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. 

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). The cornea is the clear front portion of the eye.  The femtosecond laser is used to create the corneal flap during the first step of the LASIK procedure. The excimer laser system precisely ablates (removes) corneal tissue to reduce or eliminate your nearsightedness, farsightedness, astigmatism and mixed astigmatism.  

The Elita femtosecond laser used to perform SILK surgery is not FDA-approved.  It is an investigational device.  It has been used in humans outside the United States.  SILK surgery has been performed in 154 patients outside of the United States.

You will have one eye or both eyes treated with small incision lenticule keratomileusis using the Elita femtosecond laser system.

You will be one of up to 90 near-sighted patients at Stanford to undergo treatment in this clinical research trial.  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.

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.

There are two phases of the study.  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 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 second phase of the study is the pivitol phase where SILK surgery is performed in both eyes

All participants will be followed for one year after the vision correction procedure. 

Participants scheduled to undergo small incision lenticule keratomileusis for the correction of myopia with and without astigmatism will be screened for eligibility.  Eligible participants will be examined preoperatively to establish a baseline for ocular condition (the general health and glasses prescription of the eyes).  Postoperatively, participants will undergo an ophthalmic evaluation (complete eye examination) at regular intervals as specified in this protocol.  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.  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.

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 should choose to participate, your eye will be given a thorough examination at each visit.  This examination will include the standard elements of a general eye exam including testing of the eye’s vision, contrast acuity testing, examination with the slit lamp and the ophthalmoscope to look at the various parts of the eye and a test of the inner eye’s pressure.

You will have at least one additional examination at 9 months for the study that you would not normally have if you had laser vision correction outside of the study.

Your participation in this study is entirely voluntary.

A femtosecond laser is a special type of laser system used to perform LASIK and SMILE vision correction procedures.   

SILK is a laser eye surgery that creates a thin lenticule (disc) of tissue below the surface in the cornea that is removed through a small incision.  The cornea is the clear front portion of the eye.  The femtosecond laser is used to create the corneal lenticule and small incision.  Removal of the lenticule from the small incision results in a flattening of your cornea which can reduce or eliminate your nearsightedness with and without astigmatism. 

The primary objective of this study is to evaluate the safety and efficacy of small incision lenticule surgery using the Johnson and Johnson Elita Femtosecond laser.

We will be using both subjective and objective outcome measures in our analysis. 

Standard refractive outcomes such as uncorrected visual acuity (vision without glasses or contact lenses) and best corrected visual acuity (vision with glasses or contact lenses), and intended vs. achieved postoperative refractions (the accuracy of the small incision lenticule keratomileusis procedure) will be evaluated; in addition, higher order optical aberrations (micro-irregularities in the eye that can have subtle effects on the quality of vision) will be measured. 

Inclusion criteria:

• Must be at least 22 years of age

• Myopia (nearsightedness) up to -12.00 D with and without astigmatism up to -8.00 D

• Stable refractive error

• Must be willing to discontinue use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the preoperative examination, and through the day of surgery in the eye(s) to be treated

• Willing and able to return for scheduled follow-up examinations

•Able to follow study instruction in English

Exclusion criteria:

• Abnormal corneal topographic findings, e.g. keratoconus, pellucid

marginal degeneration in either eye

• History of or current eye pathology, including cataracts in the eye(s) to be treated

• Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study (e.g., dry eyes, immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.)

• Residual, recurrent, active ocular or uncontrolled eyelid disease, corneal scars or other corneal abnormality such as recurrent corneal erosion or severe basement membrane disease in the eye(s) to be treated

• Any signs of progressive or unstable myopia or keratoconus suspect in either eye

• History of ocular herpes zoster or herpes simplex keratitis in either eye

• Difficulty following directions or unable to fixate

• Previous intraocular or corneal surgery of any kind in the eye(s) to be treated, including any type of surgery for either refractive or therapeutic purposes

• History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP > 21 mmHg in either eye

• Immunocompromised or requires chronic systemic corticosteroids or

other immunosuppressive therapy that may affect wound healing

• History of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia)

• Enrollment in another drug or device clinical study within the prior 3 months

• Subjects who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control

Payment:   You will not be paid to participate in this research study.                                                                                                         

Costs:  

There is no charge to participate in the study.   

If you participate in this study, there may be additional costs to you. 

Participation in this study is not a substitute for health insurance.  You and/or your health insurance must pay for those services, supplies, procedures, and care that you require during this study for routine medical care.  You will be responsible for any co-payments and/or deductibles as required by your insurance. 

Participation in this study is not a substitute for health insurance.

Appointment Contact:  Please contact the clinic at 650 498-7020 to obtain additional information about the study or to schedule an appointment for an evaluation.