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

August 18, 2015 updated by: Steve H. Linn, OD

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.

This study compares two FDA approved Cataract Lasers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84020
        • Hoopes Vision

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Catalys Treated Eyes
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
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.
Other Names:
  • Optimedica Catalys Precision Laser System
ACTIVE_COMPARATOR: LenSx Treated Eyes
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
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.
Other Names:
  • Alcon LenSx Laser System

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steve H. Linn, OD

Investigators

  • Principal Investigator: Robert P Rivera, MD, Hoopes Vision
  • Study Director: Steve H Linn, OD, Hoopes Vision

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (ESTIMATE)

June 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HV-AVO1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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