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Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia (REVOIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02886663
Recruitment Status : Active, not recruiting
First Posted : September 1, 2016
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary:
This study will assess the effectiveness of a stimulus, in the blind field of hemianopsic patients, to restore the vision of patients with homonymous hemianopsia consecutive to stroke (unilateral occipital lesion). Hemianopsia occurs in 30% of strokes regardless of the cerebral localization and in 60% of stroke interesting the territory of the posterior cerebral artery.

Condition or disease Intervention/treatment Phase
Hemianopsia Other: stimulation of the blind visual field Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia
Actual Study Start Date : December 13, 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: immediate rehabilitation Other: stimulation of the blind visual field
delayed rehabilitation Other: stimulation of the blind visual field



Primary Outcome Measures :
  1. change in the sensitivity of detection of a visual stimulus after rehabilitation [ Time Frame: change from baseline sensitivity at week 22 ]
    change in the mean number of points where the sensitivity is lower than 15db in each contralesional hemifield, before and after rehabilitation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Presence of an homonymous visual field amputation after vascular retrochiasmatic lesion of the occipital region (visual cortex alone or with optical radiations or with other associated occipital areas)
  • inclusion 3 months to 36 months after stroke
  • Patients aged 18 years and older

Exclusion criteria:

  • Brain injury history
  • Severe neuropsychological, psychiatric or behavioral disorder
  • Severe eye disorder or visual impairment (visual acuity less than 3/10)
  • Progressive eye disorder (cataracts or glaucoma)
  • insufficient French language proficiency to understand the questionnaires and rehabilitation tasks
  • patient under legal protection
  • patient's opposition to participate in the study
  • no medical insurance coverage
  • pregnant pr breastfeeding patient

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): NCT02886663


Locations
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France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, France, 75019
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
Investigators
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Study Director: Sylvie CHOKRON Fondation OPH A de Rothschild
Principal Investigator: Olivier GOUT, MD Fondation OPH A de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT02886663     History of Changes
Other Study ID Numbers: OGT_2015_16
First Posted: September 1, 2016    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemianopsia
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Blindness
Eye Diseases
Signs and Symptoms