Study on the Visual Condition in Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Study Regarding the Realization of a Standardized Protocol for the Evaluation of the Visual Condition in Parkinson's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03743467
• Other study ID #: NMOD_01
• Status: Recruiting
• Start date: November 5, 2018
• Est. completion date: May 26, 2019

Study information

• Verified date: November 2018
• Source: Neuromed IRCCS
• Contact: Nicola Modugno, MD, PhD
• Phone: 00390865929250
• Email: nicusmod[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 26, 2019
• Est. primary completion date: November 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Italy	Irccs Neuromed	Pozzilli	Isernia
Italy	Neuromed IRCCS	Pozzilli	Isernia

Sponsors (1)

Lead Sponsor	Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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