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A Study of Cataract Surgery With the Femtosecond Laser

This study has been terminated.
(Sponsor decided not to pursue market release of prototype device used in this study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00922571
First Posted: June 17, 2009
Last Update Posted: August 3, 2016
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):
Abbott Medical Optics
  Purpose
The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.

Condition Intervention
Cataract Procedure: FS Laser Surgery Device: FS Laser System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study of Cataract Surgery With the Assistance of the Femtosecond Laser

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Capsulotomy Size [ Time Frame: Day of Surgery ]
    Capsulotomy size will be measured during surgery.


Secondary Outcome Measures:
  • Cumulated 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.
Enrollment: 100
Study Start Date: June 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FS Laser Surgery
For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the OptiMedica Catalys™ Precision Laser System (Catalys System)
 Procedure: FS Laser Surgery
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
Device: FS Laser System
The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery. The intervention consists of the both surgery and the use of the device.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System)

  Eligibility

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, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able and willing to comply with the treatment/follow-up schedule and requirements
  • Able to understand and provide written Informed Consent
  • 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
  • Patient age between 50 and 80 years old
  • Pupil dilates to at least 8 mm
  • Patient able to fixate
  • 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions)
  • Axial length between 22 and 26 mm

Exclusion Criteria:

  • Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
  • 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
  • Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
  • History of prior ocular surgery
  • History of ocular trauma
  • Co-existing ocular disease affecting vision
  • Astigmatism greater than five diopters (D.)
  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): NCT00922571


Locations
Dominican Republic
Laser Center
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Abbott Medical Optics
Investigators
Principal Investigator: Juan F. Batlle, MD Laser Center, Santo Domingo, Dominican Republic
  More Information

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00922571     History of Changes
Other Study ID Numbers: OMC-C-1.1
First Submitted: June 16, 2009
First Posted: June 17, 2009
Last Update Posted: August 3, 2016
Last Verified: August 2016

Keywords provided by Abbott Medical Optics:
Cataract
Femtosecond laser

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases


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