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

NCT ID: NCT01383057

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-02-29

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.

Conditions

Cataracts

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Femtosecond Laser

Group Type: EXPERIMENTAL

Femtosecond Laser

Intervention Type: PROCEDURE

Using the Femtosecond Laser to make a clear corneal incision.

Interventions

Femtosecond Laser

Using the Femtosecond Laser to make a clear corneal incision.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Loden Vision Centers

Goodlettsville, Tennessee, United States

Countries

United States

Other Identifiers

FEMTO 2011-2

Identifier Type: -

Identifier Source: org_study_id