Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: LASIK

• Registration Number: NCT01675492
• Lead Sponsor: Abbott Medical Optics

Brief Summary

To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

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: 2012-12-06
• Primary Completion: 2016-11-22
• Study Completion: 2016-11-22
• Results First Submitted: 2017-02-03
• Results First Submitted QC: 2017-05-23
• Results First Posted: 2017-05-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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 lest 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
wave-front guided LASIK	LASIK	-

Primary Outcome Measures

Name	Time	Method
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)	3 Months	\< 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
Uncorrected Visual Acuity (UCVA) of 20/40 or Better	3 Months	85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Trial Locations

Locations (8)

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

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

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

King LASIK; 🇺🇸 Renton, Washington, United States

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

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

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

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