Femtosecond Laser for Cataract Surgery

Study Overview
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Brief Summary
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The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Official Title
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A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification

Conditions
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Cataract

Intervention / Treatment
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* Procedure: U/S Surgery and CCC
* Device: FS Laser Surgery


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 ETDRS visual acuity equal to or worse than 20/32 (best corrected) Age between 50 and 80 years old Pupil dilates to at least 6 mm Subject able to fixate Grade 1-4 nuclear sclerotic cataract (LOCS III) Axial length between 22 and 26 mm Exclusion Criteria: Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding 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 or for which cataract surgery is contraindicated Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss). History of prior ocular surgery History of ocular trauma Co-existing ocular disease affecting vision History or current use of alpha-1 antagonist medication (e.g., Flomax) Known sensitivity to planned concomitant medications

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: U/S Surgery and CCC<br>Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC). | Procedure: U/S Surgery and CCC<br>* Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.<br>* Other names: Standard of care for U/S and CCC was required.;|
| 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 femtosecond laser device. | Device: FS Laser Surgery<br>* The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.<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 Dimension | Capsulotomy size will be measured during surgery for both the experimental and control groups. | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative 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, Surgery, cataract extraction, Optical devices, laser