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 is a simple, outpatient procedure that 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. Each eye is treated separately. The first eye is covered, and the patient is instructed to direct his or her second eye towards a tiny light, 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 approximately 30 seconds, the procedure is completed. The procedure is then repeated to treat the first eye. In most cases, only a single treatment session should be required. We will learn more about the possible need for a second treatment session on extremely dark eyes in upcoming clinical studies.
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. Will people be able to tell I had the Strōma procedure?
The results of the Strōma procedure are indistinguishable from natural blue eyes. In fact, even a skilled ophthalmologist should be unable to tell during an eye exam.
5. Is the procedure permanent?
We do not believe that the pigment cells will regenerate after treatment, and thus far, nothing in our pre-clinical or clinical studies has suggested otherwise.
6. 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.
7. 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 hue is more gray, and in others, the blue hue 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.
8. Can the patient choose his or her eye color?
Our clinical trails thus far have been limited to changing eye color from brown to blue, since that is both the simplest and most sought-after color change. We will soon begin testing dark brown to light brown color change, as well as changing hazel or green to blue, and it is possible that our first commercial laser will also be able to accommodate these color changes. Changing brown or hazel eyes to green is more complicated, and it is unlikely our initial laser will be able to accomplish this. Because our technology relies upon the removal of pigment, it will not change eye color from light to dark, e.g., blue to green, green to hazel, or hazel to brown.
9. Will any brown pigment remain in the eye after treatment?
The procedure is capable of removing all brown pigment from the iris. After the procedure, however, many patients will have a so-called “limbal ring,” which is a ring of dark pigment around the outer perimeter of a light 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. If the patient has this feature, there is nothing we can or would do to remove it. If a patient does not have this feature, our procedure might be able to leave some pigment around the iris perimeter to create the appearance of a natural limbal ring.
Natural blue and green eyes sometimes have a ring of pigment around the pupil that fades into the iris as it moves away from the pupil. Some patients might want to leave a ring of this kind around the pupil in this manner, and our procedure should be able to accomplish this in most cases.
10. Can you treat just one eye or just a portion of 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. In most cases, however, the physician will likely choose to treat both eyes to ensure that the color matches as closely as possible.
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 or PRK and what about other conditions?
The treating physician will determine whether you are a candidate for the Strōma procedure. In general, previous LASIK or PRK treatment, properly performed, should not preclude a patient from having the Strōma procedure. Clouding or scarring of the cornea could exclude a patient from treatment but your physician will be able to advise you of possible treatments to correct those conditions. Astigmatism and myopia would not be a basis for exclusion from the Strōma procedure, unless they are the result of some other exclusionary condition. Your physician will advise you of any other exclusions.
14. How old do I have to be for the Strōma procedure?
Strōma Medical will probably insist that all patients be at least 18 years old. Physicians might impose stricter age limits.
15. Is the Strōma procedure the same as the BrightOcular and NewColorIris procedures?
No. The BrightOcular and NewColorIris procedures are completely different from the Strōma procedure. 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, by contrast, involves no incisions or other contact with the patient’s eye. The Strōma laser delivers a gentle, low-energy light beam through the cornea and onto the iris surface.
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 Medical) before having them performed.
Price and Availability of the Strōma Procedure
16. Is the Strōma procedure currently available to the general public?
The Strōma procedure is not currently available to the general public. We have completed two generations of laser devices and a series of human studies to confirm the safety and efficacy of the procedure. Our next step will be to treat about 120 patients in multiple countries and follow them for a predetermined length of time. At that point, we should be ready to release our procedure commercially. We will not release the procedure, however, unless and until the governing regulatory bodies and we 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. Although we plan generally to release the procedure in all non-U.S. territories around the same time, the specific order of release may still depend upon the market demand and regulatory environment in each territory.
We currently expect to release the procedure commercially outside the United States sometime in late 2015, stressing, however, that there are still many conditions to release that are beyond our control. As we get closer to the scheduled release date, we will be providing periodic progress reports to those who sign up for 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.
17. Will Strōma Medical offer a list of its approved providers?
As we near commercial release, Strōma will begin posting names and contact information for licensed Strōma Medical physicians throughout the world. We will also attempt to protect our prospective patients by publishing the names and contact information of unauthorized practitioners claiming to offer our procedure. We have invested many years and several million dollars in research and development to bring you a procedure that is both safe and effective, and we want to ensure that you enjoy all of the benefits of our work.
18. 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.
19. 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.
20. Will Strōma Medical be performing the Strōma procedure?
Strōma Medical is the developer, manufacturer, and distributor of the Strōma laser device. Strōma Medical will not actually be performing the procedure on any patients. The procedure will be performed by independent physicians, trained and licensed by Strōma Medical.
Safety of the Strōma Procedure
21. Is the Strōma procedure safe?
The Strōma procedure has undergone limited clinical studies in humans, and no adverse events have been reported to date. Before the procedure can be declared safe, however, it will have to undergo additional testing and satisfy the requirements of multiple regulatory bodies. In our next study phases, we plan to treat about 120 patients and follow them for about one year. If all goes according to plan, we will then release our procedure to the general public. Under no circumstances, however, will we release our procedure unless and until the governing regulatory bodies and we are satisfied that the procedure is safe and effective.
22. How surgically invasive is the Strōma procedure?
The Strōma procedure is not surgically invasive at all. 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 should be no contact whatsoever with the patient or his or her eye. In addition, none of the clinical patients thus far have reported any pain or light sensitivity during or after the procedure.
23. 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 retinal nerves affecting vision are located. In addition, our laser beam is designed so that even if it were to enter the pupil accidentally, it could not deliver enough energy to the retinal nerves to affect vision. We believe, of course, that no cosmetic procedure is worth risking injury to a patient’s vision, and we will continue monitoring patient vision throughout our clinical studies.
24. How soon after the procedure will the patient be able to drive and return to work?
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, although night driving should be avoided for the first few hours after the procedure, because the pupils will be constricted.
25. 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 our 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.
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.
Strōma Clinical Trials
26. Is it possible to be considered for the Strōma clinical trials?
It is possible to be considered as a clinical trial candidate, and you can register here. You must, however, live local to the clinical site to be considered as a candidate. No one who relocates for the procedure will be considered. The reason for this is that many follow-up examinations and visits will be required, and those who live far away from the site are less likely to comply.
We are currently considering the following territories for our remaining clinical trials: Costa Rica, Mexico, the Philippines, London, Paris, Toronto, and Argentina. We have not yet determined where our clinical sites will be located within these territories. We have not yet determined where our clinical sites will be located within the United States.
If you register as a trial candidate, we will do our best to notify you about 30 days prior to the commencement of patient recruitment for each study in our area.
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.
27. Are any payments made or required for Strōma Medical 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. Nominal compensation may be paid to trial participants in some territories to cover lost work and travel expenses. Compensation is heavily regulated in many territories and also raises moral questions about the voluntariness of the patient’s participation, so compensation will vary from site to site.
28. Can you post photographs of actual Strōma Medical clinical patients?
Unfortunately, we are unable to release actual patient photographs from our early studies due to legal restrictions and personal commitments we made to our early trial investigators. We will, however, be posting before-and-after photographs from our upcoming trials on this site as and when they become available. Meanwhile, images of irises with a condition called “sectoral heterochromia” are available on the internet and in our pigmentary glaucoma presentation available here. These images are almost identical to the partially treated irises of our early clinical patients.
Contacting Strōma Medical
29. How do I contact Strōma Medical?
Other than press inquiries and prospective investors, Strōma Medical neither accepts nor responds 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 this FAQ thoroughly. We also operate a popular forum through this site that offers lively discussions about Strōma, and we invite you to join us through the tab at the top of this page. Finally, we encourage 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.
30. May I have the password to the HomerLabs website?
HomerLabs is our founder’s research and development company. Its website is not available to the public.
31. 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.