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A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser

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: NCT00959322
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : October 14, 2009
Information provided by:
LenSx Lasers Inc.

Brief Summary:
The LenSx 550 laser system is a femtosecond laser intended for use in performing anterior capsulotomy during cataract surgery. The anterior capsulotomy creates a circular opening in the anterior surface of the capsular bag that contains the cataractous crystalline lens. The objective of this study is to evaluate the ability of the LenSx 550 laser to successfully perform anterior capsulotomy during cataract surgery.

Condition or disease Intervention/treatment
Cataract Device: LenSx 550 Laser System

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
Study Start Date : August 2008
Primary Completion Date : February 2009
Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract
U.S. FDA Resources

Intervention Details:
    Device: LenSx 550 Laser System
    Femtosecond laser used to create capsulotomy incision.
    Other Names:
    • LenSx
    • LenSx 550 Laser
    • Femtosecond

Primary Outcome Measures :
  1. Capsulotomy is complete [ Time Frame: 1 day, 1 week, 1 month ]

Secondary Outcome Measures :
  1. No radial tears noted intraoperatively [ Time Frame: 1 day, 1 week, 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   24 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
  • Must be at least 24 years of age.
  • Must be willing and able to return for scheduled follow-up examinations.
  • Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

  • Corneal disease or pathology that precludes applanation of the cornea or transmission of laser wavelength or distortion of laser light.
  • Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally are excluded.
  • Subjects with residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease) in either eye are excluded.
  • History of steroid-responsive rise in intraocular pressure, glaucoma, or preoperative IOP>21 mm Hg in either eye.
  • Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
  • Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
  • Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
  • Known sensitivity to planned study concomitant medications.
  • Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
  • Subjects presenting any contraindications to cataract surgery.

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): NCT00959322

Semmelweis University
Budapest, Hungary, 1085
Sponsors and Collaborators
LenSx Lasers Inc.
Study Chair: Ronald M Kurtz, M.D. LenSx Lasers Inc.
Study Director: Melvin Sarayba, M.D. LenSx Lasers Inc.

Responsible Party: Dr. Melvin Sarayba, M.D., LenSx Lasers, Inc. Identifier: NCT00959322     History of Changes
Other Study ID Numbers: CAP-001
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by LenSx Lasers Inc.:

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases