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NCT Number: NCT07433088

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

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.

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Key information

Conditions

Dry AMD Eye Diseases Geographic Atrophy Healhty Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Object recognition and selection task

Other

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.

Primary outcomes

  1. Number of Net selection assessed by the SPOT test

    Time frame: Baseline

    Net selection is the number of selected targets, less the number of selected distractors

  2. Number of Net selection assessed by the SPOT test

    Time frame: Hour 1

    Net selection is the number of selected targets, less the number of selected distractors

  3. Number of target selection assessed by the SPOT test

    Time frame: Baseline

  4. Number of target selection assessed by the SPOT test

    Time frame: Hour 1

Sponsors and collaborators

Lead sponsor

Streetlab

Industry

Collaborators

  • CIL - Centre Ophtalmologique d'Imagerie et de Laser
  • Fondation Ophtalmologique Adolphe de Rothschild

Registry information

Official study title

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

Acronym: VIRETTA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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