This pilot study aims to investigate the retina, macula and optic nerve head with Optical Coherence Tomography (OCT) in AD patients in order to identify a neurodegenerative signature of AD in the eye. With Fundus Autofluorescence (FAF), amyloid…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Methods: We will conduct an overal examination of the eye, including vision,
eye pressure and fundusphotography. With the use of FDT visual field
examination and HRT scan of the optic disc, we aim to exclude glaucoma.
Moreover, we conduct OCT and FAF measurements. Prior to measurements with OCT
and FAF, pupil dilatation will be performed using tropicamide 0.5%. In total,
the examinations will take around 45 minutes.
Primary study parameters/outcome of the study:
(1) Thickness of retina, macula and/or optic disc with OCT
(2) Visualization of amyloid plaques in AD with FAF
Secondary outcome
nvt
Background summary
The diagnosis of Alzheimer*s disease (AD) is based on clinical criteria
supported by either MRI or PET scan or CSF analysis. These ancillary
investigations are expensive and/or invasive. The eye is a direct protrusion
from the brain and the retina contains neuronal cells. With ophthalmological
examination, the retina is easily accessible for investigation. Thus, the
retina may be of interest as a *window to the brain* and a potential new
diagnostic method for early diagnosis of AD and/or follow-up of possibly
therapeutic agents in the future.
Study objective
This pilot study aims to investigate the retina, macula and optic nerve head
with Optical Coherence Tomography (OCT) in AD patients in order to identify a
neurodegenerative signature of AD in the eye. With Fundus Autofluorescence
(FAF), amyloid plaques in the retina may be visualized. With the use of HRT
(Heidelberg Retina Tomograph)-scan and visual field examination with FDT
(Frequency Doubling Technology), we aim to exclude glaucoma, since glaucoma can
cause decreased retinal thickness (McManus 2013, Mowatt 2008). This pilot study
serves three goals: 1. To explore the feasibility and logistics of retina
research in AD in the VUMC; 2. To investigate whether OCT and FAF reflect
neuropathological changes in AD; 3. To gather data for the calculation of the
sample size in a subsequent larger study.
Study design
observational study
Study burden and risks
To conduct reliable ophthalmic examination and to improve the quality of the
OCT and FAF, pupil dilatation is necessary with mydriatic drug droplets. Pupil
dilatation may cause a modest amount of transient photophobia and blurred
vision in some participants, lasting several hours. This may interfere with car
driving, so patients are advised not to drive themselves. Adverse ocular or
systemic side effects of tropicamide are rare (Vuori et al., 1994; Oqut et al.,
1996).
The opthalmic examination, fundus photography and visual field testing are
non-invasive examinations without risks. Also OCT, HRT and FAF are non-invasive
eye examinations in which light bundles are used to examine the posterior part
of the eye. This is harmless and without risks.
De Boelenlaan 1117
Amsterdam 1081 HV
NL
De Boelenlaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
- Study cases: Patients with early onset (<70 years) AD according to the NINCDS/ADRDA criteria. The patients need to be fully capacitated and able to give informed consent, with a minimum MMSE-score of 17/30 (according to other AD-protocols);- Controls: patients with subjective memory complaints visiting the Alzheimer center, without diagnosis of AD or other neurodegenerative disease.
Exclusion criteria
- Patients with neuro-opthalmological conditions, which may interfere with the OCT and/or FAF data will be excluded (Table 2, Tewarie et al., 2012).
- Patients with progressive dementia, with an MMSE below 17/30 and/or incapacitated and not capable to give informed consent
- Patients with a narrow anterior angle of the eye and/or increased intra-ocular pressure. These patients have a contra-indication to use mydriatic agents.
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 | NL49053.029.14 |