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

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

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

Official Title
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A Multi-Center Prospective Study to Evaluate the Safety and Effectiveness of Arcuate Incisions Performed With the IntraLase iFS Femtosecond Laser System

Conditions
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Corneal Astigmatism

Intervention / Treatment
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* Device: iFS Femtosecond Laser System


Participation Criteria
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Eligibility Criteria
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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 </= 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Natural Astigmatism<br>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. | Device: iFS Femtosecond Laser System<br>* arcuate incisions placed with the iFS femtosecond laser<br>|
| Experimental: Post Cataract with Residual Astigmatism<br>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. | Device: iFS Femtosecond Laser System<br>* arcuate incisions placed with the iFS femtosecond laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of Astigmatism | Reduction of astigmatism as determined by manifest refractive cylinder | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Eyes With Loss of ≥ 2 Lines of Best Spectacle Corrected Visual Acuity (BSCVA) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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astigmatism