Optic NeuritisPhase 2VISIONNCT01274702
Visual Reconstitution Therapy After Optic Neuritis
A Phase 2 study testing Visual Reconstitutions Therapy and Saccadic Eye Movement Training in people with Optic Neuritis and Multiple Sclerosis, run by Friedemann Paul at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Optic Neuritis, Multiple Sclerosis
- What is being tested?
- Visual Reconstitutions Therapy and Saccadic Eye Movement Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
- Additional significant ophthalmological disease
- Pregnancy
- History of Epilepsy
- Significant arterial Hypertension
Trial locations and contacts
1 site in 1 country.
Germany1 site
NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin
Berlin, 10117
About this study
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.
Read the 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.
- Conditions
- Optic Neuritis, Multiple Sclerosis
- Being tested
- Visual Reconstitutions Therapy, Saccadic Eye Movement Training
- Keywords
- History of, Patients, acute
- Medical subject headings
- Optic Neuritis, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Reconstitutions TherapyOther
Saccadic Eye Movement TrainingOther
| Study group | Role | What they receive |
|---|---|---|
| Visual Reconstitution Therapy | Experimental | Not described Receives: Other: Visual Reconstitutions Therapy |
| Saccadic Eye Movement Training | Active comparator | Not described Receives: Other: Saccadic Eye Movement Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field
visual field perimetry and kampimetry at baseline and after 3 and 6 months
Measured: 6 months
Secondary outcomes (2)
structural retinal changes
Optical coherence Tomography is performe at baselline and after 6 months
Measured: 6 months
Quality of Life
Quality of life is determined by questionaires at baseline and after 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2011 (estimated)
- Study startMay 2010
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Optic NeuritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friedemann Paul
- Sponsor type
- University, hospital or other
- Collaborators
- Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie
- Responsible party
- Sponsor-investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Friedemann Paul, MD, Principal investigator, NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274702
- Sponsor's protocol ID
- Vision Study
- Acronym
- VISION
- Status last verified
- Jul 2021
- First submitted
- 10 Jan 2011
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schinzel J, Schwarzlose L, Dietze H, Bartusch K, Weiss S, Ohlraun S, Paul F, Dorr J. Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial. Trials. 2012 Jun 28;13:94. doi: 10.1186/1745-6215-13-94.
PubMed 22742888
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Reconstitution Therapy After Optic Neuritis
- ClinicalTrials.gov ID
- NCT01274702
- Acronym / sponsor ID
- VISION / Vision Study
- Conditions
- Optic Neuritis, Multiple Sclerosis
- Keywords
- History of, Patients, acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Friedemann PaulUniversity, hospital or other
- Collaborators
- Beuth Hochschule für Technik Berlin, NovaVision AG, Zentrum für Sehtherapie
- Study start
- May 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 11 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visual Reconstitution Therapy | Experimental | Other: Visual Reconstitutions Therapy |
| Saccadic Eye Movement Training | Active comparator | Other: Saccadic Eye Movement Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Systemic Treatment with Glucocorticosteroids within 30 days prior to Screening
- Additional significant ophthalmological disease
- Pregnancy
- History of Epilepsy
- Significant arterial Hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Reconstitutions Therapy | Other | Visual Reconstitution Therapy |
| Saccadic Eye Movement Training | Other | Saccadic Eye Movement Training |
Primary outcome
Visual field
Time frame: 6 months
visual field perimetry and kampimetry at baseline and after 3 and 6 months
2 secondary outcomes
structural retinal changes
Time frame: 6 months
Quality of Life
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 22742888Schinzel J, Schwarzlose L, Dietze H, Bartusch K, Weiss S, Ohlraun S, Paul F, Dorr J. Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial. Trials. 2012 Jun 28;13:94. doi: 10.1186/1745-6215-13-94.
- NeuroCure Clinical Research Center, Charité Berlin, GermanyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Friedemann Paul, MD principal investigator
NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visual Reconstitutions Therapy and Saccadic Eye Movement Training in people with Optic Neuritis and Multiple Sclerosis, run by Friedemann Paul at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01274702, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.