Trial Outcomes & Findings for Corneal Incisions With the IntraLase iFS Femtosecond Laser System (NCT NCT01713660)
NCT ID: NCT01713660
Last Updated: 2025-02-04
Results Overview
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).
COMPLETED
NA
37 participants
Day 0, Operative (Within 2 hours of incision creation)
2025-02-04
Participant Flow
Subjects were recruited from private medical practices from October to December 2012
No preassignment details
Participant milestones
| Measure |
FS Corneal Incisions
iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
|
|---|---|
|
Overall Study
STARTED
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corneal Incisions With the IntraLase iFS Femtosecond Laser System
Baseline characteristics by cohort
| Measure |
FS Corneal Incisions
n=37 Participants
iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
FS Corneal Incisions
n=37 eyes
iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
|
|---|---|
|
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
Achieved Clear Corneal Incision (CCI) Measurement
|
2.75 mm
Standard Deviation 0.09
|
|
Demonstration That the Femtosecond Laser Consistently Produces Desired Incisions.
Intended CCI Incision Size (as programmed)
|
2.74 mm
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: Day 0, OperativeSurgeon questionnaire (completed at the end of each surgery and the end of each surgical day): Were incisions created as intended?
Outcome measures
| Measure |
FS Corneal Incisions
n=37 Participants
iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
|
|---|---|
|
Surgeon Assessment of Workflow
|
97.3 percentage of yes answers
|
SECONDARY outcome
Timeframe: Day 0 (performed immediately post-incision creation), Day 1Demonstration of no wound leakage as measured by Seidel test at slit lamp with fluorscein dye. A negative Seidel test result indicates no wound leakage.
Outcome measures
| Measure |
FS Corneal Incisions
n=37 eyes
iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
|
|---|---|
|
Percent of Seidel Staining
|
100 percentage of eyes with negative Seidel
|
Adverse Events
FS Corneal Incisions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Trial Agreement including "Neither Institution nor Principal Investigator shall have any right to publish or present any information or results concerning the Study without express written consent of Sponsor. Under no circumstances shall Institution or Principal Investigator publish or disclose any of Sponsor's proprietary information, as defined by the CDAs, without Sponsor's prior written approval."
- Publication restrictions are in place
Restriction type: OTHER