Clear Corneal Incisions and Arcuate Incisions Utilizing FemtoSecond Laser Technology for Cataract Surgery

Innovative Medical1 site in 1 country29 target enrollmentJune 2011

ConditionsCataracts

Overview

The purpose of this study is to prove the efficacy and safety of the Femtosecond laser to create a clear corneal incision during cataract surgery.

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

February 2012

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Responsible Party

Sponsor

•Study participants must have a cataract for which phacoemulsification extraction and posterior IOL implantation has been planned in at least one eye.
•Study participants should be capable of achieving better than 20/30 Snellen best corrected distance vision after cataract extraction and IOL implantation.
•The surgeon may use the Mentor Potential Acuity Meter (PAM) laser interferometer, McIntyre Pinhole, or his/her judgment to estimate the patient's potential acuity.

•Concurrent participation or participation in the last thirty days in any other clinical trial.
•Known steroid IOP responder
•Taking medications that may affect vision, IOP or ease of cataract surgery (e.g., Flomax, Glaucoma mediations, etc.)
•Acute or chronic disease or illness that would increase risk or confound study results (e.g., uncontrolled diabetes mellitus, immunocompromised, etc.)
•Uncontrolled systemic or ocular disease
•Corneal abnormalities (e.g., stromal, epithelial or endothelial dystrophies)
•Pseudoexfoliation
•Ocular hypertension IOP \>25 mmHg by tonometry or glaucomatous changes in the optic nerve