Visual Restoration for Hemianopia

NCT03350919 | Completed Results FDA Device

• 1 other identifier: 69879
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke Induced Vision Loss; Hemianopia; Quadrantanopia

Outcome Measures

Primary Outcomes (1)

• 24-2 Humphrey PMD Change From Baseline to 6-month Post-training Timepoint

  Change in the perimetric mean deviation (PMD) generated by standard Humphrey automated perimetry using a 24-2 testing pattern between baseline and post-training after a 6-month training interval.

  6 months

Study Arms (2)

Training in the blind field

EXPERIMENTAL

Training in the blind field using software

Device: Training in the blind field

Training in the intact field

EXPERIMENTAL

Training in the intact field using software

Device: Training in the intact field

Interventions

Training in the blind field DEVICE

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.

Training in the blind field

Training in the intact field DEVICE

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.

Training in the intact field

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Envision Solutions, LLC: collaborator

Study Sites (3)

Bascom Palmer Eye Institute, University of Miami Health Services

Miami, Florida, 33136, United States

Location

Flaum Eye Institute, University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Hemianopsia

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Blindness; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Steven E. Feldon, MD
• Organization: University of Rochester

Steven_Feldon@urmc.rochester.edu

585-273-1050

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Ophthalmology

Study Record Dates

• First Submitted: November 18, 2017
• First Posted: November 22, 2017
• Study Start: March 15, 2018
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: December 24, 2020
• Results First Posted: December 24, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

US (3)