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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease
• Intervention / Treatment: Diagnostic test: Clinical evaluation of vision and eye tests

Detailed Description

In Parkinson's disease (PD) several non-motor signs and symptoms already occur in the early stages of the disease; the symptoms are diverse and these also involve visual difficulties which commonly affect the majority of patients and which gradually worsen the quality of life.

The most common malfunction produced by PD is the dysfunction of dopaminergic pathways that may be responsible for a series of visual deficits too:

• decreased visual acuity and decreased sensibility to light and color,
• strabismus and forms of sensory and eye movement dysfunctions,
• eyelid dysfunctions and dry eye syndrome

Moreover, in patients affected by PD, typical retinal features were discovered for the first time in 2004 by the use of OCT (Optical Coherence Tomography) such as:

• the reduction of the retinal nerve fiber layer (RNFL)
• a typical thinning of the macular thickness, even if with different results. In the follow-up of the PD, these retinal features, verifiable by the use of OCT, could be considered as a marker of the pathology.

For these reasons it may be useful:

• quantify in an objective manner how much the visual aspects affect the overall deterioration of the quality of life in patients with PD
• demonstrate the validity of a specific and integrated outpatient diagnostic protocol for the study of visual and ophthalmological disorders in patients with PD
• demonstrate the diagnostic role of early changes in macular thickness and of the optic disc in subjects suffering from PD using the OCT
• establish orthoptic evidence in patients with PD

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Nicola Modugno, MD, PhD; Phone Number: 00390865929250; Email: nicusmod@gmail.com
• Study Contact Backup: Name: Michele Meglio, BSc, M.Sc; Phone Number: 00393332069181; Email: michele.meglio@neuromed.it

Study Locations

• Italy
  • Isernia
    • Pozzilli, Isernia, Italy, 86077
      • Recruiting
      • Neuromed IRCCS
      • Contact: Michele Meglio, BSc, M.Sc; Phone Number: 00393332069181; Email: michele.meglio@neuromed.it
      • Contact: Modugno Nicola, MD, PhD; Phone Number: 00390865929250; Email: nicusmod@gmail.com
    • Pozzilli, Isernia, Italy, 86170
      • Recruiting
      • IRCCS Neuromed
      • Contact: Nicola Modugno, MD, PhD; Phone Number: +393922571585; Email: nicusmod@gmail.com
      • Contact: Michele Meglio, BSc,M.sc; Phone Number: 00393332069181; Email: michele.meglio@neuromed.it
      • Principal Investigator: Nicola Modugno, MD, PhD
      • Sub-Investigator: Michele Meglio, BSc,M.sc
      • Sub-Investigator: Enrica Olivola, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group; Health subjects	Diagnostic test: Clinical evaluation of vision and eye tests; 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
PD patients Hoehn Yahr 1; Patients with Hoehn Yahr stage 1	Diagnostic test: Clinical evaluation of vision and eye tests; 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
PD patients Hoehn Yahr 2-3; Patients with Hoehn Yahr stage 2 and 3	Diagnostic test: Clinical evaluation of vision and eye tests; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Neuromed IRCCS
• Investigators: Principal Investigator: Modugno Nicola, MD, PHD, Neuromed IRCCS

Study record dates

Study Major Dates

• Study Start (Anticipated): November 5, 2018
• Primary Completion (Anticipated): November 5, 2018
• Study Completion (Anticipated): May 26, 2019

Study Registration Dates

• First Submitted: November 7, 2018
• First Submitted That Met QC Criteria: November 13, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): November 16, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: quality of life; Parkinson's disease; vision
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NMOD_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No