- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03794752
Visual Enhancement Device in Low Vision Patients (Evergaze)
Evaluation of a Head Mounted Electronic Visual Enhancement Device in Low Vision Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Vision Aided by a Head Mounted Device
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.
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
5 minutes post intervention
|
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. |
10 minutes post intervention
|
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.
|
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.
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. |
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
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. |
Initial Baseline and 3 minutes
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rafael Ufret-Vincenty, MD, UTSW Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Eye Diseases
- Neurologic Manifestations
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Degeneration
- Retinal Diseases
- Sensation Disorders
- Vision Disorders
- Macular Degeneration
- Diabetic Retinopathy
- Vision, Low
Other Study ID Numbers
- STU 012014-015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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