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

This study has been completed.
Sponsor:
Information provided by:
LenSx Lasers Inc.
ClinicalTrials.gov Identifier:
NCT00959322
First received: August 12, 2009
Last updated: October 12, 2009
Last verified: October 2009
  Purpose

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 Intervention
Cataract
Device: LenSx 550 Laser System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser

Resource links provided by NLM:


Further study details as provided by LenSx Lasers Inc.:

Primary Outcome Measures:
  • Capsulotomy is complete [ Time Frame: 1 day, 1 week, 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No radial tears noted intraoperatively [ Time Frame: 1 day, 1 week, 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: August 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: LenSx 550 Laser System
    Femtosecond laser used to create capsulotomy incision.
    Other Names:
    • LenSx
    • LenSx 550 Laser
    • Femtosecond
  Eligibility

Ages Eligible for Study:   24 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00959322

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

No publications provided

Responsible Party: Dr. Melvin Sarayba, M.D., LenSx Lasers, Inc.
ClinicalTrials.gov Identifier: NCT00959322     History of Changes
Other Study ID Numbers: CAP-001
Study First Received: August 12, 2009
Last Updated: October 12, 2009
Health Authority: Hungary: Institutional Ethics Committee

Keywords provided by LenSx Lasers Inc.:
Capsulotomy

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014