Visual Reconstitution Therapy After Optic Neuritis (VISION)
Primary Purpose
Optic Neuritis, Multiple Sclerosis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Visual Reconstitutions Therapy
Saccadic Eye Movement Training
Sponsored by
About this trial
This is an interventional treatment trial for Optic Neuritis focused on measuring History of, Patients, acute
Eligibility 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
Sites / Locations
- NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Visual Reconstitution Therapy
Saccadic Eye Movement Training
Arm Description
Outcomes
Primary Outcome Measures
Visual field
visual field perimetry and kampimetry at baseline and after 3 and 6 months
Secondary Outcome Measures
structural retinal changes
Optical coherence Tomography is performe at baselline and after 6 months
Quality of Life
Quality of life is determined by questionaires at baseline and after 6 months
Full Information
NCT ID
NCT01274702
First Posted
January 10, 2011
Last Updated
July 28, 2021
Sponsor
Friedemann Paul
Collaborators
Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie
1. Study Identification
Unique Protocol Identification Number
NCT01274702
Brief Title
Visual Reconstitution Therapy After Optic Neuritis
Acronym
VISION
Official Title
Visual Reconstitution Therapy After Optic Neuritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Friedemann Paul
Collaborators
Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuritis, Multiple Sclerosis
Keywords
History of, Patients, acute
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Visual Reconstitution Therapy
Arm Type
Experimental
Arm Title
Saccadic Eye Movement Training
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Visual Reconstitutions Therapy
Intervention Type
Other
Intervention Name(s)
Saccadic Eye Movement Training
Primary Outcome Measure Information:
Title
Visual field
Description
visual field perimetry and kampimetry at baseline and after 3 and 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
structural retinal changes
Description
Optical coherence Tomography is performe at baselline and after 6 months
Time Frame
6 months
Title
Quality of Life
Description
Quality of life is determined by questionaires at baseline and after 6 months
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, MD
Organizational Affiliation
NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22742888
Citation
Schinzel J, Schwarzlose L, Dietze H, Bartusch K, Weiss S, Ohlraun S, Paul F, Dorr J. Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial. Trials. 2012 Jun 28;13:94. doi: 10.1186/1745-6215-13-94.
Results Reference
derived
Links:
URL
https://neurocure.de/ncrc/ueber-uns.html
Description
NeuroCure Clinical Research Center, Charité Berlin, Germany
Learn more about this trial
Visual Reconstitution Therapy After Optic Neuritis
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