Visual Reconstitution Therapy After Optic Neuritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-03-31

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.

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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.

Conditions

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Optic Neuritis Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Visual Reconstitution Therapy

Group Type EXPERIMENTAL

Visual Reconstitutions Therapy

Intervention Type OTHER

Saccadic Eye Movement Training

Group Type ACTIVE_COMPARATOR

Saccadic Eye Movement Training

Intervention Type OTHER

Interventions

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Visual Reconstitutions Therapy

Intervention Type OTHER

Saccadic Eye Movement Training

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No