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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
LenSx 550 Laser System
Sponsored by
LenSx Lasers Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Capsulotomy

Eligibility Criteria

24 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Semmelweis University

Outcomes

Primary Outcome Measures

Capsulotomy is complete

Secondary Outcome Measures

No radial tears noted intraoperatively

Full Information

First Posted
August 12, 2009
Last Updated
October 12, 2009
Sponsor
LenSx Lasers Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00959322
Brief Title
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
Official Title
A Prospective Single Center Clinical Study for Capsulotomy Using the LenSx 550 Laser
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
LenSx Lasers Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Capsulotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
LenSx 550 Laser System
Other Intervention Name(s)
LenSx, LenSx 550 Laser, Femtosecond
Intervention Description
Femtosecond laser used to create capsulotomy incision.
Primary Outcome Measure Information:
Title
Capsulotomy is complete
Time Frame
1 day, 1 week, 1 month
Secondary Outcome Measure Information:
Title
No radial tears noted intraoperatively
Time Frame
1 day, 1 week, 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M Kurtz, M.D.
Organizational Affiliation
LenSx Lasers Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Melvin Sarayba, M.D.
Organizational Affiliation
LenSx Lasers Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1085
Country
Hungary

12. IPD Sharing Statement

Learn more about this trial

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

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