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

Completed · Phase 4

Conditions studied: Cataracts

In brief

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.

Key facts

Study ID

NCT01383057

Run by

Innovative Medical

People needed

29

Starts

2011-06-01

Expected to finish

2012-02-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Loden Vision Centers — Goodlettsville, Tennessee, United States

Full record on ClinicalTrials.gov

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