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Corneal Incisions With the IntraLase iFS Femtosecond Laser System

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iFS Femtosecond Laser
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Cataract surgery, Femtosecond laser, Corneal incisions

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Eye Surgeons of Indiana
  • Cleveland Eye Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

FS Corneal Incisions

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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?
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.

Full Information

First Posted
October 22, 2012
Last Updated
June 4, 2013
Sponsor
Abbott Medical Optics
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1. Study Identification

Unique Protocol Identification Number
NCT01713660
Brief Title
Corneal Incisions With the IntraLase iFS Femtosecond Laser System
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Cataract surgery, Femtosecond laser, Corneal incisions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FS Corneal Incisions
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
iFS Femtosecond Laser
Intervention Description
corneal incisions created by the femtosecond laser
Primary Outcome Measure Information:
Title
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
Description
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).
Time Frame
Day 0, Operative (Within 2 hours of incision creation)
Secondary Outcome Measure Information:
Title
Surgeon Assessment of Workflow
Description
Surgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?
Time Frame
Day 0, Operative
Title
Percent of Seidel Staining
Description
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.
Time Frame
Day 0 (performed immediately post-incision creation), Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Cleveland Eye Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States

12. IPD Sharing Statement

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Corneal Incisions With the IntraLase iFS Femtosecond Laser System

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