Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

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. Identifier: NCT01069172
Recruitment Status : Completed
First Posted : February 17, 2010
Results First Posted : September 4, 2014
Last Update Posted : September 4, 2014
Information provided by (Responsible Party):
Abbott Medical Optics

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Condition or disease Intervention/treatment Phase
Cataract Device: FS Laser Surgery Procedure: CCC Surgery Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification
Study Start Date : February 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: FS Laser Surgery
For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.
Device: FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System) = femtosecond laser; Alcon Infiniti System = U/S (ultrasound) phacoemulsification system

Active Comparator: CCC Surgery
For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.
Procedure: CCC Surgery
Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.
Other Name: Alcon Infiniti System = U/S (ultrasound) phacoemulsification system.

Primary Outcome Measures :
  1. Deviation From Intended Capsulotomy Diameter [ Time Frame: Day of Surgery ]
    Capsulotomy diameter measured during surgery for both the experimental and control groups.

Secondary Outcome Measures :
  1. Cumulative Dissipated Energy (CDE) [ Time Frame: Day of Surgery ]

    CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows:

    CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4)

    0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Able and willing to comply with the treatment/follow-up schedule and requirements
  • Able to understand and provide written Informed Consent
  • ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
  • Age between 50 and 80 years old
  • Pupil dilates to at least 7 mm
  • Subject able to fixate
  • Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - LOCS III)
  • Axial length between 22 and 26 mm

Exclusion Criteria:

  • Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
  • Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
  • Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
  • Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
  • History of prior ocular surgery
  • History of ocular trauma
  • Co-existing ocular disease affecting vision
  • History or current use of alpha-1 antagonist medication (e.g., Flomax)
  • Known sensitivity to planned concomitant medications

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 identifier (NCT number): NCT01069172

Dominican Republic
Laser Center
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Abbott Medical Optics
Principal Investigator: Juan F Batlle, MD Laser Center
Study Director: William W Culberston, MD Bascom Palmer Eye Institute

Responsible Party: Abbott Medical Optics Identifier: NCT01069172     History of Changes
Other Study ID Numbers: OMC-C-2.0
First Posted: February 17, 2010    Key Record Dates
Results First Posted: September 4, 2014
Last Update Posted: September 4, 2014
Last Verified: August 2014

Keywords provided by Abbott Medical Optics:
Surgery, cataract extraction
Optical devices, laser

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases