Safety and Effectiveness of Arcuate Incisions Performed With the iFS Femtosecond Laser System

Phase 2

Completed

Brief Summary: To determine if arcuate incisions performed with the iFS femtosecond laser are safe and effective in reducing corneal astigmatism.

Detailed Description: Surgeons will perform arcuate incisions in the cornea in arc segment patterns using the iFS femtosecond laser to treat subjects with corneal astigmatism.

Recruitment & Eligibility

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)
1. Group 1:
  - Natural astigmatism, no cataract - BSCVA of 20/25 or better
  - Pre cataract or phakic IOL surgery - no BSCVA criteria
2. 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 </= 0.75 D in magnitude and 15 degrees axis when cylinder </= 1.5 D or 10 degrees axis when cylinder > 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

Arm && Interventions

Group	Intervention	Description
Natural Astigmatism	iFS Femtosecond Laser System	Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
Post Cataract with Residual Astigmatism	iFS Femtosecond Laser System	Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.

Primary Outcome Measures

Name	Time	Method
Reduction of Astigmatism	6 months	Reduction of astigmatism as determined by manifest refractive cylinder

Secondary Outcome Measures

Name	Time	Method
Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA)	6 months

Locations (4): Paracelsus Medizinische Privat-Universitat, PMU
🇦🇹
Salzburg, Austria
Bochum-Langendreer
🇩🇪
Bochum, Germany
CHU Morvan
🇫🇷
Brest, France
Potsdamer Augenklinik im
🇩🇪
Potsdam, Germany