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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383057
• Other study ID #: FEMTO 2011-2
• Status: Completed
• Phase: Phase 4
• First received: June 24, 2011
• Last updated: February 15, 2012
• Start date: June 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Innovative Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Procedure:
• Femtosecond Laser
Using the Femtosecond Laser to make a clear corneal incision.

Locations

Country	Name	City	State
United States	Loden Vision Centers	Goodlettsville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Innovative Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Pressure	Measure the fluid pressure inside the eye	3 months	No
Primary	Uncorrected and Best corrected Visual Acuity	Vision obtained with the best possible lens correction (Best corrected). Vision obtained without the use of glasses or contact lenses (Uncorrected).	one month	No