Parkinson’s Disease

Clinical Study

Ophthalmologic Baseline Characteristics and 2-Year Ophthalmologic Safety Profile of Pramipexole IR Compared with Ropinirole IR in Patients with Early Parkinson’s Disease

Table 2

Percentages of patients () with abnormal ophthalmologic or ERG values at baseline (see text of baseline cross-sectional analyses). Normal cutoff values for non-ERG parameters are shown; patients’ ERG parameter abnormalities were scored against site-specific lower bounds of normal determined from 9 healthy control subjects per site. The Roth error score threshold for abnormality used in baseline analyses was lower than the Expert Panel’s threshold used for the on-treatment COA.
MeasureNormal cutoff value (if applicable)% of patients abnormal
Drusen, photographyPresent47.4
Mean deviation<−2 dB40.2
LensAbnormal31.6
RPE hypopigmentation, photographyPresent30.0
Roth error score12818.8
RPE alterations, macular examPresent17.9
LidsAbnormal15.9
Snellen acuity20/2512.6
CorneaAbnormal10.6
Vitreous bodyPresent9.8
Pattern standard deviation>5 dB9.0
Optic discAbnormal8.9
ConjunctivaAbnormal8.1
Retinal hemorrhage or microaneurysm, photographyPresent6.5
Cylinder2 diopters6.1
Motility smooth pursuitAbnormal5.7
Retinal vesselsAbnormal5.7
NystagmusPresent3.7
Cup-to-disc ratio, vertical>0.752.4
Intraocular pressure>21 mmHg2.0
Cup-to-disc ratio, horizontal>0.751.6
Motility eye positionAbnormal1.6
Motility full versionsAbnormal1.6
IrisAbnormal1.2
Sphere<−5 or >5 diopters0.4
Pupil consensualityAbnormal0.0
Direct response to lightAbnormal0.0
Relative afferent pupillary defectAbnormal0.0
Hard exudates, photographyPresent0.0
Retinal edema or whitening, photographyPresent0.0
ERG Parameters% of patients abnormal (by site-specific lower bounds of normal)
Implicit time b-wave, rod-cone mixed response33.3
Implicit time a-wave, single flash cone response26.5
Amplitudes, cone flicker response24.4
Implicit time a-wave, rod-cone mixed response22.6
Amplitudes, oscillatory potentials21.4
Implicit time b-wave, rod-response20.5
Amplitude b-wave, single flash cone response18.8
Amplitude b-wave, rod-response18.4
Implicit time, cone flicker response17.1
Amplitude a-wave, single flash cone response16.2
Implicit time b-wave, single flash cone response16.2
Amplitude b-wave, rod-cone mixed response15.8
Amplitude a-wave, rod-cone mixed response11.5
COA: comprehensive ophthalmologic assessment; RPE: retinal pigment epithelium.