Cataract
Conditions
Keywords
Cataract surgery, Femtosecond laser, Corneal incisions
Brief summary
The IntraLase iFS femtosecond laser system can create corneal arcuate incisions for cataract surgery.
Interventions
DEVICEiFS Femtosecond Laser
corneal incisions created by the femtosecond laser
Sponsors
Abbott Medical Optics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. | Day 0, Operative (Within 2 hours of incision creation) | 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
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Assessment of Workflow | Day 0, Operative | 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 | Day 0 (performed immediately post-incision creation), Day 1 | 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. |
Participant flow
Recruitment details
Subjects were recruited from private medical practices from October to December 2012
Pre-assignment details
No preassignment details
Participants by arm
| Arm | Count |
|---|---|
| FS Corneal Incisions iFS Femtosecond Laser : corneal incisions created by the femtosecond laser | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | FS Corneal Incisions |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 66 years STANDARD_DEVIATION 6 |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
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).
Time frame: Day 0, Operative (Within 2 hours of incision creation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FS Corneal Incisions | Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. | Achieved Clear Corneal Incision (CCI) Measurement | 2.75 mm | Standard Deviation 0.09 |
| FS Corneal Incisions | Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions. | Intended CCI Incision Size (as programmed) | 2.74 mm | Standard Deviation 0.08 |
Secondary
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.
Time frame: Day 0 (performed immediately post-incision creation), Day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS Corneal Incisions | Percent of Seidel Staining | 100 percentage of eyes with negative Seidel |
Secondary
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?
Time frame: Day 0, Operative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FS Corneal Incisions | Surgeon Assessment of Workflow | 97.3 percentage of yes answers |