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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
Friedemann Paul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Neuritis focused on measuring History of, Patients, acute

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 10, 2011
Last Updated
July 28, 2021
Sponsor
Friedemann Paul
Collaborators
Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie
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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

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Visual Reconstitution Therapy After Optic Neuritis

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