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

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Procedure: Femtosecond Laser

• Registration Number: NCT01383057
• 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: 2011-06
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-28
• Status Verified: 2012-02
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Last Update Submitted: 2012-02-15
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Femtosecond Laser	Femtosecond Laser	-

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure	3 months	Measure the fluid pressure inside the eye
Uncorrected and Best corrected Visual Acuity	one 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