Corneal Incisions With the IntraLase iFS Femtosecond Laser System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01713660
First received: October 22, 2012
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Cataract
Device: iFS Femtosecond Laser

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Abbott Medical Optics:

Primary Outcome Measures:
  • Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. [ Time Frame: Day 0, Operative (Within 2 hours of incision creation) ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Surgeon Assessment of Workflow [ Time Frame: Day 0, Operative ] [ Designated as safety issue: No ]
    Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?

  • Percent of Seidel Staining [ Time Frame: Day 0 (performed immediately post-incision creation), Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 37
Study Start Date: November 2012
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
FS Corneal Incisions Device: iFS Femtosecond Laser
corneal incisions created by the femtosecond laser

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01713660

Locations
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Ohio
Cleveland Eye Clinic
Cleveland, Ohio, United States, 44141
Sponsors and Collaborators
Abbott Medical Optics
  More Information

No publications provided

Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT01713660     History of Changes
Other Study ID Numbers: FMTO-105-CCIP
Study First Received: October 22, 2012
Results First Received: April 5, 2013
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Medical Optics:
Cataract surgery
Femtosecond laser
Corneal incisions

Additional relevant MeSH terms:
Cataract
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on October 21, 2014