Study to assess and compare the safety of long term oral treatment for Parkinson's Disease with pramipexole versus bromocriptine or other dopamine agonists, by measuring cross-sectional the incidence of ophthalmologic disturbances, especially signs of retinal degeneration, in a matched pair design
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
705
Incidence of drug related signs of retinal degeneration
based on the evaluation of assessors blind to the treatment allocation
Time frame: up to 8 months
Assessment of ophthalmological history
Time frame: within 2 month after neurologic visit
Assessment of visual acuity
Time frame: within 2 month after neurologic visit
Number of abnormal findings in clinical examination in miosis and mydriasis
including ophthalmoscopy
Time frame: within 2 month after neurologic visit
Assessment of intraocular pressure (mmHg)
Time frame: within 2 month after neurologic visit
Assessment of colour vision
using the Hardy-Rand-Rittler (H-R-R) pseudoisochromatic plates
Time frame: within 2 month after neurologic visit
Findings in kinetic perimetry
Time frame: within 2 month after neurologic visit
Percentage of patients with elevated dark adaptation thresholds
Time frame: within 2 month after neurologic visit
Assessment of Parkinson's Disease stage rated by modified Hoehn and Yahr Scale
Time frame: within less than 2 months before ophthalmologic visit
Assessment of Parkinson's Disease stage rated of unified Parkinson's Disease Rating Scale (UPDRS) Part IV
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Time frame: within less than 2 months before ophthalmologic visit
Number of patients with adverse events
Time frame: up to 2 month after neurologic visit
Findings in standardised electroretinography (ERG)
performed according to International Standardization Committee for the Electrophysiology of Vision (ISCEV) standard
Time frame: within 2 monhts after neurologic visit