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Clinical Trials/NCT04836715
NCT04836715
Completed
Not Applicable

Prevalence of Visual Dysfunction in Persons With Parkinson's Disease and Other Neurological Disorders

University of Florida2 sites in 1 country92 target enrollmentJanuary 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
University of Florida
Enrollment
92
Locations
2
Primary Endpoint
Visual Dysfunction
Status
Completed
Last Updated
last year

Overview

Brief Summary

The objective is to determine the prevalence of visual dysfunction in People with Parkinson's Disease (PwP). The investigators will administer the: Visual Impairment in Parkinson's Disease Screen and Revised-Self-Report Assessment of Functional Visual Performance. Patients seen at Fixel Institute and their caregivers will be invited to participate. Responses to the 2 questionnaires will help determine prevalence rates of visual dysfunction in PwP compared to those both with and without other neurological conditions.

Detailed Description

The purpose of this study is to identify the prevalence of visual dysfunction among Persons with Parkinson's Disease, compared to other neurological conditions and controls without neurological conditions. Data will be collected anonymously via RedCap. Patients seen at the Fixel Institute that have consented to be contacted regarding research opportunities will be recruited via blast email and advertisement in our Institute's monthly newsletter, the Movement Messenger. The email and newsletter will contain a link for participation in surveys within RedCap so the surveys can be completed anonymously at home. Participation will be completely voluntary and responses will be recorded anonymously. Data will include responses to the following: screening questions, the VIPDQ (Visual Impairment in PD Questionnaire), and the R-SRAFVP (Revised-Self-Report Assessment of Functional Visual Performance). The investigators will calculate the prevalence of visual impairment (from the VIPDQ) and dysfunction in performance of daily activities (from the R-SRAFVP) for PwP and compare this to the prevalence occurring in other neurological populations as well as the population without any neurological conditions. Other data are collected so the investigators can then evaluate potential confounds or covariates. To ensure statistical methods are accurate, a statistician will be consulted.

Registry
clinicaltrials.gov
Start Date
January 10, 2021
End Date
December 1, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Persons with Parkinson's Disease: Confirmed diagnosis of Parkinson's Disease without presence of any other neurological condition.
  • Persons without Parkinson's Disease (Controls): No previous diagnosis of any neurological condition
  • Persons with a single other neurological disorder (Neuro Controls): Confirmed diagnosis of other neurological condition (e.g. ALS, multiple sclerosis, essential tremor, ataxia, etc).

Exclusion Criteria

  • Children (ages younger than 18 years of age)
  • Persons with more than one diagnosed neurological condition.

Outcomes

Primary Outcomes

Visual Dysfunction

Time Frame: 1 day

Determined from VIPDQ: (with the highest and lowest scores on the VIPD-Q Score). Answers are given on a 4-point Likert scale ranging from "never have problems" to "daily problems"

Functional Visual Performance

Time Frame: 1 day

Determined from R-SRA FVP: SRAFVP %

Study Sites (2)

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