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

Myopia Clinical Trial

Official title:

A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Myopic Refractive Errors With the iDesign Advanced Wavescan Studio™ System and Star S4IR™ Excimer Laser

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01663363
• Other study ID #: STAR-110-IDMY
• Status: Completed
• Phase: Phase 3
• First received: August 9, 2012
• Last updated: September 30, 2015
• Start date: August 2012
• Est. completion date: July 2015

Study information

• Verified date: June 2015
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: July 2015
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

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

Locations

Country	Name	City	State
United States	Contact Abbott Medical Optics for locations	Milpitas	California

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)		6 Months	Yes
Secondary	Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better		6 Months	No