WaveLight® Refractive Flap Accuracy Study

Alcon

Status

Completed

Conditions

Refractive Error

Treatments

Device: WaveLight® Refractive Suite

Procedure: LASIK surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT01941485

A01354

Details and patient eligibility

About

The purpose of this study is to evaluate the accuracy of the WaveLight FS200 femtosecond laser, as assessed by 1 day and 1 month post-operative optical coherence tomography (OCT) anterior segment corneal measurements compared to pre-operative flap thickness target.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Willing and able to understand and sign an informed consent form.
Have refractive error (in both eyes) that requires refractive surgery.
Willing to undergo LASIK surgery using the Wavelight® Refractive Suite.
Myopia between 0.00 to -12.0 Diopters pre-operatively.
Astigmatism between 0.00 to +6.00 Diopters pre-operatively.
Willing and able to attend post-operative examinations per protocol schedule.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Participation in a clinical study within the last 30 days.
History of previous corneal surgery in either eye.
Multifocal ablations in either eye.
PRK or PTK surgery in either eye.
Suffering from acute or recurring eye diseases in either eye, such as corneal ulcers, cataract, etc.
Any ocular disease and/or condition that, in the Investigator's clinical judgment, may put subject at significant risk, compromise study results, or interfere significantly with subject's participation in the study.
Unable to discontinue contact lens wear as specified in protocol.
History of Herpes simplex or Herpes zoster keratitis.
Active ocular rosacea.
Lyme disease.
Severe ocular allergies.
Other medical conditions and use of medications as specified in protocol.
Pregnant or planning to become pregnant during the study.
Other protocol-specified exclusion criteria may apply.