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

Sponsor
LenSx Lasers Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00959322
Collaborator
(none)
60
1
7
8.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: LenSx 550 Laser System
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
N/A
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 :
Aug 1, 2008
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Mar 1, 2009

Outcome Measures

Primary Outcome Measures

  1. Capsulotomy is complete [1 day, 1 week, 1 month]

Secondary Outcome Measures

  1. No radial tears noted intraoperatively [1 day, 1 week, 1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00959322
Other Study ID Numbers:
  • CAP-001
First Posted:
Aug 14, 2009
Last Update Posted:
Oct 14, 2009
Last Verified:
Oct 1, 2009
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 14, 2009