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OCT-Angiography and Adaptive Optics in Patients With Memory Impairment

Study acronym: OCTAVO
StatusRecruiting
PhaseNot applicable
Started2020-06-26
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 29, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-09-26
minor
Study Status, Oversight v7
Re-verified, no change to tracked fields
2023-07-28
minor
Study Status v6
Primary completion date2023-06→2026-06
Completion date2023-06→2026-06
2023-06-16
minor
Study Status, Eligibility v5
Eligibility criteria+62 characters
[...] ia greater in absolute value than 3 diopters on the sphere, or/and 1.5 diopters on the cylinder. history of taking ethambutol orfor syntheticmore than 2 months history of takingsynthetic antimalarial for more than 2 years Mini Mental State Score (MMS) and / or Montreal Cognitive A [...]
2023-02-11
minor
2 amendments v3-v4
2 re-verifications since 2022-07-22, no change to tracked fields
2021-07-09
minor
Study Status, Arms and Interventions v2
InterventionsOphthalmological exam (Procedure)→Blood pressure measurement (Procedure), Ophthalmological exam (Procedure)
2020-07-07
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-06→confirmed 2020-06-26
Study sitesdetails revised at 1 of 1 site
2020-05-14
minor
Original filing
Studies suggest an association between retinal abnormalities and NCD (Neuro Cognitive Disorders) whether they are linked to proven or prodromal Alzheimer's disease (aMCI : amnestic mild cognitive impairment), or to other neurodegenerative diseases such as frontotemporal dementia or Lewy body diseases. These retinal anomalies objectified by OCT-A (Optical coherence tomography angiography) and adaptive optics (AO) appear different depending on the pathologies and could therefore serve as markers in vivo of the pathophysiological processes underlying NCD. No study to date has studied the retina and its vessels in NCD using adaptive optics. In this pilot study, we are proposing a combination of two new ophthalmological imaging techniques (OCT-A and AO), which allow rapid in vivo analysis in a completely non-invasive way of the morphology of small vessels as well as architecture of the retina to better specify the retinal anomalies associated with NCD. We will compare the parameters in OCT-A and AO between patients with NCD and controls without NCD (with memory complaint or without) and will seek to determine if there are different profiles according to the causes of NCD.
Trial Details
NCT Number NCT04389437
Lead Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Conditions Amnesia, Alzheimer Disease, Lewy Body Disease, Parkinsons Disease With Dementia
Enrollment 450 participants
Start Date 2020-06-26
Primary Completion 2026-06 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-29