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

NCT ID: NCT00959322

Last Updated: 2009-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-03-31

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.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

LenSx 550 Laser System

Femtosecond laser used to create capsulotomy incision.

Intervention Type: DEVICE

Other Intervention Names

LenSx; LenSx 550 Laser; Femtosecond

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.

• Minimum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LenSx Lasers Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

LenSx Lasers, Inc.

Principal Investigators

Ronald M Kurtz, M.D.

Role: STUDY_CHAIR

LenSx Lasers Inc.

Melvin Sarayba, M.D.

Role: STUDY_DIRECTOR

LenSx Lasers Inc.

Locations

Semmelweis University

Budapest, , Hungary

Countries

Hungary

Other Identifiers

CAP-001

Identifier Type: -

Identifier Source: org_study_id