Visual Reconstitution Therapy After Optic Neuritis (VISION)
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.
Other: Visual Reconstitutions Therapy
Other: Saccadic Eye Movement Training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Visual Reconstitution Therapy After Optic Neuritis|
- Visual field [ Time Frame: 6 months ] [ Designated as safety issue: No ]visual field perimetry and kampimetry at baseline and after 3 and 6 months
- structural retinal changes [ Time Frame: 6 months ] [ Designated as safety issue: No ]Optical coherence Tomography is performe at baselline and after 6 months
- Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]Quality of life is determined by questionaires at baseline and after 6 months
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Experimental: Visual Reconstitution Therapy||Other: Visual Reconstitutions Therapy|
|Active Comparator: Saccadic Eye Movement Training||Other: Saccadic Eye Movement Training|
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.
|NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin|
|Berlin, Germany, 10117|
|Principal Investigator:||Friedemann Paul, MD||NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin|