The primary aim of this study is to validate a screening instrument for ophthalmologic disorders using full, in depth ophthalmologic assessment as the gold standard. Secondary aims include:* To study the severity and clinical impact of different…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Endpoints include both ophthalmological outcomes and clinical outcomes.
Secondary outcome
n.a.
Background summary
In addition to the characteristic motor symptoms rigidity, bradykinesia, tremor
and postural instability, non-motor symptoms are very common in Parkinson*s
disease (PD) and have a sometimes equally invalidating impact on daily
functioning and quality of life. The presence of visual impairments in PD has
remained not well studied, both in research and in clinical practice. The exact
frequencies, types and severity of visual problems are not known.The impact of
visual problems is particularly vexing for patients with PD, because many
patients compensate for their motor deficits by guiding their movements
visually. Moreover, many visual problems can be treated effectively. Timely
recognition of ophthalmological disorders is therefore essential, so that
tailored treatment can be installed to prevent complications, to restore
mobility, to ascertain independence, and to improve quality of life.
Study objective
The primary aim of this study is to validate a screening instrument for
ophthalmologic disorders using full, in depth ophthalmologic assessment as the
gold standard. Secondary aims include:
* To study the severity and clinical impact of different types of
ophthalmologic disorders in patients with PD and explore the treatment options.
* To determine the prevalence of visual disorders in a sample of patients with
PD.
Study design
We will perform an observational, cross- sectional study in 30 patients.
Patients will be invited for a single day of ophthalmologic and clinical
assessment.
Study burden and risks
The burden for the patients consists of coming to Nijmegen one time for the
assessments. This will take approximately 6 hours (10am untill 16 pm). No
assessements that include any risk for the patients will be performed.
Reinier Postlaan 4
Nijmegen 6524 GC
NL
Reinier Postlaan 4
Nijmegen 6524 GC
NL
Listed location countries
Age
Inclusion criteria
Patients that were diagnosed with PD by a neurologist at age >30 years at time of diagnosis will be included.
Exclusion criteria
- Previous eye surgery other than phacoemulsification for cataract
- blindness in 1 eye.
- Medication that influences normal visual function other than PD medication13 (parasympathicolytic function, phenothiazines, sulphonamides, tetracyclines, isotretinoïn).
- Systemic diseases associated with eye problems14 (sjögren*s disease, marfan, myotonic dystrophy, M. Bechterew, M. Wegener).
- History of lesions near the optic chiasm or occipital cortex (e.g. tumor, infarct, bleed); migraine.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL58535.091.16 |