Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:July 2015

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A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser

The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and
effective for the correction of myopic refractive errors.


Inclusion Criteria:

- 18 years of age or greater

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

- Uncorrected visual acuity (UCVA) of 20/40 or worse

- Less than 0.75D difference between cycloplegic and manifest refraction sphere.

- Demonstration of refractive stability

- Anticipated post-operative stromal bed thickness of at least 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
1
site
Milpitas, California 95035
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mi
from
Milpitas, CA
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