Clinical trial NCT01713660: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Keywords: Cataract surgery
Femtosecond laser
Corneal incisions
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2012-10-25
Enrollment: 37
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
timeFrame: Day 0, Operative (Within 2 hours of incision creation)
Secondary outcomes:
measure: Surgeon Assessment of Workflow
timeFrame: Day 0, Operative
measure: Percent of Seidel Staining
timeFrame: Day 0 (performed immediately post-incision creation), Day 1
Other outcomes:
Locations:
Study officials:
References: