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

The attenuation coefficient of the retinal nerve fiber layer derived from spectral domain optical coherence tomography AND diplopia in Parkinson*s disease - New OCT technique and diplopia in Parkinson's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44886

Enrollment

100

Registered

2014-10-13

Start date

2014-12-13

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Part 1: The main study parameter is the RNFL-ac and its association with the presence of PD will be investigated. Part 2: The main study parameter is diplopia and its association with the presence of PD will be investigated.	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results