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Validation of Virtual Reality Tests for the Assessment of Patients With Age-related Macular Degeneration as Clinical Endpoints

Validation of Virtual Reality Tests for the Assessment of Patients With Age-related Macular Degeneration

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07433088
Acronym
VIRETTA
Enrollment
60
Registered
2026-02-25
Start date
2026-04-01
Completion date
2027-04-01
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry AMD, Geographic Atrophy, Healhty

Brief summary

Age-related macular degeneration (AMD) is the leading cause of irreversible blindness in industrialized countries and affects tens of millions of people worldwide, with a rapidly increasing prevalence. It causes irreversible central vision loss and significant difficulties in daily activities, impairing patients' quality of life and independence. Conventional clinical assessments, which focus on visual acuity and retinal imaging, do not fully reflect the functional impact of the disease. Virtual reality (VR) makes it possible to create immersive, controlled environments to accurately measure functional vision and simulate real-life situations. The study proposes to develop a standardized and reproducible functional test in virtual reality that can complement conventional examinations and support clinical and industrial research.

Interventions

OTHERObject recognition and selection task

The Sight Performance Object Task (SPOT) is a virtual reality (VR) based assessment designed to measure the object recognition and selection capabilities. It functional vision by replicating the real-world challenge of "finding things" under controlled environmental conditions.

Sponsors

Streetlab
Lead SponsorINDUSTRY
CIL - Centre Ophtalmologique d'Imagerie et de Laser
CollaboratorUNKNOWN
Fondation Ophtalmologique Adolphe de Rothschild
CollaboratorNETWORK

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 50 years * Sufficient knowledge of the French language * Ability to give personal, express, free, and informed consent * Ability to comply with the requirements of the protocol * Person covered by Social Security * Clarity of the ocular environment, adequate pupil dilation to allow the collection of good quality images, as determined by the investigator Additional inclusion criteria for group 1, healthy subjects: * No detectable visual pathologies * Best monocular visual acuity ≥ 8/10 Additional inclusion criteria for group 2, subjects with LMA, early AMD, or intermediate AMD without atrophy: * Diagnosis of AMD, early AMD, or intermediate AMD * Absence of geographic atrophy * Presence of drusen (diameter \> 63 µm) with or without pigmentary changes Additional inclusion criteria for group 3, subjects with dry AMD with perifoveal atrophy: * Diagnosis of atrophic AMD * Presence of drusen (diameter \> 125 µm) * Location of geographic atrophy as determined by the investigator: extrafoveal, juxtafoveal * Preservation of central vision confirmed by the investigator based on a comprehensive and integrated interpretation of SD-OCT, FAF, retinography, and best corrected visual acuity examinations. Additional inclusion criteria for group 4, Subject with dry AMD with foveal atrophy: * Diagnosis of atrophic AMD * Presence of drusen (diameter \> 125 µm) * Investigator's localization of geographic atrophy: retrofoveal * Central vision impairment confirmed by the investigator based on a comprehensive and integrated interpretation of SD-OCT, FAF, retinography, and best corrected visual acuity examinations.

Exclusion criteria

* Pregnant women, women in labor, or breastfeeding women * Subjects undergoing drug treatments that may cause motor, visual, vestibular, or cognitive disorders (PSA, neuroleptics, etc.) or that could interfere with the study examinations * Any concomitant intraocular condition in the eye being studied (e.g., glaucoma or cataract) * Any retinal pathology that could cause retinal atrophy other than AMD (eliminate dystrophy, chronic CRSC, pachyatrophy, resorption of vitelliform material with atrophy, high myopia, etc.) * Known systemic disease that, in the investigator's opinion, would prevent active participation in the study * Participation in any other therapeutic study evaluating a drug. * Subjects with cognitive impairment, illiterate subjects, and subjects who do not speak the national language. * Persons subject to enhanced protection or legal safeguards (guardianship, trusteeship).

Design outcomes

Primary

MeasureTime frameDescription
Number of Net selection assessed by the SPOT testBaselineNet selection is the number of selected targets, less the number of selected distractors
Number of target selection assessed by the SPOT testBaseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026