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Clinical Trials/NCT02886663
NCT02886663TerminatedNot Applicable

Visual Field Restoration in Patients With Post-stroke Homonymous Hemianopsia

Fondation Ophtalmologique Adolphe de Rothschild1 site in 1 country9 target enrollmentStarted: December 13, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
9
Locations
1
Primary Endpoint
change in the sensitivity of detection of a visual stimulus after rehabilitation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

immediate rehabilitation

Experimental

Intervention: stimulation of the blind visual field (Other)

delayed rehabilitation

Other

Intervention: stimulation of the blind visual field (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (1)

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