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van CCT (UK)


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van CCT (UK)


New OCT technique in Parkinson's disease.


- candidate number21126
- NTR NumberNTR5003
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-dec-2014
- Secondary IDsNL47617.029.14 
- Public TitleNew OCT technique in Parkinson's disease.
- Scientific TitleThe attenuation coefficient of the retinal nerve fiber layer derived from spectral domain optical coherence tomography in Parkinson’s disease
- ACRONYM
- hypothesisThe Retinal Nerve Fiber Layer attenuation coefficient (RNFL-ac) in patients with Parkinson's disease differs significantly from the RNFL-ac in healthy controls.
- Healt Condition(s) or Problem(s) studiedretinal nerve fiber layer, Optical coherence tomography, Parkinson's disease
- Inclusion criteriaIn 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
- Exclusion criteria- 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
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytype[default]
- planned startdate 13-dec-2014
- planned closingdate1-jun-2015
- Target number of participants40
- InterventionsNone
- Primary outcomeThe primary objective is to investigate if the RNFL-ac in PD patients differs significantly from the RNFL-ac in healthy controls.
- Secondary outcome1) 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.
- TimepointsEnd date: 1-jun-2015
- Trial web siteNone
- status[default]
- CONTACT FOR PUBLIC QUERIESDrs. F. Visser
- CONTACT for SCIENTIFIC QUERIESDrs. F. Visser
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Stichting Parkinson Fonds
- Publications
- Brief summaryRationale: 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.
- Main changes (audit trail)
- RECORD8-dec-2014 - 3-apr-2015


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