New Disposable Contact Lens Patient Interface For The Lensx Laser

Cataract Clinical Trial

Official title: Evaluation Of A New Disposable Contact Lens Patient Interface For The Lensx Laser In Cataract And Corneal Surgery

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the ease of use of a modified, disposable contact lens and suction ring assembly.

Clinical Trial Description

This will be a prospective, single center clinical trial of up to 300 consecutive eyes of subjects scheduled to undergo ocular surgery requiring an initial incision, specifically, cataract surgery. Subjects will be screened for eligibility. Eligible subjects will be examined preoperatively to establish a baseline for ocular condition.

Subjects will undergo unilateral cataract surgery using the LenSx Laser for one or a combination of the following laser procedures: anterior capsulotomy, laser lens phacofragmentation and corneal incision with implantation of an intraocular lens (IOL). Surgeon and staff comments will be solicited for ergonomic and packaging features of the new disposable contact lens. Subjects will be evaluated intraoperatively to assess comfort of the new disposable contact lens, as well as the completion of anterior capsulotomy, laser lens phacofragmentation and completion of corneal incisions. All patients will be evaluated postoperatively at one day, one week and 1 month to follow the condition of the surgical eye. Further follow up can be performed at the discretion of the surgeon. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cataract
• Corneal Disease
• Corneal Diseases

• NCT number: NCT01141985
• Study type: Interventional
• Source: LenSx Lasers Inc.
• Status: Completed
• Phase: Phase 0
• Start date: February 2010
• Completion date: December 2010