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CompletedNCT04836715Updated Jun 12, 2024

Prevalence of Visual Dysfunction in Neurological Disorders

An observational study in Parkinson Disease, Other Neurological Disorders and Healthy, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-12.

Sponsored by University of Florida · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
92
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Parkinson Disease
  • Other Neurological Disorders
  • Healthy
03

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 92 is close to the median of 96 across 1,057 observational studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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).

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

Exclusion Criteria:

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

Observational model
Other
Time perspective
Other
Enrollment
92 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. 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"

    Time frame: 1 day

  2. Functional Visual Performance

    Determined from R-SRA FVP: SRAFVP %

    Time frame: 1 day

Other outcomes

  1. Correlations between Visual Dysfunction and Functional Visual Performance

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

    Time frame: 1 day

07

Study locations

2 sites
  • UF Health Rehab - Fixel Institute
    Gainesville, Florida 32608, United States
  • University of Florida
    Gainesville, Florida 32608, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04836715
Lead sponsor
University of Florida
Responsible party
Sponsor
First posted
Apr 8, 2021
Start date
Jan 10, 2021
Primary completion
Dec 1, 2023
Completion
Dec 1, 2023
Last update
Jun 12, 2024

Study contacts

Nicole J Tester, PhD, MOT, OTR/L, MSCS
principal investigator · University of Florida/UF Health Rehab

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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