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

Not Applicable

Completed

• Conditions: Nuclear Sclerosis of the Lens; Posterior Subcapsular Cataract; Cortical Cataract
• Interventions: Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser; Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

• Registration Number: NCT01878838
• Lead Sponsor: Steven H. Linn, OD

Brief Summary

This study compares two FDA approved Cataract Lasers.

Detailed Description

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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-06-12
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LenSx Treated Eyes	Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser	Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser.
Catalys Treated Eyes	Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser	Patient's aged 22 and older with visually significant cataracts undergoing Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser

Primary Outcome Measures

Name	Time	Method
Cumulative Dissipated Energy	Intraoperative	The total amount of phacoemulsification energy delivered during the procedure.

Secondary Outcome Measures

Name	Time	Method
Complete Laser Capsulotomy	Intraoperative	Did the laser perform a complete capsulotomy with no tags or untreated segments.

Trial Locations

Locations (1)

Hoopes Vision; 🇺🇸 Salt Lake City, Utah, United States