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Prevalence of Visual Dysfunction in Neurological Disorders

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ClinicalTrials.gov Identifier: NCT04836715
Recruitment Status : Enrolling by invitation
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Nicole J Tester, University of Florida

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.

Condition or disease
Parkinson Disease Other Neurological Disorders Healthy

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.

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Other
Official Title: Prevalence of Visual Dysfunction in Persons With Parkinson's Disease and Other Neurological Disorders
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Parkinson's Disease
Individuals with idiopathic Parkinson's Disease and no other neurological disease
Other Neurological Disorders
Individuals with one neurological disorder other than Parkinson's Disease (e.g. Multiple Sclerosis, Amyotrophic Lateral Sclerosis, Traumatic Brain Injury, Parkinsonism)
Healthy
Individuals without any neurological disorder



Primary Outcome Measures :
  1. Visual Dysfunction [ Time Frame: 1 day ]
    Determined from VIPDQ: VIPDQ Score

  2. Functional Visual Performance [ Time Frame: 1 day ]
    Determined from R-SRA FVP: SRAFVP %


Other Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
  1. Persons with Parkinson's Disease
  2. Persons without a Neurological Condition (Controls)
  3. Persons with Other Neurological Conditions (e.g. ALS, TBI, MS, CBT/CBS, MSA, PSP, MCI, etc).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04836715


Locations
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United States, Florida
UF Health Rehab - Fixel Institute
Gainesville, Florida, United States, 32608
University of Florida
Gainesville, Florida, United States, 32608
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Nicole J Tester, PhD, MOT, OTR/L, MSCS University of Florida/UF Health Rehab
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Responsible Party: Nicole J Tester, Occupational Therapist, PhD, MOT, OTR/L, MSCS/Adjunct Research Assistant Professor, University of Florida
ClinicalTrials.gov Identifier: NCT04836715    
Other Study ID Numbers: IRB202100649
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Vision Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Sensation Disorders
Neurologic Manifestations
Eye Diseases