Visual Reconstitution Therapy After Optic Neuritis

Phase 2

Completed

• Conditions: Optic Neuritis; Multiple Sclerosis
• Interventions: Other: Visual Reconstitutions Therapy; Other: Saccadic Eye Movement Training

• Registration Number: NCT01274702
• Lead Sponsor: Friedemann Paul

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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visual Reconstitution Therapy	Visual Reconstitutions Therapy	-
Saccadic Eye Movement Training	Saccadic Eye Movement Training	-

Primary Outcome Measures

Name	Time	Method
Visual field	6 months	visual field perimetry and kampimetry at baseline and after 3 and 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin; 🇩🇪 Berlin, Germany