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.
The Strōma procedure is 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.
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 the procedure is completed. The procedure is then repeated to treat the other eye.
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 shortly after the procedure. 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.
The Strōma procedure is not currently available to the general public. We have completed a preliminary human study to test the safety and efficacy of the procedure and using what we've learned to design and build our next-generation device. Our next steps 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 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 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 first. The order of release in the non-U.S. territories will depend on upon the market demand and regulatory environment in each territory. While 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.
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, it will have to undergo extensive additional testing and satisfy the requirements of multiple regulatory bodies. 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.
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.
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 and measured in our initial pre-clinical and clinical studies. Thus far, pigmentary glaucoma has not proved to be a problem in our pre-clinical or clinical studies. For a more detailed discussion of this issue, please see our FAQ. We have also prepared a PDF presentation on this issue, which you can access here.
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