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

Not Applicable

Completed

• Conditions: Hyperopia
• Interventions: Device: LASIK correction of hyperopic refractive errors

• Registration Number: NCT01675479
• Lead Sponsor: Abbott Medical Optics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-28
• Study First Posted: 2012-08-30
• Study Start: 2012-12-31
• Primary Completion: 2016-10-31
• Study Completion: 2016-10-31
• Results First Submitted: 2018-02-06
• Results First Submitted QC: 2018-03-27
• Results First Posted: 2018-04-25
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-07
• Last Update Posted: 2021-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 167

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
wavefront-guided LASIK	LASIK correction of hyperopic refractive errors	-

Primary Outcome Measures

Name	Time	Method
Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)	12 Months	Hypothesis: \<5% of eyes will have a loss of \> 2 lines of BSCVA at any postoperative visit, as measured using ETDRS logMAR visual acuity charts at 4 meters

Secondary Outcome Measures

Name	Time	Method
Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better	12 Months	Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Trial Locations

Locations (9)

King LASIK; 🇺🇸 Renton, Washington, United States

Coleman Vision; 🇺🇸 Albuquerque, New Mexico, United States

Lehmann Eye Center; 🇺🇸 Nacogdoches, Texas, United States

Pepose Vision Institute; 🇺🇸 Chesterfield, Missouri, United States

Durrie Vision; 🇺🇸 Kansas City, Missouri, United States

Maloney Vision Institute; 🇺🇸 Los Angeles, California, United States

Kraff Eye Institute; 🇺🇸 Chicago, Illinois, United States

University of Miami Bascom Palmer Eye Institute; 🇺🇸 Miami, Florida, United States

The Eye Center; 🇺🇸 Fairfax, Virginia, United States