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A Study of Cataract Surgery With the Femtosecond Laser

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ClinicalTrials.gov Identifier: NCT00922571
Recruitment Status : Terminated (Sponsor decided not to pursue market release of prototype device used in this study)
First Posted : June 17, 2009
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Cataract Procedure: FS Laser Surgery Device: FS Laser System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study of Cataract Surgery With the Assistance of the Femtosecond Laser
Study Start Date : June 2009
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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)


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


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00922571     History of Changes
Other Study ID Numbers: OMC-C-1.1
First Posted: June 17, 2009    Key Record Dates
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