Carl Zeiss Meditec MEL-90 excimer laser system
A prospective multicenter clinic study to evaluate the safety and effectiveness of the MEL-90 excimer laser using LASIK (laser in-situ keratomileusis) for the correction of myopia, hyperopia, astigmatism and mixed astigmatism.
PURPOSE OF RESEARCH
You are invited to participate in a research study evaluating the safety and effectiveness of the Carl Zeiss Meditec MEL-90 excimer laser system used to perform LASIK (laser in-situ keratomileusis) for nearsightedness, farsightedness, astigmatism and mixed astigmatism (a non-spherical shape) as part of a multicenter FDA clinical trial.
LASIK is a two-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.
You will have one eye or both eyes treated with LASIK using the MEL-90 excimer laser system..
You will be one of 50 (up to 90) near-sighted patients at Stanford to undergo treatment in this clinical research trial. Three-hundred and sixty patients will be enrolled study wide at up to 8 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 LASIK at Stanford and 360 patients study-wide for the correction of myopia (nearsightedness), hyperopia (farsightedness), astigmatism, and mixed astigmatism will be enrolled.
All participants will be followed for one year after the vision correction procedure.
Participants scheduled to undergo LASIK for the correction of myopia, hyperopia, astigmatism, and mixed 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 LASIK 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 LASIK using the MEL-90 excimer laser system in patients with nearsightedness farsightedness, astigmatism and mixed 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.
An excimer laser is a special type of laser system used to perform LASIK vision correction procedure. The excimer laser uses ultraviolet light to remove tissue from the cornea.
LASIK is a two-step procedure consisting of initial creation of a corneal flap and subsequent corneal ablation with an excimer 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. Wavefront aberrometry is an automated device that measures the refractive status of the eye. This data is then transferred to the laser system and calculates a unique treatment to reduce or eliminate your nearsightedness with and without astigmatism.
The primary objective of this study is to evaluate the safety and efficacy of LASIK surgery using the Carl Zeiss Meditec MEL-90 excimer 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 LASIK 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 AND EXCLUSION CRITERIA
• Must be at least 18 years of age
• Myopia (nearsightedness) up to -10.00 D with and without astigmatism up to -4.00 D
• Hyperopia up to +5.00 D with and without cylinder up to +4.00 D,
• Mixed astigmatism up to 4.00 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
• 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
• For hyperopic (farsighted) patients, clinically measurable strabismus or amblyopia in the eye(s) to be treated
• 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.
There is no charge to participate in the study. You will need to purchase your ophthalmic medications and lubricating drops.
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 Ms. Linda Schwartz at 650 498-7020 to obtain additional information about the study or to schedule an appointment for an evaluation.