Correction of Myopia Wtih or Without Astigmatism Using the VisuMax™ Femtosecond Laser

Completed · Not applicable

Conditions studied: Myopia, Astigmatism

In brief

The objective of this clinical trial is to evaluate the safety and effectiveness of the Carl Zeiss Meditec VisuMax™ Femtosecond Laser lenticule removal procedure for the reduction or elimination of myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder (myopia with or without astigmatism) and MRSE ≤ -11.50 D.

Key facts

Study ID

NCT02430428

Run by

Carl Zeiss Meditec, Inc.

People needed

357

Starts

2015-03-01

Expected to finish

2017-10-01

Last updated by the study team

2021-01-27

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female subjects age 22 years of age and older;
• Myopia from ≥ -1.00 D to ≤ -10.00 D with ≤ -3.00 D cylinder and MRSE ≤ -11.50 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

You may not qualify if…

• Mesopic pupil diameter >8.0 mm;
• Cylinder > -3.00 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;
• Keratometry readings via Sim-K values less than 40.00 D;
• 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 immunosuppresive 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.

Where it is running

• Dishler Laser Institute — Greenwood Village, Colorado, United States
• Discover Vision Centers — Leawood, Kansas, United States
• Vance Thompson Vision — Sioux Falls, South Dakota, United States
• Slade and Baker Vision Center — Houston, Texas, United States
• Davis Duehr Dean — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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