Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
Phase: NA
Conditions: Cataract
Sponsor: Alcon Research

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a Novartis company
Clinical Trial Protocol
Clinical Investigation of the AcrySof® IQ PanOptix™ IOL Model TFNT00
Protocol Number: 
Sponsor Name & Address:
Project Name / Number:
Test Article(s) / Product(s):
Release Date:
ILH297-C003 / NCT03090256
Alcon Research, Ltd.
Toranomon Hills Mori Tower
1-23-1 Toranomon, Minato-ku
Tokyo, 105-6333 Japan
AcrySof® IQ PanOptix™ IOL Model TFNT00 / 
A01875
AcrySof® IQ PanOptix™ IOL Model TFNT00
See last page for electronic approvals.
Property of Alcon Laboratories
Confidential
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon 
Laboratories
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Clinical Investigation of the AcrySof® IQ PanOptix™ IOL 
Model TFNT00
Protocol
Alcon Japan Ltd.
1-23-1, Toranomon, Minato-ku, Tokyo
Protocol No.: ILH297-C003
SUMMARY of the clinical study
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Protocol Number
ILH297-C003
Objective(s):
To evaluate effectiveness and safety of the AcrySof IQ PanOptix Intraocular Lens 
(IOL) Model TFNT00 when implanted to replace the natural lens following cataract 
removal.
Trial Population:
Japanese subjects with bilateral cataract aged 20 or over
Trial Design:
Multi-center, Non-control, Open-label
Test Article:
AcrySof® IQ PanOptix™ IOL Model TFNT00
Variable(s):
Effectiveness:
Primary Effectiveness
-
Monocular photopic best corrected distance visual acuity (5 m)
-
Monocular photopic distance corrected intermediate visual acuity (60 cm)
-
Monocular photopic distance corrected near visual acuity (40 cm)
Safety:
Adverse Events
Secondary Surgical Intervention related to optical properties
Device Deficiencies
Fundus visualization
Intraocular Pressure
Slit Lamp Examination
Dilated Fundus Examination
IOL Observations
Subjective Posterior Capsule Opacification
Posterior Capsulotomy
Lens decentration and tilt
Laser Flare meter
Subjective symptoms
Problems during surgery
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Usage
The investigational lens will be placed within the capsular bag after removal of the 
natural crystalline lens following phacoemulsification.
Eye examinations 
schedule
Visit 0            ：Pre ope
Visit 00/00A  ：Ope (00: 1st eye, 00A: 2nd eye)
Visit 1/1A      ：1-2 days after implantation (1: 1st eye, 1A: 2nd eye)
Visit 2/2A      ：7-14 days after implantation (2: 1st eye, 2A: 2nd eye)
Visit 3/3A      ：30-60 days after implantation (3: 1st eye, 3A: 2nd eye)
Visit 4A         ：120-180 days after 2nd eye implantation
No. of Subjects:
60 subjects 120 eyes
Anticipated study period
01-Apr-2017 ~ 30-Jun-2018
Medical Monitor
Alcon Japan Ltd.
Sponsor
Alcon Japan Ltd.
GCP compliance:
This clinical study is subject to the Good Clinical Practice for Medical Devices (GCP 
for Medical Devices) (MHLW Notification No.36 dated March, 2005.)
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Table of Contents
1．INTRODUCTION............................................................................................................................................. 10
(1) History of development...................................................................................................................................... 10
(2) Summary of known and possible risks and benefits to subjects......................................................................... 11
2．OBJECTIVE(S)................................................................................................................................................. 12
3．TEST ARTICLE(S)........................................................................................................................................... 12
(1) Investigational lens............................................................................................................................................. 12
(2) Usage.................................................................................................................................................................. 13
(3) Instructions on package and labeling ................................................................................................................. 13
(4) Storage and Management................................................................................................................................... 15
4．SUBJECTS........................................................................................................................................................ 15
(1) Estimated Total Sample Size.............................................................................................................................. 15
(2) Inclusion Criteria................................................................................................................................................ 15
(3) Exclusion Criteria............................................................................................................................................... 15
5．STUDY DESIGN .............................................................................................................................................. 17
6．STUDY PROCEDURE ..................................................................................................................................... 17
(1) Outline................................................................................................................................................................ 17
(2) Eligibility Assessment and Subject Identification Code Allocation................................................................... 17
(3) Surgical Technique............................................................................................................................................. 17
(4) Eye Examinations Schedule............................................................................................................................... 18
(5) Examinations Procedure..................................................................................................................................... 20
(6) Anticipated study period .................................................................................................................................... 29
7．CONCOMITANT THERAPY........................................................................................................................... 29
(1) Permissible concomitant therapy........................................................................................................................ 29
(2) Prohibited concomitant therapy.......................................................................................................................... 29
8．DISCONTINUED SUBJECTS ......................................................................................................................... 29
(1) Discontinued Subjects........................................................................................................................................ 29
(2) Discontinuation of the entire study .................................................................................................................... 30
9．Analysis Plan..................................................................................................................................................... 30
9.1 Subject Evaluability........................................................................................................................................... 30
9.2 Analysis Dataset ................................................................................................................................................ 30
9.3 Demographics and Baseline Characteristics...................................................................................................... 31
9.4 Effectiveness Analysis....................................................................................................................................... 31
9.5 Handling of Missing Data.................................................................................................................................. 33
9.6 Safety Analysis .................................................................................................................................................. 33
9.7 Interim Analysis................................................................................................................................................. 34
9.8 Sample Size Justification................................................................................................................................... 34
10．ADVERSE EVENTS and DEVICE DEFICIENCIES .................................................................................... 34
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(1) General Information ........................................................................................................................................... 34
(2) Reporting of serious adverse events (SAE)........................................................................................................ 35
(3) Report of adverse events and evaluation of the causal relationship................................................................... 35
(4) Intensity Assessment .......................................................................................................................................... 36
(5) Follow-up of Subjects / Subjects with Adverse Events...................................................................................... 36
(6) Subject Pregnancy.............................................................................................................................................. 36
11．ETHICS ........................................................................................................................................................... 36
(1) Institutional review board................................................................................................................................... 36
(2) Ethical consideration.......................................................................................................................................... 37
(3) Protection of subjects’ privacy ........................................................................................................................... 37
(4) Specifications to secure safety of study subjects................................................................................................ 37
(5) Compensation for health hazards ....................................................................................................................... 37
(6) Payment to subjects............................................................................................................................................ 38
12．PROTOCOL AMENDMENTS ....................................................................................................................... 38
13．CONSIDERATIONS FOR DOCUMENTATION AND COMPLETION OF CASE REPORT FORM.......... 38
14．MONITORING................................................................................................................................................ 38
15．RETENTION OF THE RECORDS................................................................................................................. 38
16．REFERENCES................................................................................................................................................ 39
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1．INTRODUCTION
(1) History of development
The first clinical results of the multifocal intraocular lenses were reported in the United States in 1987. The 
first Japanese clinical study was performed and reported in the early 1990’s 1). In general, multifocal 
intraocular lenses are roughly divided into diffractive and refractive types. Diffractive lenses are structured 
to separate incident light energy to far and near visions, while refractive lenses have an optical zone structure 
consisting of far and near vision zones arranged in an alternate, concentric manner 2). Since the diffractive 
multifocal intraocular lens product, “Alcon® AcrySof® ReSTOR® Single Piece” (medical device approval 
number: 21900BZX00605000, Alcon Japan Ltd.) was first approved in 2007, various multifocal intraocular 
lenses have been developed in Japan. As opposed to monofocal intraocular lenses, intraocular lenses with 2 
or more focuses are collectively called multifocal intraocular lenses. Actually, however, bifocal intraocular 
lenses focusing on far and intermediate or near objects account for most of multifocal intraocular lenses: all 
the multifocal intraocular lenses approved in Japan are bifocal. Bifocal intraocular lenses have become 
popular because they correct an intermediate (1 m to 50 cm) or near vision sacrificed in monofocal 
intraocular lenses and therefore reduce the dependence on corrective devices including eyeglasses. However, 
bifocal intraocular lenses may not make the patient satisfy enough because they are designed to focus on 
distant and near or intermediate visions.
Recently, three trifocal intraocular lenses focusing on far, intermediate, and near objects were released in 
Europe. All the commercially available trifocal intraocular lenses are classified into the diffractive type. 
FineVision developed by PhysIOL has a 6.15 mm optical zone that serves as a diffractive zone, with an add 
power of +1.75D and +3.50D and an intermediate and near focal distance (theoretical value) of about 60 and 
30 cm, respectively. AT LISA® tri 839 MP (Carl Zeiss Meditec AG) has a 6-mm optical zone that serves as a 
diffractive zone, with an add power of +1.66D and +3.33D and a focal distance (theoretical value) of about 
80 and 40 cm, respectively. These two trifocal intraocular lenses have been reported to provide not only 
good distance and near, but also intermediate uncorrected visions 3) to 8). Neither of them has been approved 
in Japan. 
The remaining one lens is TFNT00 developed by US Alcon (hereinafter called the investigational lens). It 
was given the CE mark in June 2015 and is now commercially available in EU. As with the Alcon®
AcrySof® IQ ReSTOR® Single Piece of Alcon Japan (medical device approval number: 
22000BZX00970000; hereinafter called SN6AD1) approved in Japan, the investigational lens provides 
multiple focuses based on the diffractive structure of the optical zone. SN6AD1 is a bifocal intraocular lens 
designed to have a diffractive zone with 3.6 mm around the optical part center, with an add power of +3D 
and a near focal distance (theoretical value) of about 40 cm. The investigational lens is designed to have a 
diffractive zone with 4.5 mm around the optical part center. This design change of the diffractive zone 
allows focusing on distance, intermediate, and near objects. The investigational lens has an add power of 
+2.17D and +3.25D and intermediate and near focal distances (theoretical value) of about 60 and 40 cm, 
respectively. It has an intermediate focus of 60 cm in addition to the distance and near (40 cm) focuses of 
SN6AD1. A non-clinical study (simulation with Badal images) performed to compare the visions potentially
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achieved with the investigational lens and SN6AD1 showed that the investigational lens had a potential to 
provide equivalent distance and near visions to SN6AD1 and better intermediate visions at 80 and 60 cm 9). 
In general, diffractive lenses are structurally associated with diffraction loss and resulting reduced contrast 
sensitivity because not all the lights passing through the lens are focused on the retina.
 
 
 A clinical study of SN6AD1 (C-
07-44) showed an uncorrected distance VA (logMAR) of 0.03 ± 0.14, uncorrected near vision of 0.04 ±
0.12, and normal photopic contrast sensitivity for both distance and near visions at 1 year postoperation10, 11). 
Although these visual acuity values from Badal images were obtained from a simulation, the investigational 
lens can correct not only distance and near visions, but also an intermediate vision of about 60 cm and is 
therefore expected to contribute to the improved quality of vision after cataract surgery.
The present study (ILH297-C003) is intended to confirm the safety of the investigational lens and examine 
its effectiveness as a multifocal lens by examining the vision results at different distances and investigating
the postoperative use of eyeglasses by subjects.
(2) Summary of known and possible risks and benefits to subjects
Alcon has received the Approval to Market for TFNT00 with a CE mark in the European Union. But the 
results of clinical study have not been made available yet. In USA, a clinical study on this lens is in the 
planning stage. However, the plural clinical studies on same material IOLs were completed and in 
widespread clinical use in Japan and other countries. These clinical study data is described on investigator’s 
brochure.
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1 2 / 5 8 pa ge
2 ．O B J E C TI V E( S)
T he o bjecti ve of t his st u d y is t o e val uate safet y a n d effecti ve ness of Acr y S of ® I Q Pa n O pti x ™ I O L M o del 
T F N T 0 0 w he n i m pla nte d t o re place t he nat ural le ns f oll o wi n g cataract re m o val.
3 ．T E S T A R TI C L E( S)
( 1) I n v e sti g ati o n al l e n s
Acr y S of ® I Q Pa n O pti x ™ I O L M o del T F N T 0 0（+ 3. 2 5 D a n d + 2. 1 7 D a d d p o wer ）
C o nstr ucti o n
Si n gle -piece c o nstr ucti o n le ns c o nsisti n g of t he o ptic a n d t he ha ptic ma de of t he sa me material, o ptic dia meter: 
6. 0 m m, o verall le n gt h: 1 3. 0 m m,
 
 ( See Fi g. 3- 1)
Fi g . 3-1 Pr o d u ct Dr a wi n g ( T F N T 0 0)
O ptic
Material: Cr oss -li n ke d, acr ylate/ met hacr ylate c o p ol y mer wit h a c he micall y b o n de d ultra vi olet a n d bl ue li g ht 
a bs or ber *
* : N - 2-[ 3-( 2-met h yl p he n ylaz o) - 4-h y dr o x y p he n yl] et h yl met hacr yla mi de 
E d ge t hic k ness: 0. 2 1 0. 0 5 m m
As p heric a nteri or 
s urface wit h a n 
diffracti ve o ptical 
str uct ur
 
creati n g a 
+ 3. 2 5 D near a n d
+ 2. 1 7 D i nter me diate
a d d p o wer
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7

1 3 / 5 8 pa ge
A d d p o wer: + 3. 2 5 D 、+ 2. 1 7 D
Refracti ve p o wer: 1 2. 5 ～2 6. 5 D (i n 0. 5 D i ncre me nts)
Ha ptic
Material: Sa me as t he o ptic material
S ha pe: M o difie d - L
A n g ulati o n: 0 
( 2) U s a g e
T he i n vesti gati o nal le ns will be place d wit hi n t he ca ps ular ba g after re m o val of t he nat ural cr ystalli ne le ns 
f oll o wi n g p hac oe m ulsificati o n. Bilateral i m pla ntati o n of t he i n vesti gati o nal le ns is pla n ne d f or all s u bjects . T he 
le ns is i m pla nte d first t o t he e ye wit h m ore a d va nce d cataract. If b ot h e yes ha ve a si milar de gree of cataract, 
perf or m t he s urger y  first f or t he ri g ht e ye.  The ti me of s urger y  for t he re mai ni n g e ye ( 2 n d e ye) will be wit hi n 
3 0 da ys fr o m t he first s ur ger y w hic h will be deci de d b y  t he i n vesti gat ors base d o n t he res ults of t he e xa mi nati o n 
a n d o bser vati o n at Visit 1 ( 1-2 da ys after 1st e ye i m pla ntati o n).
[J ustificati o n f or t he i nte n de d use]
Si nce t he i n vesti gati o nal le ns, li ke c o n ve nti o nal I O Ls, is a p osteri or c ha m ber le ns w hic h is wi del y i m pla nte d 
f oll o wi n g cataract e xtracti o n, p hac oe m ulsificati o n is a d o pte d. To assess t he bi n oc ular visi o n, t he i n vesti gati o nal 
le ns will be i m pla nte d t o bilateral e yes. C o nsi deri n g t he safet y of t he st u d y su bjects, t he ti me of i m pla nt t o t he 
re mai ni n g e ye ( 2n d e y e) will be deci de d base d o n t he res ults of t he 1st i m pla nt.
( 3) I n str u cti o n s o n p a c k a g e a n d l a b eli n g
P a c k eac h i n vesti gati o nal le ns i nt o t he cart o n wit h la beli n g of:

Na me a n d a d dress of t he S p o ns or

P ur p ose (f or use i n cli nical st u d y)

Le ns m o del , serial n u m ber a n d refracti ve p o wer, A -c o nsta nt

Met h o d of st ora ge a n d preca uti o ns
T he pac ka ge c o ntai ns t he f oll o wi n g a d hesi ve la bels besi des t he i n vesti gati o nal le ns:

I nvesti gati o nal le ns c o ntr ol la bels (t o be attac he d t o I n vesti gati o nal le ns C o ntr ol L o g, me dical 
rec or d)

A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7
C o p y  of t he i n vesti gati o nal le ns i nf or mati o n gi ve n t o st u d y su bjects (t o be attac he d t o t he St u d y 
Partici pa nts Car d).

1 4 / 5 8 pa ge
< Cart o n of t he i n vesti gati o nal le ns >
( Si de vie w)
( Fr o nt vie w)
< A d hesi ve la bel >
(I n vesti gati o nal le ns C o ntr ol La bel)
( C o p y of t he i n vesti gati o nal le ns i nf or mati o n gi ve n t o st u d y s u bjects)
St ora ge met h o ds:
Kee p t he le ns n ot at a hi g h te m perat ure/ h u mi dit y a n d a wa y fr o m 
direct li g ht.
D o n ot kee p t he le ns at 4 5 C or hi g her.
Preca uti o ns:
・T his pr o d uct is a sterilize d pr o d uct use d o nl y o nce.  Do n ot re-
sterilize or re-use t he o nce o pe ne d pr o d uct.
・D o n ot use t he pr o d uct if t he pac ka ge has a tear or if t he 
pac ka ge is o pe ne d a n d t he sterilit y is n ot ass ure d.
A L C O N J A P A N L T D. 1 - 2 3-1, T ora n o m o n, Mi nat o -k u, T o k y o
M o del:
Refracti ve 
p o w er:
Serial N o.:
M o del:
Refr acti ve 
p o wer:
N a m e of st u d y s u bject:
I mpla nt e ye:
ri g ht / left
O verall le n gt h i ncl u di n g 
t he ha ptic:
O ptic dia meter:
Serial N o.:
Date of s ur ger y:
   
S ur ge o n:
F or Use 
of
Cli nical
st u d y
M o del: 
Serial N o
A- c o nsta nt : * * *. *
Barc o de
Ill ustrati o n 
of t he le ns
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7
F or Use of 
Cli nical st u d y

15 / 58 page
(4) Storage and Management
The investigational lens storage manager appointed at each study site appropriately stores and manages the 
investigational lens according to the investigational lens management operating procedure provided by Sponsor 
beforehand, and prepares the inventory on which the receipt and delivery of the product, such as use of the 
product by each investigator, are recorded.
4．SUBJECTS
(1) Estimated Total Sample Size
60 subjects 120 eyes
(2) Inclusion Criteria
The patient who meets all criteria specified in the following 1) through 9).
1）
Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with 
bilateral cataracts;
2）
Able to comprehend and sign a statement of informed consent;
3）
Willing and able to complete all required postoperative visits;
4）
Calculated lens power within the available range;
5）
Planned cataract removal by phacoemulsification;
6）
Potential postoperative BCDVA of 0.5 decimal or better in both eyes;
7）
Subject with preoperative astigmatism < 1.0 D
Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the 
study.
8）
Clear intraocular media other than cataract in both eyes;
9）
The subject must be able to undergo second eye surgery within 30 days of the first eye surgery.
[Justification for the inclusion criteria]
1 and 5: Cataract extraction is the indication of the clinical study.
2 and 3: One of GCP requirements
4: Essential condition for implant of the investigational lens.
6, 7, 8 and 9: Conditions to minimize the potential non-IOL factors which may affect the visual acuity data
(3) Exclusion Criteria
[Exclusion Criteria Prior to Surgery]
The patient who meets any criteria specified in the following 1) through 21).
1）
Significant irregular corneal aberration as demonstrated by corneal topography;
2）
Inflammation or edema (swelling) of the cornea affecting post-operative visual acuity;
3）
Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal 
disorders) that are predicted to cause future acuity losses to a level worse than 0.5 decimal for 
BCDVA;
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4）
Subjects who may be expected to require ocular surgery (other than blepharo-surgery, laser surgery 
of fundus and YAG capsulotomy) during the study;
5）
Previous refractive surgery;
6）
Amblyopia;
7）
Clinically severe corneal dystrophy (eg., epithelial, stromal, or endothelial dystrophy), keratitis, 
keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia;
8）
Diabetic retinopathy;
9）
Extremely shallow anterior chamber, not due to swollen cataract;
10）Microphthalmos;
11）Previous retinal detachment;
12）Previous corneal transplant;
13）Recurrent severe anterior or posterior segment inflammation of unknown etiology;
14）Rubella or traumatic cataract;
15）Iris neovascularization;
16）Glaucoma;
17）Aniridia;
18）Optic nerve atrophy;
19）Pregnancy;
20）Any subject currently participating in another investigational drug or device study.
21）Disqualified by the investigator or the sub-investigator because of physical or ophthalmic diseases
[Exclusion Criteria During Surgery]
The patient who meets any criteria specified in the following 1) through 8).
1）
Mechanical or surgical manipulation required to enlarge the pupil; pupil size must be at least 4.5 
mm or larger just prior to implantation;
2）
Other planned ocular surgery procedures for the duration of the study;
3）
Excessive iris mobility;
4）
Significant vitreous loss;
5）
Significant anterior chamber hyphema;
6）
Uncontrollable intraocular pressure;
7）
Zonular or capsular rupture or tear;
8）
Bag-sulcus, sulcus-sulcus or unknown placement of the haptics.
In the event of zonular damage, capsulorhexis tear, or decentered capsulorhexis during surgery, the surgeon 
should decide whether the stability of the IOL would be compromised by the complication. If the IOL 
stability would be compromised, the study IOL should not be implanted, the subject should be discontinued 
from the study, and the surgeon should make arrangements to implant an alternative non-study IOL.
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[Justifications for the exclusion criteria]
{Exclusion Criteria Prior to Surgery}
9, 12, 13, 17 and 20: Factors potentially affecting effectiveness evaluability and criteria to secure safety of 
study subjects
1, 2, 4, 5, 6, 7, 8, 11, 18 and 19: Factors potentially affecting effectiveness evaluability
3, 10, 14, 15, 16 and 21: Criteria to secure safety of study subjects
{Exclusion Criteria During Surgery}
1: Factors potentially affecting effectiveness evaluability
2-7: Criteria to secure safety of study subjects
5．STUDY DESIGN
Multi-center, single-arm and non-masked study
6．STUDY PROCEDURE
(1) Outline
The investigational lens will be implanted to both eyes in subjects with bilateral cataract. Registration of 
patients and the implantation of the investigational lens will be conducted in consideration of securing 120 eyes 
in 60 subjects as the analysis subjects. As shown in (4) of this section, subjects will be followed for 120 to 180 
postoperative of the second implant for effectiveness and safety evaluation of the investigational lens.
(2) Eligibility Assessment and Subject Identification Code Allocation
Subjects are selected and subject code is assigned according to the following procedures.
1.
After explanation of the content of study to subject, obtain consent to participate in the clinical study 
from the qualified subject. Subject code will be assigned after obtain consent.
2.
Perform tests/observations (screening tests) necessary for the assessment according to the 
inclusion/exclusion criteria and the investigator will assess the qualification. In the case of meeting the 
exclusion criteria during surgery, do not implant the investigational lens to the eye and do not enroll the 
eye in the clinical study.
3.
The same subject code will be used for both the first and second implants. Prior to the second implant, 
obtain consent to continuously participate in the clinical study from the subjects.
(3) Surgical Technique
The lens is implanted first to the eye with more advanced cataract (1st eye). If both eyes have a similar degree 
of cataract, perform the surgery first for the right eye.  The time of surgery for the remaining eye (2nd eye) will 
be within 30days from the first surgery which will be decided by the investigator based on the results of the 
examination and observation at Visit 1 (1-2 days after 1st eye implantation).
Each investigator should use his or her standard surgical technique on all subjects.  A continuous tear 
capsulorhexis should be performed to open the anterior capsule.  Implant of the investigational lens will follow 
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phacoemulsification.  The investigational lens, including both haptics, should be placed within the capsular 
bag. If the standard surgical technique cannot be applied or if the investigational lens cannot be implanted, the 
subject should be discontinued from the study and an approved and marketed lens should be implanted instead 
of the investigational lens.  All study subjects should receive the investigator’s standard regimen of 
preoperative, operative, and postoperative medications.
(4) Eye Examinations Schedule
As shown in Table 6-1, the examination and observation are carried out for the period from before surgery day 
120 to 180 after surgery of second eye. At Visit 0 and Visit 4A, the examination and observation of both eyes 
are carried out on the same day.
Both the examination and the observation may be per Visited on the same day if the day is within the window 
for the examination and observation of the eye concerned (first or second operated eye). Also examination and 
observation can be performed separately over days if these are performed within the set window.
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Table 6-1 Eye Examinations Schedule
PROCEDURES/ 
MEASUREMENTS/
STATUS
Visit 0
(Preop)
Visit 00
(Op)
Visit 00A
(Op)
Visit 1
(d1-2)
Visit 1A
(d1-2)
Visit 2
(d7-14)
Visit 2A
(d7-14)
Visit 3
(d30-60)
Visit 3A
(d30-60)
Visit 4A
(d120-180)
Informed Consent*
X
Demographics
X
Inclusion/Exclusion Criteria
X
1st
2nd
Urine Pregnancy Test (female only)
X
Intraocular Pressure
B
1st
2nd
1st
2nd
1st
2nd
B
Laser Flare Meter (mydriatic)
1st
2nd
(1st)
(2nd)
Slit Lamp Examination
B
1st
2nd
1st
2nd
1st
2nd
B
Dilated Fundus Examination
B
1st
2nd
B
Fundus visualization
1st
2nd
B
IOL Observations
1st
2nd
1st
2nd
1st
2nd
B
Lens decentration and tilt
1st
2nd
1st
2nd
1st
2nd
B
Subjective Posterior Capsule 
Opacification / Posterior 
Capsulotomy
1st
2nd
1st
2nd
1st
2nd
B
Subjective Symptoms
Xb
Xb
Xb
Operation Records**
1st
2nd
Ocular Concomitant Medications
B
1st
2nd
1st
2nd
1st
2nd
1st
2nd
B
Secondary Surgical Interventions
1st
2nd
1st
2nd
1st
2nd
B
Device Deficiencies
Adverse Events
1st: First eye, 2nd: Second eye, B: Both eyes (1st eye and 2nd eye), Xb: Binocular Testing, X: Conduct
,
(1st) (2nd): If there is any inflammation sign at Visit 2 or Visit 2A, perform examination again.
* : Consent continuously participate of this clinical study is obtained between 1st and 2nd implant.
** : Operative Eye, Problems During Surgery, Other Procedures at Surgery, Insertion Instrument, Incision Site, Final Incision Size, 
anterior capsulotomy size, and Lens Information
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(5) Examinations Procedure
Below examination and observation are carried out at Visit 0, Visit 00/00A, Visit 1/1A, Visit 2/2A, Visit 3/3A 
and Visit 4A. The same instruments and methods should be used for all measurements at all visits in each site.
1）Preoperative Examination (Visit 0)
・Informed consent
Routine test conducted for cataract subjects is performed. Subjects still qualifies after these tests are 
explained this study. Ensure that the subject has read, understood, and signed and dated a statement of 
informed consent prior to undergoing any study specific testing. Even though routine test was operated 
before informed consent, these data can be use as study data.
・Demography
Sex, age, systemic complication, ophthalmologic surgical history
・Urine Pregnancy Test (female subjects only)
Perform a urine pregnancy test if the subject is female and of childbearing potential.
・Visual acuity
Measure the monocular visual acuity about both eyes. Measure the visual acuity 
 
 using the 100% contrast chart at each measurement distance as below. 
 
 
・Subjective Symptoms
To the following inquiries by the investigator or co-investigator, the subject will declare the following 
Subjective symptoms.
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・Target Residual Refractive Error
Indicate the amount of postoperative refractive error (±) anticipated based on the power calculation software 
used for the lens power that is chosen. 
 
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・Intraocular pressure
Perform tonometry using a contact or a non-contact ocular tonometer.
・Slit Lamp Examination
Record the presence or absence of clinically significant ophthalmologic findings.
・Dilated Fundus Examination
Record the presence or absence of clinically significant ophthalmologic findings.
・Ocular concomitant medications
Indicate the type of concomitant ocular medications used by the subject at the time of the examination.
・Inclusion/exclusion criteria
Ensure that the subject meets inclusion/exclusion criteria and meet all qualifications for participation.
・Adverse Events, Device Deficiencies
Presence/absence of adverse events and device deficiencies are recorded since informed consent.
2）Surgery Day (Visit 00/00A)
Record surgical information at Visit 00 (1st eye) and Visit 00A (2nd eye) respectively, Obtain consent in 
continuation of the study from each subject prior to the surgery on the 2nd eye.
・Operative Eye
Indicate which eye is being implanted.
・Qualification during the surgery.
Assess qualification according to the inclusion/exclusion criteria during the surgery.
・Incision Site
Record the incision site (sclera, at limbus, or cornea).
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・Anterior capsulorhexis Diameter
Indicate anterior capsulorhexis diameter (mm) to the nearest 0.1 mm.
・Final Incision Size
Indicate final incision size (mm) to the nearest 0.1 mm.
・Insertion Instrument
Indicate which approved instrument and cartridge was used to fold and insert the IOL through the wound.
・Problems during surgery
Indicate what problems, if any, occurred during surgery.  If any exclusion criteria occur, discontinue the 
subject from the clinical study.
・Other procedures at this surgery
Any other procedures performed at this surgery should be indicated.  Since other procedures at this surgery 
are included in the exclusion criteria, discontinue the subject from the clinical study.
・Ocular concomitant medications
Indicate the type of concomitant ocular medications (e.g. adrenocorticosteroid, chemotherapy, NSAIDs, IOP 
reducing drug) used during the surgery.
・Lens Information
Provide the IOL information (IOL model, refractive power, serial No.) also in the event of discontinuation of 
implant. Attach the adhesive label contained in the package of the investigational lens to the CRF and the 
Study Participants Card.
・Adverse events and Device deficiencies
Presence/absence of adverse events and device deficiencies are recorded.
3）Postoperative Examinations
Below examination and observation are carried out at Visit 1/1A, Visit 2/2A, Visit 3/3A and Visit 4A.
・Visual acuity
Visual acuity is tested under photopic 
 using the 100% contrast chart at 
each measurement distance as below.
 
 
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・Subjective Symptoms (Visit 3A, Visit 4A: Binocular）
To the following inquiries by the investigator, the subject will declare the following Subjective symptoms.
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・Intraocular Pressure (Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd eye), Visit 4A: Both 
eyes)
Perform tonometry using a contact or a non-contact ocular tonometer.
・Laser Flare Meter (Visit 2/2A: Monocular (1st or 2nd eye), Visit 4A: Both eyes)
Perform examination using a laser flare meter at mydriatic condition. If there is any inflammation sign at 
Visit 2 or Visit 2A in laser flare mater and Slit lamp examination, perform examination again at Visit 4A.
・Slit Lamp Examination (non-mydriatic or mydriatic)
(Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd eye), Visit 4A: Both eyes)
Record the presence or absence of clinically significant ophthalmologic findings.
・Dilated Fundus Examination (Visit 2/2A: Monocular (1st or 2nd eye), Visit 4A: Both eyes)
Record the presence or absence of clinically significant ophthalmologic findings.
・Fundus visualization (Visit 2/2A: Monocular (1st or 2nd eye), Visit 4A: Both eyes)
Indicate whether the investigational lens has caused any loss in fundus visualization that would alter a
surgeon’s ability to administer retinal treatment, as compared to experience with monofocal IOLs.
・IOL observation (Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd eye), Visit 4A: Both eyes)
Observe the IOL surface and the inside of the haptic and optic of the investigational lens with a slit-lamp 
microscope, and record the presence/absence of visible abnormal findings (debris on IOL surface, forceps 
mark on IOL surface, glistening, formation of membrane on IOL, pigmentation on IOL, etc.). And regarding 
the observed findings, evaluate the clinical significance. If the problem may negatively affect postoperative 
visual acuity, etc., handle it as the clinical significant, and if possible, take photos.
・IOL position change (Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd eye), Visit 4A: Both 
eyes)
Tilt and/or decentration should be reported if greater than 10 degrees or 0.5mm.
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・Posterior Capsule Opacification (PCO) (Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd
eye), Visit 4A: Both eyes)
Indicate the presence/absence of PCO. If PCO is present, it will be graded as clinically non-significant, 
clinically significant or clinically significant requiring YAG as follows:
・Posterior capsulotomy (Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd eye), Visit 4A: Both 
eyes)
Indicate whether a posterior capsulotomy was performed or not. If it was performed, report the date of the 
procedure and size.
・Ocular concomitant medications (Visit 1/1A, Visit 2/2A, Visit 3/3A Monocular (1st or 2nd eye), Visit 
4A: Both eyes）
Indicate the type of concomitant ocular medications used by the subject at the time of the examination.
・Secondary surgical intervention (Visit 1/1A, Visit 2/2A, Visit 3/3A: Monocular (1st or 2nd eye), Visit 
4A: Both eyes)
Record the presence/absence of any postoperative surgical procedure that may be caused by the 
investigational lens. The SSI include iridotomy/ iridectomy for pupillary block, vitrectomy for pupillary 
block, adjustment of the position of the investigational lens, removal of the investigational lens due to 
inflammation, exchange of the investigational lens, etc., but not limited to them. Meanwhile, retinal 
reattachment surgery and posterior capsule resection are not included as SSI.
・Adverse events and Device efficiencies (Visit 1/1A, Visit 2/2A, Visit 3/3A and Visit 4A)
Presence/absence of adverse events and device efficiencies are recorded.
4）Unscheduled Visits Examinations
When a subject makes an unscheduled visit for adverse events etc., inquire about the reason for the visit and 
retain the record.  The investigator will perform examinations/observations those are necessary and retain 
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the record. If the visit is associated with any ophthalmologic symptom, identify the eye and retain the record.
(6) Anticipated study period
01-Apr-2017 ~ 30-Jun-2018 
7．CONCOMITANT THERAPY
(1) Permissible concomitant therapy
The use of spectacles and contact lenses is permitted.
(2) Prohibited concomitant therapy
Concomitant application of other ways of correcting refraction, possibly affecting evaluation of the 
investigational lens, is prohibited during the study.  For example, laser in situ keratomileusis, PRK and 
refraction corrective contact lens (orthokeratology).
8．DISCONTINUED SUBJECTS
(1) Discontinued Subjects
The subject is discontinued in the following cases:
1）The investigational lens was removed for reasons of adverse events.
2）The investigator (or sub-investigator) judged it necessary to replace the investigational lens with 
another IOL.
3）The investigator (or sub-investigator) judged it necessary to discontinue the subject from the study.
4）The subject canceled the consent once issued.
5）The subject requested discontinuation of the study.
6）Continuation of the study was judged as impossible because of subject’s referral or move during the 
study.
7）Other (discontinuation is necessary)
Upon discontinuation of the study, if the investigator or sub-investigator decided the examination or 
observation is necessary, the examination or observation should be carried out as far as possible under the 
subject’s consent, and the date and reason of discontinuation are entered in the electric case report form.  In 
case where continuation of the study is difficult because of discontinued visit of the subject to the clinic, the 
subject is followed over telephone, by mail or other appropriate means and the reason for discontinued visit, 
survival/death of the subject, presence/absence of adverse events, etc., are entered in the electric case report 
form.  
If the investigational lens remained implanted in the subject after discontinuation of the study, the subject is 
informed as to the necessity of receiving periodical ophthalmological follow-up to assure safety at least 6 
months after surgery, and the subject is asked to extent cooperation as much as possible.
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( 2) Di s c o nti n u ati o n of t h e e ntir e st u d y
If disc o nti n uati o n of t he e ntire st u d y has bec o me i ne vita ble f or reas o ns of re p orts o n seri o us safet y i nf or mati o n 
fr o m a n y partici pati n g st u d y site or o verseas, pr o ble ms pertai ni n g t o t he q ualit y of t he i n vesti gati o nal le ns, a n d 
s o o n, t he S p o ns or is re q uire d t o i m me diatel y i nf or m t he i n vesti gat or a n d t he hea d of eac h st u d y site of 
disc o nti n uati o n of t he st u d y a n d its reas o n i n writi n g.
9 ．A n al y si s Pl a n
9. 1 S u bj e ct E v al u a bilit y
T he fi nal s u bject e val ua bilit y will be deter mi ne d pri or t o data base l oc k. A nal ysis datasets use d f or safet y  a n d 
effecti ve ness a nal yses of t his st u d y are defi ne d as f oll o ws.
9. 1. 1 Safet y A nal y sis Set
T he pre -treat me nt safet y a nal ysis set will i ncl u de all s u bjects w h o c o nse nte d t o partici pate i n t he st u d y. 
T he pre -treat me nt safet y a nal ysis set will be t he set t hat will be use d t o s u m marize occ urre nce of 
a d verse e x perie nces pri or t o e x p os ure t o t he test article. T he treat me nt-e mer ge nt safet y anal ysis set will 
i ncl u de all e yes wit h atte m pte d i m pla ntati o n wit h t he test article (s uccessf ul or a b orte d after c o ntact 
wit h t he e ye).
9. 1. 2 All- I m pla nte d A nal y sis Set ( A A S)
All- I m pla nte d A nal y sis Set ( A A S) will i ncl u de all e yes wit h s uccessf ul test article i m pla ntati o n.
9. 1. 3 Best -Case A nal ysis Set ( B A S)
Best- Case A nal ysis Set ( B A S) will i ncl u de all e yes wit h s uccessf ul test article i m pla ntati o n t hat ha d

at least 1 p ost o perati ve visit;

n o mac ular de ge nerati o n at a n y ti me; a n d

n o maj or pr ot oc ol vi olati o n
9. 2 A n al y si s D at a s et
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7
A nal ysis datasets use d f or effecti ve ness a n d safet y a nal yses are as f oll o ws.
9. 2. 1 Dataset f or Pri mar y Ef fecti ve A nal y sis
A A S a n d B A S will be use d f or pri mar y effecti ve ness a nal ysis.  The pri mar y a nal ysis set f or 
effecti ve ness a nal yses will be t he A A S.

3 1 / 5 8 pa ge
9. 2. 3 Dataset f or Safet y A na l ysis
Pre -treat me nt safet y a nal ysis set will be use d f or a d verse e x perie nces pri or t o e x p os ure t o t he test 
article.  T he treat me nt -e mer ge nt safet y a nal ysis set will be use d f or all safet y varia bles after c o ntact wit h 
t he test article.
9 . 3 D e m o gr a p hi c s a n d B a s eli n e C h ar a ct eri sti c s
F o r all a nal ysis datasets ( Safet y Anal y sis Set, A A S a n d B A S), de m o gra p hics (se x, a ge [ < 6 0, 6 0 - 6 9, 7 0-7 9, 
≥8 0], s yste mic c o m plicati o n [ N o ne/ Yes, details] a n d past oc ular s urger y [ N o ne/ Yes, details]) will be 
s u m marize d wit h t he n u m b er a n d perce nt of s u bjects i n eac h cate g or y f or t he varia ble.  Age will als o be 
s u m marize d wit h descri pti ve statistics ( mea n, sta n dar d de viati o n, n u m ber of s u bjects, me dia n, mi n a n d ma x).
9. 4 Ef f e cti v e n e s s A n al y si s
T he o bjecti ve of t his st u d y is t o descri be safet y a n d ef fecti ve ness of t he i n vesti gati o nal le ns ( T F N T 0 0) w he n 
i m pla nte d t o re place t he nat ural le ns f oll o wi n g cataract re m o val.  Mo n oc ular a nal ysis will be perf or me d at 
b ot h first a n d sec o n d e yes.  Bi n oc ular a nal ysis will be perf or me d f or bi n oc ular testi n g para meters.
9. 4. 1 Pri mar y A nal y sis
Pri mar y ef fecti ve ness varia bles are as f oll o ws. 

M o n oc ular p h ot o pic best c orrecte d dista nce vis ual ac uit y ( 5 m)

M o n oc ular p h ot o pic dista nce c orrecte d i nter me diate vis ual ac uit y ( 6 0 c m)

M o n oc ular p h ot o pic dista nce c orrecte d near vis ual ac uit y ( 4 0 c m)
9. 4. 1. 1 Statistical H y p ot hesis
N o f or mal h y p ot hesis testi n g is pla n ne d.
9. 4. 1. 2 A nal ysis Met h o d
Deci mal m o n oc ular p h ot o pic best c orrecte d dista nce vis ual ac uit y ( 5 m) a n d deci mal m o n oc ular 
p h ot o pic dista nce c orrecte d i nter me diate vis ual ac uit y ( 6 0 c m) will be cate g orize d as f oll o ws.
・
< 0. 5
・
0. 5 - < 0. 7
・
0. 7 - < 1. 0
・
1. 0 -
Deci mal m o n oc ular p h ot o pic dista nce c orrecte d near vis ual ac uit y ( 4 0 c m) will be cate g orize d as 
f oll o ws. 
・
< 0. 4
・
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7
0. 4 -
T he N a n d perce nt of eac h categ or y will be pr o vi de d b y visit. F or t hese deci mal vis ual ac uit y, 
descri pti ve statistics ( ge o metric mea n, dis persi o n fact or ( D F), N, me dia n, mi n a n d ma x) will be 
pr o vi de d b y visit. Descri pti ve statistics (arit h metic mea n, sta n dar d d e viati o n, N, me dia n, mi n a n d 

32 / 58 page
max) will also be provided for logMAR visual acuity by visit.
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9. 5 H a n dli n g of Mi s si n g D at a
N o missi n g data will be i m p ute d.
9. 6 S af et y A n al y si s
Patie nt listi n gs will be pr o vi de d f or a d verse e x perie nces occ urre d fr o m i nf or me d c o nse nt t o e x p os ure t o t he 
test article usi n g Pre- Tr eat me nt Safet y A nal y sis Set.  Safet y varia bles bel o w will be a nal yze d usi n g 
Tr eat me nt-E mer ge nt Safet y A nal ysis Set.  F or c o nti n u o us varia bles, descri pti ve statistics ( mea n, sta n dar d 
de viati o n, N, me dia n, mi n a n d ma x) will be pr o vi de d f or act ual val ue a n d c ha n ge fr o m baseli ne at eac h visit. 
F o r cate g orical varia bles, N a n d perce nt will be pr o vi de d f or eac h cate g or y at eac h visit.

Sec o n dar y S ur gical I nter ve nti o ns relate d t o t he o ptical pr o perties of t he I O L

A d verse E ve nts (i ncl u di n g sec o n dar y s urgical i nter ve nti o ns n ot -relate d t o t he o ptical pr o perties of t he 
I OL)

De vice Deficie ncies

F u n d us vis ualizati o n

I ntra oc ular Press ure

Slit La m p E xa mi nati o n

Dilate d F u n d us E xa mi nati o n

I OL O bser vati o ns

S u bjecti ve P osteri or Ca ps ule O pacificati o n

P osteri or Ca ps ul ot o m y

Le ns dece ntrati o n a n d tilt


A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7
Laser Flare meter

3 4 / 5 8 pa ge

S u bjecti ve s y m pt o ms

Pr o ble ms d uri n g s ur ger y
9. 7 I nt eri m A n al y si s
N o i nteri m a nal ysis is pla n ne d.
9. 8 S a m pl e Si z e J u stifi c ati o n
T he 6 0 eli gi ble s u bjects will be bilaterall y i m pla nte d wit h t he Acr y S of I Q P a n O pti x I O L (T F N T 0 0). T he 
p ur p ose of t his st u d y is t o descri be safet y a n d effecti ve ness of t he i n vesti gati o nal le ns. T he sa m ple size is 
n ot deter mi ne d o n t he basis of a statistical p o wer calc ulati o n. Wi t h a sa m ple size of 6 0, a t w o-si de d 9 5 % CI 
f or t he mea n base d o n t he t-statistic will e xte n d 0. 2 6 * S D u nits fr o m t he o bser ve d mea n. Als o, a 9 5 % 
c o nfi de nce i nter val of 5 0 % ( 3 0/ 6 0) is ( 3 6. 8 %, 6 3. 2 %) base d o n t he e xact met h o d.
1 0 ．A D V E R S E E V E N T S a n d D E VI C E D E FI CI E N CI E S
A de vice defi cie nc y a n d a n a d verse e ve nt will be c ollecte d fr o m t he ti me i nf or me d c o nse nt is si g ne d .
( 1) G e n er al I nf or m ati o n
Defi niti o ns
De vice Deficie nc y
- a n y alle ge d deficie nc y relate d t o t he i de ntit y, q ualit y, d ura bilit y, relia bilit y, safet y, 
effecti ve ness, or perf or ma nce of a de vice.
A d verse E ve nt ( A E) - a n y unt o war d me dical occ urre nce i n a s u bject, user , or ot her pers o ns re gar dless of 
w het her or n ot t he e ve nt has a ca usal relati o ns hi p wit h t he me dical de vice(s) or test pr oce d ure(s) i n t he 
st u d y. Sec o n dar y s urgical i nter ve nti o n is als o re p orte d as a n a d verse e ve nt ( A d diti o nal i nf or mati o n 
a d dressi n g a d verse e ve nts is prese nte d i n S u p ple me ntal Attac h me nt B: Defi niti o n of A d verse E ve nts )
N o nseri o us A d verse E ve nt - a n a d verse e ve nt t hat d oes n ot meet t he criteria f or a seri o us a d verse e ve nt.
Seri o us A d verse E ve nt ( S A E) - a n a d verse e ve nt t hat le d t o a n y of t he f oll o wi n g:
・Deat h
・A seri o us deteri orati o n i n healt h t hat:
A) res ulte d i n a life -t hreate ni n g ill ness or i nj ur y.
N O T E: Life -t hre ate ni n g me a ns th at t he i n divi d u al w as at i m me di ate risk of de at h fro m t he eve nt 
as it occ urr e d, i.e., it d oes n ot i ncl u de a n eve nt w hic h hy p ot hetic ally mi g ht h ave c a use d de at h 
h a d it occ urr e d i n a m ore severe f or m.
B) res ulte d i n a n a n y p ote ntiall y si g ht-t hreate ni n g e ve nt or per ma ne nt i m pair me nt t o a b o d y str uct ure or 
a b o d y f u ncti o n.
C) re q uire d i n -s u bject h os pitalizati o n or pr ol o n gati o n of a n e xisti n g h os pitalizati o n.
A lc o n - B usi ness Use O nl y  
 
Effecti ve D ate:  
D oc u me nt:  
Versi o n:  
St at us:  E f f e c t i v e
Pri nte d B y:  
Pri nt Date:  
2 . 0 ;  M o s t - R e c e n t ;  E f f e c t i v e ;  C U R R E N T
T D O C - 0 0 5 2 9 7 5
P r o t o c o l  -  C l i n i c a l
2 3-Ja n- 2 0 1 7
N O T E: H os pit aliz ati o n t h at is st a n d ard of pr actice f oll o wi n g a s urgic al pr oce d ur e f or t he device 
ty pe w o ul d n ot be a S A E. I n ge ner al, h os pit aliz ati o n si g nifies t h at t he i n divi d u al rem ai ne d at t he 

35 / 58 page
hospital or emergency ward for observation and/or treatment (usually involving an overnight 
stay) that would not have been appropriate in the physician's office or an out-subject setting. 
Complications that occur during hospitalization are AEs. If a complication prolongs 
hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to 
whether
“hospitalization” occurred, the event should be considered serious.
D) resulted in a medical intervention to prevent A) or B) or any surgical intervention(excluding 
posterior capsulotomy).
E) resulted in any indirect harm as a consequence of incorrect diagnostic test results when used within 
manufacturer's instructions for use.
・Fetal distress, fetal death, or a congenital abnormality or birth defect.
Adverse Device Effect - any untoward and unintended response to a medical device (adverse device effect 
that cannot be denied the relations with the medical device), including any event resulting from device 
malfunction, insufficiencies or inadequacies in the instructions for use, or user error.
Serious Adverse Device Effect -
an adverse device effect that has resulted in any of the
consequences/characteristics of a serious adverse event or that might have led to any of these consequences 
if suitable action had not been taken or intervention had not been made or if circumstances had been less 
opportune.
(2) Reporting of serious adverse events (SAE)
If any serious adverse event occurs, the investigator will report the type of the serious adverse event to Alcon 
Japan within 24 hours after confirming the event. After obtainment of detailed information on the serious 
adverse event, the investigator will prepare a report and immediately submit it to Alcon Japan and the head of 
the study sites.
Contact for emergent communication (e.g. reporting of SAE)
Contact
Company 
telephone/facsimile
Email
Home telephone/ 
Cellular phone
TEL
FAX 
(3) Report of adverse events and evaluation of the causal relationship
All adverse events (related and unrelated to the medical device or test procedures) will be entered in the 
Adverse Event form. Surgically-related post-operative conditions that are normal consequences of the ocular 
surgery (see Appendix B) and not clinically relevant will be only reported as adverse events at the discretion of 
the investigator.
In addition, the investigator must document all serious adverse events (related and unrelated) on the Serious 
Adverse Event Form. Any device deficiencies will be entered in the device deficiency form within 24 hours 
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after confirming the event.
Adverse events will also be reported for any clinically relevant change from screening in any protocol specific 
safety parameter evaluated during the study, based upon an assessment by the investigator following exposure 
to an investigational product. 
Regarding the relationship with the investigational lens, a judgment will be made whether “not related” or 
“related.” Adverse events will be reported for any change in an ongoing medication and/or addition of a new 
medication, based upon an assessment by the investigator.
(4) Intensity Assessment
For every AE, the investigator must assess the intensity (severity). Events should be classified as mild, 
moderate, or severe. These classifications should be based on the following definitions:
(5) Follow-up of Subjects / Subjects with Adverse Events
The Investigator is responsible for adequate and safe medical care of patients during the trial and for 
ensuring that appropriate medical care and relevant follow-up procedures are maintained after the trial. 
For subjects who are experiencing ongoing unresolved adverse events at the time of their study 
completion or early discontinuation from the study, it is recommended that the investigator schedule an 
appropriate follow-up visit in order to determine the outcome of the event.
(6) Subject Pregnancy
If the subject becomes pregnant during the study, the investigator or sub-investigator will report it to Alcon 
Japan immediately. However, pregnancy is not included in adverse event. Subjects who become pregnant 
during the study will not be discontinued; however, all data will be excluded from the Best-Case Analysis Set 
(BAS).
11．ETHICS
(1) Institutional review board
Prior to the start of the study, the institutional review board (IRB) of each study site is required to inspect and 
evaluate the planned study as to the acceptability of implementing the study, appropriateness of the contents of 
the protocol, case report form and informed consent document, and other matters related to the study from the 
ethical, scientific and medical points of view, with an ultimate goal of protecting the human rights and well-
being of the subjects.  
The inspection and examination by the IRB may be performed again also during a certain period of time after 
the start of the study or when the head of the study site sees the necessity of additional inspection/examination 
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so that the study may be monitored continuously.
(2) Ethical consideration
The study is implemented after a contract on implementation of the study is concluded between the Sponsor 
and each study site following inspection and authorization of the study by the IRB of each study site. 
If deemed necessary to ensure safe implementation of the study, the protocol of this study may be revised in 
accordance with the provisions set forth in “Section 12. PROTOCOL AMENDMENTS” This study is carried 
out in accordance with the principles set forth in the Declaration of Helsinki and pursuant to the provisions of 
the protocol, Article 14 Paragraph 3 and Article 80-2 of the Pharmaceutical and Medical Device Act, the 
Ministerial Ordinance on Clinical Studies of Medical Devices (No. 36, Ministry of Health, Labor and Welfare, 
March 23, 2005) and the Notification about Enforcement of the Ministerial Ordinance on Clinical Studies of 
Medical Devices (No. Yakushoku-0720003, Director of Pharmaceutical and Food Safety Bureau, Ministry of 
Health, Labor and Welfare, July 20, 2005).
(3) Protection of subjects’ privacy
To protect the privacy of individual subjects, only the identification codes are used to represent the subjects 
whose data are used in case report form, etc., so that leakage of the identifiable individual information about 
the subjects can be prevented.
(4) Specifications to secure safety of study subjects
1)
Actions to take for adverse events
In the event of acknowledging any adverse events, the investigator or the sub-investigator should immediately 
take appropriate actions irrespective of the presence or absence of causal relationship with the investigational 
lens.
2)
Supply of new information
In the case of obtaining safety-related new and significant information related to the clinical study, the sponsor 
should supply the information in writing to the investigator and the head of the study site and take necessary 
actions.
3)
Avoiding emergent risks
In the event of deviating from the study protocol to avoid the emergent risk and secure safety of the study 
subject or because of other unavoidable clinical reasons, the investigator will retain the record and submit the 
documentation and justification of the protocol deviation to the sponsor and the head of the study site.
(5) Compensation for health hazards
If any subject has sustained health hazards arising from this study, best healthcare is provided to that subject.  
The Sponsor needs to be covered by insurance for liability arising from medical devices.
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(6) Payment to subjects
As a reward to the cooperation of each subject with the study, the Sponsor pays an amount of money, 
predetermined through negotiation with each participating study site, to each subject.  This payment is not 
intended to force any subject to remain in the study.
12．PROTOCOL AMENDMENTS
When the protocol is revised, the sponsor and the investigator will exchange an agreement in writing.  The 
revised protocol, etc. will be reviewed and approved by the IRB of the study site before new subjects are 
enrolled, depending on the necessity.
13．CONSIDERATIONS FOR DOCUMENTATION AND COMPLETION OF
CASE
REPORT FORM
The Investigator, or coordinator etc. will complete the electronic case report form by himself or herself based 
on source data in accordance with the protocol and the preparation procedure of the electronic case report form. 
14．MONITORING
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate intervals. The 
clinical investigation will be monitored to ensure that:
1．The rights and well-being of the subjects are protected.
2．The reported data are accurate, complete, and verifiable from the source documents.
3．The study is conducted in compliance with the current approved protocol (and amendment[s], if 
applicable), with current Good Clinical Practices (GCPs), and with applicable regulatory 
requirements.
15．RETENTION OF THE RECORDS
The records for this clinical study shall be stored properly: At expiration of the retention period of the records, 
the sponsor will notify the study sites thereof.
Study sites and investigators shall preserve the protocol, source documents, informed consent forms agreed, 
informed consent form and other written information, records on handling of the study devices and other 
documents required by the provisions of MHLW Ordinance No. 36 date March 23, 2005. Above documents 
should be retained either three years after the date of termination or completion of the clinical study or approval 
of the importing of the devices (in case of termination of the development, three years after the date of the 
termination) whichever date is later.
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16．REFERENCES
1)
Bissen-Miyajima H.: Multifocal IOL; 3-12, 2008
2)
Bissen-Miyajima H.: Multifocal IOL; 13-25, 2008
3)
Vryghem JC, Heireman S. Visual performance after the implantation of a new trifocal intraocular lens. Clin 
Ophthalmol. 2013; 7: 1957–1965.
4)
Marques EF, Ferreira TB. Comparison of visual outcomes of 2 diffractive trifocal intraocular lenses. J 
Cataract Refract Surg. 2015; 41:354–363
5)
Mojzis P, Kukuckova L, Majerova K, Liehneova K, Piñero DP. Comparative analysis of the visual 
performance after cataract surgery with implantation of a bifocal or trifocal diffractive IOL. J Refract Surg. 
2014;30(10):666-72.
6)
Mojzis P, Majerova K, Hrckova L, Piñero DP. Implantation of a diffractive trifocal intraocular lens: One-year 
follow-up. J Cataract Refract Surg. 2015;41(8):1623-30.
7)
Jonker SM, Bauer NJ, Makhotkina NY, Berendschot TT, van den Biggelaar FJ, Nuijts RM. Comparison of a 
trifocal intraocular lens with a +3.0 D bifocal IOL: Results of a prospective randomized clinical trial. J 
Cataract Refract Surg. 2015;41(8):1631-40.
8)
Cochener B, Vryghem J, Rozot P, Lesieur G, Chevalier JP, Henry JM, David T, Lesueur L, Gatinel D, Ganem 
C, Blanckaert J, Van Acker E, Heireman S, Ghekiere S. Clinical outcomes with a trifocal intraocular lens: a 
multicenter study. J Refract Surg. 2014;30(11):762-8.
9)
In-house reference: TDOC-0050087 Clinical Evaluation Report for:ACRYSOF IQ PANOPTIX IOL Model 
TFNT00
10) Bissen-Miyajima H., Hayashi K., Yoshino M., Nakamura K., Yoshida M.: Atarashii Ganka 27(12); 1737-
1742, 2010
11) In-house reference : CSR Supplement (C-07-44 date of preparation 2010/2/4)
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Signature page
The sponsor and the Investigator agree to conduct the study in accordance with the 
details and procedures described in this study protocol and electronic CRF.
       Investigator
         Medical institution:［                                                                       ］
         Affiliation and position:［                                                                      ］
         Name:［                                                               ］
                                                                                                         (Signature or seal)
         Date:
       Sponsor
Study manager
Alcon Japan Ltd.  Development department
Name (signature):［
                  
］
                                                               
Date:
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APPENDIX
APPENDIX A:
APPENDIX B: 
Definition of Term
Definition of Adverse Events
APPENDIX C:
APPENDIX D:
Clinical Trial System, Participating Facilities and Principal Investigators
Confidentiality and Publication of the Study
APPENDIX E:
APPENDIX F:
APPENDIX G:
APPENDIX H:
Direct Access to Source Data and Documents
Quality Control and Quality Assurance of the Study
Obligations of Investigators
Informed consent
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Clinical Investigation of the AcrySof® IQ PanOptix™ IOL 
Model TFNT00
Protocol Appendix
A
Definition of Term
B
Definition of Adverse Events
C
Clinical Trial System, Participating Facilities and Principal Investigators
D
Confidentiality and Publication of the Study
E
Direct Access to Source Data and Documents
F
Quality Control and Quality Assurance of the Study
G
Obligations of Investigators
H
Informed consent
Alcon Japan Ltd.
1-23-1, Toranomon, Minato-ku, Tokyo
Protocol No.: ILH297-C003
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APPENDIX A: Definition of Term
Corneal edema - Fluid in stromal layer of cornea with or without epithelial edema.
Hyphema - Blood in the anterior chamber, present over a period of time.
Hypopyon - Accumulation of white blood cells in the anterior chamber.
Intraocular infection/Endophthalmitis - Inflammation of ocular tissue including confirmed infection and sterile 
inflammation.
Iritis - Inflammation of the iris causing pain, tearing, blurred vision, small pupil (miosis), and a red congested 
eye, as evidences by flare and/or cell in the anterior chamber.
Lens Dislocation – Displacement of the lens from its intended place.
Macular degeneration - Deterioration of macular tissue usually evident as a loss of pigment from the pigment 
epithelial layer.  Included in this category are central serous chorioretinopathy, choroidal neovascular membrane 
and pigment epithelial detachment.
Macular edema - Swelling of macular tissue from excess fluid accumulation in the macular area diagnosed by 
clinical symptoms and/or fluoroscopic exam. This includes cystoid macular edema.
Membrane formation on IOL - Outgrowth of epithelial cells from the capsularhexis onto the surface of the IOL.
Pigment precipitates on IOL - Iris pigment deposits on the surface of the IOL.
Pupillary block - Blockage of normal aqueous flow through the pupil.
Retinal detachment - Separation of the retina from the pigment epithelium layer.
Secondary Surgical Intervention - Any secondary surgical procedure that can reasonably be expected to be IOL-
related.  This includes, but is not limited to, iridectomy for pupillary block, vitreous aspiration for pupillary block, 
repositioning of the lens, IOL removal for inflammation, and IOL replacement.  This excludes posterior 
capsulotomy.
Vitreous detachment - Separation of vitreous gel from the retinal surface.
Vitritis – Inflammatory intraocular reaction (with clouding and cells) in the vitreous.  Often accompanies 
inflammation of the ciliary body, iris, choroid, or retina.  Can be sterile or due to infection.
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Raised IOP Requiring Treatment - A persistent elevation of intraocular pressure secondary to cataract surgery 
that requires medical and/or surgical treatment.
Synechiae - Iris adhesion to adjacent ocular structures.
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APPENDIX B: Definition of Adverse Events
Following findings are not regarded as AE because that it is a series of wound healing reaction related to cataract 
surgery. However, when investigator judged it is not wound healing reaction, it is treated as AE.
-  Edema or haze around sclerocorneal incision: Occurred by 1 month post surgery
-  Fold or swelling of Descemet’s membrane at central cornea: Occurred by 1 month post surgery
-  Post surgery inflammation: Occurred by 3 months post surgery
-  Raised IOP related to post operation inflammation and fibrin reaction: Occurred by 1 month post surgery
Investigator (or sub-investigator) should judge when the events below occurred after the test IOL implantation 
whether the events is AE or not.
If the events are regarded as AE, investigator must fill out AE forms in the electric case report forms.
-  IOP: 10mmHg or more than 10 mmHg change from Visit 0 after 1 month post surgery
-  Slit lamp findings (anterior and posterior segment): Worse than Visit 0 
(Ocular finding which is caused by inflammation related to cataract surgery is excluded.)
-  Best corrected distance visual acuity: Worse than Visit 0 at the last exam (Visit 4A)
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APPENDIX C: Clinical Trial System, Participating Facilities and Principal 
Investigators
1.
Clinical Trial System
(1)
Sponsor
Alcon Japan Ltd.
Representative: 
TEL: 
FAX: 
(2)
Study Supervisor
, Alcon Japan, Ltd.
(3)
Study Manager
, Alcon Japan, Ltd.
(4)
Persons in Charge of Monitoring (delegate)
, Alcon Japan, Ltd.
(5)
Medical Monitor
 Alcon Japan, Ltd.
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2.
Medical Institutions and Investigators
No.
Clinical study site
Job title
Principal investigator
Location
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APPENDIX D: Confidentiality and Publication of the Study
All information related to this clinical study including the protocol and therapeutic results are the property of the 
sponsor, and the investigator and other medical staff engaged in the clinical study must keep such information 
confidential.
The sponsor can submit the results of this clinical study to the health authority for the purpose of obtaining an 
approval for manufacture (import) and publish them in the congresses or medical journals. When publishing the 
results of this clinical study in the congresses or medical journals, the investigators and other medical staff must 
obtain prior approval from the sponsor. The sponsor can confirm the contents of presentation beforehand.
APPENDIX E: Direct Access to Source Data and Documents
The investigator and the study site must make source data available to the sponsor or the regulatory authority at 
their request. Such direct examination of source data will be performed so that the sponsor may confirm whether 
the clinical study is conducted in accordance with the protocol and whether data of the case report form are 
indicated accurately.
With reference to [Evaluation] and [Comment of the investigator, etc.], there are no source data and they are 
information directly indicated on the case report form.
APPENDIX F: Quality Control and Quality Assurance of the Study
Quality control and Quality assurance shall be carried out in accordance with GCP standard operational 
procedures (SOP) of the Sponsor.
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APPENDIX G: Obligations of Investigators
Selection of Trial Subjects
In the selection of trial subjects, investigator(s) and sub-investigators shall, from the standpoint of human rights 
and on the basis of the standards for selection and exclusion set forth in the trial protocol(s), carefully consider 
whether to request participation in the trial, taking into consideration such factors as the subject’s general state of 
health, symptoms, age, sex, capacity to consent, dependency on investigator(s), etc., and participation in other 
trials.
Obtaining Consent of Subjects
Investigator(s) and sub-investigators shall obtain from the subject or legally acceptable representative thereof, in 
accordance with GCP, consent for the subject to participate in the trial.
Medical Treatment of Subjects
The investigator shall have the responsibility for all decisions on medical treatment relating to the trial.
The director of the institution and the investigator shall ensure that the subject is provided with adequate medical 
treatment for all trial-related adverse events that constitute clinical problems during and after the subject’s 
participation in the trial. Further, when an investigator or sub-investigator becomes aware of the need for medical 
treatment of an adverse event, he or she shall so inform the subject.
The investigator or sub-investigator shall conform whether the subject has another attending physician, and with
the consent of the subject, inform the attending physician of trial participation.
If a subject desires to withdraw or withdraws participation during the trial, the subject is not obliged to clarify the 
reason for withdrawal, but the investigator or sub-investigator shall make appropriate efforts, based on full respect 
for the rights of the subject, to determine the reason.
Agreement on and Compliance with Trial Protocol(s)
Prior to reaching an agreement with the sponsor on the trial protocol(s) and case report forms (CRF), the 
investigator shall confer with the sponsor on the basis of the trial protocol(s), CRF and current investigator’s 
brochure(s), and other required materials and information submitted by the sponsor, and shall give full 
consideration to the ethical and scientific suitability of conducting the trial. The same shall apply if the trial 
protocol(s) or CRF are revised.
The investigator shall reach agreement with sponsor on the content of the trial protocol(s) and CRFs, and as 
evidence of agreement to comply with the trial protocol(s), the investigator and sponsor shall date and affix their 
signatures or personal seals to a trial contract or alternative document. The same shall apply if the trial protocol(s) 
or CRFs are revised, or if, due to a directive of the director of the institution based on the opinion the IRB, the trial 
protocol(s) or CRF is corrected.
Submission of documents to the IRB
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Before and during the trial period, the investigator(s) shall keep current those documents that are subject to review 
by the IRB and are to be submitted by the investigator(s).  If these documents are augmented, updates or revised, 
all must be submitted promptly to the director of the institution.
Directive and Decisions of the Director of the Study site
When IRB gives its approval to conduct the trial on condition of certain revisions, and the investigator has been 
informed in writing of the directives and decisions of the director of the institution based thereon, the investigator 
shall commence the trial in accordance with these directives and decisions.
When the IRB gives its approval to continue a trial in progress or to continue a trial on condition of certain 
revisions, and the investigator has been informed in writing of the directives and decisions of the director of the 
institution based thereon, the investigator shall continue the trial in accordance with these directives and decisions.
When the IRB cancels its approval to an item related to a trial in progress (including its termination or suspension) 
and the investigator has been informed in writing of the directives and decisions if the director of the institution 
based thereon, the investigator shall comply with these directives and decisions.
Use, etc., of the Investigational Product(s)
The investigator shall ensure that the investigational product(s) are used only in accordance with methods that 
comply with the approved trial protocol(s).
Deviations etc. from Trial Protocol(s)
The investigator or sub-investigators shall not undertake any deviation from or modification of the trial 
protocol(s) without prior written agreement between the investigator and the sponsor and written approval based 
on prior inspection by the IRB.  This is not, however, applicable in the case of changes related solely to cases that 
are medically unavoidable in order to avoid imminent danger to the subject, or in the case of management matters 
(e.g., a change in telephone number).
The investigator or sub-investigators shall keep a record of all actions deviating from the trial protocol(s).  The 
investigator or sub-investigators shall prepare a record describing the reason(s) etc. therefore, submit the record 
regarding to deviation in order to avoid imminent danger to the subject to the sponsor, and retain a copy.
The investigator or sub-investigators may undertake deviations from or modification of the trial protocol(s) within 
prior written agreement between the investigator and the sponsor and written approval based on prior inspection 
by the IRB in medically unavoidable situation, in order to avoid imminent danger to the subject,  In such an event, 
the investigator notify as soon as possible the sponsor, as well as the director of the institution and, via the director 
of the institution, to the IRB, of the nature of and reasons for the deviation or modification, together with a 
proposal for revision of the trial protocol(s), if appropriate, and obtain their approval, and at the same time shall 
obtain in writing the approval of the director of the institution and, via the director of institution, the agreement of 
the sponsor.
Filling and submitting electronic case report forms, etc
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The Principal Investigator or the sub investigator etc. should fill the electronic case report forms for individual 
patients in accordance with the preparation procedure of the electronic case report form.  The Principal 
Investigator will e-sign all electronic case report forms including those which would be filled in by the Sub-
investigator etc. after checking it to verify.  If the Sub-investigator etc. have modified or corrected the electronic 
case report form, the Principal Investigator should confirm that the electronic case report form is free of errors and 
should e-sign the electronic case report forms. An electronic copy of the electronic case report forms should be 
retained by the Principal Investigator.
The Principal Investigator should assure that the electronic case report form and all other reports are correct, 
complete, and easily understandable and submitted at an appropriate timing.  It should also be assured that 
identification codes are used for distinction between individual patients.
The Principal Investigator or the Sub-investigator etc. should follow the manual of the electronic case report form 
prepared by the Sponsor when modifying or correcting the electronic case report form. If the electronic case report 
form is revised, added to or deleted, the revision/addition/deletion must be kept as an audit trail, and the name of 
the person that has entered (revised) the information, the date of the entry (revision) and the description of the 
information entered must be recorded. The reason for any significant change or revision to the electronic case 
report form is also required to be recorded.
Reports, etc. in the Course of the Trial
In order to be available for ongoing review by the IRB, the investigator shall submit to the sponsor annually, or 
more frequently when requested by the IRB, a written overview of the status of the trial.
With respect to any trial modification that could have a significant effect on the conduct of the trial or could 
increase the risk to subjects, the investigator shall promptly submit a written report to the director of the institution 
and, via the director o the institution, to the IRB.
Except in cases in which the trial protocol(s) or investigator’s brochure(s) provide that urgent notification is not 
required, the investigator shall notify the sponsor promptly of all serious adverse events.  After the urgent 
notification, a detailed written report shall be made in due course.
With respect to adverse events that are specified in the trial protocol(s) as serious for evaluation the safety of the 
investigational product(s), the investigator shall report to the sponsor, observing the reporting requirements and 
deadlines set forth in the trial protocol(s).
The investigator shall report all serious adverse events to the director of the institution promptly and in writing.  In 
this case, the investigator shall identify those of the reported serious adverse events involving serious and 
unpredictable device deficiencies.
With respect to serious adverse events or device deficiencies, including cases of death, shall submit to the sponsor, 
director of the institution or IRB any additional information (autopsy reports, final treatment records or other 
requisite information that they may request).
Termination or Suspension of the Trial
When for any reason the trial is terminated or suspended, the investigator shall notify the subjects promptly to that 
effect, and shall ensure that subjects receive appropriate medical treatment and post-treatment.
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When the investigator terminates or suspends the trial, the investigator shall notify the director of the institution 
promptly and in writing to that effect, and shall provide a detailed written explanation for the termination or 
suspension.
Completion of the Trial
When the trial is completed, the investigator shall notify the director of the institution in writing to that effect, and 
report in writing an overview of the trial results.
Storage of records
The investigator shall retain essential documentation relating to the conduct of the trial in accordance with the 
directives of the director of the institution.
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APPENDIX H: Informed consent
Time to obtain consent
The investigator or sub-investigator will obtain written consent by the trial subject prior to the commencement of 
study specific examination. Prior to the second implant, obtain consent to continuously participate in the clinical 
study from the subjects.
Methods for explaining to trial subjects
The investigator (or sub-investigator) will give explanations to trial subjects.  Study collaborators can give 
supplemental explanations.
The explanations should be given based on the explanation/consent document using terms which are the most easy 
to understand (non-technical terms).  Questions made by trial subjects should be answered appropriately in the 
way the trial subjects can understand.
Methods for obtaining consent
The investigator (or sub-investigator) who has given explanations will sign and date the consent document.
If any study collaborator has given supplemental explanations, the study collaborator will also sign and date the 
consent document. (Study collaborators are not allowed to solely give all necessary explanations to trial subjects.)
Supply the trial subject with the consent document and explanation document describing aforementioned 
necessary information and take sufficient time for the trial subject to decide whether or not he/she should 
participate in the clinical study.
Before obtaining consent, take sufficient time for the trial subject to sufficiently review the consent items and ask 
any questions.  Answer the questions in a convincing manner.
Obtain the trial subject's spontaneous written consent to participate in the clinical study.
After obtaining the consent document signed and dated by the trial subject, the investigator (or sub-investigator) 
will enter the date of consent in the CRF and in the medical record.  All consent documents must be retained.
Supply the trial subject with the copy (duplicate for the trial subject) of the consent document and the explanation 
document before the trial subject participates in the clinical study.
If the explanation document or consent document is subject to revision during the participation of the trial subject, 
follow the above procedures and re-obtain consent.
Items mentioned for the written Informed Consent Form and other explanatory documents
The written Informed Consent Form and other explanatory documents must mention the following, at least.
The fact that the clinical study involves research.
The purpose of the trial.
The name and title of the investigator or sub-investigator, and how he or she can be contacted.
The trial method (including the aspects of the trial that are experimental, subject’s inclusion/exclusion criteria, and 
when the trial is randomized, the probability of randomization for each treatment).
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The expected clinical benefits, and the foreseeable risks or inconveniences to the subjects.  (If any benefits for the 
subject will not be expected, it must be informed to the subject.)
When the persons to be enrolled as trial subjects are subjects, the availability of other medical treatments for their 
condition, and the potential major benefits and risks of such treatments as are available.
The expected duration of the subjects’ participation in the trial.
That participation in the trial is voluntary; that the trial subject can refuse to participate in the trial or can withdraw 
from the trial at any time and that the subjects will not be disadvantaged or lose any benefit to which they are 
entitled if they refuse to enroll in the trial or if they withdraw from the trial after enrolling.
The handling of investigational product; if the subjects decied to diccontinue participation of clinical trial.
That the trial monitor, auditor, IRB, and regulatory authorities are allowed to examine the source data; that the 
confidentiality of the trial subjects will be protected when those data are examined by those persons; and that the 
subjects authorize the perusal of those data by those persons by sealing and/or signing the written consent form.
That the subjects’ confidentiality will be protected even when the results of the clinical study are published.
The person in the study site conducting the trial whom the subjects should contact for further information about 
the trial or their rights, or if they develop a health problem associated with the trial.
The compensation and medical treatment the trial subjects can receive should they develop a health problem 
associated with the trial.
The number of subjects expected to be enrolled in the trial (including discreate variable).
That if information is received that may affect the wishes of the subjects regarding the subjects’ ongoing 
participation in the trial, that information will be passed on promptly to the subjects.
The circumstances under which or the reasons subjects will be withdrawn from the trial.
The specifics about any expense the trial subjects will have to pay.
The specifics about any cash or the like that will be paid to the trial subjects (including the arrangement for 
calculating the sum to be paid).
Responsibilities of the trial subjects.
Information about Institutional review board.
Revision of consent document
If the investigator acknowledges the necessity of revising the explanation document used for obtaining consent, in 
the case of the obtainment of the information which may affect the trial subject's intention to continuously 
participate in the clinical study or in other cases, immediately revise the explanation document and have the 
revision approved by the IRB.
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Date/Time 
(mm/dd/yyyy GMT):
Signed by:
Justification:
01/10/2017 20:43:14
01/06/2017 17:53:50
01/06/2017 15:36:34
01/06/2017 10:48:39
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