Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00469612
Status:
TERMINATED
Last Update Posted:
2018-09-25
First Post:
2007-05-03
Brief Title:
Evaluating NeuroVisions Neural Vision Correction NVC Myopia Treatment
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Evaluating the Efficacy of NeuroVisionss NVC Treatment for Low Myopia
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was stopped due to lack of resources on part of investigators
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the present study is to carry out a trial to evaluate the clinical efficacy of the NeuroVision Low Myopia Treatment
The specific questions to be answered are
1 Is there an improvement in vision following the treatment without bringing about a change in the subjects prescription for glasses
2 Can any treatment effect be seen at 6 months and 12 months after the termination of the treatment
The specific questions to be answered are
1 Is there an improvement in vision following the treatment without bringing about a change in the subjects prescription for glasses
2 Can any treatment effect be seen at 6 months and 12 months after the termination of the treatment
Detailed Description:
Myopia and its treatment modalities are one of the widely studied areas in vision research So far all the treatment options have been optical ie patients with myopia are either corrected with spectacles contact lenses or refractive surgery to provide clear vision NeuroVisions NVC vision correction technology will be a novel method in the treatment of low myopia as the technology is directed at specific neuronal interactions at the level of the visual cortex area responsible for vision in the brain It uses a non-invasive patient-specific treatment that purports to improve neuronal efficiency and induce improvement in the overall ability to see due to a reduction in noise and increase in signal strength As visual perception quality depends both on the input received through the eye and the processing in the visual cortex NeuroVisions technology is hypothesized to compensate for blurred myopic inputs by enhancing neural processing
We will conduct a clinical evaluation of the effectiveness of this system The subject will be exposed to a set of visual stimulations pattern with black and white lines and visual threshold level will be obtained The subject will look at these patterns on a computer The treatment will be applied in successive 30-40 minute sessions administered 2-3 times a week for a total of 40 sessions Every 5 sessions subjects visual performance visual acuity ability to see letters of varying size and CSF ability to see black and white lines of varying contrast will be tested in order to continuously monitor a subjects progress At the end of a session the data will be sent to the NeuroVision Web Server Proprietary algorithmic software will analyze the patients performance and progress and will generate the parameters for the next treatment session The purpose of the study is to assess the effect on corrected or uncorrected visual performance following treatment
We will conduct a clinical evaluation of the effectiveness of this system The subject will be exposed to a set of visual stimulations pattern with black and white lines and visual threshold level will be obtained The subject will look at these patterns on a computer The treatment will be applied in successive 30-40 minute sessions administered 2-3 times a week for a total of 40 sessions Every 5 sessions subjects visual performance visual acuity ability to see letters of varying size and CSF ability to see black and white lines of varying contrast will be tested in order to continuously monitor a subjects progress At the end of a session the data will be sent to the NeuroVision Web Server Proprietary algorithmic software will analyze the patients performance and progress and will generate the parameters for the next treatment session The purpose of the study is to assess the effect on corrected or uncorrected visual performance following treatment
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