A Study of Cataract Surgery With the Femtosecond Laser

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.

Official Title
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A Study of Cataract Surgery With the Assistance of the Femtosecond Laser

Conditions
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Cataract

Intervention / Treatment
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* Procedure: FS Laser Surgery
* Device: FS Laser System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to comply with the treatment/follow-up schedule and requirements Able to understand and provide written Informed Consent 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected) Patient age between 50 and 80 years old Pupil dilates to at least 8 mm Patient able to fixate 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions) Axial length between 22 and 26 mm Exclusion Criteria: Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements History of prior ocular surgery History of ocular trauma Co-existing ocular disease affecting vision Astigmatism greater than five diopters (D.)

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FS Laser Surgery<br>For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the OptiMedica Catalys™ Precision Laser System (Catalys System) | Procedure: FS Laser Surgery<br>* The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.<br>Device: FS Laser System<br>* The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.<br>* Other names: OptiMedica Catalys™ Precision Laser System (Catalys System);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capsulotomy Size | Capsulotomy size will be measured during surgery. | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulated Dissipated Energy (CDE) | CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. | Day of surgery | 

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