Visual Reconstitution Therapy After Optic Neuritis (VISION)

Friedemann Paul

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis; Optic Neuritis

Treatments: Other: Visual Reconstitutions Therapy; Other: Saccadic Eye Movement Training

Study type: Interventional

Funder types: Other

Identifiers

NCT01274702

Vision Study

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Visual Reconstitution Therapy

Experimental group

Treatment:

Other: Visual Reconstitutions Therapy

Saccadic Eye Movement Training

Active Comparator group

Treatment:

Other: Saccadic Eye Movement Training