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Visual Restoration for Hemianopia

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ClinicalTrials.gov Identifier: NCT03350919
Recruitment Status : Recruiting
First Posted : November 22, 2017
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
Envision Solutions, LLC
Information provided by (Responsible Party):
Steven Feldon, University of Rochester

Brief Summary:
The purpose of this research is to assess the efficacy of a visual training task on reducing the size of a visual field deficit caused by brain damage in adults, and its ability to improve visual functions in this patient population.

Condition or disease Intervention/treatment Phase
Stroke Induced Vision Loss Hemianopia Quadrantanopia Device: Training in the blind field Device: Training in the intact field Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Visual Restoration for Hemianopia
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : May 1, 2019

Arm Intervention/treatment
Experimental: Training in the blind field
Training in the blind field using software
Device: Training in the blind field
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.

Experimental: Training in the intact field
Training in the intact field using software
Device: Training in the intact field
A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.




Primary Outcome Measures :
  1. 24-2 Humphrey PMD [ Time Frame: 6 months ]
    Change in the perimetric mean deviation (PMD) from 24-2 Humphrey perimetry between baseline and post-training



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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 21-75 years old
  • Ability and willingness to sign informed consent
  • Willingness to participate in both the training and evaluation sessions
  • MRI or CT scan demonstrating lesion in the occipital lobe of the brain and/or affecting white matter tracts that provide visual input to the occipital lobe of the brain
  • Brain injury due to ischemic or hemorrhagic causes that occurs after age 18 and at least 90 days prior to screening visit
  • At least two reliable HVF's demonstrating good fixation and a stable homonymous incomplete (e.g., quadrantanopia or relative defect) or complete hemianopia
  • Reliable HVFs with repeat HVFs if randomization takes place more than 4 weeks after screening visit
  • A homonymous, contiguous visual deficit measured by the 24-2 HVF to be a minimum of two testing locations high and two testing locations wide, where impaired locations are any that measure a threshold of less than 15 dB.
  • Demonstration of good fixation on visual training task - able to fixate the small targets presented as fixation letters reliably for 1000ms with jitter over less than 1 degree of visual angle in any direction away from target edge

Exclusion Criteria:

  • Physical, neurological or mental disability that would interfere with study intervention
  • Concurrent participation in "vision therapy" other than standard occupational or physical therapy
  • Unreliable visual fields on prior testing, indicated by greater than 20% fixation losses, false positives, or false negatives.
  • Inability to discontinue medications judged to affect training and/or assessment (e.g., Ritalin, amphetamines, dopamines, or chemotherapeutic agents)
  • Physical condition likely to preclude completion of the clinical trial (e.g. end-stage or uncontrolled cancer, uncontrolled epilepsy, or end-stage heart disease)
  • Ocular or neurological condition that would interfere with training or assessment (e.g. damage to the optic nerves or lateral geniculate nucleus, any degenerative ocular condition)
  • Best corrected vision worse than 20/40
  • Impaired foveal Humphrey sensitivity as indicated by the HVF tests.
  • Presence of vision loss resulting from ocular disease or disorder
  • Presence of bilateral visual acuity loss from any source
  • Inability to demonstrate fixation stability on eye movement monitored testing
  • Inability to follow training instructions

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): NCT03350919


Contacts
Contact: Lisa Blanchard 585-276-5425 lisa_blanchard@urmc.rochester.edu

Locations
United States, Florida
Bascom Palmer Eye Institute, University of Miami Health Services Recruiting
Miami, Florida, United States, 33136
Contact: Byron Lam    305-326-6021    blam@med.miami.edu   
United States, New York
Flaum Eye Institute, University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Lisa Blanchard    585-276-5425    lisa_Blanchard@urmc.rochester.edu   
United States, Pennsylvania
Scheie Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Madhura Tamhankar    215-662-8042    Madhura.Tamhankar@uphs.upenn.edu   
Sponsors and Collaborators
University of Rochester
Envision Solutions, LLC

Responsible Party: Steven Feldon, Professor and Chair of Ophthalmology, University of Rochester
ClinicalTrials.gov Identifier: NCT03350919     History of Changes
Other Study ID Numbers: 69879
First Posted: November 22, 2017    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Hemianopsia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Blindness
Eye Diseases
Signs and Symptoms