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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:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT00922571
First received: June 16, 2009
Last updated: July 7, 2014
Last verified: July 2014
  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 Surgery

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Study of Cataract Surgery With the Assistance of the Femtosecond Laser

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Capsulotomy Size [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    Capsulotomy size will be measured during surgery.


Secondary Outcome Measures:
  • Cumulated Dissipated Energy (CDE) [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    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.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System)
Device: 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.
Other Name: OptiMedica Catalys™ Precision Laser System (Catalys System)

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT00922571     History of Changes
Other Study ID Numbers: OMC-C-1.1
Study First Received: June 16, 2009
Last Updated: July 7, 2014
Health Authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

Keywords provided by Abbott Medical Optics:
Cataract
Femtosecond laser

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on November 20, 2014