A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Phase: NA
Conditions: Cataracts, Meibomian Gland Dysfunction (MGD)
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
Study Protocol 
 
 
A Post-Market Evaluation of LipiFlow 
Treatment in Cataract Surgery Practice 
 
NCT Number: NCT03708367 
Document date: 19 Nov 2018 
 
 
 
 
 
 

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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision, Inc. 
 
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery 
Practice 
 
PROTOCOL NUMBER:  DRYE-102-SELF 
 
SPONSOR:  Johnson & Johnson Surgical Vision, Inc.  
1700 E. St. Andrew Place 
Santa Ana, CA 92705 
714-247-8200 
 
Investigator Agreement 
 
As an Investigator, I agree to: 
• Implement and conduct this study diligently and in strict compliance with 
this agreement; the protocol; Good Clinical Practices; ISO 14155 and all 
other applicable regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB) and all other applicable laws 
and regulations. 
• Supervise all testing of the device where human subjects are involved. 
• Ensure that the requirements for obtaining informed consent are met. 
• Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
• 
Maintain all information supplied by Johnson & Johnson Surgical Vision 
in confidence and, when this information is submitted to an independent 
IRB or any other group, it will be submitted with a designation that the 
material is confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
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Signature 
 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
 
Date 
 
 
 

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TABLE OF CONTENTS 
TITLE 
PAGE 
Table of Contents .............................................................................................. ii 
Personnel and Facilities.................................................................................... v 
Protocol Change History .................................................................................. vi 
1. 
Synopsis ................................................................................................. 1 
2. 
Background/Introduction ...................................................................... 9 
3. 
Clinical Hypothesis .............................................................................. 10 
4. 
Study Design ........................................................................................ 10 
5. 
Acronyms ............................................................................................. 11 
6. 
Study Objectives and Endpoints ........................................................ 11 
6.1 
Key Study Endpoints ........................................................................... 12 
6.2 
Other Endpoints ................................................................................... 13 
7. 
Study Products .................................................................................... 14 
7.1 
LipiFlow Thermal Pulsation System ..................................................... 14 
7.2 
Intraocular Lenses ............................................................................... 15 
8. 
Study Population ................................................................................. 15 
8.1 
Inclusion Criteria .................................................................................. 16 
8.2 
Exclusion Criteria ................................................................................. 16 
9. 
Investigator Selection .......................................................................... 18 
9.1 
Investigator Qualifications .................................................................... 18 
9.2 
Investigator Obligations ....................................................................... 19 
9.3 
Investigator Approval ........................................................................... 20 
10. 
Experimental Plan ................................................................................ 21 
10.1 Overview ............................................................................................. 21 
10.2 Visit Schedule ...................................................................................... 22 
Table 1: Visit Schedule ........................................................................... 23 
10.3 Preoperative Visit #1 Procedures......................................................... 23 
Informed Consent ................................................................................... 23 
Screening and Baseline ......................................................................... 24 
Randomization and Enrollment ............................................................. 27 
LipiFlow Treatment ................................................................................. 28 
10.4 Preoperative Visit # 2 Procedures ........................................................ 29 
10.5 Activator II Supply ................................................................................ 30 
10.6 Postoperative Procedures ................................................................... 30 
Postoperative Examination Procedures ................................................ 31 
Crossover LipiFlow Treatment (Only for Control Group) ..................... 34 
10.7 Exit of Subjects .................................................................................... 34 

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10.8 Unscheduled Visits .............................................................................. 35 
10.9 Protocol Deviations .............................................................................. 36 
11. 
Adverse Events and Product Complaints .......................................... 36 
11.1 Adverse Event Definitions .................................................................... 36 
11.2 Product Complaint/Device deficiency Definition ................................... 38 
11.3 Adverse Event and Complaint Reporting Requirements ...................... 38 
11.4 Causal relationship .............................................................................. 39 
11.5 Adverse Event Follow-up ..................................................................... 40 
12. 
Protocol Changes/Amendments ......................................................... 41 
13. 
Ethics Review and Patient Welfare ..................................................... 41 
13.1 Institutional Review Board (IRB) .......................................................... 41 
13.2 Informed Consent ................................................................................ 41 
14. 
Documentation ..................................................................................... 42 
14.1 Source Documents .............................................................................. 42 
14.2 Subject Confidentiality ......................................................................... 42 
14.3 Case Report Form Completion ............................................................ 43 
14.4 Study Summary ................................................................................... 43 
15. 
Monitoring ............................................................................................ 43 
15.1 Data Monitoring ................................................................................... 43 
15.2 Administrative Monitoring .................................................................... 44 
15.3 Medical Oversight ................................................................................ 45 
16. 
Publications ......................................................................................... 45 
17. 
Risk Analysis ....................................................................................... 45 
18. 
Records Retention ............................................................................... 47 
19. 
Termination of the Investigation ......................................................... 47 
20. 
Statistical Methods .............................................................................. 48 
20.1 Analysis Population ............................................................................. 48 
20.2 Key Study Endpoints ........................................................................... 48 
20.3 Other Endpoints ................................................................................... 50 
20.4 Interim Reports .................................................................................... 52 
20.5 Sample Size Calculations .................................................................... 52 
Appendix A   Diagram of Study Flow ............................................................. 53 
Appendix B   Summary of Procedures Required at Each Visit .................... 54 
Appendix C   Equipment and Ancillary Supplies Provide to Study Sites .... 55 
Appendix D  Manual of Testing Procedures .................................................. 56 
Appendix E   Instructions for Eyelid Margin Cleaning .................................. 59 
Appendix F   Instructions for Blinking Exercise ............................................ 63 

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Appendix G   Instructions for Meibomian Gland Assesssment ................... 65 
Appendix H   Instructions for Ocular Surface Staining ................................. 69 
Corneal Staining ..................................................................................... 69 
Conjunctival Staining ............................................................................. 70 
Appendix I   Instructions for Meibomian Gland Imaging .............................. 71 
LipiView II ................................................................................................. 71 
LipiScan .................................................................................................... 71 
Appendix J   Instructions for Eyelid Margin Evaluation ............................... 73 
Appendix K   Instructions for Standard Patient Evaluation of Eye Dryness 
(SPEED) Questionnaire ............................................................ 74 
Appendix L  Instructions for Tear Break-up Time Testing ........................... 75 
Appendix M  Maximum Plus Manifest Refraction Technique With 
Cylinder Refinement ................................................................. 76 
Appendix N  Refraction Adjustments ............................................................. 77 
Appendix O   Instructions for Using The M&S System ................................. 78 
Appendix P  Instructions for Distance Visual Acuity Testing ...................... 81 
Appendix Q   Instructions for Intermediate Visual Acuity Testing ............... 82 
Appendix R   Instructions for Near Visual Acuity Testing ............................ 83 
Appendix S   Instructions for Contrast Acuity Testing ................................. 84 
Photopic 10% Contrast Acuity Testing ................................................. 84 
Photopic 20/40 Contrast Threshold Testing ......................................... 84 
Appendix T   Instructions for Keratometry .................................................... 85 
Appendix U  American Academy of Ophthalmology Task Force Consensus 
Statement on Adverse Events for Intraocular Lenses ........... 86 
REFERENCES .................................................................................................. 90 
 
 
 

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PERSONNEL AND FACILITIES 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. 
(“JJSV”) 
 
1700 East Saint Andrew Place 
 
Santa Ana, CA 92705 
 
Main Number:  714-247-8200 
 
Fax:  714-247-8784 
 
SPONSOR PERSONNEL: 
 
Medical Monitor: 
 
 
 
 
 
 
 
 
 
 
 
 
Study Managers: 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinical Scientist 
 
 
 
 
 
 
Biostatistician: 
 
 
 
 
 
 
EMERGENCY TELEPHONE NUMBERS: 
 
 
      
 
 
 
 

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PROTOCOL CHANGE HISTORY 
Version 
Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original 
N/A 
2.0 
Personnel and Facilities 
v 
Study personnel update 
Change in study manager 
 
1.0 Synopsis, 8.1 Inclusion 
Criteria and 8.2 Exclusion 
Criteria  
3-4 and 
16-18 
Updated exclusion criteria  
Clarify dry eye treatment information 
(medication and home remedies), definition 
of keratitis, and contact lens restrictions. 
 
10.3 Preoperative Visit # 1 
Procedures: Screening and 
baseline; Appendix B 
26 
53 
Clarified the number of measurements required for 
keratometry and biometry 
Some keratometers only measure 3 sets of 
measurement per test, instead of the 5 sets 
per test.  This change allows either, as long 
as 3 tests are done.  
 
10.3 Randomization and 
Enrollment 
27 
Wording has been updated to reflect the electronic 
randomization method used for the study 
Randomization will be done electrically 
rather than manually.  
 
10.4 Preoperative Visit # 2 
Procedures 
29 
Clarified the number of measurements required for 
keratometry and biometry 
Some keratometers only measure 3 sets of 
measurement per test, instead of the 5 sets 
per test.  This change allows either, as long 
as 3 tests are done.  
 
10.6 Postoperative 
procedures 
30 
Note 2 was clarified for contact lens wearers and a note was 
added to address subject follow-up should only one eye be 
implanted with a TECNIS Symfony IOL 
To clarify contact lens wear restrictions and 
subject follow-up if both eyes are not 
implanted with a study lens. 
 
10.6 Postoperative 
procedures 
31-32 
Wording for near visual acuity testing was changed to be 
specific for the M&S system 
The M&S System was validated for near 
visual acuity testing, so this System will be 
used for continuity across all test distances, 
rather than using a light box for near only. 
 
Appendix C 
54 
Removed equipment that is not being used in this study and 
expanded the ancillary supplies to allow the clinical sites to 
use any commercially-available standard fluorescein strip to 
replace the Amcon DET fluorescein strips 
To clarify equipment being used in the study 
and to address shortages in the world-wide 
supply of Amcon DET fluorescein strips 
 
Appendix F 
63-64 
Clarified the number of times the blinking exercises had to 
be performed 
The instructions are not standardized and 
the medical monitor felt we needed to 
reduce the number of times per day  
 
Appendix R 
82 
Near visual acuity changed to be specific to M&S System 
The M&S System was validated for near 
visual acuity testing, so this System will be 
used for continuity across all test distances, 
rather than using a light box for near only. 
 
 

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1. 
SYNOPSIS 
PROTOCOL TITLE: 
A Post-Market Evaluation of LipiFlow Treatment in 
Cataract Surgery Practice 
PROTOCOL NUMBER:  
DRYE-102-SELF 
STUDY TREATMENTS: 
LipiFlow® Thermal Pulsation System (“LipiFlow”) 
TECNIS Symfony® Extended Range of Vision IOLs, 
Model ZXR00, and TECNIS Symfony® Toric Extended 
Range of Vision IOLs, Models ZXT150, ZXT225, 
ZXT300 and ZXT375 (“Symfony”), (Johnson & Johnson 
Surgical Vision, Santa Ana, CA) 
STUDY OBJECTIVE: 
The study objective is to evaluate the LipiFlow 
treatment in adult patients with mild to moderate 
meibomian gland dysfunction (MGD) undergoing 
bilateral cataract surgery in terms of preoperative 
surgical planning and postoperative outcomes 
including refractive outcomes, visual outcomes and 
ocular comfort. 
CLINICAL HYPOTHESIS: 
LipiFlow treatment will improve the precision of 
preoperative biometric measurements, improve 
postoperative refractive predictability, improve 
postoperative visual outcomes and improve 
postoperative ocular comfort, due to improved 
Meibomian gland function. 
OVERALL STUDY DESIGN: 
Structure: 
This is a post-market, prospective, randomized, 
multi-center, bilateral, open-label, cross-over, 
comparative clinical study.  
Study group will undergo preoperative LipiFlow 
treatment and Control group will not receive 
preoperative LipiFlow treatment. Three (3) months 
postoperatively, both groups will be evaluated for 
clinical outcomes and the Control group will receive 
LipiFlow treatment as the cross-over group. The 
Control group will be evaluated at 4 months 
postoperative for clinical outcomes.   
Number of sites: 
Up to 7 sites in the USA 
Duration: 
6 months (1 month preoperative to approximately 4 
months postoperative) 

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Administration: 
Preoperative: Biometry measurements will be 
performed in both study and control groups on two 
measurement visits 2 - 4 weeks apart.  Only the study 
group will receive a LipiFlow treatment preoperatively.
 
 
 
 
Operative: Study and control groups will undergo 
bilateral cataract surgery with Symfony non-toric or 
Symfony toric IOL implantation. 
 
Postoperative: Postoperative evaluations at 1-day and 
1-week will be performed per investigators standard of 
care. Study specific visits include 1-month and 3-month 
postoperative evaluations in both study and control 
groups. The control group will receive a cross-over 
LipiFlow treatment at the end of the 3-month visit and 
return for 4-month postoperative evaluations. 
Visit Schedule: 
Study group (pre-operative LipiFlow treatment) 
subjects will undergo a minimum of 4 visits for both 
eyes: one baseline preoperative visit (per site standard 
of care), which includes the LipiFlow treatment (can 
occur on the same day after biometric measurement 
has been performed, or within 1 week of Visit #1), a 
second preoperative visit 2 – 4 weeks after the 
LipiFlow treatment visit, and two postoperative visits at 
1 month and 3 months.   
 
Control group (post-operative LipiFlow treatment) 
subjects will undergo a minimum of 5 visits for both 
eyes: one preoperative visit at baseline (per site 
standard of care), a second preoperative visit (2 - 4 
weeks after first preoperative visit), and Postoperative 
Visits at 1 month, 3 months including crossover 
LipiFlow treatment, and 4 months.  
 
See Appendix A for a diagram of the study visit flow.    
STUDY POPULATION CHARACTERISTICS: 
Condition: 
Bilateral mild to moderate MGD with none to moderate 
dry eye symptoms, scheduled for bilateral cataract 
surgeries with Symfony IOL implantation. 
Number of Subjects: 
Approximately 140 subjects will be randomized and 
bilaterally implanted, to achieve approximately 110 
evaluable subjects (55 in the study arm and 55 in the 
control arm). 
 

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Inclusion Criteria (all criteria apply to each study eye): 
• 
Minimum 22 years of age.  
• 
Bilateral cataracts for which phacoemulsification extraction and implantation with 
Symfony IOLs have been planned. 
• 
Evidence of MGD in both eyes based on assessment of meibomian glands of the 
lower eyelid with a total meibomian gland secretion score of ≤ 15 (on a scale of 0 
to 45) for each eye. 
• 
None to moderate dry eye symptoms with questionnaire total scores between 0 
and 15 on the Standard Patient Evaluation of Eye Dryness (SPEED) 
questionnaire.  
Note: In each site, there should be no more than 30% enrolled subjects with 
none dry eye symptoms.   
• 
Clear intraocular media other than cataract in each eye. 
• 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
the study protocol including: randomization; examination procedures; completion 
of planned bilateral cataract surgeries; compliance with no use of other MGD or 
dry eye treatments (except over-the-counter artificial tears, ocular lubricants, 
ointments, emollients or ω-3 dietary supplements) during the study; and 
attendance of all study visits. 
• 
Ability to understand, read and write English to consent to study participation and 
complete study questionnaires. 
• 
Willingness to sign informed consent and HIPAA authorization or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to 
medical treatment in the governing country. 
Exclusion Criteria (all criteria apply to each study eye): 
• 
Any medical finding that would predictably result in a postoperative best 
corrected distance visual acuity worse than 20/30 in either eye. 
• 
Use of systemic or ocular medications that, in the opinion of the investigator, may 
affect vision or impact pupil dilation or iris structure. 
• 
Irregular corneal astigmatism. 
• 
Any clinically-significant corneal pathology / abnormality other than regular 
corneal astigmatism. 
• 
Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils). 

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• 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects. 
• 
Unwillingness or inability to stop wearing contact lens at least two weeks prior to 
the baseline visit. 
• 
Known ocular disease or pathology that, in the opinion of the investigator, may 
affect visual acuity or require surgical intervention during the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.). 
• 
Systemic disease condition that causes dry eye (e.g., Stevens-Johnson 
syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, 
sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, 
Sjögren's syndrome). 
• 
Unwillingness or inability to abstain from the use of systemic medications known 
to cause dryness (e.g., isotretinoin (Accutane®)) for the study duration.  Subjects 
must have discontinued these medications for at least 1 month prior to the 
baseline Preoperative Visit #1 measurements. 
• 
Unwillingness or inability to abstain from the use of systemic antihistamines: 
o at least two weeks prior to the baseline Preoperative Visit #1 measurements 
through Preoperative Visit #2, or per site standard of care for cataract 
surgery, whichever is longer; and 
o at least 2 weeks prior to the Month 3 measurements; and 
o at least 2 weeks prior to the Month 4 measurements (Control group only) 
• 
Unwillingness or inability to abstain from use of prescription medications for 
treatment of MGD or dry eye.  Subjects must have discontinued using 
prescription medications (e.g., lifitegrast (Xiidra) for MGD or dry eye at least 1 
month prior to the baseline Preoperative Visit #1 measurements.  
• 
Any of the following ocular (eye or eyelid) conditions in either eye within 3 
months prior to the LipiFlow treatment visit: 
o Prior intraocular, oculoplastic, corneal or refractive surgery procedure (LASIK, 
LASEK, RK, PRK, etc.). 
o Ocular trauma. 
o Ocular Herpes simplex or Herpes zoster (eye or eyelid) infection. 
o History of recurrent ocular inflammation (e.g., retinitis, macular inflammation, 
choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis). 
o Punctal plug insertion or punctal occlusion. 

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• 
Any of the following active ocular (eye or eyelid) conditions in either eye at the 
baseline Preoperative Visit #1 measurements: 
o Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or 
fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or 
eyelids including hordeolum/stye). 
o Active ocular inflammation (e.g., retinitis, macular inflammation, choroiditis, 
uveitis, iritis, scleritis, episcleritis, keratitis). 
o Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis 
o Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, 
staphylococcal blepharitis or seborrheic blepharitis). 
o Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, 
edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis). 
o Ocular surface abnormality that may compromise corneal integrity (e.g., prior 
chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 
corneal fluorescein staining, or map dot fingerprint dystrophy). 
• 
Concurrent participation or participation within 30 days prior to study visit in any 
other clinical trial. 
• 
Planned monovision correction. 
• 
Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
changes. 
 
STUDY ENDPOINTS: 
Key Study Endpoints: 
• 
Mean monocular UCDVA at 3 months postoperative in the Study and Control 
groups. 
• 
Precision (standard deviation) of preoperative axial length (AL), anterior chamber 
depth (ACD), and keratometric measurements (K) for the study and the Control 
group. 
• 
Rate of refractive predictability (i.e., within 0.50 D of target refraction, and within 
1.00 D of target refraction) at 3 months postoperative for the Study and Control 
groups. 
• 
Rate of bothersome ocular symptoms (halos, night glare, starbursts, and night 
vision difficulties) at 3 months postoperative for the Study and the Control 
groups. 
• 
Mean change in total meibomian gland score in the Study group compared to the 
Control group from Baseline to the 1-month postoperative visit. 

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Other Endpoints: 
• 
1-Month Postoperative Visit: 
o Mean change in Number of Meibomian Glands Yielding Liquid Secretion 
(MGYLS) from Baseline visit to 1 month postoperative in the Study group 
compared to the Control group. 
o Mean change in ocular surface stain grade from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
o Mean change in Tear Break-up Time (TBUT) from Baseline visit to 1 
month postoperative in the Study group compared to the Control group. 
o Mean change in Eyelid Margin Evaluation from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
• 
3-Months Postoperative Visit:  
o Mean monocular BCDVA in the Study group at 3 months postoperative 
compared to the Control group. 
o Mean binocular UCDVA and BCDVA in the Study group at 3 months 
postoperative compared to the Control group. 
o Mean binocular UCIVA in the Study group at 3 months postoperative 
compared to the control. 
o Mean binocular UCNVA in the Study group at 3 months postoperative 
compared to the Control group. 
o Mean manifest refraction spherical equivalent (MRSE) at 3 months 
postoperative compared to target MRSE in the Study group compared to 
the Control group. 
o Contrast acuity in the Study group at 3 months postoperative compared to 
the Control group. 
o Mean change in total Standard Patient Evaluation of Eye Dryness 
(SPEED) score from Baseline visit to 3 months postoperative in the Study 
group compared to the Control group. 
o Mean change in total meibomian gland score in the Study group 
compared to the Control group from Baseline to 3 months postoperative. 
• 
Control Group 4-Months Postoperative Visit:  
o Mean change in monocular UCDVA and BCDVA from 3 months to 4 
months postoperative.  
o Mean change in binocular UCDVA and BCDVA from 3 months to 4 
months postoperative 
o Mean change in binocular UCIVA from 3 months to 4 months 
postoperative 
o Mean change in binocular UCNVA from 3 months to 4 months 
postoperative 

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o Mean MRSE at 4 months postoperative compared to target MRSE 
o Percent of eyes with MRSE within 0.50 D and within 1.00 D of target 
MRSE at 4 months postoperative 
o Contrast acuity at 4 months postoperative compared to 3-month. 
o Mean change in total meibomian gland score from 3 months to 4 months 
postoperative. 
o Mean change in total SPEED score from 3 months to 4 months 
postoperative. 
• 
Rates of adverse events in the Study and Control groups. 
• 
Rates of medical and/or lens findings in the Study and Control groups. 
 
STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the start of Preoperative 
Visit #1 according to the protocol criteria.  The Informed Consent Document and 
Authorization for Use/Disclosure of Health Information form (HIPAA authorization) 
must be signed by any subjects who agree to participate in the study prior to 
undergoing any study-specific procedures.  After determination that all 
inclusion/exclusion criteria have been met, enrolled subjects will be randomized to 
either Study group or Control group in a 1:1 ratio.   
Study visit schedule, procedures and key data collected at each visit are shown in 
Appendix A, Appendix B, and Section 10.2, Visit Schedule, Table 1.  
 
DATA ANALYSIS: 
Key study endpoints are the comparisons between study group and control group for 
precision of biometric measurements preoperatively, mean change in total 
Meibomian gland score at 1 month postoperatively, mean monocular UCDVA at 
3 months postoperatively, rate of refractive predictability at 3 months postoperatively 
and rate of directed reported ocular symptoms at 3 months postoperatively.  
Additional endpoints will be evaluated at 1 and 3 months postoperatively for the both 
groups and 4 months postoperatively for crossover Control group.  
Visual acuity data will be converted to LogMAR values prior to analysis.  
Comparisons between study group and control group for the mean monocular 
UCDVA at 3 months postoperatively will be performed using one-sided two-sample t-
tests with alpha set at 0.05.  Precision of preoperative biometric measurements is 
defined as the average of the three computed standard deviations from each 
preoperative visit.  The Study group is expected to have better total Meibomian gland 
score at 1 month postoperatively compared to the Control group, and to have better 

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precision of preoperative biometric measurements, lower rate of refractive outliers, 
and lower rate of bothersome ocular symptoms at 3 months postoperatively 
compared to the Control group.   
ANALYSIS POPULATION: 
The primary study population will be all eyes that are randomized and implanted with 
study IOLs, except for the precision of biometric measurements, which will be 
evaluated at the preoperative visits.  Mean change in total Meibomian gland score 
will be compared between the study group eyes and the control group eyes at 1 
month postoperatively.  All other key study endpoints will be evaluated at 3 months 
postoperatively.  Additional endpoints will be evaluated at 1 month and 3 months 
postoperatively for the study group and the control group, and 4 months 
postoperatively for crossover control group only.  
ADDITIONAL ANALYSES: 
Descriptive statistics for all continuous data such as visual acuity, manifest refraction 
and meibomian gland score will include mean, standard deviation, minimum and 
maximum values.  Mean LogMAR BCDVA, UCIVA, UCNVA and contrast acuity will 
be reported and compared between the Study group and Control groups at 3 months 
postoperatively.  Mean MRSE at 3 months postoperatively will be reported and 
compared to target MRSE between the Study group and Control groups.  The 
frequency and proportion of eyes with MRSE within 0.50 D and within 1.00 D of 
target MRSE will be reported.  Mean change from preoperative visit to 1 month 
postoperatively in number of Meibomian Glands Yielding Liquid Secretion (MGYLS), 
assessment of eyelid margin evaluation, ocular surface stain grade and TBUT will be 
compared between the Study group and the Control group.  Mean change from 
preoperative visit to 3 months postoperatively in total SPEED score will be compared 
between the Study group and the Control group.  Mean change in monocular and 
binocular UCDVA and BCDCA, binocular UCIVA and UCNVA, contrast acuity, total 
Meibomian gland score, and total SPEED score from 3 months to 4 months 
postoperatively in the cross-over Control group will be reported.  The frequency and 
proportion of eyes with optical/visual, medical and lens complications will also be 
reported over time.  Rates of adverse events will be reported.  
SAMPLE SIZE DETERMINATION: 
The sample size determination is based on the primary endpoint of uncorrected 
distance visual acuity (UCDVA).  There is 90% power to detect a 1-line or greater 
difference in mean UCDVA between the treatment and control groups with 55 
subjects in each group.  This assumes one-sided two-sample t-test with an alpha of 
0.05 and standard deviation of 1.6 lines.  Adding 20% screen failure/drop-out rate will 
require enrolling 69 subjects per group. 

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Interim database locks will be allowed; for example, one may be performed for after 
completion of the second preoperative visit. 
2. 
BACKGROUND/INTRODUCTION 
As defined by the Tear Film and Ocular Surface Society (TFOS) International 
Workshop on MGD involving more than 50 clinical and research experts, “Meibomian 
gland dysfunction is a chronic, diffuse abnormality of the meibomian glands, 
commonly characterized by terminal duct obstruction and/or qualitative/quantitative 
changes in the glandular secretion.  It may result in alteration of the tear film, 
symptoms of eye irritation, clinically apparent inflammation, and ocular surface 
disease.”i 
Clinical signs of MGD may include rounding, thickening and irregularity of the eyelid 
margin; changes in the lid vascularity and presence of telangiectasia; pouting, 
plugging and narrowing of the gland orifices; reduction in volume and number of 
glands secreting liquid; and changes in gland secretion quality, clarity and viscosity 
with greater pressure required to express secretions.ii  The clinical cascade of 
obstructive MGD involves reduced lipid secretions, which leads to hyperosmolarity 
and instability of the tear film, increased opportunity for bacterial growth, evaporative 
dry eye and ocular surface inflammation and irritation.i  
MGD is one of the most common ophthalmic conditions found in clinical practice.ii  
Yet MGD is often underdiagnosed because it requires diagnostic expression of the 
meibomian glands, particularly in patients without obvious signs of MGD.iii  
Population-based studies have reported a prevalence of MGD ranging from 3.5% to 
69.3% with differences among studies by race/ethnicity and parameters used to 
define presence of MGD.iv  According to the International Workshop on MGD Report 
published in 2011, “MGD may well be the leading cause of dry eye disease 
throughout the world”. i 
Patients undergoing cataract surgery frequently have MGD because of the increased 
prevalence of the chronic disease with age.v  Several studies have observed 
significant increases in the frequency of lid margin changes, meibomian gland 
abnormalities and lipid profile alterations with older age, particularly in patients older 
than 50 years.vi,vii,viii  Not surprisingly, patients undergoing cataract surgery often 
present with MGD-related dry eye symptoms, which also increase in prevalence with 
older age.ix  
The limited studies in the literature indicate that the treatment of patients with MGD 
prior to cataract surgery may be beneficial but further study is needed.x  Since a 
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comfort after cataract surgery, treating MGD before surgery may help promote better 
post-surgical meibomian gland function, which is essential for tear film stability, 
visual quality and ocular comfort.  
Building upon the concept of eyelid warming and massage/expression, the LipiFlow 
Thermal Pulsation System is designed to remove the meibomian gland obstruction, 
thus alleviating a cause of the resultant evaporative dry eye.  The LipiFlow provides 
controlled, localized heat and pressure application to the eyelids as a prescription 
device used in a 12-minute in-office procedure by a physician.  The LipiFlow uses an 
efficient method of melting the meibomian gland obstructions by applying heat to the 
inner eyelid surface, in closest proximity to the meibomian glands.  Additionally, the 
LipiFlow improves upon the physician practice of manual eyelid expression by 
expressing the glands at a level of force far below that required to manually express 
the glands without heat. The use of LipiFlow has been reported in several 
publications and presentations to date.xi,xii,xiii,xiv,xv,xvi,xvii,xviii,xix,xx,xxi  Prior clinical studies 
demonstrate safety, effectiveness and clinical utility of treatment with the LipiFlow in 
patients with MGD and dry eye symptoms. 
In addition, JJSV designed the Symfony IOL series in response to a patient need for 
lenses that can provide good distance vision, improved intermediate and near vision 
compared to standard monofocal IOLs, and less dysphotopsia compared to a 
multifocal IOL.  The Symfony IOL utilizes diffractive technology to elongate the range 
of focus while keeping halos to a minimum and also to reduce chromatic aberration 
to maintain contrast sensitivity.  The purpose of the current study is to evaluate if the 
LipiFlow treatment prior to cataract surgery with Symfony IOL implantation improves 
IOL power planning and postoperative visual outcomes and ocular comfort. 
3. 
CLINICAL HYPOTHESIS 
This study will demonstrate that the LipiFlow treatment will improve the precision of 
preoperative biometric measurements, improve postoperative refractive 
predictability, improve postoperative visual outcomes and improve postoperative 
ocular comfort, due to improved Meibomian gland function.  
4. 
STUDY DESIGN 
This study is a 6-month, post-market, prospective, randomized, multicenter, bilateral, 
open-label, cross-over, comparative clinical investigation. 
The study will be conducted at up to 7 sites in the U.S.A. Approximately 140 subjects 
will be randomized and bilaterally implanted, to achieve approximately 110 evaluable 
subjects (55 in the study arm and 55 in the control arm).  Subjects are to be treated 
on both eyes by LipiFlow and to be implanted bilaterally with the Symfony IOLs. 

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JUSTIFICATION OF STUDY DESIGN 
The study is to be conducted in USA as a post-market study.  The study is designed 
to evaluate improvements in biometry reliability, visual outcomes and refractive 
outcomes after LipiFlow treatment versus an active control group and, through a 
cross-over design, to evaluate visual and refractive outcomes after postoperative 
LipiFlow treatment.  The study design allows evaluation of preoperative and 
postoperative LipiFlow treatments on cataract surgery outcomes.  
5. 
ACRONYMS 
The following acronyms are used throughout the document:   
• 
ACD: Anterior Chamber Depth 
• 
AL: Axial Length 
• 
BCDVA: Best Corrected Distance Visual Acuity 
• 
D:  Diopters 
• 
IOL: Intraocular Lens 
• 
MGD: Meibomian Gland Dysfunction 
• 
MGE: Meibomian Gland Evaluator 
• 
MGYLS: Meibomian Glands Yielding Liquid Secretion 
• 
MR:  Manifest Refraction 
• 
MRC:  Manifest Refractive Cylinder 
• 
MRS:  Manifest Refractive Sphere 
• 
MRSE:  Manifest Refraction Spherical Equivalent 
• 
SPEED: Standard Patient Evaluation of Eye Dryness 
• 
TBUT: Tear Break-up Time 
• 
UCDVA: Uncorrected Distance Visual Acuity 
• 
UCIVA: Uncorrected Intermediate Visual Acuity 
• 
UCNVA: Uncorrected Near Visual Acuity  
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this study is to evaluate the LipiFlow treatment in adult patients with 
mild to moderate meibomian gland dysfunction (MGD) undergoing bilateral cataract 
surgery in terms of preoperative surgical planning and postoperative outcomes 
including refractive outcomes, visual outcomes and ocular comfort.  

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6.1 
KEY STUDY ENDPOINTS 
• 
MEAN MONOCULAR UCDVA AT 3 MONTHS POSTOPERATIVE IN THE 
STUDY AND CONTROL GROUPS  
o Success criteria:  Statistically significantly lower mean LogMAR UCDVA 
is expected in the study group eyes compared to control group eyes at 
3 months postoperative.  
• 
PRECISION (STANDARD DEVIATION) OF PREOPERATIVE AL, ACD, AND 
KERATOMETRIC MEASUREMENTS (K) FOR THE STUDY AND THE 
CONTROL GROUP  
o AL, ACD and K values will have three sets of measurements at the 
Preoperative Visit #1 and again at the Preoperative Visit #2.  For AL, ACD 
and keratometry, the standard deviation of each set of measurements will 
be computed at both preoperative visits, and the average of the three 
computed standard deviations from each preoperative visit is defined as 
the precision.  The difference in precision between the two preoperative 
visits will be calculated for AL, ACD and K values.  The precisions of the 
AL, ACD and keratometry measurements are expected to be better 
(smaller standard deviation) for study group eyes than the ones for 
control group eyes.  
• 
RATE OF REFARACTIVE PREDICTABILITY AT 3 MONTHS POSTOPERATIVE 
FOR THE STUDY AND CONTROL GROUPS 
o The frequency, proportion and 95% confidence intervals of eyes with 
achieved MRSE within 0.50 D and 1.00 D of targeted MRSE will be 
summarized at 3 months postoperatively. The proportion of study group 
eyes with achieved MRSE within 0.50 D and within 1.00 D of targeted 
MRSE is expected to be greater compared to control group eyes.  
• 
RATE OF BOTHERSOME OCULAR SYMPTOMS AT 3 MONTHS 
POSTOPERATIVE FOR THE STUDY AND CONTROL GROUPS 
o The rate of directed reports of bothersome ocular symptoms (halos, night 
glare, starburst, and night vision difficulties) at 3 months postoperatively is 
expected to be lower for study group eyes than that for control group 
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• 
MEAN CHANGE IN TOTAL MEIBOMIAN GLAND SCORE IN THE STUDY 
GROUP COMPARED TO THE CONTROL GROUP FROM BASELINE TO 1 
MONTH POSTOPERATIVE 
o Change in total Meibomian gland score is defined as total Meibomian 
gland score at 1 month postoperative minus the score at Baseline (before 
LipiFlow treatment). Greater mean change in total Meibomian gland score 
is expected for study group eyes than that for control group eyes.  
6.2 
OTHER ENDPOINTS 
• 
1-Month Postoperative Visit: 
o Mean change in Number of Meibomian Glands Yielding Liquid Secretion 
(MGYLS) from Baseline visit to 1 month postoperative in the Study group 
compared to the Control group. 
o Mean change in ocular surface stain grade from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
o Mean change in Tear Break-up Time (TBUT) from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
o Mean change in Eyelid Margin Evaluation from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
• 
3-Month Postoperative Visit: 
o Mean monocular BCDVA in the Study group at 3 months postoperative 
compared to the Control group. 
o Mean binocular UCDVA and BCDVA in the Study group at 3 months 
postoperative compared to the Control group. 
o Mean binocular UCIVA in the Study group at 3 months postoperative 
compared to the control. 
o Mean binocular UCNVA in the Study group at 3 months postoperative 
compared to the Control group. 
o Mean manifest refraction spherical equivalent (MRSE) at 3 months 
postoperative compared to target MRSE in the Study group compared to the 
Control group. 
o Contrast acuity in the Study group at 3 months postoperative compared to the 
Control group. 
o Mean change in total Standard Patient Evaluation of Eye Dryness (SPEED) 
score from Baseline visit to 3 months postoperative in the Study group 
compared to the Control group. 
o Mean change in total meibomian gland score in the Study group compared to 
the Control group from Baseline to 3 months postoperative. 

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• 
Control Group 4-Months Postoperative Visit: 
o Mean change in monocular UCDVA and BCDVA from 3 months to 4 months 
postoperative.  
o Mean change in binocular UCDVA and BCDVA from 3 months to 4 months 
postoperative 
o Mean change in binocular UCIVA from 3 months to 4 months postoperative 
o Mean change in binocular UCNVA from 3 months to 4 months postoperative 
o Mean MRSE at 4 months postoperative compared to target MRSE 
o Percent of eyes with MRSE within 0.50 D and within 1.00 D of target MRSE 
at 4 months postoperative 
o Contrast acuity at 4 months postoperative compared to 3-month. 
o Mean change in total meibomian gland score from 3 months to 4 months 
postoperative. 
o Mean change in total SPEED score from 3 months to 4 months 
postoperative. 
• 
Rate of adverse events in the Study and Control groups. 
• 
Rates of medical and/or lens findings in the Study and Control groups.  
7. 
STUDY PRODUCTS 
7.1 
LIPIFLOW THERMAL PULSATION SYSTEM 
The LipiFlow® Thermal Pulsation System is a prescription device with an indication 
for use for the application of localized heat and pressure therapy in adult patients 
with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, 
also known as evaporative dry eye or lipid deficiency dry eye.  The LipiFlow is used 
by a physician in an in-office procedure to provide controlled heat to the inner eyelid 
surface and intermittent pressure to the outer eyelid to facilitate release of lipid from 
the cystic glands.  
The LipiFlow has been cleared under pre-market notification (K161357) to market 
the device in the U.S (Class II device). The LipiFlow is in commercial distribution 
based upon a determination by the FDA that the device is substantially equivalent to 
a legally marketed device.  In addition, the use of the device in this study is in 
accordance with the cleared indication for use in the commercial product labeling.  
The risk assessment supports that the use of the LipiFlow in this post-market study is 
non-significant risk because the device is designed to control the application of heat 
and pressure within a safe range and time.  Thus, this post-market study is an 
exempted investigation under 21 CFR 812.2(c)(2). 

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7.2 
INTRAOCULAR LENSES 
The lens models to be used in this study are the commercially-available Symfony 
IOLs.  The TECNIS Symfony Extended Range of Vision Intraocular Lenses (IOLs), 
lens model ZXR00 and toric lens models ZXT150, ZXT225, ZXT300, and ZXT375, 
are ultraviolet light-absorbing posterior chamber IOLs which are intended to mitigate 
the effects of presbyopia and provide a continuous range of high-quality vision by 
extending the depth of focus.  
The TECNIS Symfony® Extended Range of Vision IOL, Model ZXR00, is indicated 
for primary implantation for the visual correction of aphakia, in adult patients with less 
than 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has 
been removed.  The lens mitigates the effects of presbyopia by providing an 
extended depth of focus.  Compared to an aspheric monofocal IOL, the lens provides 
improved intermediate and near visual acuity, while maintaining comparable distance 
visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only. 
The TECNIS Symfony® Toric Extended Range of Vision IOLs, Models ZXT150, 
ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual 
correction of aphakia and for reduction of residual refractive astigmatism in adult 
patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, 
in whom a cataractous lens has been removed. The lens mitigates the effects of 
presbyopia by providing an extended depth of focus.  Compared to an aspheric 
monofocal IOL, the lens provides improved intermediate and near visual acuity, while 
maintaining comparable distance visual acuity.  The Model Series ZXT IOLs are 
intended for capsular bag placement only. 
8. 
STUDY POPULATION 
All study subjects will be enrolled from the normal surgical cataract population with 
bilateral mild to moderate MGD, scheduled for bilateral cataract surgeries with 
Symfony IOL implantation, at up to 7 sites in the U.S.A.  Approximately 140 subjects 
will be randomized and bilaterally implanted, to achieve approximately 110 evaluable 
subjects (55 in the study arm and 55 in the control arm).  
This study will include mild to moderate MGD subjects scheduled for bilateral primary 
phacoemulsification cataract extraction and Symfony IOL implantation and who meet 
all the study inclusion and exclusion criteria in both eyes.  All subjects who meet the 
inclusion/exclusion criteria will be offered enrollment in the study.  Eligibility criteria 
may not be waived by the investigator.  Any questions regarding patient eligibility are 
to be discussed with JJSV prior to subject enrollment.  Those subjects who meet the 
inclusion/exclusion criteria and agree to participate will be randomized to either the 
Study group or the Control group and will be bilaterally treated with the LipiFlow 

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system.  The subjects will be enrolled at each site sequentially until the recruitment 
goals are met or the site limit is reached.  To minimize bias, each investigator will 
manage subject enrollment at his/her site to the extent possible to achieve an even 
distribution with respect to age among the study groups. 
8.1 
INCLUSION CRITERIA  
Note: All criteria apply to each study eye. 
• 
Minimum 22 years of age.  
• 
Bilateral cataracts for which phacoemulsification extraction and implantation with 
Symfony IOLs have been planned. 
• 
Evidence of MGD in both eyes based on assessment of meibomian glands of the 
lower eyelid with a total meibomian gland secretion score of ≤ 15 (on a scale of 0 
to 45) for each eye. 
• 
None to moderate dry eye symptoms with questionnaire total scores between 0 
and 15 on the Standard Patient Evaluation of Eye Dryness (SPEED) 
questionnairexxii. 
Note: In each site, there should be no more than 30% enrolled subjects with 
none dry eye symptoms.   
• 
Clear intraocular media other than cataract in each eye. 
• 
Availability, willingness, ability and sufficient cognitive awareness to comply with 
the study protocol including: randomization; examination procedures; completion 
of planned bilateral cataract surgeries; compliance with no use of other MGD or 
dry eye treatments (except over-the-counter artificial tears, ocular lubricants, 
ointments, emollients or ω-3 dietary supplements) during the study; and 
attendance of all study visits. 
• 
Ability to understand, read and write English to consent to study participation and 
complete study questionnaires. 
• 
Willingness to sign informed consent and HIPAA authorization or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to 
medical treatment in the governing country. 
8.2 
EXCLUSION CRITERIA  
Note: All criteria apply to each study eye. 
• 
Any medical finding that would predictably result in a postoperative best 
corrected distance visual acuity worse than 20/30 in either eye. 
• 
Use of systemic or ocular medications that, in the opinion of the investigator, may 
affect vision or impact pupil dilation or iris structure. 
• 
Irregular corneal astigmatism. 

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• 
Any clinically-significant corneal pathology / abnormality other than regular 
corneal astigmatism. 
• 
Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or 
abnormally-shaped pupils). 
• 
Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects. 
• 
Unwillingness or inability to stop wearing contact lens at least two weeks prior to 
the baseline visit. 
• 
Known ocular disease or pathology that, in the opinion of the investigator, may 
affect visual acuity or require surgical intervention during the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.). 
• 
Systemic disease condition that causes dry eye (e.g., Stevens-Johnson 
syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener’s granulomatosis, 
sarcoidosis, leukemia, Riley-Day syndrome, systemic lupus erythematosus, 
Sjögren's syndrome). 
• 
Unwillingness or inability to abstain from the use of systemic medications known 
to cause dryness (e.g., isotretinoin (Accutane®)) for the study duration.  Subjects 
must have discontinued these medications for at least 1 month prior to the 
Baseline Visit measurements. 
• 
Unwillingness or inability to abstain from the use of systemic antihistamines: 
o at least two weeks prior to the baseline Preoperative Visit #1 measurements 
through Preoperative Visit #2, or per site standard of care for cataract 
surgery, whichever is longer; and 
o at least 2 weeks prior to the Month 3 measurements; and 
o at least 2 weeks prior to the Month 4 measurements (Control group only) 
• 
Unwillingness or inability to abstain from use of prescription medications (e.g., 
lifitegrast (Xiidra) for treatment of MGD or dry eye.  Subjects must have 
discontinued using prescription medications for MGD or dry eye at least 1 month 
prior to the baseline Preoperative Visit #1 measurements. 
• 
Any of the following ocular (eye or eyelid) conditions in either eye within 3 
months prior to the LipiFlow treatment visit: 
o Prior intraocular, oculoplastic, corneal or refractive surgery procedure (LASIK, 
LASEK, RK, PRK, etc.). 
o Ocular trauma. 
o Ocular Herpes simplex or Herpes zoster (eye or eyelid) infection. 

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o History of recurrent ocular inflammation (e.g., retinitis, macular inflammation, 
choroiditis, uveitis, iritis, scleritis, episcleritis, keratitis). 
o Punctal plug insertion or punctal occlusion. 
• 
Any of the following active ocular (eye or eyelid) conditions in either eye at the 
baseline Preoperative Visit #1 measurements: 
o Active ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or 
fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or 
eyelids including hordeolum/stye). 
o Active ocular inflammation (e.g., retinitis, macular inflammation, choroiditis, 
uveitis, iritis, scleritis, episcleritis, keratitis). 
o Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis 
o Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, 
staphylococcal blepharitis or seborrheic blepharitis). 
o Eyelid abnormalities that affect lid function (e.g., entropion, ectropion, tumor, 
edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis). 
o Ocular surface abnormality that may compromise corneal integrity (e.g., prior 
chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 
corneal fluorescein staining, or map dot fingerprint dystrophy). 
• 
Concurrent participation or participation within 30 days prior to study visit in any 
other clinical trial. 
• 
Planned monovision correction. 
• 
Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
changes. 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in 
ophthalmology (or its documented equivalent) and are licensed to practice medicine 
and perform surgery at his/her investigative site. Each site will have one designated 
principal investigator; some sites may have additional implanting sub-
investigators/surgeons.   
Investigators will be selected from surgeons who are experienced in LipiFlow 
treatment in MGD patients, as well as in small-incision, phacoemulsification and 
multifocal IOL implantation in cataract patients.  All sites are required to have 
adequate staff support for reporting and subject follow-up, as well as the necessary 
instrumentation to conduct study testing. 

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9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol.  
Investigator will only make changes to a protocol after notifying and obtaining 
approval from JJSV and the Investigational Review Board (IRB), except when 
necessary to protect the safety, rights or welfare of subjects 
• 
Personally conduct and supervise the study 
• 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
• 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
• 
Shall not obtain written informed consent from any subject to participate or allow 
any subject to participate before obtaining IRB approval 
• 
Document in each subject’s case history that informed consent was obtained 
prior to participation in the study  
• 
Report to JJSV and the reviewing IRB any adverse experiences that occur during 
the course of the study in accordance with applicable laws and regulations 
• 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records 
for inspection by either JJSV and/or the IRB 
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB at 
regular intervals, but no less often than yearly 
• 
Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
• 
Report all changes in research activity and all unanticipated problems involving 
risks to patients to the IRB and JJSV 
• 
Supervise and permit device use and disposition in accordance with applicable 
regulations and protocol requirements. Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at JJSV’s 
request, return to JJSV any remaining ancillary supplies 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during 
the course of the investigation or for up to one year following completion of the 
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• 
Comply with all other obligations of clinical investigators and requirements 
according to all applicable laws and regulations, and all conditions of approval 
imposed by the reviewing IRB 
• 
Ensure that all associates, colleagues and employees assisting in the conduct of 
the study are adequately informed about the protocol, the study device, their 
study-related duties and functions and agree to fulfill their obligations in meeting 
the above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study. The Investigator, or delegate, shall notify JJSV of any change in the conduct 
of the study including changes in study personnel assigned to the study project, 
location of the investigational device(s), or maintenance of study records, etc.  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other 
relevant documents (e.g., advertisements) from the IRB.  All correspondence with 
the IRB should be retained in the Investigator Study Files/Notebook.  Copies of IRB 
submissions and approvals should be forwarded to JJSV.  Study sites will obtain IRB 
approvals and fulfill any other site-specific and/or region-specific regulatory 
requirements.  The investigator is required to report to JJSV within five working days 
any withdrawal of approval by the reviewing IRB for his/her participation in the 
investigation. 
Prior to the start of subject enrollment, the following documents must be signed and 
returned to JJSV: 
• 
Confidentiality Agreement 
• 
Clinical Trial Agreement 
• 
Investigator Agreement/Protocol Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license 
• 
Hospital/Ambulatory Surgery Center Clinical Study Acknowledgement, if required 
By signing the study documents, the investigator agrees to conduct this study 
according to the obligations above and all other applicable regulatory and legal 
requirements.  

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10. 
EXPERIMENTAL PLAN 
10.1 
OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, 
the Declaration of Helsinki, ISO 14155 and all other applicable laws and regulations.  
The study will not begin until IRB approvals have been obtained. 
This study will be a post-market, prospective, multicenter, bilateral, randomized, 
open-label, cross-over, comparative clinical study conducted at up to 7 sites in the 
U.S.  Approximately 140 subjects will be randomized and bilaterally implanted, 
resulting in approximately 110 evaluable subjects (55 in the study arm and 55 in the 
control arm).  
After signing the informed consent, subjects meeting all inclusion and exclusion 
criteria will be randomized to either the Study group or the Control group.  
The duration of study participation is from the initial Preoperative Visit #1 to a final 
visit at 3 months or 4 months after the second-eye cataract surgery, depending upon 
the subject’s randomized group assignment.  All subjects in both arms are intended 
to have bilateral cataract surgery.  The subjects randomized to Study group will 
undergo preoperative LipiFlow treatment and the subjects randomized to Control 
group will not receive preoperative LipiFlow treatment. Three months 
postoperatively, both groups will be evaluated for clinical outcomes and the Control 
group will receive LipiFlow treatment as the cross-over group.  The Control group will 
be evaluated at 4 months postoperative for clinical outcomes. 
Key data collection for all subjects/eyes includes distance visual acuities, manifest 
refraction, contrast acuity, keratometry, biometry, corneal topography, visual 
symptoms, Meibomian gland evaluation, biomicroscopic slit-lamp findings, 
complications and adverse events.  A chart summary of all examination or treatment 
procedures required at each study visit is provided in Appendix B.  If needed, 
specific equipment necessary to perform the required procedures will be supplied for 
the duration of the study (Appendix C).  The study visit schedule is described in 
Section 10.2. 
Although the study is not masked, to maintain consistency, it is recommended that a 
single individual (study technician or coordinator designated by the investigator) 
conduct all study-related vision testing, although a back-up person should also be 
designated and trained. 

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10.2 
VISIT SCHEDULE 
The study visit schedule for all study subjects is outlined in Table 1.   
Subjects randomized to the Study Group will undergo a minimum of the following 
four study visits (with visit windows shown in parentheses):  
1) Preoperative Visit #1, including LipiFlow treatment (may occur on the same 
day or within 1 week of Visit #1) 
2) Preoperative Visit #2 (2 - 4 weeks after LipiFlow treatment)  
3) 1 Month Postop (30 - 60 days after cataract surgery on second eye)  
4) 3 Months Postop (10 to 14 weeks after cataract surgery on second eye) 
Subjects randomized to the Control group will undergo a minimum of the following 
five study visits (with visit windows shown in parentheses):  
1) Preoperative Visit #1 
2) Preoperative Visit #2 (2 - 4 weeks after Preoperative Visit #1)  
3) 1 Month Postop (30-60 days after cataract surgery on second eye)  
4) 3 Months Postop (10 to 14 weeks after cataract surgery on second eye), 
including the crossover LipiFlow treatment, which should occur within 0 - 7 
days after the 3 months postoperative visit 
5) 4 Months Postop (4 to 6 weeks after receiving crossover LipiFlow treatment) 
Unscheduled visits may be conducted as necessary at the discretion of the 
investigator for medically-indicated follow-up.  

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Once the Investigator or designee has answered all the subject’s questions to the 
subject’s satisfaction and the potential study participant has voluntarily agreed to 
participate in the study, written informed consent is obtained using the IRB-approved 
informed consent document.  The subject and the person conducting the consent 
discussion (Investigator or designee) print their names, sign and date the consent. 
All subjects enrolled in the study must sign the current IRB-approved informed 
consent document.  The informed consent must be signed before any study-specific 
examinations are performed, and this must be documented in the source documents.  
An Authorization for Use/Disclosure of Health Information Form (HIPAA 
authorization) or similar medical treatment privacy law documentation must also be 
signed.   
The Investigator maintains the signed informed consent document and the signed 
authorization form as a permanent part of the subject’s medical records and provides 
a copy of the consent to the subject.  The Investigator or designee documents in the 
medical records that informed consent was obtained prior to any study-specific 
procedures and a copy of the signed consent was given to the subject. 
As the Informed Consent Form is signed at the beginning of the preoperative visit, 
some subjects may not qualify after study-specific testing is performed.  Subjects will 
be considered screen-failures if they do not qualify or if they qualify but decide not to 
proceed with surgery. These subjects will be exited from the study.   
Screening and Baseline 
Following the informed consent process, the Investigator or designee will perform the 
screening and baseline exam procedures and evaluate the subject conditions that 
affect study eligibility, as listed in Sections 8.1 and 8.2. The screening and baseline 
exam may be ended prior to completion if the Investigator or designee determines 
that the subject does not meet one or more of the eligibility criteria. The subject must 
meet all the study inclusion and exclusion criteria based on testing conducted at the 
Visit #1. 
Besides Medical and Ocular History, the screening and baseline exam to be 
performed for each eye includes: 
MEDICAL AND OCULAR HISTORY 
To determine the presence of any systemic or ophthalmic factors that may affect the 
subject’s eligibility based on the study inclusion and exclusion criteria in Sections 8.1 
and 8.2, the Investigator or designee obtain the subject’s medical and ophthalmic 
history at the visit, including assessment of:   

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1) demographic information (age, gender, race/ethnicity);  
2) systemic conditions and concomitant systemic medications that may cause dry 
eye;  
3) ophthalmic conditions and medications, including last use of medications for 
MGD or dry eye and dosage and frequency of pre-existing use of OTC products;  
4) history of contact lens wear (must be removed prior to examination and 
treatment);  
5) history of ocular surgery, ocular injury, ocular infection, ocular inflammation, 
ocular allergy, eyelid abnormality, or ocular surface abnormality;  
6) recent participation in another ophthalmic clinical trial. 
BIOMICROSCOPIC SLIT-LAMP EXAM   
A biomicroscopic slit-lamp exam must be performed at the study visit to determine if 
the subject meets inclusion/exclusion criteria. The Investigator or designee evaluates 
the eyelids, palpebral and bulbar conjunctiva, cornea, anterior chamber, iris and lens 
using a slit lamp biomicroscope. The Investigator or designee everts the upper eyelid 
to evaluate the upper palpebral conjunctiva. The Investigator or designee assesses 
the findings for the presence of any adverse events. 
MEIBOMIAN GLAND ASSESSMENT 
To evaluate the function of the meibomian glands, the Investigator or designee 
assesses the color and consistency of the secretion characteristics from the gland 
orifices along the lower eyelid. The Investigator or designee evaluates the glands 
using a slit-lamp biomicroscope and a handheld diagnostic instrument, Meibomian 
Gland Evaluator (MGE) (as shown in Appendix G), to apply gentle pressure along 
the eyelid margin, which simulates a forceful blink in yielding secretions from the 
glands. This instrument provides a standardized method to apply the same amount 
of pressure at each visit and for each subject to ensure measurement consistency.  
This Class I, 510(k)-exempt device is commercially available, and is being used in 
this study in accordance with the indications in the commercial product labeling. 
There are approximately 20 to 30 meibomian glands along the lower eyelid.  The 
Investigator or designee assesses and grades glands located temporally, centrally 
and nasally, as shown in Appendix G.  The central region of the Meibomian Gland 
Evaluator should be carefully placed in the temporal, central and nasal regions as 
described in Appendix G to avoid overlap in the gland assessment. 

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VISUAL ACUITY TEST   
The subject must be predictably capable of achieving Snellen 20/30 (Decimal 0.6) or 
better best corrected distance vision in each eye after cataract extraction and IOL 
implantation. The surgeon may use his/her judgment, the Potential Acuity Meter 
(PAM), or other methods (e.g., pinhole, laser interferometer, etc.) to estimate the 
subject’s potential postoperative acuity.  
Preoperative UCDVA and BCDVA tests should be performed per site standard of 
care. 
MANIFEST REFRACTION AND REFRACTION ADJUSTMENTS  
Preoperative manifest refraction is required.  Preoperative refraction tests would be 
performed per site standard of care. 
CORNEAL TOPOGRAPHY   
In each designated preoperative visit, corneal topography measurements will be 
collected on both eyes.  The instrument printouts and anonymized database export 
from the respective instruments will be collected from the site. No irregular corneal 
astigmatism should be present preoperatively. 
KERATOMETRY AND BIOMETRY, 
In each designated preoperative visit, the investigator shall repeat 3 sets of biometry 
/ keratometry measurements with at least 3 measurements in each set (depending 
on the measuring device).  
Predicted postoperative corneal astigmatism, as measured by keratometry, should 
be less than 1.00 D.  No irregular astigmatism should be present preoperatively.  If 
the preoperative keratometric astigmatism is greater than 0.50 D, assess the impact 
of posterior corneal astigmatism (PCA) on predicted residual astigmatism by using a 
calculator that accounts for PCA (e.g., J&J TECNIS Toric Calculator, Barrett Toric 
Calculator, etc.).  
IOL POWER AND TARGETED REFRACTION  
Axial length and anterior chamber depth (ACD) must be measured to determine the 
appropriate lens power to implant using an A-Constant.  Non-contact biometry is 
preferred; however, surgeons should use the biometry method with which they have 
the most experience and which was used in the determination of personalized A-
Constants for the Symfony lens.  
The lens power should be calculated to achieve emmetropia at distance.  Intentional 
over- or under-correction (outside ± 0.50 D) should NOT be planned for either eye; 

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however, surgeons may adjust the targeted refraction as necessary to achieve 
emmetropia based on surgeon factors, study subject experience and/or subject first-
eye outcomes.  
ADDITIONAL PREOPERATIVE EXAMINATION PROCEDURES AT 
PREOPERATIVE VISIT #1: 
• 
Informed consent documentation  
• 
Subject demographic information  
• 
Planned surgery dates for each eye 
• 
Cataract type and density for each eye 
• 
Potential visual acuity, targeted refraction, IOL power calculations for each eye 
• 
Fundus exam results for each eye 
• 
Ocular surface staining for each eye 
• 
Eyelid margin evaluation for each eye 
• 
TBUT for each eye 
• 
Meibomian gland imaging through LipiScan / LipiView II for each eye 
• 
Ocular / Visual symptoms assessment (non-directed; spontaneous) 
• 
PRVSQ questionnaire 
• 
Ocular and systemic medications 
• 
SPEED questionnaire 
• 
Adverse events 
Note that if the subject had a recent dilated retinal exam performed at the study site 
within 60 days prior to the Preoperative Visit #1, the prior examination data may be 
used for the baseline dilated retinal exam with the date of the dilated exam 
documented.  
Randomization and Enrollment 
Randomization will take place after the subject has signed the informed consent 
document and has met all inclusion and exclusion criteria.  As part of the informed 
consent process, the investigator or delegate will explain to the subject the 
requirements of a randomized study and the differences expected between the two 
groups.   
Randomization ensures subjects are assigned with an equal probability to the Study 
or Control groups without the subject or Investigator knowing which group the subject 
will be assigned to until after the subject has completed the baseline exam.  
Randomization helps to reduce any differences between Study and Control groups in 
baseline characteristics. 
A randomization list has been created by the JJSV biostatistician and uploaded into 
the electronic data collection (EDC) system.  Subjects will be randomized on a 1:1 

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basis to receive the LipiFlow treatment preoperatively (Study group) or after the 
3-month postoperative visit (Control group).  The randomization is stratified by site 
and blocked to reduce the imbalance between the number of subjects in the Study 
and Control groups.  Randomization will take place after the subject has signed the 
informed consent document and has met all the inclusion/exclusion criteria.  Once a 
subject has met the eligibility criteria, the site will access the EDC system to 
determine the randomization assignment.  
If the subject is randomized to the Study group, the subject is scheduled for the 
LipiFlow treatment on the same day or within 1 week of the Preoperative Visit #1.  If 
the subject is randomized to the Control group, the subject is scheduled for the 
second preoperative visit 2 - 4 weeks after Visit #1.   
All subjects who sign an informed consent document and have been evaluated as 
eligible for the study enrollment will be documented on the Screening and Enrollment 
Log.  A subject who does not meet the eligibility criteria or who chooses to 
discontinue study participation prior to randomization is documented on the 
Screening and Enrollment Log as “Not Enrolled” along with the reason.  All subjects 
who undergo randomization are documented as “Enrolled” on the Screening and 
Enrollment Log and are assigned a subject identifier.  
LipiFlow Treatment 
The preoperative LipiFlow treatment is only applicable and required for the subjects 
in the Study group. It can be performed on the subjects on the same day or within 1 
week of the Preoperative Visit #1. 
If the LipiFlow treatment is performed on the same day as Preoperative Visit #1, the 
medical/ophthalmic history and slit lamp evaluation do not need to be repeated 
before treatment.  In this case, the Investigator must review the baseline history and 
slit lamp exam information prior to treatment to ensure no contraindication to 
LipiFlow treatment is present.  If the LipiFlow treatment visit is performed on a 
different day from Preoperative visit #1, the Investigator or designee documents any 
changes to medical/ophthalmic history and performs a slit lamp evaluation to 
determine if an ocular adverse event is present prior to treatment. If the subject has 
an active ocular adverse event, the LipiFlow treatment should not be performed at 
this visit. 
The Investigator or designee cleans the lid margin (Appendix E) and then performs 
treatment with the LipiFlow system per the LipiFlow System Instructions for Use.  
The Investigator documents any problems with the LipiFlow system during treatment.  
The Sponsor will investigate any reported problem with the LipiFlow system.  

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The Investigator or designee performs slit-lamp evaluation after LipiFlow treatment to 
check for any adverse events.  At the completion of the exam, the subject is 
instructed on how to perform blinking exercises (Appendix F) for 1 month after 
treatment to facilitate the flow of oils from the meibomian glands into the tear film. 
The subject is advised to return for Pre-Operative Visit #2, which must be scheduled 
2 - 4 weeks after the LipiFlow treatment.   
At the completion of Preoperative Visit #1, the subject is reminded not to use any 
MGD or dry eye prescription medications or other treatments during the study 
(except for pre-existing OTC artificial tears, ocular lubricants, ointments, emollients 
or ω-3 dietary supplements).  The dosage and frequency of any pre-existing use of 
OTC products upon study entry must be documented in the subject’s medical record 
and in the study case report forms.  Except for LipiFlow treatment, no other MGD or 
dry eye treatment is prescribed or administered to subjects throughout the study.   
10.4 
PREOPERATIVE VISIT # 2 PROCEDURES  
Preoperative Visit #2 will be scheduled 2 - 4 weeks after LipiFlow treatment for the 
subjects in the Study Group, and 2 - 4 weeks after Preoperative Visit #1 for subjects 
in the Control group. 
The following preoperative procedures at the visit are to be performed (see also 
Appendix B).  General descriptions and requirements of the various tests are 
provided in the manual of testing procedures (Appendix D). At each designated 
preoperative visit, the investigator will repeat 3 sets of biometry / keratometry 
measurements with at least 3 measurements in each set (depending on the 
measurement device). 
Preoperative Examination Procedures at Preoperative Visit #2:  
• 
Ocular and systemic medications 
• 
Biomicroscopic slit-lam exam 
• 
Potential visual acuity, targeted refraction, IOL power calculations 
• 
Ocular / visual symptom assessment (non-directed; spontaneous) 
• 
PRVSQ questionnaire 
• 
Keratometry (auto or manual) 
• 
Biometry 
• 
Corneal topography 
• 
Ocular surface staining 
• 
TBUT 
• 
Eyelid margin evaluation 

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• 
SPEED questionnaire 
• 
Surgical target (emmetropia), treatment planning, and planned surgery dates 
• 
Adverse events 
10.5 
ACTIVATOR II SUPPLY 
For all the study subjects, Activator II will be obtained from the site consignment 
supplied by JJSV prior to study initiation.  One Activator II will be used on each eye 
of a subject.  Unused back-up Activators are to be returned to the site consignment.  
At the completion of study enrollment, any remaining Activator II devices will be 
shipped back to JJSV following the final JJSV monitoring visit.  At all times, the 
storage, access and use of all the consignment Activators must be controlled.   
The IOLs for all the study subjects will be obtained from the site’s own inventory.   
10.6 
POSTOPERATIVE PROCEDURES 
Postoperatively, subjects will be examined according to the schedule in Section 10.2, 
Visit Schedule.  The most recently operated eye will be evaluated at the 1-day and 
1-week visits per site practice standard of care.  Both eyes will be evaluated for all 
the subjects at the 1-month and 3-month visits.  For the subjects in Control group, 
both eyes will receive crossover LipiFlow treatment within 0 - 7 days after the 
3-month postoperative visit, and will be evaluated at the 4-month visit. 
To maintain consistency throughout the study, it is recommended that a single 
individual (study technician or coordinator designated by the investigator) conduct all 
postoperative study-related vision testing.  In addition, a back-up person should also 
be designated and trained. 
NOTE 1: No additional refractive procedures are to be performed during the 
operative or postoperative study period (e.g., Limbal-Relaxing Incisions (LRIs), PRK, 
LASIK or LASEK).   
NOTE 2: If the subject chooses to wear contact lenses after the cataract surgeries, 
they must be removed prior to any postoperative visits and prior to any LipiFlow 
treatment.  The subject may resume contact lens wear one hour after completion of 
treatment or per site standard of practice.   
NOTE 3: If the subject is implanted with a TECNIS Symfony IOL only in the first eye, 
the subject will be followed for monocular testing only until study exit for that first eye. 
The fellow eye will be considered exited as of the second operative date.  Both eyes 
may still receive the LipiFlow treatment if the subject was randomized to the Control 
group.   

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POSTOPERATIVE EXAMINATION PROCEDURES  
Postoperative examinations will be conducted 1 and 3 months after second-eye 
cataract surgery for all subjects, and at 4 months for Control group subjects only.  
General descriptions and requirements of the various tests are provided in 
Appendix D.  The postoperative case report form (CRF) will collect the following 
information, although not all information is required at every visit (see Appendix B): 
MANIFEST REFRACTION AND REFRACTION ADJUSTMENTS 
Postoperative study manifest refractions are to be performed using the M&S System 
at a distance of 4.0 meters.  Manifest refraction (MR) is to be performed using the 
Maximum Plus refraction method as detailed in Appendix M.   
Because 4.0 meters is not optical infinity, refraction adjustments are necessary to 
ensure proper vision testing, taking into account test distance and refraction 
distance.  Appendix N lists the refraction adjustments required for the various vision 
tests using the BCDVA refraction. 
DISTANCE VISUAL ACUITY TEST 
Monocular and binocular uncorrected and distance corrected visual acuities will be 
measured postoperatively under photopic lighting conditions (85 cd/m2, 80–110 
cd/m2 acceptable) using the M&S System at a test distance of 4.0 meters.  For eyes 
unable to achieve a postoperative BCDVA of Snellen 20/40 (i.e., LogMAR 0.3, 
number of letters correct 70), a reason must be specified.  Instructions for using the 
M&S System are detailed in Appendix O, and for distance visual acuity in 
Appendix P. 
The following distance visual acuity measurements are to be performed per the visit 
schedule in Appendix B:  
Test 
Test 
Distance 
Illumination 
Type of Testing 
Refraction 
Adjustment 
UCDVA 
4 m 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
+0.25 D 
adjustment only 
 BCDVA 
4 m 
Photopic  
(85 cd/m2) 
Monocular, 
Binocular 
No adjustment; 
ETDRS Rx only 
INTERMEDIATE VISUAL ACUITY TEST 
Binocular uncorrected intermediate visual acuity will be measured under photopic 
conditions (85 cd/m2, 80-110 cd/m2 acceptable) using the M&S System at a test 
distance of 66 cm.  Instructions for using the M&S System are detailed in 
Appendix O and for intermediate testing in Appendix Q.   

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The following intermediate visual acuity measurements are to be performed per the 
visit schedule in Appendix B: 
Test 
Test 
Distance 
Illumination 
Type of Testing 
Refraction 
Adjustment 
UCIVA 
66 cm 
Photopic  
(85 cd/m2) 
Binocular  
No adjustment 
 
NEAR VISUAL ACUITY TEST 
Binocular uncorrected near visual acuity will be measured under photopic conditions 
(85 cd/m2, 80-110 cd/m2 acceptable) using the M&S System  at a test distance of 
40 cm.   
Instructions for using the M&S System detailed in Appendix ) and for near testing in 
Appendix R.   
The following near visual acuity measurements are to be performed per the visit 
schedule in Appendix B: 
Test 
Test 
Distance 
Illumination 
Type of Testing 
Refraction 
Adjustment 
UCNVA 
40 cm 
Photopic  
(85 cd/m2) 
Binocular  
No adjustment 
 
CONTRAST ACUITY TESTING 
Binocular, photopic,10% low contrast acuity and 20/40 contrast threshold tests will 
be measured using the M&S System.  Detailed instructions for contrast acuity testing 
are provided in Appendix S.  
BIOMICROSCOPIC SLIT-LAMP EXAM   
A biomicroscopic slit-lamp exam must be performed at each postoperative visit to 
determine the presence or absence of any medical or lens findings, complications or 
adverse events.  IOL decentration and tilt are to be determined subjectively.  The 
center of the lens relative to the pupil can be used to determine IOL decentration.  
The diffractive rings of Symfony lens can be used as a guide to locate the center of 
the IOL.  Note that the pupil center may not always be aligned with the visual axis of 
the eye; therefore, the investigator should consider deviations in pupil center from 
visual axis when reporting IOL decentration.   

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ND:YAG CAPSULOTOMY 
If an Nd:YAG capsulotomy is necessary, it is recommended that the procedure be 
performed after study completion.  
MEIBOMIAN GLAND ASSESSMENT 
Meibomian glands assessment is to be measured at the designated postoperative 
visits. The method of the assessment is described in Appendix G.  
FUNDUS EXAM 
A dilated fundus exam will be done preoperatively and may be performed 
postoperatively at the investigator’s discretion.  Examinations may be done dilated 
with ophthalmoscopy or undilated with any imaging system that allows for undilated 
views of peripheral retina (e.g., Optomap).  The same fundus exam method that was 
used for preoperatively should be used postoperatively if the exam is performed.  
MEIBOMIAN GLAND IMAGING (LIPISCAN/LIPIVIEW II) 
Meibomian gland imaging will be captured through LipiScan or LipiView II at the 
designated visits, to capture Meibomian gland images of both eyes and grade 
eyelids, as shown in Appendix I.  Refer to the LipiView Interferometer and LipiScan 
Instructions for Use for detailed instructions on the device operation.  For subjects in 
Control group, both eyes will be measured at 4-month visit as well.  It is 
recommended that the same methods be used for all study subjects at the site for 
the duration of the study. 
STANDARD PATIENT EVALUATION OF EYE DRYNESS (SPEED) 
QUESTIONNAIRE 
The SPEED questionnaire will be administered at the beginning of any designated 
visits, prior to any visual acuity testing. 
OCULAR / VISUAL SYMPTOMS ASSESSMENT (NON-DIRECTED; 
SPONTANEOUS) 
The subjective ocular / visual symptoms are to be assessed at the designated visits 
by asking “Are you having any difficulties with your eyes/vision?”  Subjects should 
not be prompted for specific responses; however, if a subject complains of halos, 
glare or starbursts, the severity should be determined (mild, moderate or severe).  
PRVSQ QUESTIONNAIRE 
The PRVSQ questionnaire is to be assessed at the designated visits. Subjects will 
be prompted for specific responses, including halos, night glare or starbursts.  

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MEDICATIONS   
Postoperative medications should be used as is customary for each investigator and 
recorded in the source document for each subject.  Medications will be recorded on 
each postoperative case report form as applicable. 
ADVERSE EVENTS 
Subjects should be assessed at each visit for occurrence of and/or change in status 
of any adverse events, particularly serious and/or device-related adverse events.  
See Section 11.0, Adverse Events, for further information. 
ADDITIONAL PROCEDURES AT DESIGNATED POSTOPERATIVE VISIT(S): 
• 
Eyelid margin evaluation for each eye 
• 
TBUT for each eye 
• 
Ocular surface staining for each eye 
• 
Ocular and systemic medications 
Crossover LipiFlow Treatment (Only for Control Group) 
The crossover LipiFlow treatment is only applicable to and required for the subjects 
in the Control group.  It will be performed on the Control group subjects on the same 
day or within 1 week of the 3-month postoperative visit, after all study examination 
procedures are completed.  If the subject has an active ocular adverse event or other 
contraindications to LipiFlow treatment, the LipiFlow treatment should not be 
performed at this visit. 
The LipiFlow treatment should be performed per the LipiFlow System Instructions for 
Use.   
10.7 
EXIT OF SUBJECTS  
An Exit Case Report Form will be completed for all subjects, either when they 
complete the study or if they exit early.   
It is the responsibility of the investigator to provide complete follow-up data to JJSV 
for each subject, and every attempt should be made to gather that complete follow-
up data for all subjects enrolled as missing data can have a negative effect on the 
study results. Patients who will be traveling, relocating or otherwise unavailable for 
postoperative follow-up visits should not be chosen for this clinical study. 
A subject will be considered a “screen failure” if he/she does not meet the 
inclusion/exclusion criteria or if consent is withdrawn prior to randomization.   

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A subject will be considered “discontinued prior to treatment” if the subject is 
randomized but does not undergo bilateral LipiFlow treatment (study group) or 
receive a Symfony lens for various reasons including: the planned implant being 
aborted due to surgical complications, the subject withdrawing consent prior to 
treatment, or the subject died prior to treatment. If a subject receives at least one 
Symfony lens, he/she is to be followed according to the protocol. 
A subject will be “discontinued” from the study if one study lens (if implanted 
unilaterally) or both study lenses (if implanted bilaterally) are removed or if the 
subject dies.  
Subjects will be considered “lost-to-follow-up” from the study only if irretrievably lost 
for unavoidable reasons such as: subject moved/unable to locate, subject 
uncooperative/refuses further study participation, subject ill/unable to travel.  In the 
event of subject relocation, efforts must be made by the investigator to secure follow-
up information (i.e., slit-lamp findings and general visual acuity, etc.) from the 
subject’s new physician.  
If a subject is exited early from the study, the investigator will send an Exit Case 
Report Form to JJSV indicating the reason for study exit.  In the event of a lens 
removal or other serious adverse event, the subject may be exited from the study; 
however, efforts must be made by the investigator to follow the subject until 
resolution of the adverse event. 
Following study completion or early exit, all study subjects are to be instructed to 
undergo regular eye examinations at least yearly and also to return to their doctor if 
any eye complications are experienced in the interim.   
10.8 
UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of 
medically-indicated follow-up for a study eye, data from this visit should be reported 
using the Unscheduled Visit CRF.  The need for unscheduled visits is at the 
investigator’s discretion.  Specific examinations to be performed at unscheduled 
visits are also at the discretion of the investigator (based on the reason for the 
unscheduled visit) and data are to be recorded in the appropriate section of the case 
report form. 

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Data to be collected may include: 
• 
UCDVA and BCDVA 
• 
Manifest refraction 
• 
Biomicroscopic slit-lamp examination for medical and/or lens findings  
• 
Fundus exam 
• 
Ocular symptoms 
• 
Adverse events 
• 
Ocular and systemic medications 
10.9 
PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation. Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.). All protocol deviations will be documented using protocol 
deviation case report forms. Any deviation made to protect the life or physical well-
being of a subject in an emergency as well as any use of the investigational device 
without obtaining informed consent must be reported to JJSV within 5 working days. 
Protocol deviations will be monitored by JJSV, and if the non-compliance is 
persistent or egregious, JJSV may take action, including but not limited to 
termination of the investigator’s participation in the study. The investigator is also 
responsible for informing the reviewing IRB of instances of protocol non-compliance 
in accordance with the IRB requirements. 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 
ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical 
occurrence, unintended disease or injury, or untoward clinical signs (including 
abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
• 
is sight- or life-threatening,  
• 
results in death,  
• 
requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in 
health is not considered a serious adverse event), 

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• 
results in permanent impairment of a body structure or body function,  
• 
necessitates medical or surgical intervention to prevent permanent impairment to 
a body structure or function, or 
• 
results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse even that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 11.4, Causal Relationship).  A device-related event is also considered an 
adverse device effect (ADE; following ISO 14155) resulting from the use of the study 
device that may result from user error, insufficiencies or inadequacies in the 
instructions for use, deployment, implantation, installation, operation of any 
malfunction of the device.   
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular serious adverse events that 
are anticipated and must be reported to JJSV for this study.  Adverse event 
definitions in accordance with the American Academy of Ophthalmology Task Force 
Consensus Statement are included in Appendix U. 
• 
Endophthalmitis/Intraocular infection 
• 
Hypopyon 
• 
Hyphema 
• 
IOL dislocation 
• 
Cystoid macular edema 
• 
Pupillary block 
• 
Retinal detachment/tear 
• 
Persistent corneal edema 
• 
Persistent iritis 
• 
Persistent uveitis 
• 
Persistent raised IOP requiring treatment 
• 
Toxic anterior segment syndrome 
• 
Visual symptoms requiring secondary surgical intervention (e.g., lens removal) 
• 
Tilt and decentration requiring secondary surgical intervention (e.g., 
repositioning) 
• 
Residual refractive error resulting in a secondary surgical intervention 
• 
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NOTE 1:  Wound burps during the first week postoperatively, suture removal, 
planned blepharoplasty and Nd:YAG capsulotomy (for PCO) are not considered 
adverse events for this study. 
NOTE 2:  Persistent corneal edema, IOP increase, and uveitis/iritis will be 
considered serious according to the guidelines listed in Appendix U. (i.e., persistent 
IOP increase of 10 mm Hg from baseline to at least 25 mm Hg; corneal edema 
resulting in BCDVA of 20/40 or worse at 1 month or later; and Grade 1+ uveitis/iritis 
longer than 3 months.   
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused 
by, or associated with, a device, if that effect, problem, or death was not previously 
identified in nature, severity, or degree of incidence in the investigational plan (i.e., 
this protocol), application (including a supplementary plan or application), or risk 
assessment, or any other unanticipated serious problem associated with a device 
that relates to the rights, safety, or welfare of subjects.   
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) 
as any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. This may include malfunctions, use error 
and inadequacies in labeling.  Product complaints can pertain to any marketed JJSV 
device being used in the study.  The investigator is to assess whether the deficiency 
could have led to a serious adverse event without suitable action or intervention or 
under less fortunate circumstances. 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, 
regardless of severity and whether or not attributed to the study device(s), are to be 
reported to JJSV and recorded on the case report form corresponding to the visit 
during which awareness of the event occurred.  Adverse events are also to be 
reported to the reviewing IRB as per the IRB’s reporting requirements.  If required, 
adverse events will be reported to the appropriate regulatory agencies (e.g., FDA) 
according to all applicable laws and regulations.   
Reporting of adverse events shall follow the USA Code of Federal Regulations for 
sites in the USA.  General guidelines are provided below: 

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Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJSV in a 
timely manner.  Notification of non-serious and non-device related adverse events 
will occur by recording events on the CRF when noted.  Such adverse events are 
also to be reported to the reviewing IRB per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 
complaints on the CRF when the complaint occurred (e.g. operative form) or by a 
phone call to the Sponsor.  Any device deficiency that could have led to a serious 
adverse event without suitable action or intervention, or under less fortunate 
circumstances, must be reported to the sponsor immediately (no later than 48 hours 
after detection). Device deficiencies that could have led to a serious adverse event 
should also be reported to the investigator’s IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device related events (ADEs) are to be documented using the 
Serious Adverse Event/Adverse Device Effect (SAE/ADE) CRF.  In the event of a 
serious adverse event (SAE), which may or may not be related to use of the study 
device, JJSV must be notified immediately (no later than 48 hours after detection).  
Any SAE is to be reported by phone (and/or email) and by submitting the completed 
SAE/ADE CRF.  Any SAE or device-related AE should also be reported to the 
investigator’s IRB per their reporting requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded 
as device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to JJSV within 48 hours, 
and to the investigator’s IRB as soon as possible (and no later than 10 working days 
after learning of the event for sites in the USA). 
11.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or the use of the study device (i.e., the procedure specific to the initial 
application of the device).  An attempt should be made in every case to determine 
the causality of the event.  The following definitions are to be used as guidelines in 
determining the relationship between the event and the study device and/or use of 
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Definitely related: 
If the event is associated with the device and/or the use of 
the device beyond a reasonable doubt, a causal relationship 
exists between the adverse event and the device and/or the 
use of the study device. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device and/or the use of 
the study device and/or the adverse event cannot be 
reasonably explained by another cause. 
Possibly related:   
The adverse event has not been determined to be related to 
the device or the use of the device, but no other cause has 
been identified and the device and/or the use of the study 
device cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device and/or the use of the device 
could exist, but the adverse event can be reasonably 
explained by another cause. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study 
device and/or the adverse event can be attributed to another 
cause. 
If an adverse event is believed to be definitely, probably or possibly related to the 
study device and/or the use of the device, the event will be considered related to the 
study device and/or the use of the device.   
11.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  Obtain and maintain in the subject's files 
all pertinent medical data relating to the event including the subject’s medical records 
and medical reports and/or judgments from colleagues or outside specialists who 
assisted in the treatment and follow-up of the subject. The investigator should keep 
JJSV closely informed as to the outcome of serious and/or device-related adverse 
events, thereby allowing JJSV to comply with the appropriate regulatory reporting 
requirements.  A SAE/ADE CRF should be completed each time the subject returns 
to the investigator or other specialist(s) for follow-up of serious and/or device-related 
adverse event until resolution of the event.  Any subject who is exited from the study 
due to a serious and/or device-related adverse event will be followed until the 
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12. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator desires to modify any procedure and/or the design of the study, he 
or she must contact and obtain consent from JJSV regarding the proposed changes 
prior to implementation.  Any modifications (including additional data collection) 
require approval by the FDA and all other appropriate regulatory agencies, as well as 
approval of governing IRBs prior to implementation.   
13. 
ETHICS REVIEW AND PATIENT WELFARE 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other 
relevant documents (e.g., advertisements) from the IRB.  All correspondence with 
the IRB should be retained in the Investigator Notebook.  Copies of IRB submissions 
and approvals should be forwarded to JJSV. 
The investigator is responsible for notifying the IRB of reportable adverse events as 
well as any other circumstance in which additional procedures outside the protocol 
were conducted to eliminate apparent hazards to subjects. 
13.2 
INFORMED CONSENT 
The current version of the IRB-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent is to be signed and dated by the subject as well as 
by the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the 
subject.  The investigator will provide JJSV written acknowledgement on the 
preoperative case report form that a signed agreement of informed consent has been 
obtained and is in the investigator’s possession for each subject.  The site shall 
document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s 
signature on an Authorization for Use/Disclosure of Health Information for Research 
Form or equivalent documentation necessary to comply with applicable privacy laws 
pertaining to medical treatment in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to 
study start. 

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14. 
DOCUMENTATION 
14.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may 
include a subject’s medical records, hospital charts, clinic charts, the investigator’s 
subject study files, as well as results of any diagnostic tests or procedures such as 
topographies or laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation 
requirements for medical charts/clinic notes.  However, for the purposes of this 
clinical study, the medical charts/clinic notes must also include, at a minimum, the 
following data that will be considered source data and will be reviewed by JJSV: 
• 
Subject’s name and study identification number 
• 
Subject’s contact information 
• 
Study protocol number and the Sponsor name (JJSV) 
• 
A statement that informed consent was obtained prior to participation in the study 
(including the date)  
• 
Dates of all subject visits and surgeries throughout the duration of the study 
• 
Implant serial number identification 
• 
Concurrent medications 
• 
Distance visual acuity (NOTE: M&S electronic data and near visual acuity score 
sheets are considered source documentation and are to be retained by the site; a 
paper copy of the M&S results will be printed and certified by the site) 
• 
Manifest refraction 
• 
Occurrence and status of any operative complications, postoperative medical or 
lens findings and adverse events 
• 
Occurrence and status of any subject complaints, e.g., ocular/visual symptoms 
• 
The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
14.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to the JJSV or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
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14.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system.  All study staff responsible for 
entering data into the system must complete certification prior to using the system.  
The investigator is responsible for ensuring that data are properly recorded on each 
subject’s case report forms and related documents.  Prior to database lock, the 
investigator will verify completeness and accuracy of data submitted to JJSV.  
14.4 
STUDY SUMMARY 
A final investigator’s summary will be provided to JJSV and the reviewing IRB after 
termination or the completion of the study or the investigator’s part of the 
investigation, as directed by JJSV.  
15. 
MONITORING  
JJSV will perform three types of monitoring to ensure compliance with regulations: 
data monitoring, administrative monitoring, and safety monitoring. 
15.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, JJSV will follow specific data 
monitoring procedures, routinely generate reports and periodically review safety and 
effectiveness data.  To avoid bias, any analyses generated prior to site closures will 
not be disseminated to any of the investigative sites.  
An electronic data capture system (EDC) will be used to transmit case report forms 
from the investigative site to JJSV.  Requests for data clarification will be handled 
through this same system.   
To minimize data omissions and inconsistencies on clinical reports and to ensure 
that data are accurately transcribed to computer data files, JJSV will follow internal 
data processing procedures that include automated and manual quality control 
checks to identify any data discrepancies.  Any such items will be resolved and 
documented as needed in EDC. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on 
the study integrity and reliability of its outcomes will include training study staff with 
on-line centralized and/or on-site programs.  In addition, subjects will be encouraged 
at the time of informed consent to avoid missing study visits, as missing data may 
affect the study reliability and diminish the scientific value of their contribution to the 
study.  

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15.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices, subjects, and 
forms can be traced and will allow monitoring of investigator progress and 
compliance.  Accountability and traceability of ancillary study material will be 
monitored by JJSV personnel. 
Site Monitoring Plan 
Prior to performing any study treatments, the requirements of the study and reporting 
mechanisms will be explained to each investigator.  When necessary, a pre-study 
site qualification visit may be performed to assess the adequacy of the site to 
perform the study for sites that have not previously worked with JJSV or have 
undergone significant changes or have not been visited in the past year.  A study 
initiation visit will be conducted for all sites prior to or at the time of the treatment.  
Throughout the duration of the study, site visits to monitor compliance to this protocol 
will be made at each investigative site.  During a routine site monitoring visit, JJSV 
will review informed consent documents and subject eligibility, and the data on study 
case report forms will be verified against subject charts and other source documents 
to ensure complete and accurate reporting.  The subject files will also be reviewed to 
assure that all adverse events and any issues encountered with JJSV products have 
been reported in a timely fashion.   
JJSV will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source 
Documents, for a list of items that are required for source documentation.  In addition 
to subject files, study logs will be checked and conformance to lighting levels for 
visual acuity tests will be verified.   
Training on study-specific procedures may also be conducted during monitoring 
visits.  For this study in particular, a training/monitoring visit is likely to occur just prior 
to or during the first of the 3-month visits, wherein the most extensive vision testing 
occurs.  
Upon study completion, a final close-out site visit to each site will be made to monitor 
the last of the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will 
define the type and frequency of monitoring visits and frequency of record 
monitoring.  

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15.3 
MEDICAL OVERSIGHT  
The medical monitor will be available throughout the clinical trial to review study 
results and to answer any questions from investigators. The medical monitor will 
review and assess any reports of serious and/or device-related adverse events and 
discuss these with the reporting investigator(s) as necessary. The medical monitor, 
as well as any other qualified personnel designated by JJSV, shall also review study 
reports. 
16. 
PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding JJSV publication 
policies. 
17. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS ASSOCIATED WITH USE OF LIPIFLOW 
The use of the LipiFlow System in this study is non-significant risk.  No device-
related serious adverse events are anticipated with the use of the LipiFlow system. 
Transient, non-serious adverse events which may result from the use of the LipiFlow 
system include, but are not limited to, the onset or increase in the following ocular 
signs or symptoms that are either 1) clinically significant as determined by the 
Investigator, or 2) require medical treatment for resolution: 
• 
Eyelid/eye pain requiring discontinuation of the treatment procedure;  
• 
Eyelid irritation or inflammation (e.g., edema, bruising, blood blister, dermatitis, 
hordeolum or chalazion); 
• 
Ocular surface irritation or inflammation (e.g., corneal abrasion, conjunctival 
edema or conjunctival injection/hyperemia); and 
• 
Ocular symptoms (e.g., burning, stinging, tearing, itching, discharge, redness, 
foreign body sensation, visual disturbance, sensitivity to light). 
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL 
implantation in general.  These can include worsening of vision, hemorrhage, loss of 
corneal clarity, inflammation, infections, retinal detachment, pupil changes, 
glaucoma, etc.  Complications can result in poor vision, loss of vision or loss of the 
eye.   

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RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration. The occurrence of 
adverse events and complaints will be assessed at each study visit and reported to 
JJSV according to Section 11.0, Adverse Events and Product Complaints.  
Additionally, JSJV will monitor incoming data following the procedures outlined in 
Section 15.0, Monitoring.  The Medical Monitor will ensure subjects are not exposed 
to additional risks by monitoring serious adverse events, device-related adverse 
events, and device-deficiencies that could have led to serious adverse events 
(Section 15.3, Safety Monitoring).  
POTENTIAL BENEFITS 
The general clinical benefits of the LipiFlow system in providing heat and pressure 
therapy in adult patients with MGD is expected to be similar to the other existing 
study results regarding effectiveness and safety outcomes.  The LipiFlow treatment 
is expected to improve the subjects’ number of meibomian glands secreting liquid, 
the quality of gland secretion characteristics, tear break-up time, and to improve dry 
eye symptoms, without clinically significant safety concerns. 
The TECNIS Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for 
primary implantation for the visual correction of aphakia, in adult patients with less 
than 1 diopter of preexisting corneal astigmatism, in whom a cataractous lens has 
been removed. The lens mitigates the effects of presbyopia by providing an 
extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides 
improved intermediate and near visual acuity, while maintaining comparable distance 
visual acuity.  
The TECNIS Symfony Toric Extended Range of Vision IOLs, Models ZXT150, 
ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual 
correction of aphakia and for reduction of residual refractive astigmatism in adult 
patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, 
in whom a cataractous lens has been removed. The lens mitigates the effects of 
presbyopia by providing an extended depth of focus. Compared to an aspheric 
monofocal IOL, the lens provides improved intermediate and near visual acuity, while 
maintaining comparable distance visual acuity. 
CONCLUSION 
The hazards/risks associated with the LipiFlow and the Symfony IOLs, are 
acceptable. The potential clinical benefits of the LipiFlow and the Symfony IOLs, 
outweigh the residual risks when the devices are used as intended.  

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18. 
RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and original 
case report forms should be maintained by the investigator.   
The investigator must maintain and have access to the following essential 
documents until notified by the Sponsor.   Note:  This may be for a minimum of 25 
years after completion of the study unless country-specific requirements are longer.  
JJSV requires notification if the investigator wishes to relinquish ownership of the 
data so that mutually agreed-upon arrangements can be made for transfer of 
ownership to a suitably qualified, responsible person. 
• 
All case report forms 
• 
All adverse event information (i.e., medical records, medical reports and/or 
judgments from colleagues or outside specialists who assisted in the treatment 
and follow-up of the subject) 
• 
Investigational supply records/inventory 
• 
IRB approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 
• 
Clinical Investigator’s Brochure 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information) 
• 
Subject medical chart/clinic notes (Not applicable for transfer of ownership to 
JJSV) 
19. 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of 
complications and/or adverse events that are unexpected in nature and/or severity 
and evaluated as to causality relative to the study device.  The clinical investigation 
may be suspended if the Medical Monitor or IRB, upon review and evaluation of the 
clinical data, finds unacceptable clinical performance or the level of single or total 
complications and/or adverse events unacceptable for continuation of the 
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If causality is shown not to be related to the study device, the study may be resumed 
in accordance with the IRB and regulations of the FDA.  The study will be terminated 
if causality is shown to be related to the study device. 
Additionally, the investigator, or JJSV, may stop a subject’s participation at any time.  
JJSV may also stop the study at any time for reasons it determines appropriate.  
However, no suspension of the study would be made to disadvantage the study 
subjects.  Following suspension of the study for any reason, all study subjects who 
have already received treatment would continue to be followed through completion of 
the study visit schedule. 
20. 
STATISTICAL METHODS 
This section highlights the analyses for the key study endpoints and all other study 
endpoints.  The preoperative visit and 1-month as well as 3-month postoperative visit 
are the critical analysis time point for all the key endpoints and other endpoints.  
20.1 
ANALYSIS POPULATION 
The primary study population will be all eyes that are randomized for precision of 
biometric measurements, and all eyes that are randomized and implanted for all 
other analyses.  Mean change in total Meibomian gland score will be compared 
between study group eyes and control group eyes at 1 month postoperatively.  All 
other key study endpoints will be evaluated at 3 months postoperatively.  Additional 
endpoints will be evaluated at 1 month and 3 months postoperatively for the study 
group and control group and 4 months postoperatively for crossover control group 
only.  Missing data will not be imputed. 
Since both eyes of the same subject will be randomized into the same group, eye-
specific measurements of same subject are clustered and likely to be positively 
correlated. As a subset analysis, right and left eyes of subjects will be analyzed for 
the key eye-specific study endpoints separately to assess for any differences by eye. 
Demographics/enrollment/accountability data and binocular data will be reported for 
all randomized subjects with study IOLs successfully implanted..    
20.2 
KEY STUDY ENDPOINTS 
• 
MEAN MONOCULAR UCDVA AT 3 MONTHS POSTOPERATIVE  
The mean LogMAR monocular UCDVA will be reported for study group eyes 
and control group eyes. Note that a lower LogMAR value is a better acuity. 
The success criterion is a statistically significantly lower mean LogMAR 
monocular UCDVA for study group eyes compared to control group eyes (p ≤ 

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0.05) at 3 months postoperative. The right eyes and left eyes data from each 
group will also be presented. 
• 
PRECISION (STANDARD DEVIATION) OF PREOPERATIVE AL, ACD, AND 
KERATOMETRIC MEASUREMENTS (K)  
AL, ACD and K values will have three sets of measurements at the 
Preoperative Visit #1 and three sets of measurements at the Preoperative 
Visit #2.  For AL, ACD and keratometry, the standard deviation of each set of 
measurements will be computed at both preoperative visits and the average 
of the three computed standard deviations from each preoperative visit is 
defined as the precision.  The difference in precision between the two 
preoperative visits will be calculated for AL, ACD and K values.  The 
precisions of the AL, ACD and keratometry measurements are expected to 
be better (smaller standard deviation) for study group eyes than the ones for 
control group eyes.  The right eyes and left eyes data from each group will 
also be presented.  
• 
RATE OF REFARACTIVE PREDICTABILITY AT 3 MONTHS POSTOPERATIVE  
The frequency, proportion and 95% confidence intervals of eyes with 
achieved MRSE within 0.50 D and 1.00 D of targeted MRSE will be 
summarized at 3 months postoperatively.  The proportion of study group eyes 
with achieved MRSE within 0.50D and within 1.00 D of targeted MRSE is 
expected to be greater compared to control group eyes. The right eyes and 
left eyes data from each group will also be presented. 
• 
RATE OF BOTHERSOME OCULAR SYMPTOMS AT 3 MONTHS 
POSTOPERATIVE  
The frequency and proportion of subjects who experienced moderate or 
severe ocular symptoms (halos, night glare, starburst, and night vision 
difficulties) will be reported. The rate of directed report bothersome ocular 
symptoms at 3 months postoperatively is expected to be lower for study 
group subjects than that for control group subjects. 
• 
MEAN CHANGE IN TOTAL MEIBOMIAN GLAND SCORE FROM BASELINE TO 
1 MONTH POSTOPERATIVE 
Change in total Meibomian gland score is defined as total Meibomian gland 
score at 1 month postoperative minus the score at Baseline (before the 
LipiFlow treatment). The total Meibomian gland score is the sum of the 
grades for all 15 glands with a range of 0 to 45. A higher total Meibomian 
gland score reflects better Meibomian gland function. Greater mean change 
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control group eyes. The right eyes and left eyes data from each group will 
also be presented. 
20.3 
OTHER ENDPOINTS 
• 
1-Month Postoperative Visit: 
o Mean change in Number of Meibomian Gland Yielding Liquid Secretion 
(MGYLS) from Baseline visit to 1 month postoperative in the Study group 
compared to the Control group. 
The number of MGYLS (i.e., cloudy or clear liquid with a grade of 2 or 3) will 
be counted out of the 15 glands assessed with a range of 0 to 15. Mean 
number of MGYLS will be reported at Baseline visit and 1 month 
postoperatively. A higher number of MGYLS indicates better Meibomian 
gland function. Change in number of MGYLS is defined as number of MGYLS 
at 1 month visit minus number of MGYLS at Baseline visit. Mean change in 
number of MGYLS from baseline to 1 month postoperative is expected to be 
greater for study group eyes than that for control group eyes.  
o Mean change in ocular surface stain grade from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
Corneal staining will be evaluated in five corneal regions on a scale of 0 
(none), 1 (mild), 2 (moderate) and 3 (severe).  The total corneal staining 
grade will be calculated as the sum of the grades for each of the five corneal 
regions on a scale from 0 to 15.  A lower grade indicates less corneal surface 
desiccation. Conjunctival staining will be evaluated in six conjunctival regions 
on a scale of 0 (none), 1 (mild), 2 (moderate) and 3 (severe).  The total 
conjunctival staining grade will be calculated as the sum of the grades for 
each of the six conjunctival regions on a scale from 0 to 18.  A lower grade 
indicates less conjunctival surface desiccation. Mean ocular surface stain 
grade score will be reported at Baseline visit and 1 month postoperatively.  
Change in ocular surface stain grade score is defined as the score at 1 month 
visit minus the score at Baseline visit. 
o Mean change in Tear Break-up Time (TBUT) from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
Three separate measurements of TBUT will be taken on each eye and the 
average of the three measurements will be calculated for analysis. Mean 
TBUT will be reported at Baseline visit and 1 month postoperatively. Change 
in TBUT is defined as TBUT at 1 month visit minus TBUT at Baseline visit. A 
higher tear break-up time indicates better tear film stability. Mean change in 
TBUT from baseline to 1 month postoperative is expected greater for study 
group eyes than that for control group eyes. 

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o Change in Eyelid Margin Evaluation from Baseline visit to 1 month 
postoperative in the Study group compared to the Control group. 
The eyelid appearance will be graded as ‘Obvious lid changes’, ‘Minimal lid 
changes’ or ‘Normal lid changes’. In addition, the eyelids for the presence of 
MGD will be graded as either ‘Obvious MGD’ or ‘Non-obvious MGD’. The 
frequency and percent of eyelid assessment and MGD presence assessment 
will be presented at Baseline visit and 1 month postoperatively.  
• 
3-Month Postoperative Visit: 
o Mean LogMAR monocular BCDVA, mean binocular UCDVA, UCIVA, 
UCNVA, BCDVA, and contrast acuity will be reported for study group eyes 
and control group eyes at 3 months postoperative. Better visual acuity 
outcomes (lower mean LogMAR scores) for study group eyes are expected 
compared to control group eyes. Summary statistics (mean, standard 
deviation, median, minimum and maximum) will be reported for MRSE at 3 
months postoperative for study group eyes and control group eyes. The 
difference between MRSE at 3 months postoperative visit and the target 
MRSE will be calculated. The difference is expected to be smaller (closer to 
zero) for study group eyes than that for control group eyes. Contrast acuity in 
the Study group at 3 months postoperative will be compared to the Control 
group. 
o Mean change in total Standard Patient Evaluation of Eye Dryness (SPEED) 
score from Baseline visit to 3 months postoperative in the Study group will be 
compared to the Control group.  
The SPEED score is the sum of frequency and severity scores with a range 
from 0 to 28. A lower SPEED score represents less frequent and/or less 
severe symptoms. The mean SPEED score will be reported at Baseline and 3 
months postoperative visit. Greater mean change in SPEED score from 
Baseline to 3 months for study group eyes is expected.  
o Mean change in total meibomian gland score in the Study group will be 
compared to the Control group from Baseline to 3 months postoperative. 
Greater mean change in total Meibomian gland score from Baseline to 3 
months is expected for study group eyes than that for control group eyes.  
• 
Control Group 4-Month Postoperative Visit: 
o Mean change in LogMAR monocular BCDVA and UCDVA and mean change 
in LogMAR binocular UCDVA, UCIVA, UCNVA, BCDVA, and contrast acuity 
will be reported for control group eyes from 3 months to 4 months 
postoperative. Better visual acuity outcomes (lower mean LogMAR scores) at 
4 months visit are expected. 

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o Mean MRSE at 4 months postoperative will be compared to target MRSE. 
o Frequency and percent of eyes with MRSE within 0.50 D and within 1.00 D of 
target MRSE at 4 months postoperative will be reported.  
o Mean change in total meibomian gland score and mean change in total 
SPEED score from 3 months to 4 months postoperative will be reported. An 
increase in both total Meibomian gland score and total SPEED are expected. 
• 
The frequency and proportion of eyes with optical/visual, medical and lens 
complications will also be reported over time. Rate of adverse events will be 
reported in the Study and Control groups. 
20.4 
INTERIM REPORTS 
An interim database lock will be performed for preoperative data after completion of 
the second preoperative visit. 
20.5 
SAMPLE SIZE CALCULATIONS 
The sample size determination is based on the primary endpoint of uncorrected 
distance visual acuity (UCDVA). There is 90% power to detect a 1-line or greater 
difference in mean UCDVA between the treatment and control groups with 55 
subjects in each group. This assumes one-sided two-sample t-test with an alpha of 
0.05 and standard deviation of 1.6 lines.  Adding 20% screen failure/drop-out rate will 
require enrolling 69 subjects per group. 

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APPENDIX B   SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
Examination 
Preop  
Visit #1 
LF Txd 
(Study 
Group 
Only) 
Preop 
Visit #2e 
Operative 
1-Mo. Post-
op 
 
3-Mo. Post-
op and 
Crossover 
LF Txf 
4-Mo. Post-op 
(Crossover 
Group Only) 
Informed consent, medical and ocular history, 
inclusion/exclusion criteria 
X 
 
 
 
 
 
 
Potential visual acuity, targeted refraction, IOL power 
calculations, corneal topography 
X 
 
X 
 
 
 
 
IOL power/serial number, Toric power/axis (if needed) 
 
 
 
X 
 
 
 
Monocular UCDVA, BCDVA 
Xc 
 
 
 
X 
X 
X 
Binocular UCDVA, BCDVA 
 
 
 
 
X 
X 
X 
Binocular UCIVA and UCNVA 
 
 
 
 
 
X 
X 
Manifest refraction  
Xc 
 
 
 
X 
X 
X 
Contrast acuity testing (binocular, 10% contrast acuity 
and 20/40 contrast threshold) 
 
 
 
 
 
X 
X 
Keratometry, biometry (repeat 3 sets of biometry / 
keratometry measurements) 
X 
 
X 
 
 
 
 
Meibomian gland assessment 
X 
 
 
 
X 
X 
X 
Ocular surface staining 
X 
 
X 
 
X 
 
 
TBUT 
X 
 
X 
 
X 
 
 
Eyelid margin evaluation 
X 
 
X 
 
X 
 
 
Meibomian gland imaging (LipiScan or LipiView II) 
X 
 
 
 
X 
 
X 
Biomicroscopic slit-lamp exama   
X 
X 
X 
 
X 
X 
X 
Fundus examb  
X 
 
 
 
 
 
 
Adverse events 
X 
X 
X 
 
X 
X 
X 
Ocular and systemic medications 
X 
X 
X 
 
X 
X 
X 
Ocular/Visual symptom assessment (non-directed) 
X 
 
X 
 
X 
X 
X 
SPEED and PRVSQ questionnaires 
X 
 
X 
 
 
X 
X 
a Includes determination of medical and lens findings/complications, lens orientation. Slit-lamp exam is performed both before and after LipiFlow treatment. 
b Fundus exam may be performed dilated with ophthalmoscopy or undilated per site practice standard of care.  
c Preoperative UCDVA, BCDVA and refraction tests will be performed per site practice standard of care. 
d Preoperative LipiFlow treatment can occur the same day or within 1 week of Preoperative Visit #1. 
e Preoperative Visit #2 will be 2-4 weeks after LipiFlow treatment for study group and be 2-4 weeks after the Preoperative Visit #1 for control group.  
f LipiFlow treatment after 3 months postop exams for the Crossover Control group only. 

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APPENDIX C   EQUIPMENT AND ANCILLARY SUPPLIES PROVIDE TO 
STUDY SITES 
The following equipment/supplies will be supplied to an investigative site for the duration 
of the study provided that the site does not already have such equipment/supplies 
available for use.  This information will be documented in the Clinical Trial Agreement, 
which indicates that the equipment and any remaining supplies are to be returned to 
JJSV at the completion of the study. 
• 
M&S Technologies CTS-1000 Smart System© Computerized Vision Testing 
System, including laptop computer and tablet (“M&S System”) 
• 
Commercially-available standard fluorescein strips 
• 
Commercially-available lissamine strips  
• 
Tape measure (meters) 
• 
Activator II  
 
 
 
 
 

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APPENDIX D  MANUAL OF TESTING PROCEDURES 
Biometry shall be measured with the optical biometry measurement system.  The 
measurement results will be retained by the Investigator.  
Biomicroscopic Slit Lamp Examination shall be performed via biomicroscopic slit-
lamp exam for determination of medical findings including but not limited to the adnexa, 
conjunctiva, sclera, cornea, and iris.  
Contrast Acuity Test: binocular, best corrected, photopic,10% low contrast acuity and 
20/40 contrast threshold test will be measured at the designated postoperative visits.  
Detailed instructions for contrast sensitivity testing are provided in Appendix S. 
Corneal Topography shall be measured with a corneal topography system, e.g. the 
iDesign System (preferred), a Scheimpflug (Pentacam), or Placido (Humphrey) disk-
based system.  Images will be retained by the Investigator.  
Eyelid Margin Evaluation shall be performed preoperatively and postoperatively at 
designated visits. The Investigator or designee may use 10x to 16x magnification on the 
slit lamp biomicroscope to evaluate the eyelid appearance, or they may use digital ocular 
images of the eyelid gained through LipiView II, and grade the eyelid appearance, as 
defined in Appendix J. 
Fundus Examination shall be performed with or without pharmacological pupil dilation. 
If mydriatic agents are used, then installation of mydriatic agents should be used at least 
30 minutes prior to determining the status of the ocular media, retina and lens. Based on 
prior studies, the LipiFlow treatment is not expected to have any effect on the posterior 
segment and therefore, is not routinely assessed after treatment.  However, dilated 
retinal examination will be performed at scheduled follow-up or unscheduled visits if 
needed to evaluate an ocular health problem under the physician’s discretion.     
Keratometry (not simulated K) shall be conducted preoperatively using an auto or 
manual keratometer. The same keratometry method is to be used at each required visit, 
e.g., if auto keratometry was recorded at the preoperative exam, all postoperative 
keratometry readings should be auto K’s.  Do not use “sim K” from the corneal 
topography unit.  
Lighting levels and lane calibration will be assessed by a representative of the 
Sponsor to ensure the lane length and lighting conditions are consistent across sites. 
The site or Sponsor designee will verify the chart background luminance level of 
85 cd/m2 (80-110 cd/m2 acceptable) prior to use of the measurement device. 

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Manifest Refraction is to be performed under photopic conditions (85 cd/m2, 80-110 
cd/m2 acceptable) using either the phoropter or trials frames and the M&S System.  
Manifest refraction is to be performed using the Maximum Plus refraction method as 
detailed in Appendix M.  Because 4.0 meters is not optical infinity, a refraction 
adjustment of +0.25 D sphere must be used when performing uncorrected distance 
visual acuities.  Appendix N lists the refraction adjustments. 
Meibomian Gland Assessment is used to evaluate meibomian gland function. It is 
used to determine study eligibility based on total meibomian gland secretion score of 15 
or less (on a scale of 0 to 45) for each eye at Baseline Visit. The Meibomian Gland 
Assessment is to be administered preoperatively and at designated postoperative study 
exams, as defined in Appendix G. 
Meibomian Gland Imaging through LipiScan or LipiView II will be taken preoperatively 
and at designated postoperative study visits.  LipiScan or LipiView II system will be used 
to capture, archive, and store the digital images of Meibomian glands of upper and lower 
eyelids in each eye, as defined in Appendix I. 
Ocular Surface Staining of the cornea and conjunctiva is evaluated preoperatively and 
at the designated study visits. The Investigator or designee assesses the corneal 
staining after instillation of fluorescein dye in the eye, and assesses the conjunctival 
staining after instillation of lissamine green dye in the eye, as defined in Appendix H. 
Ocular/Visual Symptom Assessment: The subjective ocular symptoms are to be 
assessed at the designated visit by asking “Are you having any difficulties with your 
eyes/vision?”  Subjects should not be prompted for specific responses. 
PRVSQ questionnaire: Patient-Reported Visual Symptom Questionnaire (PRSVQ) will 
be used for the assessment. It is a directed questionnaire intended to collect information 
on visual symptoms.  In order to minimize any effect of the doctor-patient relationship 
may have on a subject’s responses on the questionnaire, the study questionnaires will 
be self-administered by the subjects.  The PRVSQ is to be administered at the start of 
the preoperative visits and at every follow-up visit, prior to any visual acuity testing. 
SPEED Questionnaire is a self-administered, validated assessment tool designed 
specifically to assess frequency and severity of dry eye symptom.  It is used to 
determine study eligibility based on none to mild dry eye symptoms at Baseline Visit and 
to evaluate ocular comfort at Baseline and follow-up visits.  Dry eye symptoms assessed 
using the SPEED questionnaire are dryness, grittiness or scratchiness; soreness or 
irritation; burning or watering; and eye fatigue.  The SPEED questionnaire is to be 
administered preoperatively and at designated postoperative study exams, as defined in 
Appendix K.  

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Tear Break-Up Time (TBUT) is measured preoperatively and at designated 
postoperative study exams.  Three separate measurements of tear break-up time are 
taken for each eye using a stopwatch to record the time. For data analysis, the three 
measurements are averaged to represent the mean tear break-up time for each eye. 
The Investigator or designee measures tear break-up time under a slit-lamp 
biomicroscope following instillation of fluorescein dye in the eye using the Dry Eye Test 
(DET) method, as defined in Appendix L. 
 
 

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APPENDIX E   INSTRUCTIONS FOR EYELID MARGIN CLEANING  
The lower lid margins including the area directly over the meibomian gland orifices are 
cleaned to remove accumulated devitalized cellular material cell and other products that 
build up along the lid margin in patients with MGD.  Prior research has shown that 
cleaning the lid margin surface can decrease dry eye symptoms and increase 
meibomian gland function.xxiii  Performing lid margin cleaning prior to a LipiFlow 
treatment may aid in the treatment of MGD because cleaning the meibomian gland 
orifices and lid margin surface allows for optimal passage of the oil from the gland to the 
lid margin surface across the mucocutaneous junction and ultimately into the tear film.  
The lid margin surface can be divided into three distinct sections: 1) the keratinized 
surface; 2) the Line of Marx (the stained devitalized surface cells of the mucocutaneous 
junction denoting the transition between the dry keratinized surface and the wet 
conjunctival surface); and 3) the conjunctival surface.  A healthy keratinized surface has 
minimal debris, readily visible and uncapped meibomian gland orifices, minimal 
telangiectasia, and no lid margin irregularities such as lid notching or other findings 
indicating significant tissue change, as noted on the left in Figure 1.  Conversely, the 
majority of MGD patients exhibit tissue changes (e.g. meibomian gland capping) and 
build-up of material on the keratinized lid margin surface.  These changes and 
accumulated material are readily observed with the slit lamp, as shown on the right in 
Figure 1.  
 
 
 
 
Figure 1: Examples of a healthy lid margin kertanized surface (left) and                                            
an abnormal lid margin surface with capped glands and accumulation of debris (right) 
 
The Line of Marx cannot be easily visualized without staining.  The accumulated 
devitalized cells of the Line of Marx are readily observed using lissamine green dye, 
white light and the slit lamp.  A thin staining, slightly elevated Line of Marx that runs 
parallel to the lid margin and does not undulate is considered normal, as shown on the 
left in Figure 2. As loss of meibomian gland function progresses, the Line of Marx 
becomes thicker both in height and width, begins to undulate, and finally advances 

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anteriorly towards the lash line, as shown on the right in Figure 2.xxiv,xxv   Elevation and 
thickening of the Line of Marx is very common in patients with MGD and occurs in the 
vast majority of all adults over age 30.  With progression of chronic MGD, the Line of 
Marx advances over the meibomian gland orifices such that the orifices open up onto 
wet conjunctival surface as opposed to the intended dry keratinized surface.  As a result 
of the changes in the position, thickness and height of the Line of Marx, the delivery of 
oil from the gland orifices to the tear film is altered.   
 
 
 
Figure 2: Examples of a healthy stained Line of Marx (left) and  an abnormal Line of Marx 
with thickening, antero-placement and undulation (right) 
 
The Investigator or designee uses the following procedure and a commercially available 
golf club spud (Figure 3) to clean the lid margin surface of the lower eyelids.  First, the 
Line of Marx is cleaned followed by the keratinized lid surface. The wet conjunctival 
surface is not cleaned.  In addition, the upper eyelid margins are not cleaned. 
 
 
Figure 3: Golf Club Spud (Hilco Wilson Ophthalmics; Plainville, MA) 
NOTE:  The lid margin cleaning procedure is performed without anesthetic and is not 
intended to remove tissue that cannot be removed with gentle motion and mild 
pressure of the golf club spud.  The patient should not experience discomfort, 
and there should be no tissue damage evident after the procedure is complete. 
No post procedure application of topical medications should be necessary. 
 
Procedure for Cleaning the Line of Marx (the lissamine green stained cells on the 
surface of the mucocutaneous junction):  The goal of the cleaning is to remove the 
lissamine green stained cells from the Line of Marx.   
 
1. With the patient comfortably seated at the slit lamp (16x magnification with white 
light), gently evert the lower eyelid.  
2. Ask the patient to look up.  

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3. Stain the conjunctiva and lid margin with lissamine green dye so that the Line of 
Marx is clearly visible.   
4. Place the golf club spud (Figure 3) onto the lid margin directly over the Line of 
Marx. 
5. Gently maneuver the golf club spud laterally (nasal to temporal or vice versa) in 
small wiping motions with mild pressure across the entire length of the Line of 
Marx, as shown in Figure 4.  
 
 
Figure 4:  Cleaning the Line of Marx with a Golf Club Spud 
6. Adjust the pressure applied to the lid margin as needed based on individual 
morphology and resistance of the tissue, while monitoring the removal of the 
lissamine green stained cells.  The patient should be comfortable during the 
procedure. Any discomfort is an indication that the pressure applied needs to be 
adjusted.   
7. After the cleaning of the Line of Marx is complete, verify that few to no stained 
cells are still visible along the Line of Marx.  
8. Repeat steps 1 to 7 for the other eye.  
 
Procedure for Cleaning the Keratinized Lid Surface: The goal of the cleaning is to 
remove any accumulated debris on the keratinized lid margin and any accumulated 
material potentially obstructing the meibomian gland orifices.  
1. With the patient comfortably seated at the slit lamp (16x magnification with white 
light), gently evert the lower eyelid.  
2. Ask the patient to look up.  
3. Place the golf club spud (Figure 3) onto the keratinized lid margin with the tip of 
the spud placed at the edge of the Line of Marx, which was previously cleaned.  
4. Gently maneuver the golf club spud laterally (nasal to temporal or vice versa) in 
small wiping motions with mild pressure across the entire keratinized lid margin 
surface covering all areas from the edge of the Line of Marx to the base of the 
lashes at the lash line. 
5. Adjust the pressure applied to the lid margin as needed. The patient should be 
comfortable during the procedure. Any discomfort is an indication that the 
pressure applied needs to be adjusted.   

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6. After the cleaning of the keratinized lid margin is complete, verify that little to no 
sheen is visible on the lid margin surface and any functional meibomian gland 
orifices are exposed.  Narrow furrows or striations, which run perpendicular to the 
lid margin, may also be observed.  
7. Repeat steps 1 to 6 for the other eye.  
 
 

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APPENDIX F   INSTRUCTIONS FOR BLINKING EXERCISE  
Proper blinking is important to help the flow of oils from the eyelid glands into the tears.  
Proper blinking occurs when the blinks are complete, so that the upper lid makes full 
contact with the lower lid, and the frequency of blinking is at least six blinks per minute.  
Daily activities such as reading and computer use can cause poor blinking habits, 
including partial blinks where the eyelids do not fully touch and decreased frequency of 
blinks.  Poor blinking worsens the blockage in the eyelid glands.  Poor blinking may 
reduce the effect of the LipiFlow System treatment in improving eyelid gland function.  
To ensure that poor blinking habits do not interfere with the eyelid gland function, the 
blinking exercises on the following page must be performed at regular intervals during 
the day for one month after LipiFlow treatment.  
Perform 10 repetitions of the exercises at regular intervals during the day (such as 
every hour or two) for a minimum of 5 total times per day.  Perform the exercises 
every day of the week until you return for your next study visit.  A reminder, such 
as a watch or phone alarm, can be helpful in prompting the blinking exercises at 
regular intervals throughout the day.  
TIPS 
• 
As a reminder to perform blinking exercises every hour, think about something 
that you do often in your daily routine, such as answering phone calls or drinking 
sips of water.    
• 
Remember that blinking quality and frequency are affected by how you use your 
eyes.  If you are reading a book or working on a computer where concentration is 
required, your frequency of blinking will decrease dramatically.  Try remembering 
to perform one repetition of the blinking exercises whenever you turn a page or 
every time you save a document. 

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BLINKING EXERCISES:  
Perform 10 repetitions every hour for a minimum of 5 times per day every day. 
1. Hold your fingers at the corners of your eyes to feel the lid movement. 
 
 
 
 
 
2. Close your eyelids together with the upper and lower lids completely touching 
for a count of 2.  When closing your lids correctly, you will feel no lid movement 
under your fingers.  
 
 
 
 
3.  Squeeze your eyelids lightly for a count of 2.  When squeezing your eyelids 
lightly, you will feel slight lid movement under your fingers. With a moderate 
squeeze, you should feel the contraction of the lid muscles under your fingers. 
 
 
 
 
4.  Open your eyelids to complete the blinking cycle for a count of 2. 
 
 
 
 
5. Repeat the following sequence nine more times for a total to 10 repetitions:                  
CLOSE and count 1 and 2, SQUEEZE and count 1 and 2, OPEN and count 1 and 2  
 

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5. To facilitate observation of the gland secretions, gently wipe the gland orifices along 
the eyelid margin clean with a dry cotton swab immediately after applying pressure 
while maintaining the Meibomian Gland Evaluator in position and maintaining 
pressure. 
6. Hold the Meibomian Gland Evaluator in place over the meibomian glands for a 
minimum of 10 and a maximum of 15 seconds while evaluating the secretion 
characteristics from each meibomian gland. The expressed secretion from each 
gland is graded according to the characteristics displayed in Table 2. 
 
 
Table 2:  Meibomian Gland Assessment Secretion Grading Scale 
Grade 
Secretion Characteristics 
3 
Clear liquid oil secretion 
 
 
 
2 
Colored/cloudy liquid secretion 
1 
Inspissated (toothpaste-consistency) secretion 
0 
No secretion (includes capped orifices) 

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Conjunctival Staining  
The Investigator or designee assesses the conjunctival staining after instillation of 
lissamine green dye in the eye using the following method.  
1. Place one drop of commercially available saline on a standard lissamine green strip.  
Take care to avoid applying the saline to the strip holder. Do not shake the strip. Wait 
ten seconds after application of the saline before proceeding.  
2. Instruct the patient to look down and towards the opposite hand from the eye 
receiving the stain. It may be helpful to ask the subject to fixate on his/her own 
thumb. Place the subject’s thumb to rest on the opposite leg to achieve inferior 
fixation of approximately 45 degrees down and 20 degrees nasal.  
3. Retract the upper eyelid. Introduce the strip at an approximate 30-degree angle and 
touch the superior temporal bulbar conjunctiva, preferably 4 mm or more from the 
limbus, for 2 seconds, so that 1-2 mm of the flat side makes contact with the ocular 
surface. Withdraw the strip and release the upper lid.  
NOTE: If the size of the strip prevents application to the desired position on the 
superior temporal bulbar conjunctiva, apply the strip to a location on the 
bulbar conjunctiva as close as possible to the preferred position.  
4. Instruct the subject to close the eyelids completely three times.  Wait 1.5 minutes (90 
seconds) before evaluating the ocular surface for staining. 
5. To observe the lissamine green staining, evaluate the subject’s eye under the slit-
lamp biomicroscope with a beam approximately 4 mm wide and l0 mm high.  
6. Examine the entire bulbar conjunctiva. Grade the conjunctival staining observed in 
the six regions as shown in Figure 5 on a scale of 0 to 3 based on the Report of the 
National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye. Document the 
staining grade. 
 
 
 
 
 
 
 
   
 
 
       
      
              OD 
 
 
               
 
OS 
Figure 5:  Diagram of Conjunctival Regions for Lissamine Green Staining Grading 
 
                
            Superior  
 
         
 
       Superior 
 
 Temporal 
 
 
                           Nasal                                                                 
Temporal 
 
               
              
Inferior  
             
                      Inferior 
 2                   4 
 3                   5    
 
    1                                     6 
 
    6                                     1 
 4                   2 
 5                   3    

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APPENDIX I   INSTRUCTIONS FOR MEIBOMIAN GLAND IMAGING  
The Meibomian gland imaging is used to evaluate the Meibomian gland appearance.  It 
could be performed through LipiView II or LipiScan. 
LIPIVIEW II 
The LipiView® II Ocular Surface Interferometer is intended for use in adult patients to 
capture, archive, manipulate and store digital images of specular (interferometric) 
observations of the tear film, meibomian glands, as well as ocular surface and eyelids.  
The LipiView II, as shown in Figure 6, is a bench-top device and is comprised of a 
computer system and electronics, chin rest and forehead rest, camera and zoom lens, 
illuminator and a touchscreen display.  
 
 
Figure 6: LipiView II Interferometer 
Refer to the LipiView II Interferometer Instructions for Use for detailed 
instructions on the device operation. Failure to follow the instructions may result in 
improper use of this device. The electronic image data are collected as external data 
(outside of EDC) by the Sponsor using patient IDs to maintain confidentiality.   
 
LIPISCAN 
The LipiScanTM Dynamic Meibomian Imager is intended for use in adult patients to 
capture, archive, manipulate and store digital images of the meibomian glands. The 
LipiScan, as shown in Figure 14 is a bench-top device and is comprised of a computer 
system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator 
and a touchscreen display.  

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Figure 7: LipiScan 
 
Refer to the LipiScan Dynamic Meibomian Imager Instructions for Use for detailed 
instructions on the device operation.  Failure to follow the instructions may result in 
improper use of this device. The electronic image data are collected as external data 
(outside of EDC) by the Sponsor using patient IDs to maintain confidentiality.   
 
 
 

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APPENDIX J   INSTRUCTIONS FOR EYELID MARGIN EVALUATION  
At the designated visits, the Investigator or designee uses 10x to 16x magnification on 
the slit lamp biomicroscope, or use the digital ocular images of the eyelid from LipiView 
II, and then grades the eyelid appearance, as defined below.  
1) Obvious Lid Changes – Obvious morphological changes of the lid margins 
apparent upon first observation including:  erythematous lid margins; thickened lid 
margins; significant telangiectasia; excess vascularization; irregular or serrated lid 
margins, and acute or chronic inflammation.   
2) Minimal Lid Changes – Minimal changes, apparent only upon detailed examination 
of the lid margins.  
3) Normal Lid Appearance – No significant lid changes.  
In addition, the Investigator or designee grades the eyelids as defined below. 
1) Obvious MGD – Obvious changes of meibomian orifices including: pouting 
(elevation overlying an orifice); capping (a dome of solidified oil over the orifices); 
ulceration of epithelialized orifice capping; reduction in number of orifices; and loss of 
lid area (notching) indicating gland dropout.  Lid inflammation not accompanied by 
the later signs of obvious MGD does not result in a classification of obvious MGD.  
2) Non - Obvious MGD – No significant meibomian gland signs as described for 
obvious MGD. 
 
 
 
 

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APPENDIX K   INSTRUCTIONS FOR STANDARD PATIENT EVALUATION OF 
EYE DRYNESS (SPEED) QUESTIONNAIRE 
The SPEED questionnaire is used to determine study eligibility based on none to mild 
dry eye symptoms at Baseline Visit and to evaluate ocular comfort at Baseline and 
follow-up visits.  Dry eye symptoms assessed using the SPEED questionnaire are 
dryness, grittiness or scratchiness, soreness or irritation, burning or watering and eye 
fatigue.   
Symptom frequency is on a scale of:   
• 
0 (never),  
• 
1 (sometimes),  
• 
2 (often), and  
• 
3 (constant)    
Symptom severity is on a scale of:  
• 
0 (no problems),  
• 
1 (tolerable–not perfect but not uncomfortable),  
• 
2 (uncomfortable-irritating but does not interfere with my day),  
• 
3 (bothersome-irritating and interferes with my day), and  
• 
4 (intolerable-unable to perform my daily tasks)  
The total SPEED score is the sum of frequency and severity scores for all symptoms 
over a range from 0 to 28.  A lower total SPEED score represents less frequent and/or 
less severe symptoms.  At the Baseline Visit, the total SPEED score must be 
between 0 and 15 points, reflecting none to moderate dry eye symptoms, to be 
eligible for the study. 
The Investigator or designee administers the SPEED questionnaire to the subject in the 
following manner: 
1) Explain the questionnaire to the subject to ensure understanding of the instructions 
without coaching or influencing the subject’s responses.  Answer the subject’s 
questions as needed to clarify the instructions.  
2) Allow the subject to complete the questionnaire and sign/date the last page.  
3) After the subject completes the questionnaire, review the forms to ensure all 
questions have been answered.  Ensure the subject makes any corrections that are 
needed, such as to clarify only one answer for a question.    
4) To change or clarify a response, the subject crosses through the incorrect answer 
with a single line, initials and dates the correction, and writes the correct answer.   
5) At the Baseline Visit, score the SPEED questionnaire by totaling the sum of the 
frequency and severity scores for all symptoms.  Determine if the subject’s total 
SPEED score meets the eligibility criterion for none to mild dry eye symptoms.  

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APPENDIX L  INSTRUCTIONS FOR TEAR BREAK-UP TIME TESTING  
Tear break-up time is measured at the designated visits. Three separate measurements 
of tear break-up time are taken for each eye using a stopwatch to record the time. For 
data analysis, the three measurements are averaged to represent the mean tear break-
up time for each eye. The Investigator or designee measures tear break-up time under a 
slit-lamp biomicroscope following instillation of fluorescein dye in the eye using the Dry 
Eye Test (DET) method, as described in this section.  
1. Place one drop of commercially available saline solution on a commercially-available 
standard fluorescein strip.   
2. Let the excess saline run off by holding the strip vertically with the impregnated end 
held down.  Do not shake the strip after wetting.  
3. Instruct the patient to look down and towards the opposite hand from the eye 
receiving the stain. It may be helpful to ask the subject to fixate on his/her own 
thumb. Place the subject’s thumb to rest on the opposite leg to achieve inferior 
fixation of approximately 45 degrees down and 20 degrees nasal.  
4. Retract the upper eyelid. Introduce the DET strip at an approximate 30-degree angle 
and touch the superior temporal bulbar conjunctiva, preferably 5 mm or more from 
the limbus, for 2 seconds, so that 1-2 mm of the flat side makes contact with the 
ocular surface. Withdraw the strip and release the upper eyelid.  
5. To observe the fluorescein break-up, evaluate the subject’s eye under the slit-lamp 
biomicroscope using a cobalt blue filter transmitting 330 to 400 nm and a beam 
approximately 4 mm wide and l0 mm high. Use the lowest level of illumination and 
move the beam from side to side to cover the entire cornea. 
6. Ask the subject to blink three times naturally, open, and then refrain from blinking.  
Tear film break-up is defined as the first observed break-up of the tear film following 
the third blink. Using a stopwatch to record the time, start the stopwatch as soon as 
the subject opens his/her eyes after the third blink and stop the stopwatch when the 
first break-up of the tear film is observed. 
7. After the first measurement, instruct the subject to blink naturally three times and 
take a second measurement as described in step 6. Repeat step 6 for the third 
measurement.  If break-up is not observed within 20 seconds for any measurement, 
terminate the measurement to prevent possible corneal drying or other effects that 
might interfere with the subsequent measurements.  
8. After a 60-second rest period, instill fluorescein in the fellow eye with a new DET 
strip and record the tear break-up time following steps 1 through 7.  
9. Document the three measurements for each eye. 

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APPENDIX M  MAXIMUM PLUS MANIFEST REFRACTION TECHNIQUE WITH 
CYLINDER REFINEMENT  
Manifest refraction testing will be performed using the M&S System at 4.0 meters with 
the room lighting set to that required for photopic distance visual acuity testing (85 
cd/m2).  NOTE: Objective refraction by either retinoscopy or autorefraction can be used 
as a starting point for the Manifest Refraction.  Always ensure that the endpoint of 
refraction is maximum plus (or minimum minus) power that yields maximum visual 
acuity. 
1) Occlude the fellow eye. 
2) SPHERE: Starting with the objective refraction, refine the sphere to yield best visual 
acuity.  Important: Add plus power (or reduce minus) until subject demonstrates at 
least a 1-line loss from best visual acuity (fogging).  Then step down to the most plus 
(or least minus) sphere power until visual acuity and clarity show no improvement. 
3) CYLINDER AXIS: Refine cylinder with a cross-cylinder and the objective cylinder 
refraction as the starting point.  Refine axis first and power second, since the correct 
axis can be found with an incorrect power, but the correct power cannot be found 
with an incorrect axis.  
a. Direct the subject’s attention to 1 line above (larger letters) the best visual acuity.  
With the trial cylinder (axis and power) in the phoropter, introduce cross-cylinder 
for axis refinement.  When asking the subject which cross-cylinder axis position 
is better, “one or two?”, remind the subject to look at different letters on the line 
and report preference based on the overall clarity of the letters.  
b. Refine the axis based on the subject’s responses, using small steps (less than 
five degrees), until the subject reports no difference in the two choices. 
c. Cylinder axis may be further confirmed by bracketing:  Slowly rotate the trial 
cylinder in one direction until the subject reports blurring and note the axis.  
Rotate the trial cylinder in the opposite direction past the presumed axis until the 
subject reports blurring, again noting the axis. The average of the two noted axes 
can be taken as the final astigmatism axis. 
4) CYLINDER POWER:  Set the cross cylinder to refine cylinder power and present 
choices to the subject, reminding the subject to look at different letters on the line 
and report preference based on overall clarity of the letters.  Reduce or increase trial 
cylinder power accordingly.  
a. Maintain the spherical equivalent throughout cylinder power refinement by 
adjusting the sphere once for every two clicks of cylinder power change. 
5) SPHERE CHECK: Introduce fogging lenses again, typically +0.75 D to +1.00 D to 
ensure that the 20/32 line on the M&S System is blurry.  Ask the subject to read 
the visual acuity chart and move to smaller letters to finalize refraction.  Endpoint 
is when subject achieves best possible acuity and does not show an improvement 
in acuity with successive one or two clicks of 0.25 D. 
 

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APPENDIX N  REFRACTION ADJUSTMENTS 
Postoperative study manifest refractions are to be performed using the M&S System at a 
distance of 4.0 meters.  Because 4.0 meters is not optical infinity, refraction adjustments 
are necessary to ensure proper vision testing that accounts for differences between the 
test distance and refraction distance.  The adjustment required (in diopters) is 1/test 
distance (in meters).  To adjust a 4.0-meter refraction to optical infinity, -0.25 D is to be 
added to the sphere of the refraction to obtain a true distance (infinity) correction.  On 
the other hand, to adjust optical infinity to a 4.0-meter test distance, +0.25 D is to be 
given.  In the case where the refraction distance (4.0 meters) and the vision test distance 
(4.0 meters) are the same, no adjustment is necessary.  The following table lists the 
refraction adjustments required for the various vision tests in this study: 
 
Refraction Adjustments for Vision Testing 
 
Vision Test 
Test 
Distance 
Correction/Adjustment 
Uncorrected distance visual acuity  
(UCDVA) 
4.0 m 
+0.25 D adjustment only 
Best-corrected distance visual acuity 
(BCDVA) 
4.0 m 
No adjustment; ETDRS Rx only 
(phoropter) 
Uncorrected intermediate visual acuity 
(UCIVA) 
66 cm 
No adjustment 
Uncorrected near visual acuity  
(UCNVA) 
40 cm 
No adjustment 
 
 
 

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APPENDIX O   INSTRUCTIONS FOR USING THE M&S SYSTEM 
Distance, intermediate, low-contrast and near visual acuities will be performed using the 
M&S System.  This system provides descending LogMAR charts with proportionally 
spaced SLOAN letters at 100% contrast for high contrast visual acuity, 10% contrast for 
low-contrast distance visual acuity and appropriate contrast levels for letter contrast 
acuity testing.  Each presentation is randomized and is consistent and repeatable.  The 
system is calibrated for both distance to subject and pixels/inch so that optotypes 
precisely follow ANSI Z80.21-2010 and ISO 8596:2000 with regard to size, spacing 
between optotypes and spacing between lines.    
Figure 4:  Example of LogMAR 4.0 meter chart screen 
 
The M&S System background luminance is automatically set to 85 cd/m2 (range of 
80-110 cd/m2 is acceptable) for photopic testing.  Room lighting is to be set to a level 
lower than the illumination from the laptop screen.  Ambient lighting should be dim to 
dark (less than 50 lux) to maximize pupil size.  No surface (including reflective surfaces) 
within the subject’s field of vision should be brighter than the chart background in 
luminance.  The room lighting and screen luminance will be verified each time the 
computer is turned on using the JJSV-provided, auto-adjusting, monitor-calibration 
system to ensure light levels are appropriate.  
The M&S System will be set up to perform required visual tests in a specific order, with 
prompts on the screen to allow the technician to set up the subject for monocular or 
binocular testing, refraction adjustments as needed and uncorrected or best-corrected 
testing.  Letters on all charts will appear randomly, with the technician controlling 
movement through charts based on subject responses.  
As a subject completes a visual acuity line, the technician will select the total number of 
letters correctly read for that line on the handheld controller, press “Enter” and then 
confirm the number of letters correct at the next prompt.  The M&S System will then 
advance to the next line of testing and the process will repeat.  The system will end the 

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test when the subject no longer has any correct responses.  The number of letters 
correctly read will be displayed on the laptop screen, along with the LogMAR value and 
Snellen acuity.  Record the total number of letters read.  Once a test is completed, follow 
the prompts on the computer screen to start the next test. 
Test results are stored in the M&S computer and a hard copy will be printed and 
validated as a back-up. 
 
 

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APPENDIX P  INSTRUCTIONS FOR DISTANCE VISUAL ACUITY TESTING 
For distance visual acuities, the M&S System laptop should be placed at a test distance 
of 4.0 meters from the subject for testing distance visual acuities.  A laptop setting may 
be used to reverse charts for rooms that require “folding” via a mirror to reach a distance 
of 4.0 meters.  Whether standard or “folded”, measure and record the test distance 
accurately.  If the room set-up does not allow the computer to be placed at precisely 
4.0 meters, the M&S System can be adjusted to account for the actual test distance 
used. 
The M&S System will be set up to perform the required distance visual acuity tests in a 
specific order, with prompts on the screen to allow the technician to set up the subject 
for monocular or binocular testing, refraction adjustment as needed and uncorrected or 
best-corrected testing.  A phoropter may be used for distance acuity and refraction 
testing.  
Subjects should be reminded prior to testing that squinting is not allowed.  The 
technician is to observe the subject to ensure the subject is not squinting during visual 
acuity testing.  If squinting is observed, the subject is to be reminded by the testing 
technician not to squint.   
Distance visual acuity measurements (monocular and binocular UCDVA and BCDVA) 
are to be performed per the visit schedule in Appendix B.  To test subjects monocularly, 
occlude the second eye in the phoropter or with an occluder if trial lenses are used.   
Visual acuity measurements are based on the total number of correctly read letters.  
Subjects should be persuaded to read the smallest letters possible even if they must 
guess.  Follow the M&S testing process listed in Appendix O.  At the end of the test, the 
number of letters correctly read will be displayed on the laptop screen, along with the 
LogMAR value and Snellen acuity.  Record the total number of letters read in the EDC 
system.   
 

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APPENDIX Q   INSTRUCTIONS FOR INTERMEDIATE VISUAL ACUITY 
TESTING 
Intermediate visual acuity will be measured using the M&S System at a test distance of 
66 cm using phoropters or trial frames.  Subjects should be reminded prior to testing that 
squinting is not allowed and the testing technician should carefully observe to ensure the 
subject is not squinting.  If squinting is observed, the subject is to be reminded by the 
testing technician not to squint.   
Binocular uncorrected intermediate visual acuity measurements are to be performed per 
the visit schedule in Appendix B.  Visual acuity measurements are based on the total 
number of correctly read letters.  Subjects should be persuaded to read the smallest 
letters possible even if they have to guess.  Follow the M&S testing process listed in 
Appendix O.  At the end of the test, the number of letters correctly read will be 
displayed on the laptop screen, along with the LogMAR value and Snellen acuity.  
Record the total number of letters read in the EDC system.   
 
 

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APPENDIX R   INSTRUCTIONS FOR NEAR VISUAL ACUITY TESTING 
Near visual acuity will be measured using the M&S System as described in Appendix O, 
at a test distance of 40 cm.  Subjects should be reminded prior to testing that squinting is 
not allowed and the testing technician should carefully observe to ensure the subject is 
not squinting.  If squinting is observed, the subject is to be reminded by the testing 
technician not to squint.   
Binocular uncorrected near visual acuity measurements are to be performed per the visit 
schedule in Appendix B.  Visual acuity measurements are based on the total number of 
correctly read letters.  Subjects should be persuaded to read the smallest letters 
possible even if they have to guess.  Follow the M&S testing process listed in 
Appendix O.  At the end of the test, the number of letters correctly read will be 
displayed on the laptop screen, along with the LogMAR value and Snellen acuity.  
Record the total number of letters read in the EDC system. 
 
 

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APPENDIX S   INSTRUCTIONS FOR CONTRAST ACUITY TESTING  
The contrast acuity testing includes photopic 10% low contrast acuity and 20/40 contrast 
threshold test.  The contrast acuity testing is to be performed binocularly per the visit 
schedule in Appendix B, using the M&S system.   
The technician is to observe the subject to ensure the subject is not squinting during 
visual acuity testing.  If squinting is observed, the subject is to be reminded by the 
testing technician not to squint.   
Photopic 10% Contrast Acuity Testing  
Photopic 10% contrast acuity testing will be performed using the M&S system at a test 
distance of 4 meters.  This system provides a descending LogMAR chart with 10% 
contrast, proportionally-spaced SLOAN letters.   
All subjects will be tested binocularly with best refractive correction.  The test will be 
done under photopic test conditions with the M&S system (see Appendix O).  Subjects 
should be instructed to start with the smallest line where they can read all of the letters.  
If they miss any letters, have them go up a line until they are able to read all the letters 
on a line easily, then continue to read each subsequently smaller line.  The subject 
should be encouraged to read as many letters possible, even if they have to guess.  
Testing may be stopped when it is evident that no further readings can be made.  
Results will be displayed on the laptop screen along with the LogMAR and Snellen 
acuity.  Record the total number of letters read and LogMAR value on the chart.    
Photopic 20/40 Contrast Threshold Testing 
The photopic 20/40 Contrast Threshold test will be performed using the M&S system at 
a test distance of 4 meters.  The contrast threshold test is a fixed LogMAR Sloan letter 
chart (20/40) with descending contrast levels.  Each line has 5 letters of the same 
contrast, and subsequent lines have descending letter contrast.   
All subjects will be tested binocularly with best refractive correction in place.  The test 
will be done under photopic test conditions with the M&S system (see Appendix O).  
Subjects should be instructed to start at the top-most line and continue reading along the 
line and down the chart.  To test subjects binocularly, encourage subjects to read the 
lowest line of letters possible even if they have to guess, as results are based on the 
total number of correctly read letters.  Testing may be stopped when it is evident that no 
further readings can be made.  Results will be displayed on the laptop screen along with 
the contrast threshold value.  Record the total number of letters read and contrast 
threshold on the chart.  
 
 

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APPENDIX T   INSTRUCTIONS FOR KERATOMETRY  
Keratometry must be performed prior to dilation and any contact with the cornea (e.g., 
tonometry or pachymetry) as follows: 
1. Measure keratometry using the iDesign System and/or an auto or manual 
keratometer using the same method at each required visit, e.g., if auto keratometry 
was recorded at the preoperative exam, all keratometry readings postoperatively 
should be done using the same auto keratometry method. 
2. Do not use “sim K”s from the corneal topography unit.  
3. Always record the flat meridian (smaller number, e.g., 42.25) as K1. Record the 
steeper meridian (larger number, e.g., 43.00) as K2 along with the corresponding 
axis (e.g., 42.00 x 65 / 42.25 x 155).  
4. Record spherical corneas by placing the corneal curvature values in both K1 and K2 
and marking axes 180 attached to K2 (e.g., 44.00 / 44.00 x 180). Spherical Ks will 
not be accepted with axes other than 180 (do not use 0). 
 
 
 
 

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APPENDIX U  AMERICAN ACADEMY OF OPHTHALMOLOGY TASK FORCE 
CONSENSUS STATEMENT ON ADVERSE EVENTS FOR INTRAOCULAR 
LENSES 
Tables 1 and 2 in the following document give definitions for adverse events. 

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