NCT07433088

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

February 11, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 11, 2026

Last Update Submit

February 18, 2026

Conditions

Dry AMDGeographic AtrophyHealhty

Outcome Measures

Primary Outcomes (4)

  • Number of Net selection assessed by the SPOT test

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

    Baseline

  • Number of Net selection assessed by the SPOT test

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

    Hour 1

  • Number of target selection assessed by the SPOT test

    Baseline

  • Number of target selection assessed by the SPOT test

    Hour 1

Study Arms (1)

Main

EXPERIMENTAL
Other: Object recognition and selection task

Interventions

Object recognition and selection taskOTHER

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.

Main

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • No detectable visual pathologies
  • Best monocular visual acuity ≥ 8/10
  • Diagnosis of AMD, early AMD, or intermediate AMD
  • Absence of geographic atrophy
  • Presence of drusen (diameter \> 63 µm) with or without pigmentary changes
  • 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.
  • +4 more criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 25, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share