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

NCT00959322 | Completed

• 1 other identifier: CAP-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Capsulotomy

Outcome Measures

Primary Outcomes (1)

• Capsulotomy is complete

  1 day, 1 week, 1 month

Secondary Outcomes (1)

• No radial tears noted intraoperatively

  1 day, 1 week, 1 month

Interventions

LenSx 550 Laser System DEVICE

Femtosecond laser used to create capsulotomy incision.

Also known as: LenSx, LenSx 550 Laser, Femtosecond

Eligibility Criteria

• Age: 24 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LenSx Lasers Inc.: lead

Study Sites (1)

Semmelweis University

Budapest, 1085, Hungary

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Ronald M Kurtz, M.D.

  LenSx Lasers Inc.

  STUDY CHAIR

• Melvin Sarayba, M.D.

  LenSx Lasers Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 14, 2009
• Study Start: August 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: March 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

HU (1)