A new laser therapy that can potentially remove cataracts from people's eyes more efficiently and with greater precision was presented on October 24, 2009 at the American Academy of Ophthalmology (AAO) annual meeting. The technology, currently undergoing clinical trials outside the USA, was developed by LenSar, a start-up company which is in a head-to-head competition with two other players to be the first to commercialize the technology. LenSar plans to start treating patients if the FDA will consider the results of the remaining trials to be both safe and effective.
Although the new device will cost more than existing technologies, the speed of surgery may compensate for that by allowing more procedures to be performed in less time. The new laser cataract device is designed to be safer and easier to use, and it is believed that most cataract surgeons can learn to use it to perform surgeries with less complications. The laser will allow for the use of "premium" implants which set up bifocal vision as well as provide a better way to treat astigmatism.
The LensAR system will not only deliver precise all laser capsulotomies, CCIs and LRIs, but laser fragmentation of the cataract. This approach will significantly reduce, and even eliminate the use of ultrasound power in most cases.
Five years ago, I brought together a group of gifted engineers and scientists, many of whom, I had worked with on the successful development and launch of the Autonomous laser-radar tracking and small spot scanning excimer system that set a new standard in precision in LASIK surgery, when approved by the FDA in 1998. Measurement guided beam delivery was taken to a whole new frontier when Autonomous delivered wavefront guided custom LASIK treatments to ophthalmology.
This time, I challenged the team to design and develop a highly integrated measurement technology within a 3-dimensional scanning femtosecond laser system capable of performing many types of surgical incisions, in eyes of all shapes and sizes. We are specializing in laser cuts in refractive cataract surgery that are critical to successful surgical outcomes: cuts that are currently performed with a blade, or with ultrasound, and therefore, prone to a measureable degree of variability.
The LensAR approach is to bring the accuracy and precision of lasers into the operating room to replace blades and greatly reduce, if not eliminate, the need for ultrasound power to perform the majority of cataract removals. The design goals also requires that the system increase the overall surgical efficiency and safety of lens removal, and improve the stability of the intraocular lens placement.
The result is the LensAR (femtosecond) laser system, a seamless integration of an advanced femtosecond laser and proprietary measurement and laser scanning technology. The LensAR laser system is being designed to provide flexible, all laser surgical options for clear corneal incisions, paracenteses, limbal relaxing incisions, lens fragmentation and customizable capsulotomies - all in one procedure.
To date, the LensAR laser system has been successfully used in well over a hundred eyes outside of the US, and is actively under review with the FDA for approval for use in the US.
As we complete our surgical and technology webpages, you will be able to look at surgical footage of our investigators Dr. Ramon Naranjo and Dr. Jorge Villar from Mexico City, and to hear candid comments from leading US surgeons that also have experience with the LensAR laser: David Chang, MD, William Fishkind, MD and Louis “Skip” Nichamin, MD.
The 2009 contest "Changing the Way People See the World" on the other hand, aims at encouraging people to do anything positive that helps someone else, and record it on video.
Each person that submits a video will receive a $1000 discount on LASIK, and the winning entry will be awarded a 100% free LASIK eye surgery procedure.
In addition to rewarding those who enter videos, Eye Doctors of Washington’s Washington, DC and Maryland LASIK practice will donate a free pair of glasses to charity for each video submitted.
Participants may videotape themselves, a friend, a family member, or even a stranger performing a good deed.
Contestants can submit their videos from now until May 31st, 2009.
For more information on the "Changing the Way People See the World" contest, visit: http://www.edow.com/contest/
The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database.
You will need to know the manufacturer or device name of the laser.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
WRINKLE TREATMENT
Lasers are also being used to treat wrinkles. Several manufacturers have received FDA clearance to claim treatment of wrinkles, while others may claim skin resurfacing. Patients have reported reddening of the skin, which lasted from one to four months. Pain was mild and could be treated with over-the-counter analgesics. Consumers should bear in mind that skin abrasion, whether achieved by lasers, chemicals or abrasive materials, means removing one or more layers of skin, which can be painful and could cause redness, swelling or scarring, depending on how each person heals.
People considering this procedure should consult a dermatologist or the manufacturer to determine whether or not they would be good candidates. Be sure to ask your dermatologist for a copy of the patient labeling for the specific laser device used to understand the risks.
DENTAL TREATMENTS
Several manufacturers have received clearance for argon and carbon dioxide lasers to activate tooth-bleaching solutions and to treat gum disease. Several lasers have clearance for hard tissue use on teeth. On May 7, 1997 FDA cleared the first laser system for treating tooth decay, an erbium YAG laser made by Premier Laser Systems. Recently, American Dental Technologies received FDA clearance to market its laser for caries removal; it is not cleared to remove tooth enamel.
Studies conducted by the manufacturers showed that the laser is as safe and effective as a high-speed drill for removing dental decay and preparing a cavity for a filling. The manufacturer's study indicated that fewer patients needed anesthetic for pain. Any inquiries regarding this method of cavity treatment should be directed to your dentist, who can provide you with patient labeling including risks for the specific laser.
EYE SURGERY
Lasers may be used to remove tissue in eye surgery as well. This may include removing tumors, cataracts, or proliferating blood vessels common to diabetic retinopathy. Several manufacturers have lasers cleared for photorefractive keratectomy (PRK) and Laser-Assisted In Situ Keratomileusis (LASIK), two procedures for correcting nearsightedness, farsightedness, and astigmatism. The laser is used to reshape the cornea and focus images correctly on the retina. For information on eye surgery and which lasers have received clearance, you can access FDA's Website at: http://www.fda.gov/cdrh/LASIK. As with the other types of patient labeling, be sure to ask the surgeon for the patient labeling for the specific laser device being used.
OTHER MEDICAL USES
Some lasers have been cleared for medical uses such as removing tissue. Because heat from lasers cauterizes blood vessels, there is less bleeding compared to scalpel use. Usually, FDA gives manufacturers general surgical clearances; in order to promote the laser for a specific surgical procedure, manufacturers must first provide FDA with clinical evidence that their lasers are safe and effective for that specific procedure. If you wish to learn whether a specific laser has been cleared for a specific indication, you may contact FDA's Consumer Staff. You will need to provide the name of the manufacturer and the specific product name of the device before contacting the Consumer Staff.
PRACTITIONERS
States regulate who can use lasers for various therapeutic procedures. Medical lasers are prescription devices available for sale only to licensed practitioners. You should check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state.
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim.
LASER RADIATION SAFETY
All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11). This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.
Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard. The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the DSMICA web site at: http://www.fda.gov/cdrh/devadvice.
Distribution of any certified laser products internationally would also require submission of the report.
The structure of the eye is composed of a single, outwardly curved (convex) clear lens, the cornea, at the front and a lengthy 'fiber optic' cable, the optic nerve, extending from the back. It is essentially an empty structure, except for the colored iris, a circular band of muscles that controls the size of the pupil, which allows variable amounts of light to pass to the back inside the surface of the eye. The amount of pigmentation of the iris determines its color. Blue eyes, for example, have very little amount of pigment, and black eyes have the most. The pupil is the central transparent area, that is controlled by the ciliary muscles in the iris, that make the pupil smaller when the amount of light is excessive, and vice versa.
Light rays pass through the clear cornea, which due to its curved surface, is able to bend (refract) the light rays. These light rays are concentrated together and pass through the pupil. Then, they go through the normally clear lens which has two curved surfaces, the front and the back. Therefore, these light rays are bent (refracted) two more times on their trip to the back of the eye.
The light rays travel to the back surface of the eye through the vitreous, a clear jelly which fills the space between the back of the lens and the retina, the inside lining of the back surface of the eye which contains specialized cells which convert light energy into electrical impulses. These cells are either called rods, specialized for black and white images, or cones, that mainly process color images. In dim light, we use our rods, which cannot work in bright light. To deal with bright or moderate light, we use our cones, that beside providing color vision, they also process some aspects of black and white vision and the ability to discern fine detail.
What is truly amazing about the eye is how part of these cells in the retina (photosensitive cells) actually are a six inch appendage of the cell, the axon, which joins with other axons to compose the optic nerve which travels to the brain stem, the very top of the spinal cord, located at the very center of the brain. There, each axon connects (synapses) with a cell or cells, and the axon of the receiving cell(s) travels another six inches to the back of the brain, the occipital lobe, where it synapses with a brain cell(s) to produce what we call vision.
Therefore, the major functions of these parts of the visual system are composed by:
Cornea: Refracts light rays
Pupil: Controls the amount of light entering the eye
Lens: Refracts light rays
Vitreous: Light traverses this space
Retina: Converts light energy to electrical energy
Optic Nerve: Transmits electrical energy from the retina to the brain stem
Brain Stem: Intermediate 'relay station' for visual fibers
Occipital Cortex: Final destination. Converts electrical energy to visual images
A "Perfect Eye" would therefore have:
a clear and unobstructed path from the front of the eye to the back of the eye.
the proper balance between the length of the eye and the curvatures of the three refracting surfaces.
properly functioning cells in the retina and brain which allow the conversion of light energy to electrical energy, the transmission of this energy, and the interpretation of the energy into what we call vision.
Unfortunately, most people do not have "perfect eyes".
Eyes that are too long or have too much refracting power (from the cornea and the lens) are nearsighted eyes, as images are focused in front of the retina. The image received by the retina is not a 'dot for dot' representation of what the image viewed by the eye. Instead, each of these 'dots' of light becomes enlarged to form a 'disc' of light with a consequent spread of the dot image to adjacent parts of the retina. This is what causes blurring of vision.
The opposite results when eyes or too short or have too little refracting poser. These eyes are farsighted, as images are focused (or would be) behind the retina. The same type of dot to disc representation occurs.
When light rays that are vertically oriented are not refracted the same amount as the light rays that are horizontally oriented, this condition is called astigmatism. An example would be when that eye looks at a building that is built as a square, it would appear as a rectangle with different vertical and horizontal dimensions being visualized. This example refers to strictly vertical (90 degrees) and strictly horizontal (0 degrees); astigmatism can occur at any angle between 0-180 degrees.
On a more dynamic level, the eye can possess no refractive error whatsoever but is unable to adjust to near images by increasing its refractive powers. This condition is termed presbyopia and normally affects persons in their 40s and early 50s. The mechanisms within the eye that can increase the curvature of the lens (accommodation) become less efficient and external plus lenses are necessary to bring the near images into focus.
The eye is truly like a camera because it not only requires proper focusing (refraction) but it requires a clear media through which light rays must pass. Any loss of clarity of the structures through which these light rays must pass will interfere with their successful interpretation within the visual cortex of the brain. Examples of disorders which might cause this scattering or absorption of light rays are opacities or swelling of the cornea (scars, edema, abrasions, etc.), opacification of the lens (cataract), and cloudiness of the vitreous (hemorrhage or inflammation.)
Also, the receiving tissue, the retina must be functioning properly, as opposed to aged related macular degeneration, in which there is deterioration of the most important part of the retina, the macula, which is responsible for our finest and our reading vision.
The range of patologies which can be treated with Laser Eye Surgery are:
Myopia (nearsightedness): -0.75 diopters to -10.0 diopters
Hyperopia (farsightedness): +0.75 diopters to +5.0 diopters
Astigmatism (associated with myopia): 0 to 4.0 diopters
Presbyopia (the eye's diminished ability to focus that occurs with aging).
Traditionally, many of these conditions were often treated with prescription glasses or contact lenses. Today, a number of innovative Laser Eye Surgery procedures are widely available. There are three main types of Laser Eye Surgery:
PRK (Photo Refractive Keratectomy) has been the standard eye laser surgery for many years. It involves the complete removal of the epithelium or the outer layer of cells on the eye, with the use of a "cold" laser light. PRK is mostly used on patients with low to moderate amounts of Myopia Astigmatism. Below you can watch a video showing a PRK surgical intervention:
LASEK (Laser Assisted Sub-Epithelial Keratectomy) or EPIFLAP (Laser Assisted Epithelial Keratomileusis) surgery involves the fractional removal of the epithelium to reveal the cornea, which is then firmed or reshaped by a laser. The outer layer of cells is then pushed back, and the eye heals shortly after. LASEK is used on patients with low to moderate amounts of Myopia or Astigmatism. Below you can watch a video showing a LASEK surgical intervention:
All of these treatments have been approved for use in many countries around the world and are therefore considered to be safe. But it must be taken into account that all types of surgery does involve risks and eye surgery is no different. There have been cases during which patients have suffered major complications and required cornea transplants following laser treatment.
Not everyone can have laser eye surgery. Although eye laser surgery is usually suitable for healthy adults and can be performed on virtually any eye, sometimes it is not advisable. Several factors could influence negatively the outcome of these operations: AGE: It is advisable that a person undergoing Laser Eye Surgery should be at least eighteen years old. It is assumed that the refractive error (prescription) of the patient will be fairly stable at this time. However, there's no upper age limit for Laser Eye Surgery eligibility, since it does not affect the nature or outcome of the surgery. ENDOCRINE: Hormone fluctuations can affect the refractive error of a person's eye. Surgery during a period of such instability would probably produce changes which would not be correct once the endocrine system returns to normal. Therefore, Laser Eye Surgery is not recommended for women who may be pregnant, nursing, or undergoing changes in oral contraceptive therapy. HEALTH: Because the cornea is composed of a matrix of collagen fibers, the same material which comprises tendons and other connective tissue, people who have autoimmune disorders, e.g., rheumatoid arthritis, Sjogren's Syndrome, Systemic Lupus Erythematosis, etc., may be at risk for unpredicted changes following surgery. Other medical problems, such as diabetes mellitus, high blood pressure, heart problems, etc. do not affect the outcome of Laser Eye Surgery surgery. HERPES VIRUS INFECTION: A history of herpes simplex infection of the eye may be a contraindication to Laser Eye Surgery surgery. It is believed that the virus may permanently reside in nerve cells outside the eye and that any kind of surgery might reactivate an infection. However, this area is undergoing change. Studies are being done to see if treatment with antiviral medication prior and after the operation might prevent such a recurrence. Herpes infections in other parts of the body do not pertain to qualifying for Laser Eye Surgery surgery. PUPIL SIZE: The excimer lasers currently treat an area of the cornea that measures about 7 to 8 mm in diameter. Therefore, it is important that the pupil size be less than the area of treatment. Most of the reported difficulties with glare experienced by patients come from those with pupillary size irregularities. REFRACTIVE ERROR: Most persons are either nearsighted or farsighted with some degree of astigmatism. After age of 40, people also experienced difficulties with focusing at near, a condition known as presbyopia. Although none of the procedures described above can be used for this condition, for such patients there exists laser thermal keratoplasty (LAPR), in which mild laser heat is used in a three-second procedure to shrink collagen in the periphery of the cornea to steepen the eye's surface for correction of near vision in farsightedness or presbyopia. End results are similar to Conductive Keratoplasty (CK), which is also used to treat this condition. This procedure uses radio frequency energy to apply heat to very tiny spots around the cornea.
They can reshape the cornea to give patients 20/20 vision. They can smooth out wrinkles. They can reduce neck and back pain. They can even remove birthmarks.
And that's just the beginning.
Lasers can vaporize varicose veins, zap stubborn acne and get rid of unwanted hair. In the past decade, lasers also have been approved to unclog arteries, crush gallstones and repair damaged retinas.
Lasers are playing a growing role in medical care as technology has improved and doctors are finding new uses for the devices. "The industry is growing at record paces," says A. Jay Burns, a plastic surgeon in Dallas and former president of the American Society for Laser Medicine and Surgery.
Medical lasers use tubing to deliver highly focused beams of light that pass through a crystal or gas. The material the light passes through helps determine what the light energy does to the body.
Though lasers have made many inroads in medicine in the past decade, numerous other applications are now being tested.
Lasers are expected to play a greater role in diagnosing disease and helping identify cancerous tissue, Burns says. For example, studies are examining how lasers can be used in colonoscopies to help doctors immediately detect cancerous tissue rather than waiting days for a laboratory analysis. Researchers also are trying to see whether lasers can speed the healing of broken bones, help regenerate nerves in patients with injured spinal cords and help grow skin in burn victims.
"This is a compelling technology that's becoming easier to deploy," says John Ambroseo, CEO of Santa Clara, Calif.-based Coherent Inc., a major maker of medical lasers.
Costs — and sizes — shrink
Laser treatment procedures' low costs and the shrinking size of the devices have enabled spas and beauty salons to install them. But the rapid growth in the field has raised concerns about whether laser procedures are being overused and misused.
Many doctors have begun doing cosmetic laser procedures largely to augment their incomes, says J. Stuart Nelson, a surgeon and associate medical director of the Beckman Laser Institute at the University of California-Irvine. That has raised questions of whether doctors are going beyond their expertise. More than 50 medical specialties use lasers today, the American Society for Laser Medicine says.
"Lasers are not for everything," Nelson says. He recommends that people get laser procedures only from experienced medical doctors.
Nelson specializes in using a laser to remove port wine stain birthmarks or small lesions that often appear on the face. Previously, doctors had to use a painful procedure involving skin grafts to eliminate the birthmarks. Now they use a laser to destroy blood vessels under the skin while leaving healthy tissue alone. The birthmarks can be removed in a series of treatments that take five to 10 minutes.
The use of lasers in cosmetic medicine, such as hair removal and skin resurfacing, makes up about 40% of the $2.5-billion-a-year global medical laser systems market, according to a study by the market consulting firm Frost & Sullivan.
Dentistry is another big area for lasers. The Food and Drug Administration has approved lasers for teeth whitening and to help treat cavities.
Lasers work well with soft tissue in the mouth, such as in reducing gum around the tooth to prepare for installing a crown.
But there is no proof it works in other applications such as accelerating tooth whitening, says David Garber, a periodontist in Atlanta and clinical professor at the Medical College of Georgia School of Dentistry.
Removing cavities with lasers has not been widely adopted because the process is slower than the traditional method, Garber says. The only benefit of the laser is that people don't have to hear the sound of the dental drill.
Studies are trying to determine whether a laser can identify and then zap away dangerous bacteria around the teeth while leaving the healthy tissues alone. "We have no easy way of controlling aggressive periodontal disease, and this can be a very targeted approach," he says.
A potential pain fighter
Newer "cool" lasers are showing promise as the latest weapon to fight chronic pain. In 2001, the FDA approved the Erchonia laser for chronic pain. It works by stimulating the body's cells to regenerate, according to the manufacturer's studies.
"The results have been remarkable," says Mitchell Prywes, a physical medicine and rehabilitation doctor in Danbury, Conn. He uses the laser on patients who have neck and back pain. Patients come in for five- to 10-minute applications that often complement physical therapy.
"We can often see results in minutes where we see the patient's range of motion improve and it improves pain," Prywes says. The laser reduces chronic neck and back pain because it reduces inflammation and activates cells to improve the natural healing process, he says.
"The laser is very much the future of medicine," Prywes says.
He adds that while the lasers are extremely safe, precautions must be taken to keep laser light away from the eyes, those with pacemakers and pregnant women.
"It is not a panacea for everything, but it can have a dramatic effect in speeding healing," says Charlie Shanks, a vice president of laser manufacturer Erchonia Inc. of Dallas.
