Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
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
1 other identifier
interventional
126
0 countries
N/A
Brief Summary
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2012
CompletedFirst Posted
Study publicly available on registry
August 30, 2012
CompletedStudy Start
First participant enrolled
December 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2016
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedFebruary 4, 2025
January 1, 2025
4 years
August 28, 2012
February 3, 2017
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
3 Months
Secondary Outcomes (1)
Uncorrected Visual Acuity (UCVA) of 20/40 or Better
3 Months
Study Arms (1)
wave-front guided LASIK
EXPERIMENTALInterventions
Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System
Eligibility Criteria
You may qualify if:
- 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
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Clinical Operations
- 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
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2012
First Posted
August 30, 2012
Study Start
December 6, 2012
Primary Completion
November 22, 2016
Study Completion
November 22, 2016
Last Updated
February 4, 2025
Results First Posted
May 30, 2017
Record last verified: 2025-01