Clinical and Refractive Outcomes After Contoura® Refractive Surgery Planned Using Phorcides Surgery Planning Software
Conditions: Refractive Errors
Sponsor: American Corneal Consultants

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Clinical and refractive outcomes after Contoura® refractive surgery 
planned using Phorcides surgery planning software 
1.  TITLE PAGE
Protocol Number:
ML-2020-01
Amendment Number
Version 1.0
IRB / ERC
Salus IRB
2111 West Braker Lane, Suite 400
Austin, Texas 78758
Sponsor Name & Address:
Mark Lobanoff, MD
American Corneal Consultants                              
North Oaks, Minnesota                                          
15 Island Rd.
North Oaks, MN  55127
mlobanoff@gmail.com
                                   
(Alcon Inc., Fort Worth, TX, USA is providing funding only - 
this is an investigator-initiated study, IIT# 57571751)
Test Article:
Control Article:
Principal Investigator:
(not a clinical site)
Co-investigators:
Phorcides Analytical Engine with Wavelight laser
None
R. Doyle Stulting, MD, PhD
Woolfson Eye Institute
224 Konawa Lane
Loudon, TN 37774
ophtrds@emory.edu
Mark Lobanoff, MD
American Corneal Consultants                              
North Oaks, Minnesota                                          
15 Island Rd.
North Oaks, MN  55127
mlobanoff@gmail.com
Paul M. Mann II, MD
Mann Eye Institute and Laser Centers
5115 Main St, Suite#300
Houston, Texas 77002
pmann@manneye.com

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Stephen Wexler, MD
TLC Laser Eye Center 
16305 Swingley Ridge Rd, Suite 375
Chesterfield MO   63017-1777
Wexlermd@aol.com
Karl Stonecipher, MD
1002 N Church Street, Suite 101
Greensboro NC  27401
stonenc@aol.com
Richard Potvin, OD  (not a clinical site)
Science in Vision
6197 Dye Rd.
Akron, NY 14001
rick@scienceinvision.com 

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2 . INVESTIGATOR AGREEMENT
I confirm that I have read and that I understand this protocol entitled “Clinical and 
refractive outcomes after Contoura® refractive surgery planned using Phorcides 
surgery planning software”, and understand the use of the study products.  I agree 
to conduct this study in accordance with the requirements of this protocol and also 
protect the rights, safety, privacy, and well-being of study subjects in accordance 
with the following:
•
The ethical principles that have their origin in the Declaration of Helsinki.
•
All applicable laws and regulations, including, without limitation, data privacy 
laws and regulations.
•
Regulatory requirements for reporting serious adverse events defined in Section 
13 of this protocol.
Signature of Investigator (Date)
Investigator Name (print or type)
Investigator’s Title
Name of Facility
Location of Facility (City)

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3.  GENERAL INFORMATION
Objective
The objective of the current study is to prospectively evaluate 3-
month clinical outcomes from LASIK performed using the 
Phorcides surgical planning software with Contoura topography-
guided ablation in both eyes of subjects with myopia and myopic 
astigmatism seeking refractive surgery for distance correction.  
Data will be compared to published results for wavefront 
optimized LASIK and LASIK performed with Contoura using 
other refractive algorithms.  
The hypothesis is that use of the Phorcides planning software will
result in a higher percentage of eyes with residual refractive 
cylinder ≤ 0.25D than will be achieved with wavefront-optimized
(WFO) LASIK.  It is also expected that unaided postoperative 
visual acuity and visual symptoms will be improved. 
Test Article(s)  
Phorcides Analytical Engine refractive surgery planning software
Control Article(s)
None
Sample size 
140 eyes of 70 subjects
Study Population
Subjects ≥20 years of age with myopia and myopic astigmatism, 
who are suitable candidates for LASIK, meet the approved range 
of treatment for Contoura topography-guided LASIK and desire 
optimal uncorrected distance visual acuity in both eyes. 
Number of sites
Four
Study Design
Prospective, single arm, open-label study.
Masking
None
Variables
Primary: 
●Residual refractive cylinder
Secondary:
●Monocular uncorrected distance visual acuity

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●Monocular corrected distance visual acuity
●Residual refractive sphere
●Corneal aberrations
●Ocular aberrations (at sites equipped for such 
measurement)
●Subjective questionnaire evaluating visual symptoms 
such as light sensitivity glare, halos, and starbursts
Duration / Follow
-up
Preoperative to 3 months postoperative 
The study will be registered with clinicaltrials.gov.
The study will be conducted in compliance with the protocol, GCP and applicable 
regulatory requirements

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4.  TABLE OF CONTENTS
1.  TITLE PAGE
1
2 . INVESTIGATOR AGREEMENT
3
3.  GENERAL INFORMATION
4
4.  TABLE OF CONTENTS
6
5.  INTRODUCTION
8
6.  OBJECTIVE
8
7.  SUBJECTS
8
7.1. Subject Population
8
7.2. Inclusion Criteria
8
7.3. Exclusion Criteria
9
7.4. Exclusion Criteria during surgery
9
8.  STUDY DESIGN
10
8.2. Methods Used to Minimize Bias
11
9.  STUDY PROCEDURE
11
9.1. Informed Consent / Subject enrollment
11
9.2. Surgery Procedures
11
9.3. Visits and Examinations
12
9.4. Study Methods and Measurements
14
9.5.  Unscheduled Visits
14
9.6.  Discontinued Subjects
14
10.  ANALYSIS PLAN
15
10.1. Analysis Data Sets
15
10.2. Statistical Methodology
15
10.3. General Statistical Considerations
15
11.  SAMPLE SIZE JUSTIFICATION
15
12. CONFIDENTIALITY/PUBLICATION OF THE STUDY
15
13.  QUALITY COMPLAINTS AND ADVERSE EVENTS
16
13.1. General Information
16
13.2. Monitoring for Adverse Events
16
13.3. Procedures for Recording and Reporting AEs and SAEs
17
13.4. Follow-Up of Adverse Events and Quality Complaints
19
13.5. Safety Analyses
20
14. GCP, ICH and ETHICAL CONSIDERATIONS
20

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15.  STANDARD EVALUATION PROCEDURES
20
Table 15.1. Proposed Visits and Study Assessments
20
16. CONFIDENTIALITY
21
17. FINANCIAL AND INSURANCE INFORMATION/STUDY RELATED INJURIES
21
18. STUDY ENDPOINT CRITERIA
21
18.1. Patient Completion of Study
21
18.2. Patient Discontinuation
21
18.3. Patient Termination
21
18.4. Study Termination
22
18.5. Study Completion
22
19. SUMMARY OF RISKS AND BENEFITS
22
19.1. Summary of risks
22
19.2. Summary of benefits
22
REFERENCES
22

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5.  INTRODUCTION
The Contoura software for the Alcon WaveLight excimer laser was approved several 
years ago, but some surgeons are unsure about how to plan treatments when the manifest 
cylinder determined by refraction differs significantly from the Contoura-derived 
cylinder.   This has caused some surgeons to abandon the Contoura procedure.  The 
Phorcides Analytical Engine (Phorcides) refractive surgical planning software has 
demonstrated efficacy in addressing this issue.1,2  Use of the Phorcides software is 
expected to simplify surgical planning and improve overall outcomes with topography-
guided ablations; as a result, it may increase use of Contoura in clinical practice.
It is expected that clinical refractive outcomes with Phorcides will be superior to those 
obtained with wavefront-optimized refractive surgery using the same laser that have been
reported in the literature.  It is also expected that results with Phorcides will be superior 
to, and more consistent than, Contoura results reported in the literature that were based on
alternative algorithms.
6.  OBJECTIVE
The objective of the study is to prospectively compare 3-month clinical outcomes of 
LASIK performed using the Phorcides surgical planning software with Contoura 
topography-guided ablation to wavefront-optimized (WFO) LASIK results and Contoura 
results based on other algorithms reported in the literature. 
7.  SUBJECTS
7.1. Subject Population 
Eligible test subjects will be patients presenting for LASIK who meet the approved 
refractive range and clinical indications for topography-guided ablation.  Both eyes must 
be eligible for treatment.
A total of 140 eyes of 70 subjects will be enrolled across four clinical sites.  A minimum 
of 10 and a maximum of 25 subjects will be enrolled at any one site, based on speed of 
enrollment.  Subjects must meet the inclusion criteria.  Prior to enrollment, subjects will 
be provided information on the study and asked to sign a patient information and consent 
form to participate.  The patient information and consent form will be approved by an 
appropriate ethics committee.
7.2. Inclusion Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
●Candidate for Contoura excimer laser vision correction
●Gender: males and females.  

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●Age: 20 or older
●Willing and able to provide written informed consent for participation in the 
study. 
●Willing and able to comply with scheduled visits and other study procedures.  
●Good ocular health, with no pathology that compromises visual acuity (other than 
refractive error)
●Corrected preoperative visual acuity of 20/20 (0.0 logMAR) or better in the eye 
being treated
●Meet Contoura eligibility requirements (approved range): up to -8.00 D sphere, up
to -3.00 D cylinder, and a spherical equivalent no greater than -9.00 D 
●Desire good vision at distance in both eyes
7.3. Exclusion Criteria
If any of the following exclusion criteria are applicable to the subject or either eye, the 
subject should not be enrolled in the study.
●Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy, 
Fuchs’ dystrophy, etc.)
●Previous corneal surgery (e.g., radial keratotomy, corneal refractive surgery or 
corneal transplant, DSAEK, DMEK, lamellar keratoplasty)
●Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
●Desire for good uncorrected near vision in one or both eyes
●Participation in (or current participation) any investigational drug or device trial 
within the previous 30 days prior to the start date of this trial
●Unsuitability for the trial, in the opinion of the investigator, for any reason
●Pregnancy or desire to become pregnant during the trial 
7.4. Exclusion Criteria during surgery 
The following exclusion criteria are applicable to the study eye during the study
●Intraoperative complications.
Any subject whose surgery has been aborted for either eye should immediately be 
discontinued from the study and an exit form completed for that subject.  These subjects 
will be followed according to the clinic standard of care and monitored for safety, but 
their data will be excluded from the study efficacy analysis.  All adverse events will be 
appropriately documented and reported. 

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Participants who are considered to be in a vulnerable population will not be enrolled into 
the study.  Vulnerable populations include, but are not limited to, the following: 
●Prisoners 
●Nursing home residents
●Institutionalized individuals 
●Mentally disabled and cognitively impaired individuals 
●Sponsor employees and their family members 
●Site employees and their family members that are directly or indirectly involved 
in the study 
●Economically disadvantaged individuals 
●Educationally disadvantaged individuals 
●Adults who do are illiterate
●Subjects who are deaf or have a severe hearing disability 
●Terminally ill individuals
●Individuals with life-threatening conditions
8.  STUDY DESIGN
The study is a prospective, single-arm open clinical trial to evaluate residual refractive 
error and distance visual acuity after excimer laser treatment for the correction of 
refractive error to produce good uncorrected distance vision.  All eyes enrolled will have 
surgery planned with Phorcides and treated using the Contoura topography-guided 
surgery algorithm.
Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-
operatively. 
Clinical evaluations at 1 month and 3 months will include measurement of uncorrected 
distance visual acuity (UCDVA), manifest refraction, and corrected distance visual acuity
(CDVA).  At 3 months, corneal aberrations will be measured, and subjects will complete 
a questionnaire evaluating satisfaction with their visual outcome, quality of vision, and 
visual symptoms (light sensitivity, difficulty driving at night, reading difficulty, 
fluctuation in vision, glare, halos, and starbursts).
The primary outcome measure will be the residual refractive cylinder. 
Secondary outcome measures will be the following:

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●Uncorrected distance visual acuity
●Residual sphere
●Corneal aberrations
●Ocular aberrations, at sites with the appropriate equipment to measure such.
●Satisfaction with the visual outcome, quality of vision, and visual symptoms (light
sensitivity, difficulty driving at night, reading difficulty, fluctuation in vision, 
glare, halos, and starbursts).
Safety measures will be
●Change in corrected distance visual acuity
●Satisfaction with the visual outcome, quality of vision, and visual symptoms (light
sensitivity, difficulty driving at night, reading difficulty, fluctuation in vision, 
glare, halos, and starbursts).
8.2. Methods Used to Minimize Bias 
This is a single-arm study with both eyes of any subject enrolled.  Patients will not be pre
-selected for study inclusion.  Any eligible patient presenting for, and eligible for, 
binocular Contoura treatment may be invited to participate.
The measurement of the postoperative refraction and visual acuity will be conducted in a 
systematic fashion to minimize bias.  Individuals conducting visual acuity measures will 
be refracted with the methodology used in the Early Treatment Diabetic Retinopathy 
Study, with the same level of encouragement to subjects.  Subjective questions will be 
asked in a similar manner to all patients.  Alternatively, at the discretion of the 
investigator, patients may be asked to complete the questionnaire themselves. 
9.  STUDY PROCEDURE
9.1. Informed Consent / Subject enrollment 
No subject will be enrolled into the study who does not meet the inclusion/exclusion 
criteria and does not sign the current approved informed consent document.  Informed 
consent will be obtained prior to collecting any data for the study.  The original signed 
documents will be maintained by the investigator as a permanent part of the subject's 
medical records.  A signed copy will be provided to the subject. 

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Subjects will each receive a rebate of their refractive surgery payment when they 
complete the 3-month visit. This rebate will amount to $250 per eye, so subjects will 
receive a $500 rebate in total.
 9.2. Surgery Procedures
Following a complete ophthalmic examination (history, visual acuity, refraction, slit-
lamp exam, fundus exam, topography), patients who meet inclusion criteria and choose to
participate in the study after informed consent will be brought to the operating room 
where bilateral LASIK will be performed using the techniques routinely used by each 
investigator.  
9.3. Visits and Examinations 
Subjects will participate in five study visits.  Visits will include a preoperative/enrollment
visit (Visit 1), one operative visit (Visit 2), and 3 postoperative visits (Visit numbers 3, 4, 
and 5).  The preoperative visit and operative visit may occur on the same day if a fundus 
exam has been performed within the previous 6 months and the findings are available at 
the time of the preoperative/operative visit.  The visit schedule, visit windows, and 
associated Case Report Forms (CRFs), are displayed in Table 9.3-1.   Details of each 
study visit, including testing to be conducted, are provided in Table 9.3-4 and below.  
Table 9.3-1.  Visit Schedule
Visit 
Number
Visit Name
Visit Window
CRF 
Number
1
Preoperative 
-30 to 0 days before surgery
1
2
Operative
0 from surgery
2
3
1 Day Postoperative 
1-7 days after surgery
3
4
1 Month Postoperative
1 month (1 month – 2 ½ months)
4
5
3 Months Postoperative
3 months (2 ½ - 5 months) after 
surgery
5
Table 9.3-2.  Testing Schedule
Visit
Test
1
2
3
4
5
UCVA
X
X
X
X
MR
X
X
X
CDVA
X
X
X
Slit lamp exam
X
X
X
X
X
Fundus exam
  X*
X
IOP
X
X
X
Topography
X
X
X
Ocular HOA (site specific)
X
X
Questionnaire
X
X

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*Not required if fundus exam has been performed by any physician within 6 months and 
results are available for review by the investigator.
All data will be recorded on the provided CRFs.  All site personnel involved in the study 
will be trained to follow the study protocol, conduct study-specific procedures, and 
record data properly.  CRFs will be identified by the subject number assigned at each site.
No protected health information (PHI) will be included on any CRF, but a separate record
of patient names and study identifying numbers will be maintained at each investigational
site.  
9.3.1. Preoperative 
Subjects who meet inclusion criteria and provide informed consent will undergo 
the following procedures.
▪Medical history
▪Testing as shown in Table 9.3-2 as described in Section 9.4 below
▪Site-specific, routine preoperative procedures and measurements
9.3.2. Operative (Surgery)
Preoperative examination and testing procedures (with the exception of the fundus
examination) may be performed or repeated on the operative day at the discretion 
if the investigator.  A brief slit lamp examination will be performed.  The patient 
will then be brought into the operating room, where bilateral LASIK surgery 
(planned using the Phorcides analytical engine) will be performed with routine 
procedures specific for each site.  
Surgical findings will be recorded and any adverse events/serious adverse events 
(AEs/ SAEs) occurring during surgery will be noted at this visit.  Any other 
problems encountered during surgery and comments regarding surgery will be 
documented. 
Any complications preventing successful completion of surgery will be 
documented, and any subject whose surgery is not completed successfully will be 
excluded from further participation in the study and followed according to 
procedures that are standard for each individual study site. 
Postoperatively, patients will be managed according to standard procedures for 
each individual study site.
9.3.3. Postoperative Day 1, Month 1, and Month 3

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All routine postoperative procedures and measurements will be performed 
according to the standard operating procedures for each study site.  Testing will 
be performed as specified in Table 9.3-2 above and Section 9.4 below.  Adverse 
events will be monitored and documented.  Additional tests specific for this study 
will be administered at Visit 5.
 
9.3.4. Exit Procedures
In the event of premature exit from the study, all study-related examinations 
should be completed whenever possible.  The Exit CRF should be completed, 
noting that the subject did not complete the study and the reason for premature 
study exit.  If no premature exit from the study occurs, the Exit CRF should be 
completed at the end of Visit 5 (3 Months Postoperative). 
9.4. Study Methods and Measurements
All routine testing and basic eye examinations (the usual standard of care for the practice)
should be carried out at each study visit.  Abnormalities should be recorded in the CRF 
“Comment” section.  Specific study examination procedures are outlined below. 
9.4.1. Manifest refraction
Perform a manifest refraction with a high contrast logMAR ETDRS chart under 
photopic lighting conditions (>85 cd/m2).  Document refraction results with 
sphere, cylinder and axis readings using the ETDRS protocol.  If uncorrected 
visual acuity is not improved by manifest refraction, use zero for sphere and 
cylinder and draw a line through the blank for the axis.  All visual acuities should 
be recorded as letters read on the ETDRS chart.
9.4.2. Visual acuity (VA)
Measure uncorrected and corrected distance visual acuity using the MR according
to the ETDRS protocol using 100% contrast letters.  Record visual acuities as 
number of letters read on the ETDRS chart.
9.4.3. Corneal aberrations
Measure the corneal topographic aberrations with the Pentacam analyzer.
9.4.4  Ocular high order aberrations
Measure ocular HOA at sites appropriately equipped to do so.  The device used to
measure HOA’s should be indicated, and a 5 mm pupil size should be selected 
where feasible. 
9.4.5. Subjective questionnaire
Have the subject complete the subjective questionnaire. 

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Note: Avoid interpreting survey questions for subjects.  That is, avoid re-phrasing 
questions if subjects ask, “What does this mean?”
9.5.  Unscheduled Visits
Unscheduled exams may be conducted at the discretion of the investigator with all 
relevant information from the exam recorded in the source documents and on the 
Unscheduled Visit pages within the CRF booklet.
9.6.  Discontinued Subjects
Discontinued subjects are those who do not have an exit visit or who come into the office
to be exited prior to the scheduled final study visit.  Subjects may be discontinued from 
the study at any time if, in the opinion of the investigator, their continued participation in 
the study poses a risk to their health.  The reasons for discontinuation include:
a.
Adverse event;
b. Lost to follow-up;
c.
Subject decision unrelated to an adverse event;
d. Protocol violation;
e.
Treatment failure;
f.
Fear of exposure to infectious disease
g. Other.
To ensure the safety of all subjects who discontinue prior to Visit 5, investigators should 
assess each subject and, if necessary, advise them of any therapies and/or medical 
procedures that might be needed to maintain their health.  Any changes in medical health 
and/or use of concomitant medications should also be captured.
10.  ANALYSIS PLAN
10.1. Analysis Data Sets
All subjects who are enrolled in the study will be evaluated for safety.  Efficacy analyses 
will be performed based on data from those eyes for which uncomplicated LASIK was 
completed.
10.2. Statistical Methodology
All data will be collected by the site and entered into a spreadsheet.  Subjects will be 
assigned an ID number.  Data analysis will be performed without patient identification.  
Statistical analysis will be performed using standard descriptive statistics and other tests 
as deemed appropriate based on the characteristics of the data to be analyzed.  All 
statistical tests will be two-sided and interpreted at a 5% significance level.  
10.3. General Statistical Considerations
The statistical analyses will be performed using Statistica, version 12 or higher. Any 
statistical tests of hypotheses will employ a level of significance of alpha=0.05.

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11.  SAMPLE SIZE JUSTIFICATION
The sample size has been chosen to be similar to that for comparable Contoura, WFO, 
WFG and ray tracing LASIK studies published in the peer-reviewed literature.  Each of 
four sites will enroll up to 50 eyes, for a total potential study population of 140 eyes. 
With an expected 10% dropout rate before the 3M visit, 126 eyes would be available for 
analysis.
12. CONFIDENTIALITY/PUBLICATION OF THE STUDY
The existence of this study is confidential and should not be discussed with persons who 
are not involved with the study.  Results will be submitted for publication and 
presentation at national and/or international meetings.  A manuscript will be submitted to 
peer-review journals for publication but there is no guarantee of acceptance.  Presentation
or publication of data from individual sites or a subset of sites involved in the study is 
prohibited.  The company funding this study may review manuscript(s) prior to 
publication, but it may not control their content or the interpretation of the results of the 
study.
All study data will be collected on appropriate Case Report Forms (CRFs).  No protected 
health information will be included on the forms.  CRFs will be retained in the patient’s 
file for a minimum period of 3 years.  Collected information will be used for purposes of 
this study and possible future research, but no information will be sold to third parties. 
The following people will have access to study records:

Investigators and staff involved with the study

Study monitor or auditor

Sponsoring company

Research institution at which the study is being performed

Review boards and accrediting agencies

Other State or Federal regulatory agencies, as permitted by law
The de-identified data may be shared with other researchers for further analysis.
13.  QUALITY COMPLAINTS AND ADVERSE EVENTS
All subjects will be monitored for adverse events over the course of the study.  A place to
record any adverse event is included on each case report form.
13.1. General Information

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An Adverse Event (AE) is any untoward medical occurrence in a subject who is 
administered. a study treatment regardless of whether the event seems to have a causal 
relationship with the treatment.  An AE, therefore, can be any unfavorable or unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the study treatment, whether or not it is related to the treatment.  In 
clinical studies, an AE can include an untoward medical occurrence occurring at any time
after the informed consent document is signed, including run-in or washout periods, even 
if no study treatment has been administered.
13.2. Monitoring for Adverse Events
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking if the patient has any 
problems. 
13.3. Procedures for Recording and Reporting AEs and SAEs
Subsequent to signing an informed consent form, all untoward medical occurrences that 
occur during the course of the study must be documented on an Adverse Event Form 
(AEF).  A separate AEF must be filled out for each event.  When possible, signs and 
symptoms indicating a common underlying pathology should be documented as one 
comprehensive event.  For each recorded event, the AE documentation must include the 
onset date, outcome, resolution date (if event is resolved), intensity (ie., severity), any 
action with study treatment taken as a result of the event, and an assessment of the 
adverse event’s relationship to the study treatment.
Nonserious Adverse Events
A nonserious AE is defined as any untoward change in a subject's medical health that 
does not meet serious criteria noted below (e.g., is not life-threatening, does not require 
hospitalization, does not prolong a current hospitalization, is not disabling, etc.).  All 
adverse events must be reported regardless of whether they are related to the study 
treatment or not.
For nonserious adverse events, an AEF containing all available information will be 
collected on a routine basis and submitted to the Medical Monitor before the close of the 
study. 
Serious Adverse Events
A serious adverse event (SAE) is defined as any adverse experience that meets any of the
following criteria:
•
Results in death.
•
Is life-threatening.
NOTE: Life-threatening means that the subject was at immediate risk of death 
from the reaction as it occurred, i.e., it does not include a reaction which 
hypothetically might have caused death had it occurred in a more severe form.
•
Requires inpatient hospitalization or prolongation of existing hospitalization.
NOTE: In general, hospitalization signifies that the individual remained at the 
hospital or emergency ward for observation and/or treatment (usually involving 

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an overnight stay) that would not have been appropriate in the physician's office 
or an out-patient setting.  Complications that occur during hospitalization are 
AEs.  If a complication prolongs hospitalization or fulfills any other serious 
criteria, the event is serious.  When in doubt as to whether “hospitalization” 
occurred, the event should be considered serious.
•
Results in persistent or significant disability/incapacity.  Disability is defined as a 
substantial disruption of a person’s ability to conduct normal life functions.
NOTE: The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions. This definition is not intended to include 
experiences of relatively minor medical significance such as uncomplicated 
headache, nausea, vomiting, diarrhea, influenza, or accidental trauma (e.g., 
sprained ankle) which may interfere or prevent everyday life functions but do not 
constitute a substantial disruption.
•
Is an important medical event.  An important medical event is an event that may not 
result in death, be life-threatening, or require hospitalization but may be considered 
an SAE when, based upon appropriate medical judgment, it may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in the definitions for SAEs.  Examples of such medical events include
allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in subject hospitalization, or 
the development of drug dependency or drug abuse.
All available information on a serious adverse event(s) and any other associated AE, 
if applicable, must be forwarded to the study coordinator for forwarding to the 
Medical Monitor immediately (i.e., within one working day of the Investigator’s or 
site’s knowledge of the event) as follows:
o
In studies utilizing EDC (electronic data capture), all available information for
the SAE and any associated AE(s) must be entered immediately into the EDC 
system. 
o
Additional information for any applicable event is to be reported as soon as it 
becomes available.
In addition to the reporting of serious adverse events to the study Medical Monitor, the 
SAE must be reported to the IRB/IEC according to their requirements.
The investigator must document all adverse device events (serious and nonserious but 
related) and all serious adverse events (related and unrelated) on the Adverse Device 
Effect and Serious Adverse Event Form. Any device quality complaints will also be 
documented. 
●Both the Quality Complaint Form and the Adverse Device Effect and Serious
Adverse Event Form must be e-mailed immediately to the principal 
investigator at ophtrds@emory.edu.  

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●Additional relevant information is to be reported as soon as it becomes 
available.  
Principal investigator contact information is provided below.
Table 13.3.-1: 
Contact Information for Phorcides Prospective Study
Study Staff
Business Phone
E-Mail
Home Phone
R. Doyle Stulting, MD, PhD
678-938-1011
ophtrds@emory.edu
678-938-1011
Further, depending upon the nature of the adverse event (serious or nonserious) or quality
complaint being reported, the study sponsor may request copies of applicable portions of 
the subject’s medical records.  The investigator must also report all adverse events and 
quality complaints according to the relevant IRB requirements.
13.3.1 Intensity and Causality Assessments 
For every adverse event and quality complaint, the investigator must assess the 
causality as Related or Not Related to the medical device under investigation.  An
assessment of causality will also be performed by the Medical Monitor utilizing 
the same definitions, as shown below:
Causality
Related
An adverse event or quality complaint classified as related may be 
either definitely related or possibly related where a direct cause 
and effect relationship with the medical device has not been 
demonstrated, but there is a reasonable possibility that the adverse 
event or quality complaint was caused by the medical device.
Not Related
An adverse event or quality complaint classified as not related may
either be definitely unrelated or simply unlikely to be related (i.e., 
there are other more likely causes for the adverse event or quality 
complaint).
Where appropriate, the investigator must assess the intensity (severity) of the 
adverse event as mild, moderate, or severe based on medical judgment with 
consideration of any subjective symptom(s), as defined below: 
Intensity (Severity)
Mild
An adverse event is mild if the subject is aware of but can easily 
tolerate the sign or symptom.

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Moderate
An adverse event is moderate if the sign or symptom results in 
discomfort significant enough to cause interference with the 
subject’s usual activities.
Severe
An adverse event is severe if the sign or symptom is incapacitating 
and results in the subject’s inability to work or engage in their 
usual activities.
The investigator must document any action taken (i.e., medication, intervention, 
or treatment plan) and outcome of the adverse event or quality complaint when 
applicable.
13.4. Follow-Up of Adverse Events and Quality Complaints
The investigator is responsible for providing adequate and safe medical care to subjects 
during the study and for ensuring that appropriate medical care and relevant follow-up 
procedures are maintained after the study.  Any additional data from these follow-up 
procedures must be documented and available to the study coordinator who, with the 
Medical Monitor, will determine when the data need to be documented on the CRFs. 
13.5. Safety Analyses
The type, severity, duration and frequency of reported ocular adverse events will be 
tabulated.  Adverse events will also be summarized for events that were considered 
treatment-related.  
14. GCP, ICH and ETHICAL CONSIDERATIONS
This study will be conducted in compliance with Good Clinical Practices (GCPs), 
including International Harmonization (ICH) Guidelines, and in a manner consistent with
the 1996 version of the Declaration of Helsinki.  In addition, all applicable local, state 
and federal requirements will be adhered to.
This study is to be conducted in accordance with Institutional Review Board regulations. 
The investigator will obtain appropriate IRB/ethics committee approval prior to initiating 
the study.
The study will be registered with clinicaltrials.gov.

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15.  STANDARD EVALUATION PROCEDURES 
Table 15.1. Proposed Visits and Study Assessments
                  (visits are by patient, with both eyes tested)
Pre-
operative
Operative
Postoperative
Visit 1
Visit 2
Visit 3
Visit 4
Visit 5
Activity
1 Day
1 Month
3 Months
Informed consent
X
Demographics
X
General information:  
medical history
X
Surgery
X
Manifest refraction
X
X
X
Uncorrected distance VA (monocular)
X
X
X
X
Corrected distance VA (monocular)
X
X
X
Corneal aberrations
X
X
Ocular aberrations (site specific)
X
X
Subjective questionnaire
X
X
Monitor for adverse events
X
X
X
X
Complete Exit Form1
X
1 Complete Exit Form upon termination of subject participation, or at Visit 5, whichever 
occurs first.
16. CONFIDENTIALITY
No protected health information (PHI), including the patient’s name and date of birth, 
will be collected for study purposes; to ensure this, no PHI is permitted to be entered on 
any of the Case Report Forms (CRFs).  Subjects will only be identified by subject IDs, 
and identities will be removed at the initial visit so that there is no further need to protect 
or destroy the information.  Collected information will be used for purposes of this study.
No information will be sold to third parties, though the de-identified data collected may 
be used for additional research. 
17. FINANCIAL AND INSURANCE INFORMATION/STUDY RELATED 
INJURIES
Every effort to prevent study-related injury will be taken by the Study Doctor and staff. 
In the event that a patient is injured as a direct result of the study while following the 
Study Doctor’s instructions and the study requirements, the patient will be instructed to 
contact his or her doctor immediately.  The Study Doctor is to treat the injured subject as 
needed for those injuries caused directly by this research study.  In the event of injury or 
illness caused by or occurring during a subject’s participation in this research study, all 
charges for medical care provided to the subject will be billed to his or her insurance 
company.  Neither the Study Doctor nor the Sponsor offer to cover the medical care costs
for injuries or illnesses that are not caused directly by the research study.  The Sponsor 

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does not offer to provide any other compensation, unless specifically agreed to elsewhere 
in this document.  This information will be provided to each study subject before the start
of the study in the consent form.
18. STUDY ENDPOINT CRITERIA
18.1. Patient Completion of Study 
If a study patient has completed the final visit (Visit 5) of the study, he/she is considered 
to have completed the study. 
 18.2. Patient Discontinuation 
Each study patient may voluntarily discontinue the study at any time he/she chooses.  
Study patients who cannot complete the study for administrative reasons (e.g., non-
compliance, failure to meet visit schedule, etc.) will be discontinued from the study.  
Study patients discontinued during the enrollment phase (prior to surgery) of the study 
will be replaced. 
 18.3. Patient Termination 
A study patient will be terminated if the study patient develops any severe adverse event 
that may be related to the study.  A study patient will receive appropriate treatment at the 
discretion of the investigator.  Notification of termination will be clearly documented.  
These study patients are considered to have completed the study and will not be replaced.
18.4. Study Termination
The investigator with appropriate notification may terminate the study.  If, after clinical 
observations, the investigator feels that it may be unwise to continue the study, he may 
stop the study.  
18.5. Study Completion 
The study will be complete when all enrolled patients have completed Visit 5 or have 
been terminated from the study. 
 
19. SUMMARY OF RISKS AND BENEFITS
19.1. Summary of risks
The risks for LASIK surgery in this study (topography-guided or wavefront-optimized) 
are not different from the standard risks.  The excimer laser system used in the study has 
been approved for topography-guided and wavefront-optimized refractive surgery. 
The most common side effects of laser refractive surgery are glare and halos, dry eye and
residual refractive error. 
19.2. Summary of benefits

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Phorcides has been used to assist in surgical planning of topography-guided ablations 
with good results in the past.  It is expected that eyes treated using the Phorcides planning
software with the Contoura topography-guided LASIK algorithm will have results as 
good or better than can be achieved with wavefront-optimized LASIK, and Contoura 
results based on other algorithms.1,2  
REFERENCES
1. Lobanoff, Mark MD; Stonecipher, Karl MD; Tooma, Tom MD; Wexler, Stephen 
MD; Potvin, Richard OD Clinical outcomes after topography-guided LASIK, Journal 
of Cataract & Refractive Surgery: March 11, 2020 - Volume Publish Ahead of Print - 
Issue - doi: 10.1097/j.jcrs.0000000000000176 
2. Stulting RD, Durrie DS, Potvin RJ, Linn SH, Krueger RR, Lobanoff MC, Moshirfar 
M, Motwani MV, Lindquist TP, Stonecipher KG. Topography-Guided Refractive 
Astigmatism Outcomes: Predictions Comparing Three Different Programming 
Methods. Clin Ophthalmol. 2020;14:1091-1100