The Comparison of Cataract Lasers Using the Optimedica Catalys Laser and the Alcon LenSx Laser.

Study Overview
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Brief Summary
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This study compares two FDA approved Cataract Lasers.

Detailed Description
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The purpose of this study is to systematically evaluate the performance of two commercially available and FDA cleared femtosecond laser systems in patients undergoing femtosecond laser-assisted cataract surgery. Objective data on the repeatability and accuracy of the studied parameters will be gathered and reported as endpoints of the study. The two systems studied are the Catalys™ Precision Laser System (OptiMedica, CA, USA) and the LenSx® Laser System (Alcon Laboratories, Inc., Fort Worth, TX). Published data have suggested that the femtosecond laser is a useful tool for cataract surgery. This study is to determine whether differences or similarities exist in specific treatment parameters achieved with two FDA cleared and commercially available femtosecond laser cataract surgery platforms

Official Title
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A Prospective Randomized Controlled Clinical Trial Comparing the Intra-operative Effects, Safety, Efficacy and Performance of Two Commercially Available Laser Systems in Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery.

Conditions
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Nuclear Sclerosis of the Lens, Posterior Subcapsular Cataract, Cortical Cataract

Intervention / Treatment
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* Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser
* Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have grade 2 to 4 nuclear sclerotic and or cortical or posterior subcapsular cataracts with visual impairment. Pupillary dilation of at least 6.0 mm Axial length between 21 mm to 26 mm Age ≥ 22 years of either gender Require laser assisted corneal incisions, capsulotomy and nucleus segmentation Understand and sign a written Informed Consent form Be able to comply with the treatment and follow-up schedule Exclusion Criteria: Enrolment in another drug or device study within the prior 3 months History of ocular trauma Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.) Uncontrolled systemic or ocular disease Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies, severe corneal opacities, significant corneal edema, etc) Diminished aqueous clarity that obscures OCT imaging of the anterior lens capsule Corneal ring and/or inlay implant(s) Pseudoexfoliation Known steroid IOP responder or ocular hypertension IOP >25 mmHg by tonometry Retinal detachment within the last 6 months Anterior chamber depth less than 2.5 mm

Ages Eligible for Study
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Minimum Age: 22 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Catalys Treated Eyes<br>Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser | Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser<br>* Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.<br>* Other names: Optimedica Catalys Precision Laser System;|
| Active Comparator: LenSx Treated Eyes<br>Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser. | Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser<br>* Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.<br>* Other names: Alcon LenSx Laser System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Dissipated Energy | The total amount of phacoemulsification energy delivered during the procedure. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete Laser Capsulotomy | Did the laser perform a complete capsulotomy with no tags or untreated segments. | Intraoperative |