The Retinal Nerve Fiber Layer attenuation coefficient (RNFL-ac) in patients with Parkinson's disease differs significantly from the RNFL-ac in healthy controls.
ID
Bron
Aandoening
English:
- retinal nerve fiber layer
- optical coherence tomography
- Parkinson's disease
In het Nederlands:
- netvlies
- optical coherence tomografie
- de ziekte van Parkinson
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary objective is to investigate if the RNFL-ac in PD patients differs significantly from the RNFL-ac in healthy controls.
Achtergrond van het onderzoek
Rationale: Parkinson’s disease (PD) is now known to also cause retinal atrophy. Measuring the retinal never fiber layer attenuation coefficient (RNFL-ac) by means of optical coherence tomography (OCT) is a new technique to analyze the scattering properties of the retina as a sensitive measure of retinal atrophy. Using OCT-derived RNFL-ac it might be possible to differentiate PD patients from healthy subjects.
Objectives: The primary objective is to investigate if the RNFL-ac in PD patients differs significantly from the RNFL-ac in healthy controls.
Secondary Objectives are: 1) to investigate if the RNFL-ac can be used to differentiate PD patients from healthy controls. 2) to compare the sensitivity and specificity of the RNFL-ac with RNFL thickness in differentiating PD patients from healthy controls. 3) to investigate local differences in the RNFL-ac of the retina.
Study design: This is a pilot study with an observational cross-sectional design. Patients and controls will be subjected to a clinical neurological exam and a non-invasive ophthalmologic exam consisting of a visual acuity test (with a Snellen chart), an ocular pressure measurement, a slit lamp examination, fundoscopy and OCT (the RNFL-ac can be calculated from OCT data). The study protocol will take one hour and 20 minutes.
Study population: The study population consists of 20 PD patients in (modified) Hoehn and Yahr stage 2 – 4, age 50 - 70 years, recruited from the outpatient clinic of the Sint Lucas Andreas Ziekenhuis (SLAZ) and 20 adult healthy controls, matched for age, sex and ethnicity.
Main study parameters/endpoints: The main study parameter is the RNFL-ac and its association with the presence of PD will be investigated.
Doel van het onderzoek
The Retinal Nerve Fiber Layer attenuation coefficient (RNFL-ac) in patients with Parkinson's disease differs significantly from the RNFL-ac in healthy controls.
Onderzoeksopzet
End date: 1-jun-2015
Onderzoeksproduct en/of interventie
None
Publiek
F. Visser
Amsterdam
The Netherlands
f.visser@slaz.nl
Wetenschappelijk
F. Visser
Amsterdam
The Netherlands
f.visser@slaz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Clinical diagnosis of PD fulfilling the criteria of the UK PD Brain Bank (Appendix B)
- (modified) Hoehn and Yahr stage 2 – 4 (Appendix C) and a follow up of at least three years after diagnosis of PD.
- Age 50 – 70 years
- Best-corrected vision 20/30 or higher (using a Snellen chart)
- Intra-ocular pressure < 21 mmHg to rule out glaucoma
In order to be eligible to participate in this study, a control subject must meet all of the following criteria:
- Best-corrected vision 20/30 or higher (using a Snellen chart)
- Intra-ocular pressure < 21 mmHg to rule out glaucoma
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Media opacifications
- Concomitant ocular disease (glaucoma, retinal pathology, or pathology of the cornea, lens or optic nerve)
- History of ocular trauma
- History of laser therapy
- Degenerative neurological disease other than PD.
- MMSE < 26 in healthy controls (this is a possible indication of a degenerative neurological disease)
- First degree relative with PD
Opzet
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In overige registers
Register | ID |
---|---|
NTR-new | NL4901 |
NTR-old | NTR5003 |
CCMO | NL47617.029.14 |
OMON | NL-OMON44886 |