Evaluation of the LenSx Laser System for Performing Anterior Capsulotomy, Phacofragmentation, and Corneal Arc Cuts/Incisions in Patients Undergoing Cataract Surgery for Removal of the Crystalline Lens

Not Applicable

Completed

• Conditions: Cataract; Eye - Diseases / disorders of the eye; Surgery - Surgical techniques

• Registration Number: ACTRN12611000443998
• Lead Sponsor: Vision Eye Institute Chatswood

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-29
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Subjects must be eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation in at least 1 eye.
2.Subjects must be willing and able to return for scheduled follow-up examinations.
3.Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria

1.Subjects who have undergone previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
2.Subjects who are pregnant, lactating, or planning to be pregnant during the course of the study.
3.Subjects with known sensitivity to planned study concomitant medications.
4.Subjects participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation.
5.Subjects presenting any contraindications to cataract surgery.
6.Hypotony, glaucoma, or the presence of a corneal implant.
7.Presence of blood or other material in the anterior chamber.
8.Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease).
9.A history of lens or zonular instability.

Exclusion For Laser Group Only
10.Corneal disease that precludes applanation of the cornea or transmission of laser light at 1030 nm wavelength.
11.Corneal opacity that would interfere with the laser beam.
12.Descemetocele with impending corneal rupture.
13.Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for the capsulotomy.
14.Conditions which would cause inadequate clearance between the intended capsulotomy depth and the endothelium (applicable to capsulotomy only).
15.Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape.
16.Corneal thickness requirements that are beyond the range of the system (>1500 microns).

Study & Design

• Study Type: Interventional
• Study Design: Not specified