Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:December 2012
End Date:February 2018

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A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System

To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and
effective in the treatment of mixed astigmatism.


Inclusion Criteria:

- At least 18 years of age at the time of pre-operative exam

- Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better

- Demonstration of refractive stability

- Anticipated post-operative stromal bed thickness of at lest 250 microns

- Willing and capable of returning for follow-up examinations for the duration of the
study

Exclusion Criteria:

- Women who are pregnant, breast-feeding, or intend to become pregnant over the course
of the study

- Concurrent use of topical or systemic medications that may impair healing

- History of any medical conditions that could affect wound healing

- History of prior intraocular or corneal surgery, active ophthalmic disease,or other
ocular abnormality

- Evidence of keratoconus, corneal irregularity, or abnormal topography in the
operative eye(s)

- Known sensitivity or inappropriate responsiveness to any of the medications used in
the post-operative course
We found this trial at
8
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Nacogdoches, Texas 75965
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Albuquerque, New Mexico 87109
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Chesterfield, Missouri
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Chicago, Illinois 60602
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Chicago, IL
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Fairfax, Virginia 22031
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Kansas City, Missouri 66211
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Kansas City, MO
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Miami, FL
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Renton, Washington 98057
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Renton, WA
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