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

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

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

Study Overview

• Status: Completed
• Conditions: Hyperopia
• Intervention / Treatment: Device: LASIK correction of hyperopic refractive errors

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90024
      • Maloney Vision Institute
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Bascom Palmer Eye Institute
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Kraff Eye Institute
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Pepose Vision Institute
    • Kansas City, Missouri, United States, 66211
      • Durrie Vision
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Coleman Vision
  • Texas
    • Nacogdoches, Texas, United States, 75965
      • Lehmann Eye Center
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • The Eye Center
  • Washington
    • Renton, Washington, United States, 98057
      • King LASIK

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: wavefront-guided LASIK	Device: LASIK correction of hyperopic refractive errors; Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2012
• Primary Completion (Actual): October 31, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: August 28, 2012
• First Submitted That Met QC Criteria: August 28, 2012
• First Posted (Estimate): August 30, 2012

Study Record Updates

• Last Update Posted (Actual): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 7, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: refractive; errors
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: STAR-111-IDHP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No Plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No