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Visual Reconstitution Therapy After Optic Neuritis (VISION)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274702
First Posted: January 11, 2011
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beuth Hochschule für Technik Berlin
NovaVision AG, Zentrum für Sehtherapie
Information provided by:
Charite University, Berlin, Germany
  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
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274702


Locations
Germany
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
Investigators
Principal Investigator: Friedemann Paul, MD NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
  More Information

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
First Submitted: January 10, 2011
First Posted: January 11, 2011
Last Update Posted: May 21, 2015
Last Verified: October 2013

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

Additional relevant MeSH terms:
Optic Neuritis
Multiple Sclerosis
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