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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01878838
First Posted: June 17, 2013
Last Update Posted: August 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Steve H. Linn, OD, Hoopes Vision
  Purpose
This study compares two FDA approved Cataract Lasers.

Condition Intervention
Nuclear Sclerosis of the Lens Posterior Subcapsular Cataract Cortical Cataract Procedure: Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser Procedure: Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Steve H. Linn, OD, Hoopes Vision:

Primary Outcome Measures:
  • Cumulative Dissipated Energy [ Time Frame: Intraoperative ]
    The total amount of phacoemulsification energy delivered during the procedure.


Secondary Outcome Measures:
  • Complete Laser Capsulotomy [ Time Frame: Intraoperative ]
    Did the laser perform a complete capsulotomy with no tags or untreated segments.


Enrollment: 45
Study Start Date: April 2013
Study Completion Date: January 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Alcon LenSx Laser System

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01878838


Locations
United States, Utah
Hoopes Vision
Salt Lake City, Utah, United States, 84020
Sponsors and Collaborators
Steve H. Linn, OD
Investigators
Principal Investigator: Robert P Rivera, MD Hoopes Vision
Study Director: Steve H Linn, OD Hoopes Vision
  More Information

Publications:

Responsible Party: Steve H. Linn, OD, Study Coordinator, Hoopes Vision
ClinicalTrials.gov Identifier: NCT01878838     History of Changes
Other Study ID Numbers: HV-AVO1
First Submitted: June 12, 2013
First Posted: June 17, 2013
Last Update Posted: August 20, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases