Visual Reconstitution Therapy After Optic Neuritis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01274702

Acronym

VISION

Enrollment

Registered

2011-01-11

Start date

2010-05-31

Completion date

2013-03-31

Last updated

2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Optic Neuritis

Keywords

History of, Patients, acute

Brief 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.

Detailed 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.

Interventions

OTHERVisual Reconstitutions Therapy

OTHERSaccadic Eye Movement Training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Visual field	6 months	visual field perimetry and kampimetry at baseline and after 3 and 6 months

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026