Use of the VisuMax™ Femtosecond Laser

Launched by CARL ZEISS MEDITEC, INC. · Jul 9, 2012

Keywords

ClinConnect Summary

This is a prospective multi-center clinical trial in which a total of 360 eyes of consecutive subjects will be enrolled, treated with the VisuMax™ Femtosecond Laser, and followed for a 12-month period. The study will be conducted at up to 8 clinical sites.

Enrollment will be phased such that 100 eyes will be initially enrolled and followed. When 50 of the initial eyes have reached the 3-month follow-up exam, an interim clinical study report will be submitted to FDA along with a request to continue enrollment up to 360 eyes.

Subjects will be screened for eligibility, and informed consent w...

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Eligibility criteria

• Inclusion Criteria:
• • Male and female subjects age 22 years of age and older;
• • Spherical myopia from ≥ -1.00 D to ≤ -8.00 D, with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D in the eye to be treated;
• • A stable refraction for the past year, as demonstrated by a change in MRSE of ≤ 0.50 D in the eye to be treated;
• • A difference between cycloplegic and manifest refractions of \< 0.75 D spherical equivalent in the eye to be treated;
• • UCVA worse than 20/40 in the eye to be treated;
• • BSCVA at least 20/20 in the eye to be treated;
• • 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;
• • All contact lens wearers must demonstrate a stable refraction (within ±0.5 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in the eye to be treated;
• • Central corneal thickness of at least 500 microns in the eye to be treated;
• • Willing and able to return for scheduled follow-up examinations;
• • Able to provide written informed consent and follow study instructions in English.
• Exclusion Criteria:
• • Mesopic pupil diameter \> 8.0 mm;
• • Cylinder \> -0.50 D;
• • Treatment depth is less than 250 microns from the corneal endothelium;
• • Eye to be treated is targeted for monovision;
• • Fellow eye has BSCVA worse than 20/40;
• • Abnormal corneal topographic findings, e.g. keratoconus, pellucid marginal degeneration in either eye;
• • History of or current anterior segment pathology, including cataracts in the eye to be treated;
• • Clinically significant dry eye syndrome unresolved by treatment in either eye;
• • 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 to be treated;
• • Ophthalmoscopic signs of progressive or unstable myopia or keratoconus (or keratoconus suspect) in either eye;
• • Irregular or unstable (distorted/not clear) corneal mires on central keratometry images in either eye;
• • History of ocular herpes zoster or herpes simplex keratitis;
• • Deep orbits, strong blink, anxiety, pterygium, or any other finding suggesting difficulty in achieving or maintaining suction;
• • Difficulty following directions or unable to fixate;
• • Previous intraocular or corneal surgery of any kind in the eye 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;
• • History of diabetes, diagnosed autoimmune disease, connective tissue disease or clinically significant atopic syndrome;
• • Immunocompromised or requires chronic systemic corticosteroids or other immunosuppressive therapy that may affect wound healing;
• • History of known sensitivity to planned study medications;
• • Participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation;
• • Pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.