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

Completed · Not applicable

Conditions studied: Hyperopia

In brief

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

Key facts

Study ID

NCT01675479

Run by

Abbott Medical Optics

People needed

167

Starts

2012-12-31

Expected to finish

2016-10-31

Last updated by the study team

2021-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Maloney Vision Institute — Los Angeles, California, United States
• University of Miami Bascom Palmer Eye Institute — Miami, Florida, United States
• Kraff Eye Institute — Chicago, Illinois, United States
• Pepose Vision Institute — Chesterfield, Missouri, United States
• Durrie Vision — Kansas City, Missouri, United States
• Coleman Vision — Albuquerque, New Mexico, United States
• Lehmann Eye Center — Nacogdoches, Texas, United States
• The Eye Center — Fairfax, Virginia, United States
• King LASIK — Renton, Washington, United States

Full record on ClinicalTrials.gov

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