Once we pass a certain age, stress begins to take its toll. The blood pressure in blood vessels rises, our joints become even more impinched, as does the cartilage between the vertebrae in our spine, and the pressure in our eyes rises, a situation that could lead to loss of sight in a process known as glaucoma. Most of us already now how important it is to have the fluid levels in our eyes checked from a certain age onwards, in order to diagnose whether we are at risk of contracting glaucoma, and prevent the loss of vision that the pressure on the optic nerve could cause. The affects of the disease, it should be stressed, can go almost unnoticed. Its primary symptoms are the loss of peripheral vision, rather than vision in the focal area, so without testing, in many cases sufferers are unaware that they are losing their sight. This is why maintaining normal ocular pressure in the eyes is so important.
At present glaucoma is treated by medication in the form of eye drops to relieve ocular pressure. It has to be administered several times a day in order for it to be effective, and as long as the treatment regime is adhered to stringently, it does the job without too many side effects. The main problem with it is people and their lack of discipline - most patients do not have the patience or the inclination to put drops in their eyes several times a day. As people get older, their ability to stick to a chronic treatment regime declines, so many patients and doctors are looking for a procedure that will solve the problem permanently, or at least for many years. As a consequence, most patients, having tried medication, undergo a surgical procedure even though it could be expensive or a bit risky. The cost of surgery usually offsets that of protracted treatment by medication.
The surgical procedure most commonly used today is called Trabeculectomy, and entails the creation of an opening in the eye allowing fluid to drain away, thereby lowering pressure. There is also another surgical procedure, which can solve the problem without penetrating the eye, although only a few specialists feel that they are skilled enough to perform it. "The treatment is designed to drain the fluid from the sclera, the 'white of the eyes', whose function is to maintain the eye's shape and proper pressure," explains Dr. Joshua Degani, CEO of medical device start-up IOPtima Ltd. "This is a spongy tissue inflated by fluids. It has to remain inflated, so that it can continue regulating the space between the cornea and retina, thereby enabling the necessary focus of light rays for vision. To put it another way, if the eye is a kind of camera, the sclera serves as the camera box."
As mentioned earlier, the goal when treating glaucoma is to drain away the fluid from the eye. Doing this by perforating the sclera in one form or another would, perhaps, be the logical way to do this, but there is a risk that such a perforation could cause the entire sclera to collapse and stop holding the eye open. Likewise, it could also allow the passage of external contaminants into the eye itself. What is needed is a surgical procedure that will drain the eye, while leaving the eyeball intact.
"The disadvantage in the most commonly used surgical solution is that it entails an invasive penetration of the eyeball, something that can often cause contamination and the collapse of the eyeball," says Degani. "After lifting the sclera flap, a hole is made in the eyeball, which drains the excess fluid and regulates ocular pressure. Over the years, a number of expert surgeons have attempted to perform a similar procedure using a miniature scalpel, which they use to remove a layer several microns thick from the white of the eye, which makes the tissue thinner. Since the sclera is spongy in texture anyway, its narrowness allows the eye fluid to percolate out, if pressure rises above a certain level.
"This method has been found to be very safe and effective, but the drawback is that for a surgeon to do it solely by hand is almost a work of art. It's like passing water through a sponge. If we pour a lot of water on a sponge at high pressure, it will go right through it. If we pour a small amount of water at low pressure, it will be locked in the sponge. If we take a thinner sponge, the water will require less pressure to pass through it. This surgery achieves the desired result, without the risk of infection or collapse of the eye that the standard eyeball perforation entails."
This is where IOPtima's technology comes in. The company is a reincarnation of OptoTech, which was founded under the auspices of the Naiot Venture Accelerator incubator by Prof. Ehud Assia, and Michael Zlatkin, who both come from the laser technology field. Lasers are used in variety of surgical procedures but so far they have not been used in surgery to thin the scleral wall. The advantage of lasers is their ability to direct a beam of light that is extremely focused both in terms of coverage and color.
The ability to concentrate a beam of light on an very small surface and prevent its dispersal, creates a form of scalpel sharper than any existing blade. The ability to maintain a highly concentrated shade allows the laser to be adjusted so that its energy focuses solely on one specific color. So if, for example, we are projecting a red-colored beam onto the eyeball, a laser could be directed at the tissue and burn the marked area only, without affecting the surrounding tissue.
All this will be of little help to us if we want to control the depth of the surgical procedure rather than its location. IOPtima's technology is designed to provide a solution to this. The company has chosen to base its system on a carbon dioxide (CO2) laser, whose advantage is that its energy is absorbed and dissipated when it comes into contact with fluid. The procedure works by applying the laser to the fluid-laden eyeball, a process that gradually ablates it. Once the fluid begins to percolate through the scleral wall, the laser effectively ceases to ablate the tissue, and thin the wall, and is dissipated into the fluid. This ensures a natural and highly accurate level of thinning that will enable the excess fluid to drain away, but without damaging the eyeball's shape and without exposing it to the risk of collapse or infection. IOPtima also says that its procedure is "easy" to perform and takes a few minutes only.
The goal: restore vision
The system was first developed by OptoTech, which tested it on dead animals, and then live ones. It eventually received approval to conduct trials on humans, but these showed that although the device was able to carry out a basic procedure successfully and was found to be safe to use, the system and accompanying scarring prevention mechanism needed further improvements and optimization, something that OptoTech could not afford.
Bio-Light Israeli Life Sciences Investments Ltd. (TASE:BOLT) had already taken over four companies with potential that had done some significant work, but which could not continue on their own. It took over OptoTech as well, changed its name, and brought in Degani, a physicist at the Hebrew University who had worked at Bell Labs, and also at ECS (which later became Lumenis and grew Israel's laser cosmetic product industry). Over the last year, Degani and his team have been working on improvements to the system and the building of a new trials protocol. One of the system's advantages, from the financial aspect, is that a surgical procedure for thinning the scleral wall already exists and has a reimbursement code from health insurance providers, which will pay $1,000 towards the cost of surgery and also cover hospitalization costs.
IOPtima intends to complete the development of the improved laser system and begin trials on humans this year. Degani says that by supporting a safe surgical procedure, the healthcare system can save a phenomenal amount of the money that is currently spent on medication and treatment of glaucoma sufferers. "In contrast to medication, which merely slows the disease down, we believe that the surgical procedure has the potential not only to halt the onset of the disease and deterioration in vision, but also restore normal sight," he concludes.
Published by Globes [online], Israel business news - www.globes.co.il - on August 7, 2007
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