NCT03743467

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: Neuromed IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-05
• Primary completion: 2018-11-05
• Completion: 2019-05-26
• First posted: 2018-11-16
• Last updated: 2018-11-16

Locations

2 sites across 1 country: Italy