Prevalence of Visual Dysfunction in Neurological Disorders

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04836715
• Other study ID #: IRB202100649
• Status: Enrolling by invitation
• Start date: January 10, 2021
• Est. completion date: March 2024

Study information

• Verified date: June 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Nervous System Diseases
• Other Neurological Disorders
• Parkinson Disease
• Vision Disorders

Locations

Country	Name	City	State
United States	UF Health Rehab - Fixel Institute	Gainesville	Florida
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlations between Visual Dysfunction and Functional Visual Performance	Correlation Coefficient: VIPDQ score and SRAFVP % will be analyzed statistically to report correlation coefficient	1 day
Primary	Visual Dysfunction	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"	1 day
Primary	Functional Visual Performance	Determined from R-SRA FVP: SRAFVP %	1 day