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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: LenSx 550 Laser System

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Capsulotomy is complete	1 day, 1 week, 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
No radial tears noted intraoperatively	1 day, 1 week, 1 month

Collaborators and Investigators

• Sponsor: LenSx Lasers Inc.
• Investigators: Study Chair: Ronald M Kurtz, M.D., LenSx Lasers Inc.; Study Director: Melvin Sarayba, M.D., LenSx Lasers Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (ACTUAL): February 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 13, 2009
• First Posted (ESTIMATE): August 14, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 14, 2009
• Last Update Submitted That Met QC Criteria: October 12, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Capsulotomy
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CAP-001