Multiple Sclerosis Clinical Trial
— VISIONOfficial title:
Visual Reconstitution Therapy After Optic Neuritis
NCT number | NCT01274702 |
Other study ID # | Vision Study |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 2010 |
Est. completion date | March 2013 |
Verified date | July 2021 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Friedemann Paul | Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual field | visual field perimetry and kampimetry at baseline and after 3 and 6 months | 6 months | |
Secondary | structural retinal changes | Optical coherence Tomography is performe at baselline and after 6 months | 6 months | |
Secondary | Quality of Life | Quality of life is determined by questionaires at baseline and after 6 months | 6 months |
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