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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Hoopes Vision
Sponsor:
Information provided by (Responsible Party):
Robert P Rivera, MD, Hoopes Vision
ClinicalTrials.gov Identifier:
NCT01878838
First received: June 12, 2013
Last updated: June 13, 2013
Last verified: June 2013
  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 with Catalys Laser
Procedure: Femtosecond Laser Assisted Cataract Surgery with LenSx Laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 Hoopes Vision:

Primary Outcome Measures:
  • Cumulative Dissipated Energy [ Time Frame: Intraoperative ] [ Designated as safety issue: No ]
    The total amount of phacoemulsification energy delivered during the procedure.


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


Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 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 with Catalys Laser.
Procedure: Femtosecond Laser Assisted Cataract Surgery with 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 with LenSx Laser.
Procedure: Femtosecond Laser Assisted Cataract Surgery with 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

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878838

Contacts
Contact: Steve H Linn, OD (801) 568-0200 ext 7343 steve@hoopesvision.com
Contact: Nicole Q Adams, COA (801) 568-0200 ext 7342 nicole@hoopesvision.com

Locations
United States, Utah
Hoopes Vision Recruiting
Salt Lake City, Utah, United States, 84020
Contact: Steve H Linn, OD    801-568-0200 ext 7343    steve@hoopesvision.com   
Contact: Nicole Q Adams, COA    (801) 568-0200 ext 7342    nicole@hoopesvision.com   
Principal Investigator: Robert P Rivera, MD         
Sub-Investigator: Phillip C Hoopes, MD         
Sponsors and Collaborators
Robert P Rivera, MD
Investigators
Principal Investigator: Robert P Rivera, MD Hoopes Vision
Study Director: Steve H Linn, OD Hoopes Vision
  More Information

Publications:

Responsible Party: Robert P Rivera, MD, Director of Clinical Research, Hoopes Vision
ClinicalTrials.gov Identifier: NCT01878838     History of Changes
Other Study ID Numbers: HV-AVO1
Study First Received: June 12, 2013
Last Updated: June 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sclerosis
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 31, 2014