Thank you for taking the time to review the Frequently Asked Questions section of our website. Strōma is currently in the research and development stage. Consequently, we have no product or service to sell anywhere in the world, and nothing contained on this website is intended to market our product or services. The sole purpose of this site is to share our research and development and clinical progress with physicians, accredited investors, and the public. Our technology will not be commercially available until the appropriate regulatory agencies in target countries have approved the indication for use and the company and those agencies are satisfied with the safety and efficacy of the product.
FREQUENTLY ASKED QUESTIONS
Description of the Strōma Procedure
1. What is the Strōma procedure?
The Strōma procedure uses a gentle, low-energy laser to change the color of the patient’s eyes from brown to blue.
2. How is the Strōma procedure performed?
The patient sits in front of the Strōma laser, and his or her head is stabilized. The patient is instructed to direct the untreated eye toward a tiny animation (about 1 cm x 1 cm), located about one foot from the patient’s eye while a gentle, low-energy laser scans the surface of the iris of the treated eye. In less than 20 seconds, the procedure is completed. The procedure is then repeated to treat the other eye.
3. How does the Strōma procedure work?
We all have blue eyes. In the case of brown eyes, however, a thin layer of brown 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 and gradual tissue-removal process. Once the tissue is removed, the patient’s natural blue eye is revealed.
4. Is the procedure permanent?
We do not believe that the pigment cells will regenerate after treatment, and thus far, nothing in our studies has suggested otherwise.
5. Will the patient’s eyes turn blue immediately?
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.
6. Will the treatment of all patients result in a blue eye?
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 hue of a person’s blue 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 hue of the patient’s blue iris prior to treatment and generate an image of the patient with irises of the predicted hue.
7. Can you change an eye’s color from brown to hazel rom green to blue?
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 to blue.
8. Is it possible just to lighten my existing color?
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.
9. Will any brown pigment remain in the eye after treatment?
The procedure is capable of removing all brown pigment from the iris. Some patients, however, 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. Other patients might want to leave some pigment around the pupil. This creates the appearance of a larger pupil, signaling interest to others.
10. Can you treat just one eye or just a portion or an eye?
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 physician will determine whether and to what extent to offer the Strōma procedure to treat these conditions.
11. Does the Strōma procedure work on all nationalities and ethnicities?
Our studies so far indicate that the Strōma procedure will be equally effective on people of all nationalities and ethnic origins.
12. Does the patient’s skin tone or color affect the treatment?
The patient’s skin tone should have no effect on the color of the patient’s eye after treatment.
13. Can I have this procedure if I’ve had LASIK
The treating physician 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.
The Strōma procedure and the BrightOcular and NewColorIris procedures are completely different. BrightOcular and NewColorIris change iris color by making an incision in the cornea (the clear front of the eye) and implanting a colored disc in front of the natural iris. The Strōma procedure uses a gentle, low-energy laser to disrupt and eventually eliminate the pigment cells covering the natural blue eye underneath.
As a policy, we do not comment on the medical products or procedures of other companies. We do, however, encourage patients to conduct a thorough investigation of the safety and efficacy of all medical products and procedures (including Strōma) before having them performed.
Safety of the Strōma Procedure
15. Is the Strōma procedure safe?
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 about 20 patients in our initial pilot clinical study. Following the successful completion of that pilot study, we will treat about 100 patients in multiple countries and follow them for a predetermined length of time. We will not release the Strōma laser unless and until we and the governing regulatory bodies are satisfied that the procedure is safe and effective.
16. How surgically invasive is the Strōma procedure?
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 eyelid open during the procedure and the application of a mild topical medication, there is little or no contact with the patient’s eye.
17. Will the Strōma procedure affect the patient’s vision?
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.
The treating physician 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 soon after the procedure.
19. I’ve read that the Strōma procedure could cause pigmentary glaucoma. Is this true?
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 of clinical studies, so it was the first issue we tested and measured in our initial pre-clinical and clinical studies. Thus far, pigmentary glaucoma has not proved to be a problem in our 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. We have prepared a brief PDF presentation on the risks associated with pigmentary glaucoma, a copy of which is available here.
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.
Price and Availability of the Strōma Procedure
20. Is the Strōma procedure currently available to the general public?
The Strōma procedure is not currently available to the general public. We have completed a preliminary human study to confirm the safety and efficacy of the procedure and are using what we’ve learned to design and build our next-generation device. Our next step will be to complete our pilot and pivotal human clinical studies using our new device. Our plan is to treat about 20 patients in our initial pilot clinical study. Following a successful completion we will treat about 100 patients in multiple countries and follow them for a predetermined length of time. We will release the product when we and the governing regulatory bodies are satisfied with the safety and efficacy of the procedure. Due to the relative cost and complexity of releasing a cosmetic medical device in the United States, we expect to release the procedure outside the United States before releasing it in the United States. The order of release in the non-U.S. territories will depend upon the market demand and regulatory environment in each territory.
Although we are unable to provide a reliable release date at this time, we will be providing periodic progress reports to those who sign up for periodic updates through Strōma Updates. Please be patient. We appreciate the public’s eagerness for our procedure, but we also need to take all the necessary steps to be sure that our procedure is safe, that proper quality control protocols are observed, and that all regulatory approvals have been obtained. Releasing a safe and effective medical device takes time.
21. How much will the procedure cost?
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.
22. Can we get the Strōma procedure earlier if we pay more?
Some prospective patients have asked whether they can pay an additional fee to have the procedure performed prior to its scheduled release. The answer is no. The procedure will be made available to all residents of each territory as and when approved for initial release, and the pricing will be set by each physician in that territory.
Strōma Clinical Trials
2. Is it possible to be considered for the Strōma clinical trials?
We are currently designing and building our next-generation laser device. As soon as it is completed and tested, we will begin our next round of clinical trials outside the United States. We will probably establish treatment sites for these trials in four territories. We are currently considering the following territories as possible treatment sites: Europe, Asia, South America, the Middle East, Canada, and Mexico. We have not yet determined where our clinical sites will be located within these territories. We will probably not begin our clinical trials in the United States until we commercially release our technology outside the United States. We have not yet determined where our clinical sites will be located within the United States. While we are unable to provide reliable dates for any of our clinical trials at this time, we will be providing periodic progress reports to those who sign up for clinical trial candidacy through the Clinical Trial Candidate Registration Form. We will notify you about 60 days prior to commencement of any trials in your territory.
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. Several prospective clinical candidates have asked whether there is any way they would be able treat the second eye in less than one year. The answer is no. If a clinical patient has a reaction, we need some way to determine whether that reaction is due to our procedure or some other factor, and the best way to do so is to keep one eye untreated throughout the follow-up period. At the end of the follow-up period, we hope to be able to treat the other eye free of charge, provided that the patient has had no adverse reaction in the treated eye and that our commitment to treat the other eye does not violate any applicable laws governing clinical patient compensation.
2. Are any payments made or required for Strōma clinical trial participation?
Some trial candidates have asked whether they will be required to pay us, and others have asked whether we will pay them. Strōma Medical does not charge (or accept payment from) any trial candidate. We have not yet determined what, if any, compensation might be paid to trial participants. Compensation is heavily regulated in many territories and also raises moral questions about the voluntariness of the patient’s participation.
2. Can you post photographs of actual Strōma patients?
Unfortunately, we are precluded from providing actual patient photographs by a number of laws in various territories governing patient privacy and pre-approval marketing. We will be releasing several before-and-after photographs on a territory-by-territory basis as soon as our procedure is approved for marketing. Meanwhile, images of irises with a condition called “sectoral heterochromia” are available on the internet and in our pigmentary glaucoma presentation available here. These irises are similar to the partially treated irises of actual Strōma patients.
27. How do I contact Strōma Medical?
Other than press inquiries and prospective investors, Strōma Medical does not respond to individual inquiries. We truly appreciate your interest, but we operate with a small staff, and we simply do not have the capacity to answer each of your phone calls and e-mails personally. We have therefore done our best to anticipate your questions on our website, and we encourage you to read our FAQ page thoroughly. We also invite you to register with us for periodic updates, including our development progress, clinical trial dates and territories, projected commercial release dates and territories, and other up-to-the-minute information through Strōma Updates.
28. May I have the password to the HomerLabs website?
HomerLabs is the inventor’s research and development company. The company’s website is not available to the public.
29. How do I make a medical appointment to see Dr. Homer?
Dr. Homer is not a medical doctor and does not treat patients. Dr. Homer is a research scientist.