Clinical trial NCT03794752: Visual Enhancement Device in Low Vision Patients
Official title: Evaluation of a Head Mounted Electronic Visual Enhancement Device in Low Vision Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Macular Degeneration, Age-Related
Diabetic Retinopathy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will wear a head mounted visual enhancement device.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Best Corrected Visual Acuity (BCVA) With the Head-mounted Electronic Visual Enhancement Device
timeFrame: 5 minutes post intervention
measure: Best Corrected Near Visual Acuity (BCNVA) With the Head-mounted Electronic Visual Enhancement Device
timeFrame: 10 minutes post intervention
measure: Number of Participants Completing/Not Completing the Reading Assessments With the Head-mounted Electronic Visual Enhancement Device
timeFrame: Day 1 up to 6 minutes post intervention
measure: Number of Participants Able/Unable to Identify Facial Expressions With the Head-mounted Electronic Visual Enhancement Device.
timeFrame: Day 1 up to 1 minute post intervention
measure: Response Speed to Visual-motor Skills to Identify Shapes and Objects With the Head-mounted Electronic Visual Enhancement Device
timeFrame: Initial Baseline and 3 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: UTSW Medical Center
name: Rafael Ufret-Vincenty, MD
role: PRINCIPAL_INVESTIGATOR
References: