MetamorphopsiaNCT07838181
Virtual Reality Aniseikonia and Metamorphopsia Testing
A study testing Aegenta VR in people with Metamorphopsia and Aniseikonia, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metamorphopsia, Aniseikonia
- What is being tested?
- Aegenta VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
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
- Being tested
- Aegenta VR
- Medical subject headings
- Vision Disorders, Aniseikonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aegenta VRDevice
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 group | Role | What they receive |
|---|---|---|
| Amsler-negative participants | Experimental | 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. Receives: Device: Aegenta VR |
| Amsler-positive participants | Experimental | 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. Receives: Device: Aegenta VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aegenta M-Test Score
Aegenta device output - a quantitative measure intended to capture the degree of metamorphopsia.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start4 Aug 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetamorphopsiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nitish Mehta, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838181
- Sponsor's protocol ID
- 25-01702
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Aniseikonia and Metamorphopsia Testing
- ClinicalTrials.gov ID
- NCT07838181
- Acronym / sponsor ID
- 25-01702
- Conditions
- Metamorphopsia, Aniseikonia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amsler-negative participants | Experimental | Device: Aegenta VRIndividuals 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. |
| Amsler-positive participants | Experimental | Device: Aegenta VRIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aegenta VRThe 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. | Device | Amsler-negative participants, Amsler-positive participants |
Primary outcome
Aegenta M-Test Score
Time frame: Day 0
Aegenta device output - a quantitative measure intended to capture the degree of metamorphopsia.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitish Mehta, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aegenta VR in people with Metamorphopsia and Aniseikonia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitish Mehta, MD (212-263-2573, Nitish.Mehta@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aegenta M-Test Score (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.