Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

Accuracy of LASIK Flaps Created With the LenSx® Femtosecond Laser - A Pilot Study

The purpose of this study is to evaluate the thickness accuracy of Laser-assisted in situ keratomileusis (LASIK) flaps created with the LenSx® Laser.

Inclusion Criteria:

• Diagnosed with myopia or hyperopia and eligible for femtosecond laser initiated LASIK surgery;
• Best corrected visual acuity (BCVA) correctable to at least 20/25 in each eye;
• If contact lens wearer, willing to discontinue contact lens wear prior to screening procedures;
• Willing and able to return for ALL scheduled follow-up examinations;
• Willing and able to provide written informed consent;
• Eligible for bilateral LASIK procedures to be done on the same day;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Previous corneal surgery, corneal lesions that will impede laser treatment, corneal edema, hypotony, glaucoma, existing corneal implant, or keratoconus;
• Known sensitivity to planned study concomitant medications;
• Participation in any other ophthalmic drug or device clinical study for 30 days prior to or during the time of participation in this study;
• Irregular astigmatism, based on the Investigator's judgement;
• Pregnant, lactating or planning to become pregnant during the course of the study;
• Other protocol-specified exclusion criteria may apply.