Virtual Reality Aniseikonia and Metamorphopsia Testing

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT07838181
Status
Recruiting

Conditions

  • Aniseikonia
  • Metamorphopsia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aegenta VR — DEVICE
    The Aegenta VR system is a custom software application designed to operate with a virtual reality (VR) headset platform, such as a smartphone paired with a Google Cardboard V2 viewer. The application presents visual stimuli to each eye and allows users to identify perceived distortions and magnification changes. These responses are used to generate quantitative measures of metamorphopsia and aniseikonia.

Study Details

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.

Key Dates

First listed
Sep 24, 2026
Start date
Aug 4, 2026
Status verified
Sep 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2030

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Aegenta M-Test Score [ Time Frame: Day 0 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016-

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