Assessment of VCCT from ophthalmology Perspective

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1 Assessment of VCCT from ophthalmology Perspective I am a hospital based ophthalmologist and currently a professor at Northeast Ohio College of Medicine. I am also a consultant for the Neuro Rehab Unit at Mercy Medical Center. I have been frustrated over my 28 years of practice in diagnosing and monitoring patients with cerebral stroke resulting in debilitating Hemianopsia. I am extremely excited with the research that Dr. Sadeghian has done; He has proven how to effectively rehabilitate patients with this debilitating visual handicap up to thirteen years after the fact. Such a time difference between brain injury and the total rehabilitation proves that these visual defects have not healed without treatment and are not by-products of spontaneous recovery. This treatment needs to be spread worldwide. I am certain that Neurologist and Ophthalmologist such as myself who deal with patients with similar handicaps will be as excited as I am regarding the results that Dr. Sadeghian presents.

2 It's known that 5 to 10 million cases a year suffer from strokes and yet only 750,000 come to the hospital for treatment of such we predict that 10,000 patients have visual defects. This treatment provides patients with complete recovery from an incurable disease, and encourages the discussion regarding this very exciting treatment and technology. Todd D. Fladen, MD Medical Director Fladen Eye center Rehabilitation of the Visual Field by using Color The last real treatment taking care of a serious neurological condition was introduction of L-dopa in 1964 which was used in treatment of Parkinson's disease. During the last fifty years there have been tremendous achievements in diagnosis of neurological problem, from CT scan, to Functional MRI. There are a wide variety of diagnostic instruments, however the treatments have been marginal at best and there has been no real breakthrough in treatment of any of the serious neurological conditions. Visual Chromatic Cover therapy is the first real treatment for a devastating neurological condition since L-Dopa. Hemianopia: The condition known as Hemianopia is a type of deficit in visual field where the decreased vision or blindness takes place in half of the visual field of one or both eyes. In most cases, the visual field loss respects the vertical midline. The most common causes of this damage include stroke, brain tumor and trauma. The word Hemianopsia is from Greek origins, where: "Hemi" means "half",

3 "an" means "without", "posit" means "seeing". Throughout the years there have been many attempts at trying to treat this condition utilizing two distinct methods: 1) Surgery or 2) different variations of re-institutive therapy, which usually consists of making modifications to different visual devices to encourage healing of the brain without using any invasive techniques. The injury caused by any of the above incidents usually leads to varying degrees of inability to see in different parts of the visual field. The mechanism of transport of information from the eye to the brain in right-hand dominant individuals is naturally designed to take images from the left side of both eyes to the right hemisphere of the brain and the right side of both eyes to the left hemisphere of the brain. Consequently, injuries in the right hemisphere of the brain cause difficulties in the left visual field of one or both eyes and injuries to left hemisphere causes difficulties in the right visual field of one or both eyes. At times the damage is not bad enough to interrupt the patient's visual abilities significantly. At other times, the deficit in the visual field is so extensive that it would cause total cutoff to half of the visual field of both eyes. Since visual abilities are involved in many of physical and cognitive abilities of the individual, this interruption of vision could potentially affect additional abilities, creating a unique syndrome for each person. This syndrome could potentially include additional difficulties with visual memory, visual reasoning, hand-eye coordination, ambulation, visual organization, and object naming. In many cases the patient suffers from significant disabilities, permanently interfering with life. A simple example could be the person's inability to see from the left visual field. This is commonly known as left-sided neglect and it can easily prevent the person from driving, as he or she does not see incoming objects on the road. Not being able to drive would deprive the individual from many forms of employment and in the case of someone who is operating heavy machinery, he would not be able to perform his job because of the potential danger to self and others.

4 Current Treatment methods: (1) Surgery: The utilization of surgery in treatment of heminapsia is quite limited and is only used in rare cases. (2) (2) Behavioral approach: Most of the attempts at patient rehabilitation are focused on behavioral methods that teach the patient to pay extra attention to the area that they do not see naturally. Although these behavioral methods do have some value they do not remedy the problem. They mostly involve adjusting to the disability. (3) There has been also a significant attempt at utilizing what is known as visual constraint therapy. In this method of treatment, parts, or the entire healthy portion, of the visual field is completely or partially blocked by using different methods of obstructing the visual field. This can be done with glasses, lenses or other devices. Although there have been many claims of success utilizing this technique, visual constraint therapy has not been successful enough to be accepted as an effective treatment for heminapsia. Also, in practical terms, the obstruction of a portion of the patient's glasses or lenses could be risky, as the patient is deprived of most of their vision until they adapt to the device. This hindrance makes visual constraint therapy an undesirable treatment for patients, and even those patients who enter into treatment have a high dropout ratio. Even in the cases of those patients who remain in treatment and who are willing to use the device, most frequently the blockage of the visual field is cosmetically undesirable as well, causing the patient to stand out in public. This leads to patient embarrassment and to using the device only when not in the public, resulting in minimal gain and eventual discontinuation of treatment, before significant gains have been made. Confronting the above facts, there is a need for a non-invasive method of treatment, which would not have the above limitations. The current invention is the product of several years of utilizing and modifying different devices to ameliorate achieve the afore-mentioned problems.

5 (4) VISUAL CHROMATIC COVER THERAPY (VCCT) (5) Utilization of VCCT places a heavy emphasis on accurate diagnosis of the areas of the deficits and on monitoring the patient's improvement continuously, and then modifying the patient's glasses based on information obtained through visual field exams. There is also a particular emphasis on not using any constraint, in order to avoid the obstacles mentioned before. (6) During the initial examination, the patient's visual field is assessed utilizing standard visual field examinations using accurate matrices. The patient is also advised to see his Opthamologist to rule out existence of other conditions and prevent unintended consequences. (7) Once the areas of damage are established, the patient's own prescription glasses - or simple non-prescription glasses of the patient's choosing - are coated with a specific translucent paint by highly sensitive machines, spraying specific amounts of paint on specific areas of the lens. (8) In this type of therapy, the results of the visual field examination dictate the precise application of lens coloring. The patient is instructed to wear the glasses at all times except during sleep and showering, if practical. It is emphasized that even small interruptions will significantly delay the improvement of the condition. (9) The patient is examined again in two weeks and a new visual field examination is conducted. If treatment is successful, the patient's new visual field examination usually manifests a significant improvement - above 50%. This significant improvement in such a short time is one of the areas of superiority of the Visual Chromatic Cover Therapy over other treatment modalities. (10) However the main advantage of Visual Chromatic Cover Therapy is that it actually works. There is no treatment I know of which can document anything more than random chance improvement a year after a stroke. We have not had even one case of failure since we replaced visual constraint therapy with Visual Chromatic Cover Therapy. (11) Since the brain is not forced to make new synapses or cure the areas that have been damaged, and is only forced

6 to use a different pathway to get the information to visual centers of the brain (occipital lobe), the process is quite faster. It is a simple rerouting of the information from the eye to the visual centers of the brain. (12) If there is no improvement, there is a high likelihood that the patient is not a good candidate for this treatment, and perseveration will not make much difference. The unsuccessful cases are usually those where the entire half of both eyes is totally blind. The causes are specific to the patient and could have a variety of origins. The most common cause is when the damages are caused by underlying medical problems, such as Glaucoma. (13) In most cases, there is a distinct improvement. (14) The practitioner should clear the patient's glasses of paint and wash the glasses thoroughly to remove any scratches on the lens and for sanitation reasons. Glasses are painted again using the same method. However, all efforts are taken not to make major changes, as one would not want to interfere with a process that has been successful already. This process is repeated every two weeks until the problem is totally resolved or maximum gain has been reached. Treatment is usually completed in four weeks. This is followed by having the patient wear glasses with clear lenses for two weeks. At the end of six weeks, a final visual field exam is conducted to make sure there are no relapses and no recurrences of the problem. As the individual ages, one cannot take the improvement for granted. Other problems can occur, causing regression. For example, if the original cause of the problem was several TIAs there is the possibility of having more TIAs, causing regression and requiring re-institution of the treatment. It is well known that patients with a neurological problem are prone to having additional neurological problems. In the case of a stroke, the possibility of having a second stroke is more then 60%. Therefore, careful monitoring of the condition is essential.

7 (15) (16) (17)

8 It should be emphasized that the use of color is quite benign and most patients adapt after two days to the color so well that they see external objects in their true colors while their field of vision is covered with a specific paint. This result is in contrast to visual constraint therapy where the obstruction remains a hindrance. In other words, they can live with the colored lenses while adjusting to the visual constraint. Patented 2013: All rights reserved