Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

NCT ID: NCT01663363

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-07-31

Brief Summary

The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

wavefront-guided LASIK

LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.

Group Type: EXPERIMENTAL

LASIK correction of myopic refractive errors

Intervention Type: DEVICE

Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

Interventions

LASIK correction of myopic refractive errors

Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years of age or greater
• Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
• Uncorrected visual acuity (UCVA) of 20/40 or worse
• Less than 0.75D difference between cycloplegic and manifest refraction sphere.
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kendra Hileman, PhD

Role: STUDY_DIRECTOR

Abbott Medical Optics

Other Identifiers

STAR-110-IDMY

Identifier Type: -

Identifier Source: org_study_id