Study on the Visual Condition in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-05

Study Completion Date

2019-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevalence of Visual Dysfunction in Neurological Disorders

NCT04836715

Parkinson Disease Other Neurological Disorders Healthy

COMPLETED

Relationship Between Dopaminergic Asymmetric Degeneration and Attentional Resources in Parkinson's Disease.

NCT03476668

Parkinson Disease Attention Disturbances

COMPLETED NA

Assessment of Three-dimensional Vision Alteration in Parkinson Disease

NCT01620164

Parkinson Disease

COMPLETED NA

Video-oculography and Parkinson's Disease

NCT04731246

Parkinson Disease, Idiopathic

RECRUITING NA

Non-Invasive Fundus Retinal Detection Technology for Early Diagnosis of Parkinson's Disease

NCT07244640

Parkinson's Disease (PD)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Health subjects

Clinical evaluation of vision and eye tests

Intervention Type DIAGNOSTIC_TEST

* 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

Clinical evaluation of vision and eye tests

Intervention Type DIAGNOSTIC_TEST

* 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

Clinical evaluation of vision and eye tests

Intervention Type DIAGNOSTIC_TEST

* 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes