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 |
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.
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.
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