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 |
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.
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
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