Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140491
Status:
COMPLETED
Last Update Posted:
2013-10-23
First Post:
2005-08-30
Brief Title:
Vision Restoration Therapy VRT to Treat Non-Arteritic Anterior Ischemic Optic Neuropathy
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Visual Field Defects in Non-Arteritic Anterior Ischemic Optic Neuropathy Effect of Vision Restoration Therapy VRT
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 2060 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 2060 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
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 2060 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Valerie Biousse 404-778-5158 | None | None | None |