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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959322
• Other study ID #: CAP-001
• Status: Completed
• Phase: N/A
• First received: August 12, 2009
• Last updated: October 12, 2009
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2009
• Source: LenSx Lasers Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: Institutional Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 24 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• LenSx 550 Laser System
Femtosecond laser used to create capsulotomy incision.

Locations

Country	Name	City	State
Hungary	Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
LenSx Lasers Inc.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Capsulotomy is complete		1 day, 1 week, 1 month	No
Secondary	No radial tears noted intraoperatively		1 day, 1 week, 1 month	Yes