Corneal Incisions With the IntraLase iFS Femtosecond Laser System

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 37

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FS Corneal Incisions	iFS Femtosecond Laser	-

Primary Outcome Measures

Name	Time	Method
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.	Day 0, Operative (Within 2 hours of incision creation)	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).

Secondary Outcome Measures

Name	Time	Method
Surgeon Assessment of Workflow	Day 0, Operative	Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?
Percent of Seidel Staining	Day 0 (performed immediately post-incision creation), Day 1	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.