N/A
Completed N=69
Safety and Effectiveness of Wavefront-Guided LASIK Correction of Hyperopic Refractive Errors
Source: ClinicalTrials.gov NCT01675479 ↗Enrolled (actual)
69
Serious AEs
4.4%
Results posted
Apr 2018
Primary outcomePrimary: Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) — 2 eyes
Summary
Demonstrate that wavefront-guided LASIK using measurements from the iDesign System is safe and effective for the treatment of Hyperopia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Eyes With a Loss of >2 Lines for Best Spectacle Corrected Visual Acuity (BSCVA) |
2 | — |
| SECONDARY Number of Eyes With Uncorrected Visual Acuity (VA) of 20/40 or Better |
123 | — |
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
Data sourced from ClinicalTrials.gov (NCT01675479). 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. Informational only — not medical advice.