Corneal Incisions With the IntraLase iFS Femtosecond Laser System

Cataract Clinical Trial

Official title:

A MULTI-CENTER PROSPECTIVE STUDY TO EVALUATE THE USE OF THE INTRALASE iFS™ FEMTOSECOND LASER SYSTEM TO CREATE CLEAR CORNEAL INCISIONS AND PARACENTESIS INCISIONS FOR CATARACT SURGERY

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01713660
• Other study ID #: FMTO-105-CCIP
• Status: Completed
• Phase: N/A
• First received: October 22, 2012
• Last updated: June 4, 2013
• Start date: November 2012
• Est. completion date: January 2013

Study information

• Verified date: June 2013
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• At least 21 years of age

• Unilateral or bilateral cataract(s) for which phacoemulsification lens extraction and posterior chamber intraocular lens (IOL) implantation has been planned

• Visual potential of 20/25 or better in each study eye following cataract removal and IOL implantation

• Clear intraocular media other than cataract

• Available, willing and capable of complying with examination procedures and follow-up visits for the duration of the study

• Signed informed consent

Exclusion Criteria:

• Previous intraocular or corneal surgery, including refractive surgery in the operative eye(s)

• History of active or recurrent ophthalmic disease

• Abnormal topography, including evidence of keratoconus or pellucid marginal degeneration or irregular astigmatism in the operative eye(s)

• White to white measurement less than 10 mm or greater than 14 mm

• Corneal pathology/abnormality that may interfere with the transmission of laser energy, laser light or precludes applanation

• Corneal pathology/abnormality that is predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study

• Subjects with diagnosed degenerative visual disorders (e.g., macular or other retinal pathology) that are predicted to cause visual acuity losses to a level of 20/30 (Snellen) or worse during the study

• Subjects with conditions associated with increased risk of IOL/capsule instability

• Pharmacologically dilated pupil size less than 5.5 mm or the presence of any pupil abnormalities

• Prior, current, or anticipated use during the course of the study of tamsulosin, silodosin or pilocarpine (e.g. Flomax, Flomaxtra, Rapaflo)

• History of any ocular or medical conditions that could affect corneal wound healing

• Poorly-controlled diabetes or subjects with diabetic retinopathy

• Concurrent use of topical or systemic medications that may impair corneal wound healing

• Acute, chronic, or uncontrolled systemic or ocular disease or illness that would, in the opinion of the investigator, increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, etc.)

• Ocular hypertension (> 21 mm Hg)

• Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study

• Known sensitivity or inappropriate responsiveness to any of the medications used in the post operative course

• Concurrent participation or participation in any other clinical trial during the duration of this clinical study including 30 days prior to preoperative visit

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• iFS Femtosecond Laser
corneal incisions created by the femtosecond laser

Locations

Country	Name	City	State
United States	Cleveland Eye Clinic	Cleveland	Ohio
United States	Eye Surgeons of Indiana	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.	Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended incision size (as programmed) vs. achieved incision size (as measured).	Day 0, Operative (Within 2 hours of incision creation)	No
Secondary	Surgeon Assessment of Workflow	Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?	Day 0, Operative	No
Secondary	Percent of Seidel Staining	Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.	Day 0 (performed immediately post-incision creation), Day 1	No