Laser Cataract Surgery With the Femtosecond Laser Technology

Phase 4

Completed

• Conditions: Cataracts

• Registration Number: NCT01382823
• Lead Sponsor: Innovative Medical

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-05
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 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 Mento Potential Acuity Meter (PAM)laser interferometer, McIntyre Pinhole, or his/her judgement to estimate the patient's potential acuity.

Exclusion Criteria

• Concurrent participation or participation in the last 30 days in other clinical trials.
• Known steroid IOP responder.
• Taking medications that may affect vision, IOP, or ease of cataract surgery (e.g. Flomax, Glaucoma medications, 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 (>or =20hg) or glaucomatous changes in the optic nerve.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	three month	Measure the fluid pressure inside the eye.
Uncorrected and Best corrected Visual Acuity	three month	Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).

Trial Locations

Locations (1)

Loden Vision Centers; 🇺🇸 Goodlettsville, Tennessee, United States