individuals - Subjects will be queried about the facial expressions of the actors during the conversation. The device is a wide field of view (FOV) monocular head-mounted visual enhancement device (HMD). The HMD has a camera mounted coaxially with the visual axis of the worse vision eye, and also image enhancing or correction algorithms. There are breaks planned between testing on the visual function exam portion of the NEI-25.
- Being tested
- Head-Mounted Visual Enhancement Device
- Medical subject headings
- Macular Degeneration, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head-Mounted Visual Enhancement DeviceDevice
Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black \& white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).
| Study group | Role | What they receive |
|---|---|---|
| Vision Aided by a Head Mounted Device | Other | A Head-Mounted Visual Enhancement Device developed by Evergaze Technology LLC has designed an electronic visual enhancement device that is compact and similar to glasses. It will be powered by a battery pack connected to the device. The electronic display will be affixed over only one of the user's eyes. The vision through the unobstructed eye will aid with the subject's balance and spatial orientation. Receives: Device: Head-Mounted Visual Enhancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device
ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.
The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Measured: 5 minutes post intervention
Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device
ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device.
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Measured: 10 minutes post intervention
Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device
Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.
Measured: Day 1 up to 6 minutes post intervention
Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.
Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device.
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Measured: Day 1 up to 1 minute post intervention
Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device
Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device.
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Measured: Initial Baseline and 3 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study startFeb 2015
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Macular Degeneration, Age-RelatedStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will wear a head mounted visual enhancement device.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rafael Ufret-Vincenty, University of Texas Southwestern Medical Center
- Investigators
- Rafael Ufret-Vincenty, MD, Principal investigator, UTSW Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794752
- Sponsor's protocol ID
- STU 012014-015
- Acronym
- Evergaze
- Status last verified
- Dec 2020
- First submitted
- 20 Dec 2018
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Head Mounted Electronic Visual Enhancement Device in Low Vision Patients
- ClinicalTrials.gov ID
- NCT03794752
- Acronym / sponsor ID
- Evergaze / STU 012014-015
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Posted 5 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a prospective, non-randomized study of low-vision individuals diagnosed with either age-related macular degeneration (AMD) or diabetic macular edema with ETDRS visual acuity from 20/60 to 20/400 in both eyes from the University of Texas - Southwestern (UTSW) Medical Center at Dallas. Specifically, the primary objective of this testing is to establish the benefits of a wide field-of-view (FOV) monocular head-mounted visual enhancement device display (HMD), aiding the most degraded eye, as compared to best corrected visual acuity with glasses. It should be noted that in this approach, the HMD incorporates a camera, mounted coaxially with the visual axis of the eye with worse vision, and also image-enhancing or correction algorithms. Following review and execution of the informed consent, each subject will undergo an examination of their eyes, including: 1) ETDRS Best-corrected distance visual acuity; 2) Best-corrected near visual acuity; 3) Tests based on questions 5,6,7 and 11 of the National Eye Institute 25-item visual function questionnaire (NEI VFQ-25).
Detailed description
A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours. All testing will be used for research purposes. There will be an 1) Early Treatment Diabetic Retinopathy Study visual acuity test, 2) near vision test, 3) Testing based on questions 5,6,7, and 11 of the National Eye Institute 25 item visual function questionnaire, (NEI VFQ-25) which includes a speed reading test, identifying objects, physically taking them and returning the items to correct original placement, once with glasses only, once with the head mounted visual device placed over the worst eye visually. There will also be an video tracks showing a conversation between 2 individuals - Subjects will be queried about the facial expressions of the actors during the conversation. The device is a wide field of view (FOV) monocular head-mounted visual enhancement device (HMD). The HMD has a camera mounted coaxially with the visual axis of the worse vision eye, and also image enhancing or correction algorithms. There are breaks planned between testing on the visual function exam portion of the NEI-25.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will wear a head mounted visual enhancement device.
| Arm | Type | Receives |
|---|---|---|
| Vision Aided by a Head Mounted Device | Other | Device: Head-Mounted Visual Enhancement DeviceA Head-Mounted Visual Enhancement Device developed by Evergaze Technology LLC has designed an electronic visual enhancement device that is compact and similar to glasses. It will be powered by a battery pack connected to the device. The electronic display will be affixed over only one of the user's eyes. The vision through the unobstructed eye will aid with the subject's balance and spatial orientation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient of any sex, race, or ethnicity who are 18 years of age or older. Spanish speaking patients will be encouraged to participate, Spanish forms will be available to review and execute.
- Patient willing to review, understand and sign written informed consent. Parents or legal guardians will consent on behalf of minors.
- Written authorization for use or release of health and research study information.
- Patient who volunteers is suffering from a posterior segment ophthalmic disorder including AMD and/or Diabetic Retinopathy and visual acuity from 20/60 to 20/400 in the better seeing eye.
Key exclusion criteria (5 listed)
- Subjects will be excluded if they are less than 18 years of age.
- Subjects will not be considered for this research study if they will not review and execute the informed consent form.
- During the screening process, subjects will be excluded from further consideration if they are identified with having a potential ophthalmic diagnosis other than age-related macular degeneration or diabetic macular edema that could be negatively affecting the visual testing.
- ETDRS Visual Acuity better than 20/60 or worse than 20/400
- During screening, subjects will be disqualified from further assessment if it is determined that their refractive error is outside of the -5.00 to +5.00 D corrective range.
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 |
|---|---|---|
| Head-Mounted Visual Enhancement DeviceEvergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black \& white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use). | Device | Vision Aided by a Head Mounted Device |
Primary outcome
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device
Time frame: 5 minutes post intervention
ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. The single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device
Time frame: 10 minutes post intervention
ETDRS chart will be used to assess best corrected visual acuity. The outcome with the participant using head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device
Time frame: Day 1 up to 6 minutes post intervention
Reading completion with head-mounted electronic visual enhancement device was measured by reading a standard paragraph from 3-Minute Reading Assessments by Rasinski TV and Padak N, 2005. Scholastic Inc., NY.
Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.
Time frame: Day 1 up to 1 minute post intervention
Face sheet and video are shown to the subject to identify facial expression and time taken is recorded. Change in response speed to identify facial expressions using the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device
Time frame: Initial Baseline and 3 minutes
Portable shelf storage is placed at 5-feet distance and time taken to identify shapes and objects is recorded with the head-mounted electronic visual enhancement device. A single visit, prospective, non-randomized study of low vision individuals diagnosed with Age Related Macular Degeneration or Diabetic macular edema research project is designed to last about 1.5 hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Rafael Ufret-Vincenty, MD principal investigator
UTSW Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Head-Mounted Visual Enhancement Device in people with Macular Degeneration, Age-Related and Diabetic Retinopathy, run by University of Texas Southwestern Medical Center.
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 4 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: stopped early, as of the sponsor's last update on 5 Jan 2021. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device (time frame: 5 minutes post intervention). The study lists 5 primary outcomes in all. 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 5 Jan 2021.