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Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

Primary Purpose

Hyperopia

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

About this trial

This is an interventional treatment trial for Hyperopia focused on measuring refractive, errors

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 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

  • Maloney Vision Institute
  • University 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

wavefront-guided LASIK

Arm Description

Outcomes

Primary Outcome Measures

Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Hypothesis: <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

Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better
Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters

Full Information

First Posted
August 28, 2012
Last Updated
December 7, 2021
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT01675479
Brief Title
Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors
Official Title
A Prospective Study to Evaluate the Safety and Effectiveness of Wavefront-Guided Lasik Correction of Hyperopic 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
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 31, 2012 (Actual)
Primary Completion Date
October 31, 2016 (Actual)
Study Completion Date
October 31, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperopia
Keywords
refractive, errors

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
wavefront-guided LASIK
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LASIK correction of hyperopic refractive errors
Intervention Description
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Primary Outcome Measure Information:
Title
Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA)
Description
Hypothesis: <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
12 Months
Secondary Outcome Measure Information:
Title
Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better
Description
Hypothesis: 85% of eyes will have uncorrected visual acuity of 20/40 or better, as measured using ETDRS logMAR charts at 4 meters
Time Frame
12 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 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
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Maloney Vision Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University 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
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

Plan to Share IPD
No
IPD Sharing Plan Description
No Plan

Learn more about this trial

Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors

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