Corneal Incisions With the IntraLase iFS Femtosecond Laser System
This study has been completed.
Sponsor:
Abbott Medical Optics
Information provided by (Responsible Party):
Abbott Medical Optics
ClinicalTrials.gov Identifier:
NCT01713660
First received: October 22, 2012
Last updated: February 28, 2013
Last verified: February 2013
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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 FS laser consistently produces desired incisions. [ Time Frame: Day 0, Operative ] [ Designated as safety issue: No ]Evaluation of incisions created as programmed and measurement in mm. Data reported will be based on intended vs. achieved in percentage.
Secondary Outcome Measures:
- Surgeon assessment of workflow [ Time Frame: Day 0, Operative ] [ Designated as safety issue: No ]surgeon questionnaire
| Enrollment: | 38 |
| 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
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 |
| Last Updated: | February 28, 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 Lens Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013