Recruiting

Virtual Reality

Sponsor:

NYU Langone Health

Code:

NCT07838181

Conditions

Metamorphopsia

Aniseikonia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Aegenta VR

Study Details

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.

Conditions

Metamorphopsia

Aniseikonia

Study ID

NCT07838181

Start date

Aug 4, 2026

Status verified date

Sep, 2026

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

Aegenta VR

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Nitish Mehta, MD

212-263-2573Nitish.Mehta@nyulangone.org

Tonya Robin

929-455-5041Tonya.Robin@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.