Testing of a Functional Outcome Measure for Those With Visual Field Defects

NCT00731796 | Suspended

• 1 other identifier: NUSRPFOM01
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 3

Brief Summary

This study is designed in two Phases. In phase 1, the Functional Outcome Measure will be tested to determine its validity and reliability in three populations, subjects that have not had a stroke and have no visual field defect, subjects that have had a stroke but do not have a visual field defect, and lastly subjects that have had a stroke and have a visual field defect. The second phase will employ an amended version of the functional outcome measure to be administered to two groups of subjects. The first group of subjects will be those subjects diagnosed with a visual field defect from retrochiasmatic insults and they will perform vision restoration therapy. The second group with a similar diagnosis to the first but who do not undergo vision restoration therapy.

Conditions

Hemianopsia, Homonymous

Keywords

Stroke; Retrochiasmatic; Vision; VFD

Outcome Measures

Primary Outcomes (1)

• Determine the ability of a Functional Outcome Measure to distinguish visual impairment in those with retrochiasmatic insults and visual field defects compared to those without visual field defects

  18 Months

Secondary Outcomes (2)

• Identify the correlation between the degree of functional impairment and the amount of visual field loss

  18 months

• Determine the ability of a Functional Outcome Measure to detect change after a rehabilitation intervention

  18 months

Study Arms (4)

1

Stroke victims with a visual field deficit that undergo vision restoration therapy

Device: Functional Outcome Measure

2

Stroke victims with a visual field deficit who do not undergo any rehabilitation intervention

Device: Functional Outcome Measure

3

Stroke victims that do not have a visual field deficit

Device: Functional Outcome Measure

4

Normal individuals who have not had a stroke and do not have a visual field deficit

Device: Functional Outcome Measure

Interventions

Functional Outcome Measure DEVICE

Functional Outcome Measure is a computerized test performed by the subject. The subject sits at a computer and answers questions about their visual deficit and its impact. The patient then performs a Vision Preference Scale test intended to rate the overall quality of life. A reading test is performed that measures reading speed, accuracy, and comprehension. Finally a Visuospatial Attention test is given to measure object localization, object recognition,and motion recognition.

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal participants who have not suffered a stroke and do not have a visual field deficit. Individuals who have suffered a stroke and do not have a visual field deficit. Individuals who have suffered a stroke and do have a visual field deficit.

You may qualify if:

• Stroke victim
• Read / Speak English (required to respond to the questionaire)
• Ability to provide consent
• Homonymous visual field defect evident on a suprathreshold visual field test (High Resolution Perimetry)
• years fo age and older

You may not qualify if:

• Contraindication to visual stimulation: history of photogenic seizures
• Inability to complete Vision Restoration Therapy
• Significant cognitive impairment
• Complete blindness or the inability to focus on a fixation point
• Severe physical or behavioral limitations
• Aphasia
• Onset of Visual field defect less than 3 months prior to enrollment

Sponsors & Collaborators

• NovaVision, Inc.: lead

Study Sites (3)

NovaVision, Inc.

Boca Raton, Florida, 33431, United States

Location

University of Miami Bascom Palmer

Miami, Florida, 33136, United States

Location

Emory University School of Medicine Atlanta VA Medical Center Research

Atlanta, Georgia, 30332, United States

Location

Related Links

• NovaVision Corporate Web Site
• Emory University School of Medicine
• University of Miami Bascom Palmer Eye Institute

MeSH Terms

Conditions

Hemianopsia; Stroke

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sigrid Kenkel

  NovaVision, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: September 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

US (3)