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

Alcon

Status

Completed

Conditions

Myopia

Hyperopia

Treatments

Device: Femtosecond Laser System

Procedure: LASIK surgery

Study type

Interventional

Funder types

Industry

Identifiers

CTJ121-P001

Details and patient eligibility

About

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

Enrollment

34 patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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.