![]() If you should choose to participate, your eye will be given a thorough examination at each visit. The primary aim of the research is to evaluate the safety and effectiveness of small incision lenticule keratomileusis using the Elita femtoseond laser system in patients with nearsightedness with and without astigmatism. If you elect to undergo a retreatment of your small incision lenticule keratomileusis surgery prior to the 12-month post-operative visit, the data after the retreatment procedure will be excluded from the study analysis. Re-treatments (a second operation on the same eye for residual nearsightedness, farsightedness and/or astigmatism) will not be allowed during the first twelve months of this study. Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol. Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes). Participants scheduled to undergo small incision lenticule keratomileusis for the correction of myopia with and without astigmatism will be screened for eligibility. The second phase of the study is the pivitol phase where SILK surgery is performed in both eyesĪll participants will be followed for one year after the vision correction procedure. This phase may potentially be more risky since you will be among the first patients treated in the United States with the SILK surgery procedure. The first phase is the feasibility phase of the study where one eye will be treated using non-FDA approved investigational SILK procedure and the other eye will be treated with FDA-approved laser vision correction surgery. This will be a prospective, multicenter, research study in which up to 90 consecutive patients scheduled to undergo small incision lenticule keratomileusis (SILK) at Stanford and 200 patients study-wide for the correction of myopia (nearsightedness) with and without astigmatism will be enrolled. Two hundred patients will be enrolled study wide at up to 15 study sites in the United States and part of the multicenter clinical trial. You will be one of up to 90 near-sighted patients at Stanford to undergo treatment in this clinical research trial. You will have one eye or both eyes treated with small incision lenticule keratomileusis using the Elita femtosecond laser system. SILK surgery has been performed in 154 patients outside of the United States. It has been used in humans outside the United States. The Elita femtosecond laser used to perform SILK surgery is not FDA-approved. The excimer laser system precisely ablates (removes) corneal tissue to reduce or eliminate your nearsightedness, farsightedness, astigmatism and mixed astigmatism. The femtosecond laser is used to create the corneal flap during the first step of the LASIK procedure. The cornea is the clear front portion of the eye. Small incision lenticule keratomileusis is a one-step procedure consisting of initial creation of a corneal flap (a thin slice of the cornea) and subsequent corneal ablation (removal of tissue) with an excimer laser (a non-thermal laser). You are invited to participate in a research study evaluating the safety and effectiveness of the Johnson and Johnson femtosecond laser system used to perform small incisions lenticule keratomileusis nearsightedness with and without astigmatism (a non-spherical shape) as part of a multicenter FDA clinical trial. ![]()
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