An interventional study of Aegenta VR in Metamorphopsia and Aniseikonia, sponsored by NYU Langone Health. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by NYU Langone Health · Not applicable, Interventional, and Device feasibility
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.
360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.
This study's planned enrollment of 100 is above the median of 78 across 244 interventional studies indexed under Vision Disorders.
Browse Vision Disorders studies →NYU Langone Health is the lead sponsor of 1,430 studies on the registry; 258 are open to participants now.
Of its 235 completed or terminated interventional studies of FDA-regulated products, 197 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Aegenta VR
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.
Device: 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.
Aegenta M-Test Score
Aegenta device output - a quantitative measure intended to capture the degree of metamorphopsia.
Time frame: Day 0
Plan to share: Yes — The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Nitish.Mehta@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
Access criteria: Requests should be directed to Nitish.Mehta@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Jun 2028, 22 months after the start.
Of 84 non-industry interventional studies with no phase under Vision Disorders, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 51. This study's planned 22 months is below that.
Counting every sponsor, half of 94 studies reached it within 24 months; a quarter within 6 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
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