A Prospective, Randomized, Fellow Eye Comparison of Fellow Eyes Undergoing LASIK With the Intralase IFS150 Versus the Visumax
Phase: NA
Conditions: Myopia, Astigmatism
Sponsor: Edward E. Manche

 
A Prospective, Randomized, Fellow Eye 
Comparison of Fellow Eyes Undergoing LASIK 
With the Intralase IFS150 Versus the Visumax 
NCT03063164 
March 6, 2018  
Edward E. Manche, Principal Investigator 
Stanford University 
Stanford, California 94305 
1. 
PURPOSE OF THE STUDY 
a. 
Brief Summary 
The purpose of the study is to compare the results of LASIK surgery when using two 
brands of femtosecond lasers in patients with nearsightedness with and without 
astigmatism. 
b. 
Objectives 
I hope to determine if one manufacturers femtosecond laser is superior to another when 
performing wavefront-guided LASIK surgery. We will be performing tests of visual 
performance to see if there are any advantages of one femtosecond laser over the other.  
c. 
Rationale for Research in Humans 
We want to evaluate which of these commonly used femtosecond laser devices produces 
superior results in humans. 
2. 
STUDY PROCEDURES 
a. 
Procedures 
The 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 we will inform the patient and make an 
appropriate referral. if the patient is deemed appropriate for the study after a 
comprehensive examination included computerized videokeratography, then they can be 
enrolled. The patient will undergo bilateral simultaneous eye surgery. Which eye is 

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treated with the Intralase IFS 1500 and which eye is treated with VisuMax will be 
randomized so there is a 50% chance for either eye to receive one treatment. The patients 
will be seen on the day of surgery, post op day one, one month, three months, six months 
and one year. The patient will receive topical antiobiotics in each eye for one week 
following the procedure. The patient will receive pred forte 1% ophthalmic drops for one 
week after treatment. The patient 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.  
b. 
Procedure Risks 
We are studying two brands of femtosecond lasers. Both lasers are FDA approved and 
commonly used in clinical practice. The research procedures are the least risky that can 
be performed consistent with sound research design.  
c. 
Use of Deception in the Study 
No deception will be used. 
d. 
Use of Audio and Video Recordings 
No audio or video recordings are planned for the study.  
e. 
Alternative Procedures or Courses of Treatment 
Alternative procedures include no surgery and continuing to wear  
glasses and contact lenses.  
 
Alternatives also include performing LASIK or PRK surgery on both  
eyes outside of the study. 
f. 
Will it be possible to continue the more (most) appropriate therapy for the 
participant(s) after the conclusion of the study? 
The surgery is performed in both eyes at the same time. Once a patient has had a LASIK 
flap created there is no need to create an additional LASIK flap. Patients in both groups 
will receive the same postoperative care.  
g. 
Study Endpoint(s) 
We plan to follow the patients for one year. Patients can experience improvement in their 
vision 6-12 months following surgery so we will need to gather the full data to determine 
final outcomes. We will terminate the study prior to enrolling the projected participant 
population if we determine that one procedure is superior to the other. The study will end 
after a minimum of 50 subjects are enrolled and up to 100 subjects. 

March 6, 2018 
 
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3. 
BACKGROUND  
a. 
Past Experimental and/or Clinical Findings 
Most reports in the literature report comparable outcomes between different 
manufacturers of femtoecond lasers for similar levels of nearsightedness with and 
without astigmatism. 
b. 
Findings from Past Animal Experiments 
None. 
4. 
DEVICES USED IN THE STUDY 
a. 
IDE-Exempt Devices 
IND-Exempt Device 1 
Name: 
Intralase IFS; Abbott Medical Optics, Inc. 
IND-Exempt Device 2 
Name: 
AMO Visx CustomVue; Abbott Medical Optics, Inc. 
IND-Exempt Device 3 
Name: 
VisuMax; Zeiss 
 
5. 
PARTICIPANT POPULATION 
a. 
Planned Enrollment 
Up to 100 healthy subjects with myopia with and without astigmatism. These are the 
patients who typically seek out LASIK surgery to lessen or reduce their dependence on 
glasses and contact lenses. 
b. 
Age, Gender, and Ethnic Background 
Subjects age 21 and older with myopia will be eligible to participate. All genders and 
ethnic backgrounds are eligible to participate in the study.  
c. 
Vulnerable Populations 
Not applicable. 
d. 
Rationale for Exclusion of Certain Populations 
Minors are not included because the lasers are not indicated for use in minors. 
Additionally, vision is not stable in minors. 
e. 
Stanford Populations 
Employees and students are eligible to participate in the study if they qualify. They will 
get the same written informed consent. 
f. 
Healthy Volunteers 
All subjects are healthy with myopia. We are studying outcomes of LASIK surgery in 
healthy nearsighted eyes. 

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g. 
Recruitment Details 
We plan to run advertisements in the local paper regarding the study. The patients will be 
informed of the details of the study on the telephone. 
h. 
Eligibility Criteria 
i. 
Inclusion Criteria 
Subjects age 21 and older with healthy eyes. Nearsightedness between -0.25 diopters 
and -7.00 diopters with or without astigmatism of up to 3.00 diopters. 
ii. 
Exclusion Criteria 
Subjects under the age of 21. 
Patients with excessively thin corneas. 
Patients with topographic evidence of keratoconus. 
Patients with ectactic eye disorders. 
Patients with autoimmune diseases. 
Patients who are pregnant or nursing. 
Patients must have similar levels of nearsightedness and farsightedness in each eye. 
They cannot be more than 1.5 diopter of difference between eyes. 
Patients must have similar levels of astigmatism in each eye. They cannot have more 
than 1.5 diopter of difference between eyes. 
i. 
Screening Procedures 
We will attempt to screen patients on the telephone to determine if they are eligible. If 
they appear to be eligible on the telephone, then we will have them come in for a 
screening examination. 
j. 
Participation in Multiple Protocols 
We will request that the subjects do not participate in more than one study and this will 
be stated on the consent form. 
k. 
Payments to Participants 
There is no payment for participating in the study. The patients will receive a reduced fee 
of $
 per eye to participate in the study. The usual and customary fee is $
 
per eye. 
l. 
Costs to Participants 
The patient is responsible for a fee of $
 per eye w/out discount and $
 per 
eye with the discount. 
m. 
Planned Duration of the Study 
The study is for one year. We estimate that the study will take approximately three years 
to complete. Total time per participant during the screening process is approximately 45 
minutes. Total time per participant for active participation in the study will be 

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approximately 10 to 12 hours. Total time per participant for analysis of the participant 
data is approximately 30 minutes. 
6. 
RISKS 
a. 
Potential Risks 
i. 
Investigational devices 
No investigational devices are to be used. The excimer laser(AMO Visx Star S4 
CustomVue)is FDA approved for use in LASIK surgery. Both femtosecond lasers 
(VisuMax and Intralase IFS) are FDA approved for use in LASIK surgery. LASIK 
surgery is commonly performed in the excimer department. 
ii. 
Investigational drugs 
No investigational drugs are being used. 
iii. 
Commercially available drugs, biologics, reagents or chemicals 
Vigamox - ocular irritation, stinging, allergy. 
Pred Forte - ocular irritation, increased intraocular pressure, cataract formation 
Systane - ocular irritation, burning, transient blurring of vision 
Voltaren - ocular irritation, burning, allergy 
Proparacaine - ocular stinging, transient anesthesia of cornea 
Diazepam - nausea, drowsiness 
Vicodan - nausea, drowsiness 
iv. 
Procedures 
Corneal topography, slit lamp biomicroscopy, Snellen visual acuity testing, low contrast 
visual acuity testing, and anterior segment ocular coherence tomography testing are all 
routine non-contact examinations performed in the ophthalmology clinic with essentially 
little or no risk. 
Applanation tonometry and pachymetry involve touching a probe to the eye to measure 
intraocular pressure and corneal thickness respectfully. There is a low risk of a corneal 
abrasion while performing these tests (less than 1%). These tests are routinely performed 
in all the patients seen in the excimer clinic. 
Corneal sensation measurement using Cochet-Bonnet aesthesiometry utilizes a nylon 
filament to stimulate the corneal nerves to measure corneal sensation. This device is 
commonly used in the clinic with essentially little or no risk. 
Fundus examination involves a dilated examination of the posterior pole of the eye. 
Bright light is projected into the eye. Patients can experience some discomfort secondary 
to the bright light. This test is also performed as a routine part of every comprehensive 
eye exam in the excimer clinic. 
 
The following are non-investigational procedures: 
LASIK 
Corneal topography 
Slit lamp biomicroscopy 
Fundus examination 

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Pachymetry 
Applanation Tonomety 
Snellen visual acuity testing 
Low contrast visual acuity testing 
Anterior segment ocular coherence tomography 
Ultrasonic pachymetry 
Corneal sensation measurement using Cochet-Bonnet Aesthesiometry 
v. 
Radioisotopes/radiation-producing machines 
Not applicable. 
vi. 
Physical well-being 
Low risk. 
vii. 
Psychological well-being 
Low risk. 
viii. 
Economic well-being 
Low risk. 
ix. 
Social well-being 
Low risk. 
x. 
Overall evaluation of risk 
Low risk. 
b. 
International Research Risk Procedures 
Not applicable. 
c. 
Procedures to Minimize Risk 
We will perform regular examinations of subjects at frequent intervals. If any adverse 
effects are noted, the subject will receive the appropriate care as needed. Both eyes are 
being treated at the same time so we will be following patients after the treatment. 
d. 
Study Conclusion 
We expect the study to terminate after all subjects have been enrolled. We will terminate 
the study sooner if a clear advantage is seen with one laser system compared to the other. 
We may terminate the study earlier depending on our rate of enrollement. 
Individual subjects may be terminated for a variety or reasons including but not limited 
to: 
-failure to come to follow up visits 
-failure to follow the appropriate medication regimen 
-pregnancy 
-the subject needs to receive treatment not allowed in the study 
-the study is cancelled 

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-unanticipated circumstances 
-other administrative reasons 
e. 
Data Safety Monitoring Plan (DSMC) 
i. 
Data and/or events subject to review 
All measures of visual performance including uncorrected visual acuity, best 
spectacle corrected visual acuity, low contrast visual acuity, higher order aberration 
analysis, anterior segment OCT imaging. 
ii. 
Person(s) responsible for Data and Safety Monitoring 
The principal investigator will be monitoring the data. All adverse events will be 
reported to the IRB within one week of discovery. 
iii. 
Frequency of DSMB meetings 
NA 
f. 
Risks to Special Populations 
NA 
7. 
BENEFITS 
Subjects should experience a reduction or elimination of their nearsightedness with and 
without astigmatism with a resultant improvement in their uncorrected visual acuity. We may 
discover that either the VisuMax or the Intralase IFS yields better results with LASIK surgery so 
future subjects can choose the better technology. 
8. 
PRIVACY AND CONFIDENTIALITY 
All participant information and specimens are handled in compliance with the Health Insurance 
Portability and Accountability Act (HIPAA) and privacy policies of Stanford University, Stanford 
Health Care, and Stanford Children’s Health.