Corneal Incisions With the IntraLase iFS Femtosecond Laser System

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

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

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: iFS Femtosecond Laser

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Eye Surgeons of Indiana
  • Ohio
    • Cleveland, Ohio, United States, 44141
      • Cleveland Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FS Corneal Incisions	Device: iFS Femtosecond Laser; corneal incisions created by the femtosecond laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 23, 2012
• First Posted (Estimate): October 25, 2012

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Cataract surgery; Femtosecond laser; Corneal incisions
• Additional Relevant MeSH Terms: Eye Diseases; Wounds and Injuries; Lens Diseases; Cataract; Surgical Wound
• Other Study ID Numbers: FMTO-105-CCIP