- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01274702
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 10117
- NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Visual Reconstitution Therapy
|
|
Active Comparator: Saccadic Eye Movement Training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual field
Time Frame: 6 months
|
visual field perimetry and kampimetry at baseline and after 3 and 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
structural retinal changes
Time Frame: 6 months
|
Optical coherence Tomography is performe at baselline and after 6 months
|
6 months
|
Quality of Life
Time Frame: 6 months
|
Quality of life is determined by questionaires at baseline and after 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Friedemann Paul, MD, NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Eye Diseases
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Optic Nerve Diseases
- Cranial Nerve Diseases
- Multiple Sclerosis
- Neuritis
- Optic Neuritis
Other Study ID Numbers
- Vision Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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