Visual Reconstitution Therapy After Optic Neuritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Visual Reconstitution Therapy After Optic Neuritis

Conditions
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Optic Neuritis, Multiple Sclerosis

Intervention / Treatment
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* Other: Visual Reconstitutions Therapy
* Other: Saccadic Eye Movement Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual Reconstitution Therapy<br> | Other: Visual Reconstitutions Therapy<br> <br> |
| Active Comparator: Saccadic Eye Movement Training<br> | Other: Saccadic Eye Movement Training<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual field | visual field perimetry and kampimetry at baseline and after 3 and 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structural retinal changes | Optical coherence Tomography is performe at baselline and after 6 months | 6 months | 
| Quality of Life | Quality of life is determined by questionaires at baseline and after 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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History of, Patients, acute