Back to resultsA Comparison of LASIK Outcomes Using Two Femtosecond Lasers
Primary Purpose
Myopia, Astigmatism
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intralase IFS150
Visumax
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Femtosecond laser, Visumax, Intralase IFS150, LASIK
Eligibility Criteria
Inclusion Criteria:
- Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Exclusion Criteria:
- Subjects under the age of 21
- Subjects over the age of 60
- Subjects with corneal ectatic disorders
Sites / Locations
- Byers Eye Institute at Stanford
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Intralase IFS
Visumax
Arm Description
Intralase IFS vs. Visumax
Visumax vs. Intralase iFS
Outcomes
Primary Outcome Measures
ETDRS Uncorrected Visual Acuity
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Secondary Outcome Measures
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Anterior segment ocular coherence tomography
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation
Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
Best Spectacle Corrected Visual Acuity
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Aberrometry
Aberrometry images will be obtained on the iDesign aberrometer
Questionnaire Measuring Patient Preference for Laser Device
Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.
Patient Reported Outcomes With LASIK
PROWL study questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03063164
Brief Title
A Comparison of LASIK Outcomes Using Two Femtosecond Lasers
Official Title
A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
November 13, 2018 (Actual)
Study Completion Date
November 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edward E. Manche
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparing LASIK outcomes using two femtosecond lasers
Detailed Description
Patients will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the patient from the study, then the investigator will inform the patient and make an appropriate referral. Patients deemed appropriate for the study after a comprehensive examination including computerized videokeratography can be enrolled. Patients will undergo bilateral simultaneous eye surgery. Which eye is treated with the Intralase IFS 150 and which eye is treated with VisuMax will be randomized so there is a 50% chance for either eye to receive one treatment. Patients will be seen on the day of surgery, post op day one, one month, three months, six months and one year. Patients will receive topical antibiotics in each eye for one week following the procedure. Patients will receive pred forte 1% ophthalmic drops for one week after treatment. Patients will also receive vigamox ophthalmic drops for four days after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia, Astigmatism
Keywords
Femtosecond laser, Visumax, Intralase IFS150, LASIK
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eye to eye comparison
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intralase IFS
Arm Type
Active Comparator
Arm Description
Intralase IFS vs. Visumax
Arm Title
Visumax
Arm Type
Active Comparator
Arm Description
Visumax vs. Intralase iFS
Intervention Type
Device
Intervention Name(s)
Intralase IFS150
Intervention Description
Intralase flap creation
Intervention Type
Device
Intervention Name(s)
Visumax
Intervention Description
Visumax flap creation
Primary Outcome Measure Information:
Title
ETDRS Uncorrected Visual Acuity
Description
Number of eyes with an uncorrected visual acuity of 20/20 at 12 months measured using ETDRS testing charts
Time Frame
At post-operative month 12
Secondary Outcome Measure Information:
Title
Anterior Segment Ocular Coherence Tomography Measurement of Flap Thickness
Description
Anterior segment ocular coherence tomography
Time Frame
At postoperative month one
Title
Cochet Bonnet Asthesiometry Measurement of Corneal Sensation
Description
Cochet Bonnet Asthesiometry is measured on a scale of 1-6. Scores of 5 and above are considered normal.
Time Frame
At postoperative month twelve
Title
Best Spectacle Corrected Visual Acuity
Description
Number of eyes losing 2 or more lines of corrected distance visual acuity measured by ETDRS testing charts
Time Frame
Postoperative month 12
Title
Aberrometry
Description
Aberrometry images will be obtained on the iDesign aberrometer
Time Frame
One three, six and twelve months
Title
Questionnaire Measuring Patient Preference for Laser Device
Description
Participants were asked if they preferred having LASIK surgery with either the Visumax laser, the Intralase iFS laser or had no preference between the two lasers.
Time Frame
Intraoperative (Approximately 1 minute after completion of surgery)
Title
Patient Reported Outcomes With LASIK
Description
PROWL study questionnaire
Time Frame
One month, three months, six months and twelve months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters and -11.00 diopters with or without astigmatism of up to 5.00 diopters.
Exclusion Criteria:
Subjects under the age of 21
Subjects over the age of 60
Subjects with corneal ectatic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Manche, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Byers Eye Institute at Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Comparison of LASIK Outcomes Using Two Femtosecond Lasers
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