The attenuation coefficient of the retinal nerve fiber layer derived from spectral domain optical coherence tomography AND diplopia in Parkinson*s disease

Completed

Conditions: Parkinson's disease
Idiopathic parkinsonism
10028037

Registration Number: NL-OMON44886

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

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 (METC protocol, appendix B)
- (modified) Hoehn and Yahr stage 2 - 4 (METC protocol, 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

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
- 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

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Part 1: The main study parameter is the RNFL-ac and its association with the<br /><br>presence of PD will be investigated.<br /><br>Part 2: The main study parameter is diplopia and its association with the<br /><br>presence of PD will be investigated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters are the RNFL thickness and local differences of the<br /><br>RNFL-ac of the retina and diplopia. The association with these parameters and<br /><br>the presence of PD will be investigated.<br /><br>Other study parameters are age, sex, ethnicity, and MMSE score, and for PD<br /><br>patients also UPDRS score and modified Hoehn and Yahr stage (C1 protocol,<br /><br>Appendix C), years from diagnosis and the use of dopaminergic medication.<br /><br>There are no secondary endpoints.</p><br>