A Phase 2 interventional study of Visual Reconstitutions Therapy and Saccadic Eye Movement Training in Optic Neuritis and Multiple Sclerosis, sponsored by Friedemann Paul. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-29.
Sponsored by Friedemann Paul · Phase 2, Interventional, and Treatment
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.
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.
88 studies on the registry are indexed under Optic Neuritis; 16 are open to participants now.
This study's enrollment of 25 is below the median of 50 across 58 interventional studies indexed under Optic Neuritis.
Browse Optic Neuritis studies →Friedemann Paul is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Visual Reconstitutions Therapy
Other: Saccadic Eye Movement Training
Visual field
visual field perimetry and kampimetry at baseline and after 3 and 6 months
Time frame: 6 months
structural retinal changes
Optical coherence Tomography is performe at baselline and after 6 months
Time frame: 6 months
Quality of Life
Quality of life is determined by questionaires at baseline and after 6 months
Time frame: 6 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Friedemann Paul