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OpenTrials
Completed

NCT Number: NCT04836715

Prevalence of Visual Dysfunction in Neurological Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UF Health Rehab - Fixel Institute, Gainesville, Florida, United States

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About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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"

  2. Functional Visual Performance

    Time frame: 1 day

    Determined from R-SRA FVP: SRAFVP %

Other outcomes

  1. Correlations between Visual Dysfunction and Functional Visual Performance

    Time frame: 1 day

    Correlation Coefficient: VIPDQ score and SRAFVP % will be analyzed statistically to report correlation coefficient

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2021
Registry last updated
Jun 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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