N/A
N=84
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism
Astigmatism
Bottom Line
View on ClinicalTrials.gov: NCT01675492 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) — 149 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LASIK (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Optics
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Line Loss of More Than Two Lines for Best Spectacle Corrected Visual Acuity (BSCVA) |
149 | — |
| SECONDARY Uncorrected Visual Acuity (UCVA) of 20/40 or Better |
149 | — |
Summary
To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.
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
Data sourced from ClinicalTrials.gov (NCT01675492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.