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Joined: 1 Dec 2011
Activity: 2 posts
Sofia Vergara In Favor of Plastic Surgery, Considered Breast Reduction
on 1 Dec 2011
Oh please this woman is full of it. Have you seen the trailer for "New years eve" her face looks like she's been under the knife.
New Surgery Will Turn Brown Eyes Blue...Permanently
on 1 Dec 2011
I don't know why it portrayed itself as a block of text considering I spaced it accordingly. Here it is again.
"FREQUENTLY ASKED QUESTIONS - STRŌMA:
Q. What is the Strōma procedure?
A. The Strōma procedure uses a low-energy laser to change the color of the patient’s eyes from brown (or hazel) to blue.
Q. How does the Strōma procedure work?
A. We all have blue eyes. In the case of brown (and hazel) eyes, however, a thin layer of brown (or brown and yellow) pigment covers the front surface of the iris (the colored part of the eye). The Strōma laser disrupts this layer of pigment, causing the body to initiate a natural tissue-removal process. Once the tissue is removed, the patient’s natural blue eye is revealed.
Q. Is the Strōma procedure currently available to the general public?
A. The Strōma procedure is not currently available to the general public. We are in the process of completing a preliminary human study to confirm the safety and efficacy of the procedure. Our next step will be to complete our pilot and pivotal human clinical studies. Our plan is to treat 100 patients in multiple countries and follow them for a full year. We expect the procedure to be available to the general public outside the United States in about 18 months and inside the United States in about three years. We will not release the product anywhere in the world, however, unless and until the governing regulatory bodies and Strōma Medical are satisfied that the procedure is safe and effective.
If you wish to be added to our announcements list, please send another e-mail to firstname.lastname@example.org. You will be added automatically.
Q. Is it possible to be considered for the Strōma clinical trials?
A. If you wish to be considered as a candidate for Strōma’s clinical trials, please send another e-mail to email@example.com. You will be added automatically. Please include your current country of residence in the subject line of your e-mail.
Clinical studies always involve a certain degree of risk. Strōma Medical and the clinical physicians will take a variety of precautions to minimize these risks in the clinical trials, but the risks will still be greater than those posed after commercial release.
In addition, for the first year, only one eye of each clinical patient will be treated. The untreated eye will serve as a control for the study.
Q. How surgically invasive is the Strōma procedure?
A. The Strōma procedure is surgically non-invasive. It involves no incisions or injections of any kind. In fact, other than the use of a small device to help keep the patient’s eyelids open during the procedure and the instillation of a mild topical medication, there is little or no contact with the patient’s eye.
Q. Will the Strōma procedure affect the patient’s vision?
A. The Strōma procedure should have no effect on patient vision. The Strōma laser treats only the iris. It does not enter the pupil or treat any portion of the inside of the eye, which is where the nerves affecting vision are located. We will, of course, continue studying any impact on vision throughout our clinical studies.
Q. Can you describe the Strōma procedure?
A. The patient sits in front of the Strōma laser, and his or her chin is placed on a head stabilization apparatus. One of the patient’s eyes is covered, and the patient is instructed to direct his or her other eye toward a tiny animation (about 1 cm x 1 cm), located about one foot from the patient’s eye, for roughly 20 seconds. At the end of this period, the procedure is completed. The procedure is then repeated on the other eye.
Q. How soon after the procedure will the patient be able to drive and return to work?
A. The treating ophthalmologist will inform the patient when he or she may drive and return to work. In most cases, the patient should be able to do so immediately after the procedure.
Q. Will the patient’s eyes turn blue immediately?
A. For the first week or so following the procedure, the irises will get darker. Thereafter, they will grow progressively lighter, revealing the underlying natural blue color. The full color-change process should take two to four weeks following the procedure.
Q. Will any brown pigment remain in the eye after treatment?
A. The procedure is capable of removing all brown pigment from the iris. It is important, however, that the laser not enter the pupil, so as a safety precaution, a small ring around the edge of the pupil will remain untreated and thus brown. In addition, some patients might want to leave a ring of pigment around the outer perimeter to outline the iris. This can be very attractive. Consider the green eyes of Sharbat Gula, the Afghan woman featured on the cover of the June 1985 issue of National Geographic Magazine.
Q. How much will the procedure cost?
A. Strōma Medical will not be performing the procedure or setting the price. Instead, Strōma Medical will license leading ophthalmologists in each territory, and these ophthalmologists will perform the procedure and set the price for doing so. The price will likely vary from territory-to-territory and from ophthalmologist-to-ophthalmologist. We anticipate that the retail price in the United States will be around $5,000.
Q. Is the Strōma procedure safe?
A. The Strōma procedure has only undergone limited study in humans, and no adverse events have been reported to date. Before the procedure can be declared safe, however, it will have to undergo extensive additional testing and satisfy the requirements of multiple regulatory bodies. In our next study phase, we plan to treat 100 patients in several countries and follow them for a full year. We will not release the Strōma laser unless and until the governing regulatory bodies and we are satisfied that the procedure is safe.
Q. Is the procedure permanent?
A. We do not believe that that the pigment cells will regenerate after treatment, and thus far, nothing in our studies in animals or humans has suggested otherwise.
Q. I’ve read that the Strōma procedure could cause pigmentary glaucoma. Is this true?
A. Some physicians on blogs and elsewhere have suggested that the Strōma procedure could cause pigmentary glaucoma. We were concerned about this issue right from the start, so it was the first issue we tested. Thus far, it has not proved to be a problem in our animal or human studies.
The condition, known as “pigmentary dispersion syndrome,” arises from abrasion of the pigment of the iris epithelium, located at the back of the iris. This pigment is much thicker than the pigment on the front of the iris, and the abrasion causes this thicker pigment to be dislodged in relatively large pieces. These pieces travel to the front edge of the iris, where they become trapped in the trabecular meshwork covering the Schlemm’s canal, thereby reducing fluid outflow and increasing the pressure within the eye, known as intraocular pressure or “IOP.” It is believed that this increase in IOP can lead to glaucoma, a condition that begins with the gradual loss of peripheral vision.
In the case of the Strōma procedure, the pigment layer covering the front of the iris is far thinner than the pigment layer at the rear of the iris. In addition, the pigment is removed by the natural tissue elimination process initiated by laser exposure, rather than by direct abrasion. As a result, the pigment is released gradually in microscopic particles that are small enough to pass easily through the trabecular meshwork and Schlemm’s canal.
In fact, one of the most successful treatments for pigmentary glaucoma is selective laser trabeculoplasty or “SLT,” whereby a laser is used to treat the epithelial pigment trapped in the trabecular meshwork. The treatment breaks the pigment into far smaller particles so that they can pass more easily through the trabecular meshwork.
By the way, we always appreciate responsible and informed comments and criticisms from physicians and scientists. Their job is to protect the public from harmful procedures and medications, and although we’ve done our best to consider every possible complication, we always welcome the opportunity to learn more, thereby ensuring a safer product for our customers.
Q. Can I have this procedure if I’ve had LASIK?
A. The treating ophthalmologist will determine whether you are a candidate for the Strōma procedure. In general, previous LASIK treatment, properly performed, should not preclude a patient from having the Strōma procedure.
Q. Does the Strōma procedure work on all nationalities and ethnicities?
A. Our studies so far indicate that the Strōma procedure will be equally effective on people of all nationalities and ethnic origins, including Caucasian, Black, Asian, and Hispanic.
Q. Does the patient’s skin tone or color affect the treatment?
A. The patient’s skin tone should have no effect on the color of the patient’s eye after treatment.
Q. Will the treatment of all patients result in a blue eye?
A. The natural underlying color of an iris is generally blue. In some cases, however, the blue is more gray, and in others, the blue is more violet. The specific color of a person’s iris depends upon the structure of that particular iris and is unaffected by the Strōma procedure.
In order to assist the patient in deciding whether to have the procedure, Strōma Medical has designed a procedure to predict the specific underlying color of the patient’s iris prior to treatment and generate an image of the patient with irises of the predicted color.
Q. Can you treat just one eye or just a portion or an eye?
A. The Strōma procedure may be used to treat a condition known as “heterochromia,” where the color of one eye differs from the color of the other eye or where a single eye features more than one color. The treating ophthalmologist will determine whether and to what extent to offer this procedure.
Q. Can you change an eye’s color from brown to hazel or green or from green to blue?
A. We are working on procedures to change eyes from brown to hazel or green and from green to blue. We believe we will be able to do so, but these procedures are more complex, so our initial procedure will only change eyes from brown or hazel to blue.
Q. Is it possible just to lighten my existing color?
A. If your eyes are already blue, it is possible that the procedure could make them lighter. If your eyes are dark brown, however, we cannot make them light brown. This has more to do with the color of each patient’s pigment than the density of the pigment cells.
Q. May I have the password to the HomerLabs website?
A. HomerLabs is the inventor’s research and development company. The company’s website is not available to the public."