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Visual Reconstitution Therapy After Optic Neuritis (VISION)

This study is currently recruiting participants.
Verified July 2012 by Charite University, Berlin, Germany
Sponsor:
Collaborators:
Beuth Hochschule für Technik Berlin
NovaVision AG, Zentrum für Sehtherapie
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01274702
First received: January 10, 2011
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Visual Reconstitution Therapy After Optic Neuritis

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Visual field [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    visual field perimetry and kampimetry at baseline and after 3 and 6 months


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 80
Study Start Date: May 2010
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274702

Contacts
Contact: Jan M Dörr, MD +49 30 450 ext 660162 jan-markus.doerr@charite.de
Contact: Katharina Stoesslein +49 30 450 ext 539040 katharina.stoesslein@charite.de

Locations
Germany
NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin Recruiting
Berlin, Germany, 10117
Contact: Jan M Dörr, MD     +49 30 450 ext 660162     jan-markus.doerr@charite.de    
Contact: Katharina Stoesslein     +49 30 450 ext 539040     katharina.stoesslein@charite.de    
Sponsors and Collaborators
Charite University, Berlin, Germany
Beuth Hochschule für Technik Berlin
NovaVision AG, Zentrum für Sehtherapie
Investigators
Principal Investigator: Friedemann Paul, MD NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
  More Information

Additional Information:
NeuroCure Clinical Research Center, Charité Berlin, Germany  This link exits the ClinicalTrials.gov site

No publications provided by Charite University, Berlin, Germany

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Friedemann Paul, Charité Universitaetsmedizin Berlin, Germany
ClinicalTrials.gov Identifier: NCT01274702     History of Changes
Other Study ID Numbers: Vision Study
Study First Received: January 10, 2011
Last Updated: July 10, 2012
Health Authority: Ethik-Kommission der Charité Universitaetsmedizin Berlin, Germany:

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

Additional relevant MeSH terms:
Multiple Sclerosis
Neuritis
Optic Neuritis
Sclerosis
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
Pathologic Processes

ClinicalTrials.gov processed this record on October 18, 2012