To study neuronal and ophthalmological characteristics of a newly detected clinical entity called slow vision which hampers visual perception and attention of the affected patients.
ID
Source
Brief title
Condition
- Vision disorders
- Neurological disorders of the eye
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Electrophysiological responses of the retina and the cortex to visual
stimuli.
• Optical responses of the photoreceptors to visual stimuli.
• Performance on computer-based tasks testing central vision, visual attention
and motion detection.
• Electrophysiological and haemodynamic neural responses of the brain to visual
stimuli.
Secondary outcome
Diagnostic value of the speed-acuity to discriminate between patients and
controls.
Auditory processing speed using a computer-based task in order to exclude the
possibility that processing speed in general is disrupted in SV rather than
specifically in the visual modality.
Background summary
A number of patients who seek help at the Department of Ophthalmology
Radboudumc experience problems of delayed or slow processing of visual
information at home, school, work or in traffic. For example, patients can
complain about their inability to read subtitles before they disappear from the
screen. Although these patients face substantial hamper in daily life, they do
not meet current diagnostic criteria of any known ocular or neurological
disorder or of visual impairment. In fact, the source of their problems is
still unknown. There is also no current treatment option for these patients. To
fill this gap, we want to investigate their visual and attentional systems to
learn more about the origin of their symptoms thereby providing information
necessary for the development of diagnostic criteria and treatment.
Study objective
To study neuronal and ophthalmological characteristics of a newly detected
clinical entity called slow vision which hampers visual perception and
attention of the affected patients.
Study design
Observational case-control study.
Study burden and risks
We will measure processing throughout the visual system using a number of
non-invasive measurements. The measurements will last about 8 hours in total.
To limit the burden on participants, we have divided the study into three
sessions: 1) ophthalmological examination (routine ophthalmological examination
and cognitive VEP, mERG ) and psychophysics, 2) fMRI session and 3) MEG
session. The sessions will be carried out separately. Sessions 2 and 3 will
only be done if results of session 1 show differences between patients and
controls on the main psychophysical tasks (computer based attentional and
perception tasks) or on the cognitive VEP. Session 1 will last approximately 5
hours including breaks. Although all measurements will be easy to perform,
participants will have to concentrate, fixate and sometimes respond to visual
stimuli. Some of the measurements could be experienced as somewhat
uncomfortable by the participant. mERG measurements require eye drops (1%
tropicamide or 2.5% phenylephrine in case of allergies) to increase signal to
noise ratio (SNR). Additional eye drops consisting of 4 mg/ml oxibuprocaine are
used to locally anaesthetize the eyes. This is part of a routine procedure
applied in electrophysiology measurements at the ophthalmology department of
Radboudumc and in accordance with ISCEV standards (Hood et al., 2012).
Subjects should not rub their eyes for at least one hour after administration
of the oxibuprocaine drops, and they are not allowed to drive until the effects
of the drops have worn off (i.e. 2-4 hours after installation).
Sessions 2 and 3 will each last about 1.5 hours and will involve measuring
brain activity using MRI and MEG, respectively. During these sessions,
participants will have to sit or lie very still while performing psychophysical
tasks similar to those used in session 1.
Risks associated with the aforementioned techniques are minimal if procedures
are followed carefully. No significant risks are to be expected for cognitive
VEP. There is a minimal risk of corneal erosion caused by the mERG electrode.
However, this type of damage rarely occurs and is known to heal quickly and
completely. Risks associated with MRI and MEG mainly revolve around metals and
electromagnetic implants. We will therefore thoroughly screen participants
beforehand with a standard screening questionnaire provided by the Donders
Centre for Cognitive Neuroimaging. If a patient reports contraindications for
MRI and/or MEG, he will be excluded from session 2 and/or 3. Controls will be
screened before inclusion and again before session 2 and 3. If they report any
contraindications for MRI and/or MEG, they will be excluded from the study.
At the time of this study, participants will not benefit. However, it will
raise awareness of the existence of SV, describe its neurophysiological and
behavioural characteristics, provide the first steps in elucidating its causes,
and guide development of diagnostic criteria and treatment which will
eventually benefit the patients.
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Geert Grooteplein 21
Nijmegen 6525 EZ
NL
Listed location countries
Age
Inclusion criteria
- Between 18 and 65 years old
- Visual acuity >= 0.6
- Normal birth weight (i.e. >= 2500 g) and pregnancy duration (i.e. >= 37 weeks);Patients:
Probable slow vision: Complaints related to slow visual processing, for example:
- Reading slowly
- Being unable to read subtitles(e.g. during movies) in time (i.e. before they disappear from the screen).
- Not being able to quickly find objects in a pile (for example in a full drawer).
- Not being able to quickly recognize a face in a crowd.
Or, abnormally slow in identifying optotypes during standard ophthalmological examination as assessed by the optometrist/ophthalmologist.
Exclusion criteria
• Any visual field defect in central 30* with statistical significance of more than 0,95, determined with Humphrey perimetry
• Ocular surgery other than uneventful cataract surgery, within 3 months before inclusion to our study
• Diagnosis of congenital or acquired optic nerve head pathology.
• Diagnosis of manifest glaucoma with defects in the visual field.
• Diagnosis of a neurodegenerative disorder or high-energy brain trauma.;Patients:
Only for mERG:
• Presence of contraindications reported by the participant for tropicamide and phenylephrine
• Pregnancy or breast feeding
• Hypersensitivity to oxybuprocain;Only for MRI and MEG sessions:
• Exclusion criteria determined by the Donders Centre for Cognitive Neuroimaging regarding safety and/or signal interference.;Controls:
• Presence of contraindications reported by the participant for tropicamide and phenylephrine
• Pregnancy or breast feeding
• Exclusion criteria determined by the Donders Centre for Cognitive Neuroimaging regarding safety and/or signal interference.
• Hypersensitivity to oxybuprocain
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 | NL49098.091.14 |