Study on the Visual Condition in Parkinson's Disease
Study Regarding the Realization of a Standardized Protocol for the Evaluation of the Visual Condition in Parkinson's Disease
1 other identifier
observational
90
1 country
2
Brief Summary
Non motor symptoms and signs in Parkinson's disease (PD) also include a series of visual deficits; deepening these aspects could be useful for a better management of symptoms, to standardize a specific protocol for the issues related to vision and also to understand how these aspects are important for the understanding of the mechanisms underlying the PD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2018
CompletedFirst Submitted
Initial submission to the registry
November 7, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2019
CompletedNovember 16, 2018
November 1, 2018
Same day
November 7, 2018
November 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (13)
Check the impact of visual condition on the quality of life in patients with PD through the use of questionnaires.
Quantify the impact of visual condition using the VFQ-25 (Visual Functional Questionnaire) in patients with PD through the main method of this questionnaire: all items are scored, each item is then converted to a 0 to 100 scale so that the lowest and highest possible scores are set at 0 and 100 points, respectively so that scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score. The lowest percentage is the better outcome for the visual condition.
through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the best corrected visual acuity expressed in twentieths and the use of the SLOAN chart.
through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the quantification of contrast sensitivity expressed by the CSC (contrast sensitivity curve) trough the use of the Contrast Sensitivity Chart 6 lines.
through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the color sensitivity examination with the administration of the Ishihara test (38 plates) and results expressed by the Ishihara algorithm.
through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the Shirmer test with results expressed in millimeters.
through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the break up time test with results expressed in seconds of tear break.
through study completion with an avarage of 6 months
Survey the validity of a specific diagnostic protocol for the evaluation of the visual condition in patients with PD.
Review the validity of a specific and integrated ambulatory diagnostic protocol for the study of visual and ophthalmological disorders through a visit protocol and exams designed specifically for patients with PD based on the evidence of visual conditions in the disease currently present in the scientific literature trough the measurement of ocular pressure expressed in mmHg by the use of a Non- Contact Tonometry.
through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough eye movements examination to determine hypofunctions/ hyperfunctions in ductions and versions.
through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough the quantification of convergence by the calculation of the near point of convergence expressed in millimeters.
through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough the quantification of stereopsis expressed in seconds of arc trough the use of Lang stereo test and TNO stereo test.
through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD by checking the presence of latent or manifest squint trough Cover and Uncover test in 9 position of gaze.
through study completion with an avarage of 6 months
Inspection of orthoptic condition in patients with PD
Analysis of orthoptic features in patients with PD trough the quantification of the fusional amplitude expressed in prismatic diopters at distance (6 meters) and near (40 cm).
through study completion with an avarage of 6 months
Observation of retinal features in patients with PD through the use of OCT
Registration of the retinal features in patients with PD using OCT trough a quantitative analysis of the macular area and of the optical disc by the registration of retinal tickness expressed in microns for RPE, RNFL and Neuroretine Layer.
through study completion with an avarage of 6 months
Study Arms (3)
Control group
Health subjects
PD patients Hoehn Yahr 1
Patients with Hoehn Yahr stage 1
PD patients Hoehn Yahr 2-3
Patients with Hoehn Yahr stage 2 and 3
Interventions
* VFQ-25 Questionnaire * BCVA * Contrast sensitivity * Color sensitivity examination (Ishihara test 38 plates) * Complete evaluation of orthoptic features, eye movements, eyelid function, pupil function * Slit lamp examination * Shirmer test, Break up time test * Corneal pachymetry (optical pachymetry) * IOP * Quantitative and qualitative analysis of the macular area and of the optical disc by OCT: RPE, RNFL and Neuroretine Layer
Eligibility Criteria
1. Patients affected by Parkinson's disease (PD) according to the diagnostic criteria of the United Kingdom Brain Bank, in the ON phase of their usual treatment (Hoehn-Yahr Stage from 1 to 3) coming from Parkinson's Center of Neuromed IRCCS Institute with signature of the Informed Consent and of the privacy form. 2. Health subjects coming from Neurological Department of Neuromed IRCCS Institute with signature of the Informed Consent and of the privacy form.
You may qualify if:
- Patients aged ≥ 18 years
- Patients affected by Parkinson's disease (PD) according to the diagnostic criteria of the United Kingdom Brain Bank, in the ON phase of their usual treatment
- Hoehn-Yahr Stage from 1 to 3
- Signature of the Informed Consent and of the privacy form
You may not qualify if:
- Patients with symptoms and signs compatible with atypical parkinsonism
- PD patients treated with antagonist drugs for central dopaminergic receptors (first and second generation antipsychotics) in the last 6 months before enrollment
- Patients suffering from other neurological diseases
- Patients with evident cognitive impairment (MMSE \<24/30)
- Patients with manifest eye movement disorders prior to the diagnosis of PD.
- Patients with daltonism
- Patients with amblyopia
- Patients suffering from high anisometropia
- Patients suffering from advanced cataracts
- Patients suffering from glaucoma
- Patients suffering from maculopathy
- Patients suffering from pathologies of the optic nerve
- Patients with severe visual field deficits
- Patients with refractive defects above 5 diopters
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Neuromed IRCCSlead
Study Sites (2)
Neuromed IRCCS
Pozzilli, Isernia, 86077, Italy
Irccs Neuromed
Pozzilli, Isernia, 86170, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Modugno Nicola, MD, PHD
Neuromed IRCCS
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Neurologist, Head of Parkinson Center
Study Record Dates
First Submitted
November 7, 2018
First Posted
November 16, 2018
Study Start
November 5, 2018
Primary Completion
November 5, 2018
Study Completion
May 26, 2019
Last Updated
November 16, 2018
Record last verified: 2018-11