Corneal Incisions With the IntraLase iFS Femtosecond Laser System

Study Overview
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Brief Summary
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The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.

Official Title
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A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY

Conditions
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Cataract

Intervention / Treatment
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* Device: iFS Femtosecond Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 21 years of age Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation Clear intraocular media other than cataract Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study Signed informed consent Exclusion Criteria: Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s) History of active or recurrent ophthalmic disease Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s) White to white measurement less than 10 mm or greater than 14 mm Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study Subjects with conditions associated with increased risk of IOL/capsule instability Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo) History of any ocular or medical conditions that could affect corneal wound healing Poorly-controlled diabetes or subjects with diabetic retinopathy Concurrent use of topical or systemic medications that may impair corneal wound healing Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.) Ocular hypertension (> 21 mm Hg) Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: FS Corneal Incisions<br> | Device: iFS Femtosecond Laser<br>* corneal incisions created by the femtosecond laser<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. | Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured). | Day 0, Operative (Within 2 hours of incision creation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgeon Assessment of Workflow | Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended? | Day 0, Operative | 
| Percent of Seidel Staining | Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage. | Day 0 (performed immediately post-incision creation), Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cataract surgery, Femtosecond laser, Corneal incisions