To non-invasively explore the retina for (a) potential biomarker(s) using a multimodal retinal imaging platform (i.a. OCT, OCT-A, ultra-widefield fundus photography and metabolic hyperspectral retinal camera).
ID
Source
Brief title
Condition
- Neurological disorders of the eye
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Differences between AD patients, patients with SMC and healthy controls for
all parameters measured by the different retinal imaging techniques (including
OCT, OCT-A, ultra-widefield fundus photography and metabolic hyperspectral
retinal camera) at baseline and after two years.
2. Comparison of intra-individual differences (change over time) between AD
patients, patients with SMC and healthy controls for all parameters measured by
the multimodal retinal imaging platform at baseline and after two years.
Secondary outcome
1. Correlation of the results of the different retinal imaging techniques with
established disease biomarkers (CSF concentration of Aβ, Tau, and pTau,
hippocampal and cortical atrophy on MRI, and neuropsychological findings).
2. Correlation of possible new AD biomarkers in tear film (in collaboration
with Maastricht University Medical Center, MUMC+), to the different retinal
imaging
Background summary
Alzheimer*s disease (AD) is the most common cause of dementia. The optimal
window of opportunity for therapeutic strategies lies in the pre-clinical phase
of the disease when patients are asymptomatic. Thus, there is an urgent need
for tools to diagnose AD in this pre-clinical stage. A potential candidate for
such a diagnostic tool is optical imaging of the retina, as it is non-invasive,
patient friendly, rapid, and inexpensive. In this study, we aim to explore
differences in the retina of patients with (pre)clinical AD compared to
patients without AD using a multimodal retinal imaging platform (i.a. OCT,
OCT-A, ultra-widefield fundus photography and metabolic hyperspectral retinal
camera), both transversally and longitudinally.
Study objective
To non-invasively explore the retina for (a) potential biomarker(s) using a
multimodal retinal imaging platform (i.a. OCT, OCT-A, ultra-widefield fundus
photography and metabolic hyperspectral retinal camera).
Study design
This is a transversal and longitudinal, observational, prospective, monocenter
study.
Study burden and risks
The study comprises of two visits (with two years in between) that take place
at the outpatient ophthalmology department of the Amsterdam University Medical
Center (AUMC), location Vrije Universiteit Medical Center (VUmc) with a
duration of approximately 1,5-2 hours each, including a general
ophthalmological consultation comprising ophthalmological history, intraocular
pressure and refraction/visual acuity measurement, tear collection with a
Schirmer strip, and non-invasive optical eye examinations with OCT(-A),
widefield fundus photography and metabolic hyperspectral retinal camera. For
these examinations, pupil dilatation is necessary and will be achieved with a
topical mydriatic (Tropicamide 0.5%), which may cause mild transient
photophobia and blurred vision (adverse ocular or systemic side effects are
very rare). All study procedures are routine medical procedures; therefore, the
potential risks are negligible. Benefits include an extensive ophthalmological
examination. In case ophthalmological problems are detected, these will be
discussed with the involved ophthalmologist and the participant will receive
consultation.
De Boelelaan 1118
Amsterdam 1081HZ
NL
De Boelelaan 1118
Amsterdam 1081HZ
NL
Listed location countries
Age
Inclusion criteria
Age >= 50 years
Mini Mental State Exam (MMSE) greater or equal to 17 (patients who are mentally
competent)
Available AD biomarker information
Exclusion criteria
- Pupil dilation inadequate or contraindicated
- Presence of glaucoma, retinal vasculopathy (diabetic, hypertensive)
- Presence of moderate / late-stage age-related macular degeneration
- Media opacities (cataract) precluding good quality imaging
- Refractive error outside the range -6D to +6D
- Inability to obtain good quality images with the OCT(-A), widefield fundus
photography and metabolic hyperspectral retinal camera
- Ocular conditions including eye infection, eye inflammation, eye surgery
within the
last 28 days or other acute eye conditions.
Presence of other neurodegenerative disease (i.e. other causes of dementia, MS,
Parkinson Disease)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL76737.029.21 |