Clinical Trial: Visual Reconstitution Therapy After Optic Neuritis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Visual Reconstitution Therapy After Optic Neuritis

Brief Summary:

Incomplete remission after an optic neuritis attack is not uncommon. Visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions.

The primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.


Detailed Summary: Patients with an acute optic neuritis (between 60 and 180 days before screening) or with residual visual deficits after a past optic neuritis are randomized in two treatment groups. Group A is instructed to perform software-based visual reconstitution therapy on a home PC daily and regularly for 30 minutes over a period of six month. Group B will perform a similarly, also software-based training program, developed to improve saccadic eye movements rather than visual fields. Patients are blinded to the respective treatment.
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: Visual field [ Time Frame: 6 months ]

visual field perimetry and kampimetry at baseline and after 3 and 6 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • structural retinal changes [ Time Frame: 6 months ]
    Optical coherence Tomography is performe at baselline and after 6 months
  • Quality of Life [ Time Frame: 6 months ]
    Quality of life is determined by questionaires at baseline and after 6 months


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: January 10, 2011
Date Started: May 2010
Date Completion:
Last Updated: May 20, 2015
Last Verified: October 2013