Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/27/2018
Start Date:December 2012
End Date:October 2016

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A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4 IR™ Excimer Laser System

Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe
and effective for the treatment of Hyperopia.


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 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
9
sites
Albuquerque, New Mexico 87109
1333
mi
from 43215
Albuquerque, NM
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Chesterfield, Missouri
413
mi
from 43215
Chesterfield, MO
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Chicago, Illinois 60602
274
mi
from 43215
Chicago, IL
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Fairfax, Virginia 22031
314
mi
from 43215
Fairfax, VA
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Kansas City, Missouri 66211
622
mi
from 43215
Kansas City, MO
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Los Angeles, California 90024
1972
mi
from 43215
Los Angeles, CA
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996
mi
from 43215
Miami, FL
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Nacogdoches, Texas 75965
866
mi
from 43215
Nacogdoches, TX
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Renton, Washington 98057
2000
mi
from 43215
Renton, WA
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