Visual Reconstitution Therapy After Optic Neuritis

Multiple Sclerosis Clinical Trial

— VISION  

Official title:

Visual Reconstitution Therapy After Optic Neuritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01274702
• Other study ID #: Vision Study
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: March 2013

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuritis
• Optic Neuritis

Intervention

Other:
• Visual Reconstitutions Therapy

• Saccadic Eye Movement Training

Locations

Country	Name	City	State
Germany	NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Friedemann Paul	Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   NeuroCure Clinical Research Center, Charité Berlin, Germany