WaveLight® Refractive Flap Accuracy Study



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:3/1/2014
Start Date:October 2013
End Date:January 2015
Contact:ALCON Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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A Prospective, Global, Multi-Center Study to Evaluate Longitudinal Flap Accuracy on Subjects Undergoing Myopic Refractive Surgery Using the WaveLight® Refractive Suite

The purpose of this study is to evaluate outcomes on subjects undergoing myopic refractive
surgery using the WaveLight® Refractive Suite.


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.
We found this trial at
1
site
6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
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