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OpenTrials
Completed

NCT Number: NCT01274702

Visual Reconstitution Therapy After Optic Neuritis

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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Key information

Conditions

Optic Neuritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Optic Nerve Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin

Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visual Reconstitutions Therapy

Other

Saccadic Eye Movement Training

Other

Primary outcomes

  1. Visual field

    Time frame: 6 months

    visual field perimetry and kampimetry at baseline and after 3 and 6 months

Secondary outcomes

  1. structural retinal changes

    Time frame: 6 months

    Optical coherence Tomography is performe at baselline and after 6 months

  2. Quality of Life

    Time frame: 6 months

    Quality of life is determined by questionaires at baseline and after 6 months

Sponsors and collaborators

Lead sponsor

Friedemann Paul

Other

Collaborators

  • Beuth Hochschule für Technik Berlin
  • NovaVision AG, Zentrum für Sehtherapie

Registry information

Acronym: VISION

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 11, 2011
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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