The purpose of this study is to determine whether the MEL 80 Excimer Laser is effective in the treatment of mixed astigmatism up to 6.0 D, when used as part of the Laser In Situ Keratomileusis (LASIK) procedure.
LASIK has become one of the most common refractive eye procedures performed in the country. In the mixed astigmatism procedure, a combination of both a steepening (hyperopic treatment) and a flattening (myopic treatment) occur on the corneal surface. The surgeon will produce a standard keratomileusis flap using a microkeratome, exposing the corneal stroma. Recontouring under the flap is then accomplished by the removal of tissue from the stroma with the laser. This recontouring results in an altering of effective lens power of the central cornea, measured in diopters (D). The MEL 80 Excimer Laser System will be evaluated for its ability to create accurate and stable mixed astigmatic refractive correction results.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
126
Treatment of Naturally Occuring Mixed Astigmatic corrections up to 6.0 D.
US Navy Refractive Surgery Center
San Diego, California, United States
Dishler Laser Institute
Greenwood Village, Colorado, United States
Discover Vision Centers
Kansas City, Missouri, United States
Fine, Hoffman, and Packer
Eugene, Oregon, United States
At the point of stability, a minimum of 75% of eyes should have an achieved refraction within ± 1.00 D of the intended outcome, and at least 50% of eyes should be within ± 0.50 D of the intended outcome.
Time frame: Point of stability
A minimum of 85% of eyes should have an uncorrected visual acuity of 20/40 or better at the postoperative interval at which stability has been established.
Time frame: Point of stability
A minimum of 95% of eyes should have a change of < 1.00 D in manifest refraction spherical equivalent (MRSE) between 2 refractions performed at least 3 months apart, and the mean rate of MRSE change per month should be < 0.04 D.
Time frame: Point of stability
Distance BSCVA of worse than 20/40 at the postoperative interval at which stability has been established should occur in less than 1.0 % of eyes that had a BSCVA of 20/20 or better before surgery.
Time frame: Point of stability
Loss of more than 2 lines of BSCVA should occur in less than 5.0 % of eyes.
Time frame: Postoperative visits
Incidence of adverse events to occur in less than 1% of eyes
Time frame: Postoperative visits
Subject Satisfaction: As measured by a subjective questionnaire, and will be considered as a secondary efficacy variable.
Time frame: Postoperative visits 3, 6, 9 and 12 months
Incidence of complications
Time frame: Postoperative visits
Patient Symptoms: As measured by a subjective questionnaire, will be considered as a secondary safety variable.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Davis Duehr Dean Eye Clinic
Madison, Wisconsin, United States
Time frame: Preoperative and Postoperative visits 3, 6, 9 and 12 months