Non-Arteritic Anterior Ischemic Optic NeuropathyNCT00140491
Vision Restoration Therapy (VRT) to Treat Non-Arteritic Anterior Ischemic Optic Neuropathy
A study testing Vision Restoration Therapy (NOVAVISION) in people with Non-Arteritic Anterior Ischemic Optic Neuropathy, run by Emory University at 1 site in United States.
Trial summary
The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Non-Arteritic Anterior Ischemic Optic Neuropathy
- What is being tested?
- Vision Restoration Therapy (NOVAVISION)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Apr 2007
- Phase
- Interventional
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients seen by Dr Biousse or Dr Newman in the Neuro-Ophthalmology Unit at Emory University.
- Age ≥ 30 years.
- Diagnosis of non-arteritic ischemic optic neuropathy at least 6 months prior to inclusion.
- Uni- or bilateral AION (in case of bilateral AION, only one eye will be included in the study).
- Best corrected visual acuity of at least 20/60 in the study eye
- Altitudinal or arcuate visual field defect, splitting fixation by >10 decibel difference above and below horizontal meridian.
- Stable visual function demonstrated by more than two stable visual acuity measurements and two automated visual field testings prior to inclusion in the study.
- Patient willing, and able, to spend 60 minutes-a-day for 6 months working on a computer.
Who cannot join
- Patient cognitively or physically unable to perform reliable automated perimetry testing (on the 24-2 SITA Standard program) (which is grossly equivalent to the effort and attention needed to perform VRT daily at home).
- Other cause of optic neuropathy.
- Associated ocular disease requiring treatments or responsible for visual loss (such as untreated significant cataract, glaucoma, age related macular degeneration, etc…).
- Visual acuity worse than 20/60 in the study eye.
- Non-stable visual field defect on previous evaluations.
- Epilepsy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visual Field Defects in Non-Arteritic Anterior Ischemic Optic Neuropathy: Effect of Vision Restoration Therapy (VRT)
The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects.
Read the detailed description
Anterior ischemic optic neuropathy (AION) is one of the most common causes of optic neuropathy after the age of 50. There is currently no available treatment and although up to 40% of patients have some spontaneous improvement within the first few months, most patients remain visually devastated. About 50% of patients retain relatively spared central visual acuity with an inferior altitudinal visual field defect. These patients usually complain of difficulty reading and loss of depth perception.
Recently, training-induced enlargement of visual field defects has been demonstrated in some patients with VF defects secondary to lesions of the retrochiasmal visual pathways. This computer-based Vision Restoration Therapy (VRT) was developed in Germany and has been FDA-cleared in the United States for the past one year.
VRT is currently available at Emory for patients with homonymous hemianopia. Patients work on personally-designed software (on a laptop at home) twice daily (30 minutes each) for 6 months. Zones of partially damaged neurons, which are usually located between the intact and damaged area of the visual field (transition zone) are deliberately stimulated by VRT. There is only anecdotal evidence that this visual restoration therapy may be helpful in enlarging the visual field of patients with optic neuropathies.
The goal of this pilot study is to evaluate the effect of VRT on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects. The effect of VRT will be evaluated by visual acuity, color vision, stereo vision, Humphrey VF (24-2 SITA standard) testing, and scales evaluating reading speed and vision-based quality of life. These measures will be repeated before VRT, at 3 months, at 6 months, and at 1 year after VRT. 20 patients will be included in the study. Patients will be randomized at inclusion between VRT and sham (placebo)-training (10 in each group). The 10 patients receiving sham training will then receive VRT for the following 6 months if they so choose. All data will be analyzed in a blinded fashion. The company developing VRT in the United States (NOVAVISION) has agreed to provide VRT and sham-training.
- Being tested
- Vision Restoration Therapy (NOVAVISION)
- Keywords
- Non-Arteritic Anterior Ischemic Optic Neuropathy, Visual Field Defect, Neuroplasticity, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vision Restoration Therapy (NOVAVISION)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionApr 2007
- Study completionApr 2007
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 Non-Arteritic Anterior Ischemic Optic NeuropathyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valerie Biousse, Emory University
- Investigators
- Valerie Biousse, MD, Principal investigator, Emory Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00140491
- Sponsor's protocol ID
- 0435-2005
- Other IDs
- Valerie Biousse 404-778-5158
- Status last verified
- Oct 2013
- First submitted
- 30 Aug 2005
- Last updated
- 23 Oct 2013
- Results posted
- No
Publications
Jung CS, Bruce B, Newman NJ, Biousse V. Visual function in anterior ischemic optic neuropathy: effect of Vision Restoration Therapy--a pilot study. J Neurol Sci. 2008 May 15;268(1-2):145-9. doi: 10.1016/j.jns.2007.12.001. Epub 2008 Jan 22.
PubMed 18207164
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Field Defects in Non-Arteritic Anterior Ischemic Optic Neuropathy: Effect of Vision Restoration Therapy (VRT)
- ClinicalTrials.gov ID
- NCT00140491
- Acronym / sponsor ID
- 0435-2005
- Keywords
- Non-Arteritic Anterior Ischemic Optic Neuropathy, Visual Field Defect, Neuroplasticity, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 1 Sep 2005 (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.
The goal of this pilot study is to evaluate the effect of Vision Restoration Therapy, VRT, on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects.
Detailed description
Anterior ischemic optic neuropathy (AION) is one of the most common causes of optic neuropathy after the age of 50. There is currently no available treatment and although up to 40% of patients have some spontaneous improvement within the first few months, most patients remain visually devastated. About 50% of patients retain relatively spared central visual acuity with an inferior altitudinal visual field defect. These patients usually complain of difficulty reading and loss of depth perception.
Recently, training-induced enlargement of visual field defects has been demonstrated in some patients with VF defects secondary to lesions of the retrochiasmal visual pathways. This computer-based Vision Restoration Therapy (VRT) was developed in Germany and has been FDA-cleared in the United States for the past one year.
VRT is currently available at Emory for patients with homonymous hemianopia. Patients work on personally-designed software (on a laptop at home) twice daily (30 minutes each) for 6 months. Zones of partially damaged neurons, which are usually located between the intact and damaged area of the visual field (transition zone) are deliberately stimulated by VRT. There is only anecdotal evidence that this visual restoration therapy may be helpful in enlarging the visual field of patients with optic neuropathies.
The goal of this pilot study is to evaluate the effect of VRT on the visual function of patients with unilateral or bilateral AION, who have good central vision (at least 20/60) and altitudinal visual field defects. The effect of VRT will be evaluated by visual acuity, color vision, stereo vision, Humphrey VF (24-2 SITA standard) testing, and scales evaluating reading speed and vision-based quality of life. These measures will be repeated before VRT, at 3 months, at 6 months, and at 1 year after VRT. 20 patients will be included in the study. Patients will be randomized at inclusion between VRT and sham (placebo)-training (10 in each group). The 10 patients receiving sham training will then receive VRT for the following 6 months if they so choose. All data will be analyzed in a blinded fashion. The company developing VRT in the United States (NOVAVISION) has agreed to provide VRT and sham-training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients seen by Dr Biousse or Dr Newman in the Neuro-Ophthalmology Unit at Emory University.
- Age ≥ 30 years.
- Diagnosis of non-arteritic ischemic optic neuropathy at least 6 months prior to inclusion.
- Uni- or bilateral AION (in case of bilateral AION, only one eye will be included in the study).
- Best corrected visual acuity of at least 20/60 in the study eye
Key exclusion criteria (6 listed)
- Patient cognitively or physically unable to perform reliable automated perimetry testing (on the 24-2 SITA Standard program) (which is grossly equivalent to the effort and attention needed to perform VRT daily at home).
- Other cause of optic neuropathy.
- Associated ocular disease requiring treatments or responsible for visual loss (such as untreated significant cataract, glaucoma, age related macular degeneration, etc…).
- Visual acuity worse than 20/60 in the study eye.
- Non-stable visual field defect on previous evaluations.
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 |
|---|---|---|
| Vision Restoration Therapy (NOVAVISION) | Device | – |
Primary outcome
Visual Function
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 23 Oct 2013.
- Results publication: PubMed 18207164Jung CS, Bruce B, Newman NJ, Biousse V. Visual function in anterior ischemic optic neuropathy: effect of Vision Restoration Therapy--a pilot study. J Neurol Sci. 2008 May 15;268(1-2):145-9. doi: 10.1016/j.jns.2007.12.001. Epub 2008 Jan 22.
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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.
Valerie Biousse, MD principal investigator
Emory Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vision Restoration Therapy (NOVAVISION) in people with Non-Arteritic Anterior Ischemic Optic Neuropathy, run by Emory University at 1 site in United States.
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 8 inclusion and 6 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 23 Oct 2013. 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 United States. 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.
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 Function. 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 NCT00140491, 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 23 Oct 2013; AzTrials last refreshed its copy on 8 Nov 2026.