NCT07838181|RecruitingFDA Device
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Sponsor study identifier
interventional
100
1 country
1
Study Start
August 4, 2026
Actual (reported)Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 4, 2026
Actual (reported)September 18, 2026
Actual (reported)September 24, 2026
Actual (reported)June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Aegenta M-Test Score
Aegenta device output - a quantitative measure intended to capture the degree of metamorphopsia.
Day 0
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.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
NYU Langone Health
New York, New York, 10016, United States
Nitish Mehta, MD
NYU Langone Health
First Submitted
September 18, 2026
First Posted
September 24, 2026
Study Start
August 4, 2026
Actual (reported)Primary Completion
June 30, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
A Comparison of the Checkup Vision Assessment System to Standard Vision Assessment Tools
Contact the study team to confirm eligibility.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 24, 2026
Record last verified: 2026-09
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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