Corneal Incisions With the IntraLase iFS Femtosecond Laser System

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01713660
• Collaborator: (none)
• Enrollment: 37
• Locations: 2
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 18.5
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: iFS Femtosecond Laser	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 37 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: FS Corneal Incisions	Device: iFS Femtosecond Laser; corneal incisions created by the femtosecond laser

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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?

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eye Surgeons of Indiana	Indianapolis	Indiana	United States	46256
2	Cleveland Eye Clinic	Cleveland	Ohio	United States	44141

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT01713660
• Other Study ID Numbers: FMTO-105-CCIP
• First Posted: Oct 25, 2012
• Last Update Posted: Jun 12, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Abbott Medical Optics: Cataract surgery; Femtosecond laser; Corneal incisions
• Additional relevant MeSH terms: Cataract; Surgical Wound

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from private medical practices from October to December 2012
Pre-assignment Detail	No preassignment details

Arm/Group Title	FS Corneal Incisions
Arm/Group Description	iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
Period Title: Overall Study
STARTED	37
COMPLETED	37
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	FS Corneal Incisions
Arm/Group Description	iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
Overall Participants	37
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	15 40.5%
>=65 years	22 59.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66 (6)
Sex: Female, Male (Count of Participants)
Female	15 40.5%
Male	22 59.5%
Region of Enrollment (participants) [Number]
United States	37 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FS Corneal Incisions
Arm/Group Description	iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
Measure Participants	37
Measure eyes	37
Achieved Clear Corneal Incision (CCI) Measurement	2.75 (0.09)
Intended CCI Incision Size (as programmed)	2.74 (0.08)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FS Corneal Incisions
Arm/Group Description	iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
Measure Participants	37
Number [percentage of yes answers]	97.3

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FS Corneal Incisions
Arm/Group Description	iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
Measure Participants	37
Measure eyes	37
Number [percentage of eyes with negative Seidel]	100

Adverse Events

Time Frame	The time frame for reporting adverse event reports was 1 month.
Arm/Group Title	FS Corneal Incisions
Arm/Group Description	iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
All Cause Mortality
	FS Corneal Incisions
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	FS Corneal Incisions
	Affected / at Risk (%)	# Events
Total	0/37 (0%)
Other (Not Including Serious) Adverse Events
	FS Corneal Incisions
	Affected / at Risk (%)	# Events
Total	0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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."