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Visual Reconstitution Therapy After Optic Neuritis (VISION)

This study has been completed.
Beuth Hochschule für Technik Berlin
NovaVision AG, Zentrum für Sehtherapie
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: January 10, 2011
Last updated: May 20, 2015
Last verified: October 2013

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.

Condition Intervention Phase
Optic Neuritis Multiple Sclerosis Other: Visual Reconstitutions Therapy Other: Saccadic Eye Movement Training Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Visual Reconstitution Therapy After Optic Neuritis

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Visual field [ Time Frame: 6 months ]
    visual field perimetry and kampimetry at baseline and after 3 and 6 months

Secondary Outcome Measures:
  • 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

Enrollment: 25
Study Start Date: May 2010
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Visual Reconstitution Therapy Other: Visual Reconstitutions Therapy
Active Comparator: Saccadic Eye Movement Training Other: Saccadic Eye Movement Training

Detailed Description:
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Definite Optic Neuritis within 60-180 Days or < 12 months before Screening
  • Visus > 0.05
  • Visus < 0.7 or confirmed visual field deficit
  • Ability to give Informed Consent

Exclusion Criteria:

  • Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
  • Additional significant ophthalmological disease
  • Pregnancy
  • History of Epilepsy
  • Significant arterial Hypertension
  Contacts and Locations
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Please refer to this study by its identifier: NCT01274702

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Beuth Hochschule für Technik Berlin
NovaVision AG, Zentrum für Sehtherapie
Principal Investigator: Friedemann Paul, MD NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Friedemann Paul, Charité Universitaetsmedizin Berlin, Germany Identifier: NCT01274702     History of Changes
Other Study ID Numbers: Vision Study
Study First Received: January 10, 2011
Last Updated: May 20, 2015

Keywords provided by Charite University, Berlin, Germany:
History of

Additional relevant MeSH terms:
Multiple Sclerosis
Optic Neuritis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases processed this record on September 19, 2017