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Peripheral Vision Training Study (PVTS)

Primary Purpose

Visual Impairment, Cognitive Change

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
computerized training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Visual Impairment

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Right handed individuals
  • Aged 19-89
  • In good health as self-reported or visual impairments due to partial vision loss
  • Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss

Exclusion criteria:

  • Younger than 18 or older than 89
  • Being hearing-impaired
  • Not in good health except due to partial vision loss
  • Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes
  • Having hallucinations or delusions
  • Having a current or past history of a substance abuse disorder
  • Currently taking psychoactive medications

Sites / Locations

  • UAB

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Training

Control

Arm Description

Computerized vision training

Sham

Outcomes

Primary Outcome Measures

scores on acuity tests
scores on acuity tests
scores on acuity tests
scores on acuity tests
scores on spatial attention tests
scores on spatial attention tests
scores on spatial attention tests
scores on spatial attention tests

Secondary Outcome Measures

Changes in cortical thickness
Increases in cortical thickness in areas corresponding to trained visual field
Changes in functional connectivity
Changes in functional connectivity of areas corresponding to trained visual field

Full Information

First Posted
April 28, 2017
Last Updated
June 4, 2021
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03141164
Brief Title
Peripheral Vision Training Study
Acronym
PVTS
Official Title
Peripheral Vision Training Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will train participants (young people and older adults) to do a visual task, and will assess whether this results in changes in behavioral assessments. In some participants, we will be also testing whether MRI measures (cortical thickness, functional connectivity) change with training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Visual Impairment, Cognitive Change

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Computerized training for all groups. This is a pilot study.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Experimental
Arm Description
Computerized vision training
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham
Intervention Type
Other
Intervention Name(s)
computerized training
Intervention Description
Computerized training
Primary Outcome Measure Information:
Title
scores on acuity tests
Description
scores on acuity tests
Time Frame
baseline
Title
scores on acuity tests
Description
scores on acuity tests
Time Frame
immediately following training
Title
scores on spatial attention tests
Description
scores on spatial attention tests
Time Frame
baseline
Title
scores on spatial attention tests
Description
scores on spatial attention tests
Time Frame
immediately following training
Secondary Outcome Measure Information:
Title
Changes in cortical thickness
Description
Increases in cortical thickness in areas corresponding to trained visual field
Time Frame
baseline and immediately following training
Title
Changes in functional connectivity
Description
Changes in functional connectivity of areas corresponding to trained visual field
Time Frame
baseline and immediately following training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Right handed individuals Aged 19-89 In good health as self-reported or visual impairments due to partial vision loss Normal or corrected-to-normal vision with contact lenses or visual impairments due to partial vision loss Exclusion criteria: Younger than 18 or older than 89 Being hearing-impaired Not in good health except due to partial vision loss Having a previous serious head injury or neurological disorder, or loss of consciousness for more than 2 minutes Having hallucinations or delusions Having a current or past history of a substance abuse disorder Currently taking psychoactive medications
Facility Information:
Facility Name
UAB
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Peripheral Vision Training Study

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