NCT07433088Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. febr. 25.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2026. febr. 11.
- Kezdés
- 2026. ápr.
- Elsődleges befejezés
- 2027. ápr.
- Fő szponzor
- Streetlab
- Betegségek
- Időskori makuladegeneráció
- NCT-szám
- NCT07433088
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 60
- 2026. ápr. és az elsődleges befejezés (2027. ápr.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Any concomitant intraocular condition in the eye being studied (e.g., glaucoma or cataract)
- Participation in any other therapeutic study evaluating a drug.
Más betegség
- Subjects undergoing drug treatments that may cause motor, visual, vestibular, or cognitive disorders (PSA, neuroleptics, etc.) or that could interfere with the study examinations
- Known systemic disease that, in the investigator's opinion, would prevent active participation in the study
- Subjects with cognitive impairment, illiterate subjects, and subjects who do not speak the national language.
Egyéb
- Pregnant women, women in labor, or breastfeeding women
- 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.)
- Persons subject to enhanced protection or legal safeguards (guardianship, trusteeship).
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 50 év – - · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.