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Evaluation of the Role of OCT in the Detection of HIV-associated Neurocognitive Disorder

Evaluation of the Role of Optical Coherence Tomography (OCT) in the Detection of HIV-associated Neurocognitive Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02431091
Acronym
OCT-HIV
Enrollment
55
Registered
2015-04-30
Start date
2015-04-30
Completion date
2022-03-31
Last updated
2022-03-31

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

Conditions

AIDS-Related Dementia Complex

Keywords

Optical Coherence Tomography

Brief summary

The purpose of this study is to determine the sensitivity and specificity of the use of optical coherence tomography to detect HIV-associated neurocognitive disorder compared to MRI and usual cognitive screening tools.

Interventions

OTHEROptical Coherence Tomography

Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina

Sponsors

Fonds iris-Recherche, Fondation Roi Baudouin, Belgium
CollaboratorUNKNOWN
Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* HIV infection * Antiretroviral treatment * Undetectable plasmatic HIV viral load (viral load\<50 copies/ml) for at least 6 months * Ability to understand and give approved consent

Exclusion criteria

* Any present or past ophthalmologic illness that may impair OCT results * Previous cerebral infection with sequel * Previous cerebrovascular disease with sequel * Severe psychiatric illness * Active alcohol or drug abuse * Active chronic hepatitis C * Inability to perform french cognitive assessment * Inability to perform a MRI * Inability to perform a lumbar puncture

Design outcomes

Primary

MeasureTime frame
Number of patients with abnormal OCT (retinal thickness in µm) in patients with abnormal full neurocognitive evaluationBaseline

Secondary

MeasureTime frame
Number of patients with abnormal neuroscreen and/or modified dementia scale in patients with abnoraml full neurocognitve evaluationBaseline
Correlation between retinal thickness (in µm) and cerebral atrophy in % of brain parenchymal fraction ( measured by cerebral MRI)Baseline

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026