No registrations found.
ID
Source
Brief title
Health condition
Parkinson's disease
visual disorders
visual impairment
Screening questionnaire
ophthalmology
non-motor symptoms
De ziekte van Parkinson
Oogheelkunde, oogproblemen
Niet motore symptomen
Vragenlijst
Sponsors and support
Intervention
Outcome measures
Primary outcome
- validation of screening questionnaire regarding visual problems. We use in depth ophthalmological assessment as gold standard
Secondary outcome
- prevalence of visual problems within PD
- Clinical impact of visual problems
Background summary
Background: Visual disorders are common in Parkinson's disease (PD). However, the exact frequency and severity of visual problems are not known. Good visual functioning is crucial for patients with PD, because of their need to compensate visually for motor deficits and postural instability . Awareness, early detection and, when possible treatment of visual problems can lead to increased quality of life. Here, we describe the study design of an observational, multi-center, cross sectional study aiming to (1) validate a screening questionnaire to identify PD patients who should be referred to an ophthalmologist for further assessment; to (2) study the prevalence of visual disorders in PD, and to (3) study the severity and clinical impact of different types of visual disorders.
Methods: This study consists of two phases. In phase one, 750 PD patients and 250 healthy controls will be asked to fill out a newly developed screening questionnaire on visual problems. In phase two, a subgroup of responders (n=100) (with the highest and lowest scores on the screening questionnaire) is invited for an extensive neurological and ophthalmological assessment. The in depth ophthalmologic examination will serve as the ¡°gold standard¡± for validating the screening questionnaire. Moreover, these assessments will be used to study associations between visual disorders and clinical presentation in order to gain more insight in it's clinical impact.
Discussion: Our study will create awareness of ophthalmologic problems in PD, and offers a solid starting point for a careful approach to his subject. In clinical practice, the association between ophthalmologic symptoms and PD is far from obvious to both patients and clinicians. Consequently, patients may not adequately report ophthalmic problems themselves, while clinicians may miss many ophthalmologic disorders that can often be treated. Routinely asking patients about visual problems by using a simple screening questionnaire could be an easy solution leading to tailored treatment to prevent complications, to restore mobility, to ascertain independence, and to improve quality of life.
Study objective
Routinely asking patients about visual problems by using a simple screening questionnaire could be an easy solution leading to tailored treatment to prevent complications, to restore mobility, to ascertain independence, and to improve quality of life.
Study design
- phase 1: 750 PD patients screening questionnaire, 250 controls. (ending 31-07-2018)
- Phase 2: 100 PD patients selected for in depth ophthalmological assessment (ending april 2019)
Intervention
none
Radboud University Medical Center
PO Box 9101
B.R. Bloem
Nijmegen 6500 HB
The Netherlands
+31-24-3615202
Bas.Bloem@radboudumc.nl
Radboud University Medical Center
PO Box 9101
B.R. Bloem
Nijmegen 6500 HB
The Netherlands
+31-24-3615202
Bas.Bloem@radboudumc.nl
Inclusion criteria
phase 1: Parkinson's disease or control (no inclusion criteria for screening questionnaire)
phase 2:
Diagnosis of PD according to the UKPSDBB criteria
The patient must be able and willing to give written informed consent
The patient must be willing to participate in all study related activities and visits
Age of onset Parkinson's disease > 30 years
Stable doses of Parkinson medications ≥ 4 weeks
Current age≥ 60 years
Exclusion criteria
Hoehn and Yahr's Parkinson's staging score ≥ 4
Secondary cause of parkinsonism as detected by history
(e.g. drug-induced parkinsonism)
Secondary cause of parkinsonism as detected by investigation
(e.g. vascular parkinsonism as detected by neuroimaging)
Dementia according to DSM-IV
Major depressive disorder according to DSM-IV
Psychotic disorder(s) according to DSM-IV
Prior brain surgery (except deep brain stimulation)
Previous eye surgery (except phacoemulsification for cataract
and artificial lenses)
Blindness in 1 eye
Medication that influences normal visual function other than
PD medication. (Detailed information see Appendix 1)
Systemic diseases that may cause eye problems (HIV, DM type I,
type II if the patient had ophthalmologic therapy
and/or abnormalities at last screening.)
Neurodegenerative diseases other than Parkinson's disease.
History of lesions near the optic chiasm or occipital cortex.
Migraine
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7421 |
| NTR-old | NTR7663 |
| CCMO | NL58535.091.16 |
| OMON | NL-OMON42851 |