Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors
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
1 other identifier
interventional
170
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2012
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 9, 2012
CompletedFirst Posted
Study publicly available on registry
August 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedResults Posted
Study results publicly available
June 26, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 4, 2025
January 1, 2025
1.6 years
August 9, 2012
May 28, 2015
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Eyes With Loss of More Than 2 Lines Best Spectacle Corrected Visual Acuity (BSCVA)
6 Months
Secondary Outcomes (1)
Percentage of Eyes With Uncorrected Visual Acuity (UCVA) of 20/40 or Better
6 Months
Study Arms (1)
wavefront-guided LASIK
EXPERIMENTALLASIK correction of myopic refractive errors. Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
Interventions
Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ann Murphy, Manager, Clinical Research
- Organization
- Abbott Medical Optics
Study Officials
- STUDY DIRECTOR
Kendra Hileman, PhD
Abbott Medical Optics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2012
First Posted
August 13, 2012
Study Start
August 1, 2012
Primary Completion
March 1, 2014
Study Completion
July 1, 2015
Last Updated
February 4, 2025
Results First Posted
June 26, 2015
Record last verified: 2025-01