|
In March of this year, the Singapore Eye Research
Institute (SERI) in collaboration with the Defence Medical Research
Institute (DMRI) embarked on a 20 patient pilot study to evaluate
the efficacy of NVCTM treatment in enhancing vision in Singaporeans
with low degrees of myopia of -1.5 D (150 degrees) and below. The
new and highly novel clinical trial aims to evaluate an innovative
vision training programme which may have the potential to improve
vision without the use of glasses, contact lenses, drugs or surgery
in individuals with various eye problems such as myopia and amblyopia
(lazy eye).
Although this study is currently still in progress,
it seems clear that the technology does have the ability to improve
visual acuity in our patients. To date, 75% of all cases, and 83%
of those who have completed treatment have shown improvement in
unaided visual acuity. The average improvement exceeds 2 lines of
acuity as measured on a standard eye test chart, with some eyes
improving as much as 5 lines of acuity. The overall average starting
vision was just below 6/12, and the latest average vision is currently
close to 6/6 vision.
NeuroVision's NVC vision correction technology is a non-invasive,
patient-specific computerized treatment based on visual stimulation
and facilitation of neural connections responsible for vision. NeuroVision's
Neural Vision Correction™ (NVC) technology has been developed
through research focused solely on optimizing performance of the
neural or "back end" of the visual system, and is based
on two decades of visual neuroscience research by a group of leading
neuroscientists, whose work, which has been published in leading
scientific journals such as Nature, relates to understanding how
the brain processes visual information, how neural activity is related
to visual perception, and how visual processing interacts with other
neural systems. This background of sound and proven neuroscientific
principles sets this technology far apart from other less scientific
forms of purported vision training or eye relaxation exercises.
The fact that no optical devices, surgery, laser treatment or drugs
are involved in NeuroVision treatment also ensures maximum safety,
as compared to current forms of vision correction, such as contact
lenses, or laser surgery.
Vision quality depends on the ability of our eyes to capture visual
images from around us, the transmission of this visual information
to a specific area of our brain known as the visual cortex, and
the visual processing that occurs within the brain itself. NeuroVision
technology focuses on the visual processing occurring in the visual
cortex.
NeuroVision's technology probes specific neuronal
interactions, using a set of patient-specific stimuli that improve
neuronal efficiency and induce improvement of contrast sensitivity
function due to a reduction of noise and increase in signal strength.
This improved contrast sensitivity function is then followed by
an accompanying improvement in visual acuity.
Amblyopia, in which the visual function of
the brain is underdeveloped in childhood, is characterized by several
functional abnormalities in spatial vision, including reduction
in visual acuity and contrast sensitivity. However, there is plasticity
of neural interactions even in the adult brain, and the treatment
procedure developed by NeuroVision trains these neural interactions
by efficiently stimulating the specific neurons and effectively
promoting spatial interactions among these neurons.
In myopia, it is the optics of the eye that results in blurred vision,
and the visual cortex and neural connections are normal. However,
myopic individuals also perceive high spatial frequency images as
low contrast images, i.e. their contrast sensitivity is also diminished,
and NeuroVision technology is also likely to improve visual acuity
in myopic individuals by enhancement of contrast sensitivity.
Clinically Proven Treatment for Adult Amblyopia (Lazy Eye), previously
considered as untreatable
The technology has been clinically proven in
the treatment of adult amblyopia (otherwise known as "lazy
eye"), which until now has been considered untreatable - an
FDA-regulated Randomised Clinical Trial with follow-up of up to
2 years shows good retention of visual improvement. The company
has received FDA 510(k) marketing clearance indicating NVC for the
treatment of adult amblyopia in patients 9 years or older in the
US. The company also received a Medical CE-Mark to market its Amblyopia
and Low-Myopia products in the European Union. Company products
are also approved for use in Israel by the Israeli Ministry of Health
- Device License Authority. Additional proof-of-concept studies
have been performed in Israel, indicating the technology's potential
to improve vision of subjects having low degrees of myopia.
Based on the promising results of our pilot study, a pivotal, full-scale
randomized controlled trial involving 360 subjects will be conducted
by SERI in collaboration with DMRI and SNEC in 2 Phases: Phase I
will involve study subjects with low myopia not exceeding -1.5D
(150 degrees), while Phase II will involve study subjects with moderate
myopia between -1.75D to -3.00D (175 degrees - 300 degrees). Study
recruitment is envisaged to start in December 2003.
SERI will further be embarking on a second
randomized controlled trial on the treatment of adult and childhood
amblyopia. Amblyopia, or lazy eye, is thought to affect up to 2%
of the population, and was previously thought to be untreatable.
In addition, we will also be conducting 3 new pilot studies on other
eye disorders to ascertain if NeuroVision technology can enhance
vision in other conditions. These include 1) individuals with normal
vision - the idea here is to see if normal vision can be enhanced
to "supernormal" levels, 2) presbyopia - there appear
to be a few presbyopic individuals who have undergone NV treatment
who also report improvement in their near vision, and 3) enhancing
vision in individuals who have previously undergone laser refractive
surgery (eg LASIK), and who need further improvement in their vision.
NeuroVision presents an innovative, non-invasive vision improvement
technology, currently the only existing technology of its kind,
backed by strong scientific and clinical research. The Singapore
Eye Research Institute is NeuroVision's preferred research partner
to evaluate and develop new and pivotal clinical trials to enhance
vision in a variety of visual disorders.
NVCTM technology seems to be one of the most
promising technologies evaluated by SERI in recent years and has
the potential to make a tremendous impact in the eye-care industry
in Asia and worldwide.
Hotline for Singapore Neurovision Trials: 6 877 7167
Assoc Prof Donald Tan FRCSE, FRCSG, FRCOphth,
FAMS
Principal Investigator
Singapore NeuroVision Trials
Director, SERI
Deputy Director, Singapore National Eye Centre
Head, Dept of Ophthalmology, National University of Singapore
For further information, please contact:
Ravi Chandran
Corporate Communications Executive
Singapore National Eye Centre
For Singapore Eye Research Institute
E-mail: ravi@snec.com.sg
|
Copyright
© 2004. Singapore National Eye Centre. All rights reserved.
