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

Primary Purpose

Myopia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
LASIK correction of myopic refractive errors
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia focused on measuring refractive, LASIK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Contact Abbott Medical Optics for locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

wavefront-guided LASIK

Arm Description

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

Outcomes

Primary Outcome Measures

Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)

Secondary Outcome Measures

Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better

Full Information

First Posted
August 9, 2012
Last Updated
September 30, 2015
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT01663363
Brief Title
Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
refractive, LASIK

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wavefront-guided LASIK
Arm Type
Experimental
Arm Description
LASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Intervention Type
Device
Intervention Name(s)
LASIK correction of myopic refractive errors
Intervention Description
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Primary Outcome Measure Information:
Title
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kendra Hileman, PhD
Organizational Affiliation
Abbott Medical Optics
Official's Role
Study Director
Facility Information:
Facility Name
Contact Abbott Medical Optics for locations
City
Milpitas
State/Province
California
ZIP/Postal Code
95035
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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