Virtual Reality Aniseikonia and Metamorphopsia Testing
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- NYU Langone Health
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Aegenta M-Test Score
Study Overview
Brief Summary
The purpose of this study is to assess whether the use of small, lightweight, portable virtual reality headset devices can provide a more accessible, reliable, contained, and convenient testing environment compared to previous platforms.
Many tests only assess distortions in one plane or meridian and may have confounding effects from factors such as external stimuli or the use of colored filters to selectively display images to each eye. The investigators hypothesize that this device will help minimize, if not get rid of, a lot of these confounding factors that exist currently.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Over 18 years of age
- •Have no reported visual distortions with a negative Amsler test; or
- •Have visual distortions with a positive Amsler grid test and an ocular history of one of the following: epiretinal membrane (ERM), age-related Macular degeneration (AMD), central serous retinopathy (CSR), diabetic macular edema (DME), cystoid macular edema (CME)
- •Ophthalmology residents, staff, and physicians
Exclusion Criteria
- •Eye pathology limiting view to the posterior pole to obtain adequate quality fundus photograph or OCT imaging in either eye
- •Impaired visual acuity with best-corrected visual acuity equal to or worse than 20/70
- •Motor deficits of the upper extremities
Arms & Interventions
Amsler-negative participants
Individuals without retinal pathology and without reported visual distortion on the Amsler grid will undergo testing with the Aegenta VR device in addition to established clinical assessments used to evaluate metamorphopsia and aniseikonia.
Intervention: Aegenta VR (Device)
Amsler-positive participants
Individuals with retinal pathology associated with visual distortion, including epiretinal membrane (ERM), age-related macular degeneration (AMD), diabetic macular edema (DME), central serous retinopathy (CSR), or cystoid macular edema (CME), who report distortion on the Amsler grid, will undergo testing with the Aegenta VR device in addition to established clinical assessments used to evaluate metamorphopsia and aniseikonia.
Intervention: Aegenta VR (Device)
Outcomes
Primary Outcomes
Aegenta M-Test Score
Time Frame: Day 0
Aegenta device output - a quantitative measure intended to capture the degree of metamorphopsia.
Secondary Outcomes
No secondary outcomes reported