Visual Reconstitution Therapy After Optic Neuritis
VISION
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 10, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJuly 29, 2021
July 1, 2021
2.8 years
January 10, 2011
July 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual field
visual field perimetry and kampimetry at baseline and after 3 and 6 months
6 months
Secondary Outcomes (2)
structural retinal changes
6 months
Quality of Life
6 months
Study Arms (2)
Visual Reconstitution Therapy
EXPERIMENTALSaccadic Eye Movement Training
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
- Additional significant ophthalmological disease
- Pregnancy
- History of Epilepsy
- Significant arterial Hypertension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Friedemann Paullead
- Beuth Hochschule für Technik Berlincollaborator
- NovaVision AG, Zentrum für Sehtherapiecollaborator
Study Sites (1)
NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Berlin, 10117, Germany
Related Publications (1)
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.
PMID: 22742888DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Friedemann Paul, MD
NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
January 10, 2011
First Posted
January 11, 2011
Study Start
May 1, 2010
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
July 29, 2021
Record last verified: 2021-07