A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser

Study Overview
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Brief Summary
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The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in the anterior surface of the capsular bag that contains the cataractous crystalline lens. The objective of this study is to evaluate the ability of the LenSx 550 laser to successfully perform anterior capsulotomy during cataract surgery.

Official Title
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A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser

Conditions
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Cataract

Intervention / Treatment
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* Device: LenSx 550 Laser System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye. Must be at least 24 years of age. Must be willing and able to return for scheduled follow-up examinations. Subjects must sign and be given a copy of the written Informed Consent form. Exclusion Criteria: Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light. Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded. Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded. History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>21 mm Hg in either eye. Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc. Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye. Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study. Known sensitivity to planned study concomitant medications. Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation. Subjects presenting any contraindications to cataract surgery.

Ages Eligible for Study
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Minimum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

| Intervention/Treatment |
| --- |
|Device: LenSx 550 Laser System|Femtosecond laser used to create capsulotomy incision.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsulotomy is complete |  | 1 day, 1 week, 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No radial tears noted intraoperatively |  | 1 day, 1 week, 1 month | 

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