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

Primary Purpose

Astigmatism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LASIK
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

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

Sites / Locations

  • Univerisity of Miami Bascom Palmer Eye Institute
  • Kraff Eye Institute
  • Pepose Vision Institute
  • Durrie Vision
  • Coleman Vision
  • Lehmann Eye Center
  • The Eye Center
  • King LASIK

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

wave-front guided LASIK

Arm Description

Outcomes

Primary Outcome Measures

Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
< 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

Uncorrected Visual Acuity (UCVA) of 20/40 or Better
85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Full Information

First Posted
August 28, 2012
Last Updated
May 23, 2017
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT01675492
Brief Title
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
Official Title
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided LASIK Correction of Mixed Astigmatic Refractive Errors With the iDESIGN Advanced Wavescan Studio™ System and STAR S4 IR™ Excimer Laser System
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 6, 2012 (Actual)
Primary Completion Date
November 22, 2016 (Actual)
Study Completion Date
November 22, 2016 (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
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
wave-front guided LASIK
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LASIK
Intervention Description
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System
Primary Outcome Measure Information:
Title
Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Description
< 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
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Uncorrected Visual Acuity (UCVA) of 20/40 or Better
Description
85% of eyes will have UCVA of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
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
Univerisity of Miami Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Kraff Eye Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Pepose Vision Institute
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017-5065
Country
United States
Facility Name
Durrie Vision
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
66211
Country
United States
Facility Name
Coleman Vision
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Lehmann Eye Center
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States
Facility Name
The Eye Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
King LASIK
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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