Phase 2
Completed N=40
Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System
Corneal Astigmatism
Source: ClinicalTrials.gov NCT01348854 ↗
Enrolled (actual)
40
Serious AEs
5.0%
Results posted
Jun 2014
Primary outcomePrimary: Reduction of Astigmatism — -0.75; -0.88 diopter
Summary
To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Astigmatism |
-0.75; -0.88 | — |
| SECONDARY Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) |
4.9; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, of any race, and at least 21 years of age at the time of pre-op exam
- Corneal astigmatism, as determined by topographic keratometry, of 0.75 D to 4.00 diopters (D)
- Best Spectacle Corrected Distance Visual Acuity (BSCVA)
- Group 1:
- Natural astigmatism, no cataract - BSCVA of 20/25 or better
- Pre cataract or phakic IOL surgery - no BSCVA criteria
- Group 2:
- Post IOL surgery- BSCVA of 20/25 or better
- Uncorrected Visual Acuity (UCVA) of 20/40 or worse
- Demonstration of agreement: Corneal astigmatism (as determined by topographic keratometry) must be in agreement with refractive astigmatism (as determined by manifest refractions) within 1.5 D.
- Preoperative central pachymetry of >/=480 um
- Keratometry between 38.0 D (flat) to 48.0 D (steep)
- Corneal power (diopters) difference at the 3mm point from topographic center shall be </= 1D at the steepest meridian
- Intraocular pressure of 12 to 21 mm Hg with no glaucomatous retinal/optic nerve changes
- Subjects who have worn a contact lens within the past 30 days must remove the soft lens at least 2 weeks prior and a rigid or toric lens at least 3 weeks prior to baseline measurements
- Willing and capable of returning for follow-up examinations for the duration of the study
Exclusion Criteria
- Angle kappa of greater than 0.5 mm, absolute value
- Prior implantation of toric or multifocal intraocular lens
- 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 corneal wound healing
- History of any ocular or medical conditions that could affect corneal wound healing
- History of active or recurrent ophthalmic disease, including corneal dystrophy or other non-refractive abnormality such as exposure keratitis or clinically significant dry eye
- Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration in either eye
- Evidence of clinically significant corneal opacity/scar in the operative eye(s) within an 8 mm diameter zone of the visual axis
- Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
- Participation in any other conflicting clinical study
Data sourced from ClinicalTrials.gov (NCT01348854). 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.