Post-Market Clinical Study of the AcrySof® IQ PanOptix® Presbyopia Correcting Intraocular Lens in a Chinese Population
Phase: NA
Conditions: Aphakia, Presbyopia
Sponsor: Alcon Research

 
 
 
Post-market Clinical Study of AcrySof IQ PanOptix Intraocular Lens 
In Chinese Population 
 
STUDY ID 
ILH297-C004 
 
PROTOCOL 
 
NCT04755231 

Page 1 of 76 
 
Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
Medical Device Clinical Trial Protocol 
 
Post-market Clinical Study of AcrySof IQ PanOptix Intraocular Lens  
In Chinese Population  
 
Protocol number: ILH297-C004 
Name of investigational medical device: AcrySof® IQ PanOptix® Presbyopia Correcting 
Intraocular Lens 
Model and specification: TFNT00 
Management category of investigational medical device:  
Class III medical device requiring clinical trial examination and approval: Yes □No□√ 
Similar products within the territory of China Yes□√ No□ 
Protocol version number and date: V2.0 Nov 5, 2020 
Clinical trial institution (leading site):  The Second Affiliated Hospital of Zhejiang University 
 
Sponsor: Alcon Research, LLC. (“Alcon”)  
6201 South Freeway Fort Worth, Texas 76134-2099 
Agent: Alcon (China) Ophthalmic Product Co., Ltd. 
7/F, No. 20 Building, Jiuxianqiao Road, Chaoyang District, Beijing 100016, China 
 
Property of Alcon, Confidential 
May not be used, divulged, published, or otherwise disclosed without the consent of Alcon. 

Page 2 of 76 
 
Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
Filling instructions: 
1. For multi-center clinical trials, the clinical trial institutions on the cover only fill in the 
lead unit, and other institutions are listed in the protocol content. 
2. For multi-center clinical trials, the investigator on the cover should fill in the 
coordinating investigator. 
 
 
 
 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
Table of Contents 
I. Sponsor’s Information.......................................................................................................... 6 
(I) Sponsor’s Name ................................................................................................................................. 6 
(II) Sponsor’s Address ........................................................................................................................... 6 
(III) Sponsor’s Contact Information .................................................................................................... 6 
(IV) Sponsor’s Relevant Qualification Documents ......................................................................... 6 
(V) Agent’s Name, Address, Contact Information and Relevant Qualification Documents ... 6 
II. Lists of All Clinical Trial Institutions and Investigators in the Multi-center Clinical 
Trial ........................................................................................................................................... 6 
III. Clinical Trial Objective and Content ............................................................................... 6 
(I) Objective ............................................................................................................................................. 6 
(II) Content ............................................................................................................................................... 6 
IV. Background Information of the Clinical Trial .............................................................. 13 
V. Product Characteristics, Structural Composition, Working Principle, Mechanism of 
Action and Test Scope ............................................................................................................ 14 
(I) Product Characteristics ................................................................................................................... 14 
(II) Structural Composition, Working Principle, Mechanism of Action of the Product ......... 15 
(III) Trial Scope ..................................................................................................................................... 16 
VI. Indications and Contraindications, Precautions of the Product ................................. 16 
VII. Overall Design ................................................................................................................ 16 
(I) Trial Design ...................................................................................................................................... 16 
1. Trial Objective .................................................................................................................. 16 
2. Test Method Selection and Justification ........................................................................... 17 
3. Measures to Reduce and Avoid Bias ................................................................................ 17 
5. Subject Selection .............................................................................................................. 19 
6. Effectiveness Evaluation Method ..................................................................................... 22 
7. Safety Evaluation Method ................................................................................................ 27 
(II) Trial Process .................................................................................................................................... 33 
1. Trial Flowchart ................................................................................................................. 33 
2. Specification for Device Use ............................................................................................ 48 
(III) Monitoring Plan ............................................................................................................................ 48 
VIII. Statistical Considerations ............................................................................................. 49 
(1) Statistical Design, Methods and Analysis Procedures .................................................... 49 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
1. Statistical design ............................................................................................................... 49 
2. Statistical methods and procedures .................................................................................. 49 
(II) Calculation of Sample Size ............................................................................................ 53 
1. Overall Sample Size ......................................................................................................... 53 
2. Number of Cases for the Clinical Trial of Each Disease and its Justification .................. 53 
3. In a multi-center clinical trial, the minimum and maximum number of subjects and reasons 
for each clinical trial institution and site-specific targets may vary based upon individual site 
capabilities. In order to control the central effect of the trial, in principle, the single-site 
enrollment should not exceed 1/3 of the total enrolled cases. .............................................. 53 
(III) Significance Level and Power of the Clinical Trial ...................................................... 53 
(IV) Expected Dropout Rate ................................................................................................. 53 
(V) Criteria for Qualified/Unqualified Clinical Trial Results .............................................. 53 
(VI) Criteria for Terminating the Trial Based on Statistical Reasons and Justification ....... 54 
(VII) Statistical Methods for All Data, as well as Processing Methods for Missing, Unused 
or Erroneous Data (Including Halfway Exit and Withdrawal) and Unreasonable Data ....... 54 
1. Data statistical methods .................................................................................................... 54 
2. Processing methods for missing, unused or erroneous data (including halfway exit and 
withdrawal) and unreasonable data ...................................................................................... 54 
(VIII) Procedures for Reporting Deviations from the Original Statistical Plan ................... 54 
(IX) Selection Criteria for the Subjects Included in the Analysis and Justification ............. 54 
(X) Special Information Excluded from Hypothesis Verification and Justification (If 
Applicable) ........................................................................................................................... 54 
X. Data Management ............................................................................................................. 54 
(I) Data Collection ................................................................................................................ 55 
(II) Data Verification and Modification ................................................................................ 55 
(III) Database Locking ......................................................................................................... 55 
(IV) Completed Source Documents and Case Report Forms .............................................. 55 
(V) Data Review and Clarification ....................................................................................... 56 
X. Feasibility Analysis ............................................................................................................ 57 
(I) Analysis of the Possibility of Success ............................................................................. 57 
(II) Analysis of the Possibility of Failure ............................................................................. 57 
XI. Quality Control of the Clinical Trial .............................................................................. 57 
XII. Ethical Issues of the Clinical Trial and Informed Consent ........................................ 58 
(I) Ethical considerations ..................................................................................................................... 58 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
(II) Approval of the trial protocol ...................................................................................................... 58 
(III) Informed Consent Process and Informed Consent Form Text ............................................ 58 
XIII. Provisions on the Reporting of Adverse Events and Device Dfficiencies ................ 59 
(I) Adverse events and serious adverse events ..................................................................... 59 
(II) Device deficiencies ........................................................................................................ 61 
(III) Reporting procedures and contact person’s information .............................................. 61 
(IV) Severity and causality assessment ................................................................................ 64 
XIV Deviations from the Clinical Trial Protocol and Provisions on the Modification of 
the Clinical Trial Protocol ..................................................................................................... 64 
(I) Deviations from the clinical trial protocol ....................................................................... 64 
(II) Revision of clinical trial protocol ................................................................................... 65 
XV. Direct Access to Source Data and Documents ............................................................. 65 
(I) Definition of source data and source documents............................................................. 65 
(II) Provisions on direct access to source data and documents ............................................ 65 
XVI. Finance and Insurance ................................................................................................. 66 
XVII. Contents to Be Covered by the Clinical Trial Report .............................................. 66 
XVIII. Confidentiality Principle ........................................................................................... 66 
XIX. Agreement on Publication of Test Results .................................................................. 67 
XX. Responsibilities Assumed by Each Party ..................................................................... 67 
(I) Responsibilities of Sponsors ........................................................................................... 67 
(II) Responsibilities of Clinical Trial Institutions ................................................................ 71 
XXI. References ...................................................................................................................... 74 
Investigator’s statement ......................................................................................................... 74 
 
 
 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
I. 
Sponsor’s Information  
(I) Sponsor’s Name 
Sponsor: Alcon Research, LLC. (“Alcon”) 
(II) Sponsor’s Address 
6201 South Freeway Fort Worth, Texas 76134-2099 
 
 
(IV) Sponsor’s Relevant Qualification Documents 
See the business license, medical device business certificate and other qualification 
documents.  
(V) Agent’s Name, Address, Contact Information and Relevant Qualification Documents 
Agent’s name: Alcon (China) Ophthalmic Product Co., Ltd. 
Address and contact information: 7/F, No. 20 Building, Jiuxianqiao Road, Chaoyang 
District, Beijing, China 
See the business license, medical device business certificate and other qualification 
documents.  
II. Lists of All Clinical Trial Institutions and Investigators in the Multi-center Clinical 
Trial 
Principal investigator (Coordinating investigator):
 (The Second Affiliated Hospital 
of Zhejiang University) 
The lists of all participating clinical trial institutions and investigators have been attached 
as separate documents. 
III. Clinical Trial Objective and Content 
(I) Objective 
The objective of this clinical study is to assess the clinical performance of PanOptix® 
Intraocular Lens (model: TFNT00) in Chinese population, especially the observation of visual 
acuity and adverse events related to vision (visual disturbance). The data in this clinical study 
will be submitted to the National Medical Products Administration for renewal registration of 
PanOptix® Intraocular Lens. 
(II) Content 
This clinical study is a prospective, single-arm, multi-center, post-marketing clinical study. 
The study is designed based on the Guidelines for Clinical Trials of Intraocular Lenses 
(hereinafter referred to as the Guidelines), and refers to the content about clinical trials in 
ISO11979-7.  
 
 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
The product in this clinical study is PanOptix Intraocular Lens (model: TFNT00), which is 
an ultraviolet and blue light filtering foldable multifocal IOL. It is intended for implantation in 
the capsular bag in the posterior chamber of the human eye to replace the human eye lens. This 
position allows the IOL to function as a refractive medium, thereby correcting the aphakic state. 
The IOL is a biconvex optical surface design, and its front surface includes an aspheric design 
and a diffractive structure. The diffractive structure divides the incoming light to provide 
distance, intermediate, and near vision ranges. The IOL provides clinicians with more options 
by providing a +2.17 D addition power of intermediate visual acuity and a +3.25 D addition 
power of near visual acuity. This product is suitable for adult patients who require primary 
implantation of an intraocular lens in the capsular bag in the posterior chamber after cataract 
extraction with distance, intermediate and near visual acuity requirements so as to improve near, 
intermediate and distance visual acuity and reduce spectacle dependence. 
In this clinical study, subjects will receive binocular implantation of PanOptix Intraocular 
Lens. In terms of effectiveness, the study will mainly assess the visual performance at Month 6 
after surgery; in terms of safety, the study will mainly assess the safety of TFNT00 at Month 6 
and Month 12 after surgery. All the effectiveness and safety evaluation indicators will be 
followed up to Month 12 after surgery, and an interim analysis will be performed on the data 
when all subjects have completed the 6-month follow-up. 
The clinical study will be carried out at approximately 8 clinical trial institutions with 
relevant qualifications, and approximately 142 implanted subjects (284 eyes) will be included. 
See Table 3-1 for a summary of the study protocol. The acronyms and abbreviations used 
in this protocol are shown in Table 3-2. 
 
Table 3-1 Protocol summary 
Study Title 
Post-market Clinical Study of AcrySof IQ PanOptix Intraocular Lens in Chinese 
Population 
Study 
Objective 
To assess the clinical performance of PanOptix® Intraocular Lens in Chinese population, 
especially the observation of visual acuity and adverse events related to vision (visual 
disturbance). 
Study Product Intraocular Lens 
AcrySof IQ PanOptix Presbyopia Correcting Intraocular Lens (Model: TFNT00) 
Study Design 
A prospective, single-arm, multi-center, post-marketing clinical study 
Sample size 
Enrolled: 158 subjects 
Implanted: 142 subjects (284 eyes) 
Completed: At least 127 subjects (254 eyes) available for evaluation at 12 months  
Sites  
It is expected that 8 sites will participate in the clinical study in China 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
Study 
Population 
Adult Chinese subjects, 18 years of age or older, who require primary implantation of an 
intraocular lens in the capsular bag in the posterior chamber after cataract extraction with 
distance, intermediate and near visual acuity requirements so as to improve near, 
intermediate and distance visual acuity and reduce spectacle dependence. 
Inclusion 
Criteria 
Eligible subjects must meet all of the following inclusion criteria:  
1) Able to comprehend and sign an informed consent form.  
2) Adult Chinese subjects, 18 years of age or older, diagnosed with bilateral 
cataracts. 
3) Pre-operative regular corneal astigmatism of less than 1.0 D. 
4) Planned bilateral cataract removal by routine phacoemulsification.  
5) Calculated IOL power between +6.0 D and +34.0 D. (when targeted for 
emmetropia 0.0 D) 
6) Able to complete all study visits required in the protocol.  
7) Pre-operative best corrected distance visual acuity (BCDVA) worse than or equal 
to 0.3 LogMAR in each eye.  
8) Potential postoperative best corrected distance visual acuity (BCDVA) of 0.3 
logMAR or better in both eyes based on the investigator expert medical opinion. 
Exclusion 
Criteria 
Subjects who do not meet the inclusion criteria or meet any of the following exclusion 
criteria will be excluded: 
1) History of anterior segment (corneal, anterior chamber, sulcus) or posterior 
segment (uveal, vitreo-retinal) pathologic change including retinal vascular 
occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, 
ARMD, glaucoma, diabetic retinopathy, retinitis pigmentosa and any pathologic 
changes associated with the optic nerve. 
2) Corneal Endothelial Cell Count less than 2000 cells/mm2. 
3) History of recurrent anterior segment/posterior segment inflammation. 
4) Clinically significant corneal diseases (epithelium, stromal, and/or endothelium) 
may, according to the investigator's medical opinion, adversely affect visual 
outcomes. These ocular pathologies include but are not limited to old significant 
corneal scars (including Salzman’s nodular degeneration), active or inactive 
keratitis with compromise of the refractive capability of the cornea, 
keratoconjunctivitis sicca with compromise of visual function, active 
keratouveitis, endothelial dystrophy (Fuch’s and non-guttate),keratoconus, etc. 
(Note: Patients with any pathological manifestations that may potentially affect 
postoperative visual acuity should not be included in this study) 
5) Clinically significant/severe dry eye that would affect study measurements based 
on the investigator’s expert medical opinion. 
6) History of previous intraocular or corneal (refraction or trauma related) surgery. 
7) Currently or planning to be pregnant/lactating or has another condition with 
associated fluctuation of hormones that could lead to refractive changes. 
8) Current or past history of amblyopia or monofixation syndrome with poor 

Page 9 of 76 
 
Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
stereoscopic vision. 
9) Systemic medications that, in the opinion of the investigator, may confound the 
outcome or increase the risk to the subject (e.g. Tamsulosin Hydrochloride – 
Flomax) or other medications including anticholinergics, alpha adrenergic 
blocking agents with similar side effects (e.g. small pupil/floppy iris syndrome) 
10)  Any subject currently participating in another investigational drug or device 
study that may confound the results of this investigation. 
11) Any other ocular or systemic co-morbidity that, in the investigator’s medical 
opinion, may confound the results of this study or prohibit the completion of the 
study assessments or increase the risk for the subject. 
12) Subjects with conditions that increase the risk of zonular rupture during cataract 
extraction procedure that may affect the postoperative centration or tilt of the IOL 
(e.g., patients of exfoliation Syndrome, Marfan syndrome). 
13) Any other planned ocular surgical procedures including but not limited to limbal 
relaxing incision (LRI)/Astigmatic Keratotomy and laser-assisted in situ 
keratomileusis (LASIK). 
14) Subjects who desire monovision correction.  
Reasons for 
non-
implantation* 
(During 
Surgery) 
1) Surgical complications including but not limited to loss of zonular 
integrity/zonular weakness, zonular rupture, anterior or posterior capsule rupture 
interfering with the stability of the IOL, any evidence of fluid misdirection during 
the cataract procedure with progressive shallowing of the anterior chamber, 
uncontrollable IOP. Mechanical manipulation of the pupil during surgery.  
2) Mechanical or Surgical Manipulation of the pupil. 
3) Excessive iris mobility. 
4) Inability to place the IOL in the capsular bag due to surgical complications. 
*If the first eye implantation was aborted and the IOL did not touch the eye, then the 
subject is required to discontinue from the study and standard of care for IOL is followed. 
If the implantation was aborted and the IOL did touch the eye, then the subject is 
encouraged to attend all follow-up study visits for safety evaluation on this eye only. 
Please refer to Table 7-6 for detail information. 
Primary 
Effectiveness 
Endpoints 
All effectiveness endpoints will be described for each visit, with postoperative Month 6 
visit results being the key endpoint. 
• 
The percentage of eyes with Best Corrected Distance Visual Acuity (BCDVA) of 
0.3 LogMAR or better 
• 
Mean monocular and binocular BCDVA 
• 
Mean monocular and binocular Distance Corrected Intermediate Visual Acuity 
(DCIVA) (60 cm) 
• 
Mean monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) 
(40 cm) 
 
 
 
  

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Protocol version number: V 2.0 
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Primary 
Safety 
Endpoints 
All safety endpointswill be discribed at each visit, with postoperative Month 6 and Month 
12 results being the key endpoints. 
• 
Estimate the rates of ocular adverse events 
• 
Estimate the rates of secondary surgical interventions (SSIs) 
• 
Estimate rates of severe and most bothersome visual disturbances as reported by 
the subjects using a questionnaire (QUVID) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up 
The surgery day is Day 0 
First eye 
Second eye 
Day -28 to Day 0 
Visit 0 (screening of both eyes) 
Surgery day (Day 0) 
Visit 00 (Day 0) 
Visit 00A*(Day 0) 
Post-op Days 1-2  
Visit 1 (Day 1) 
Visit 1A (Day 1) 
Post-op Days 7-14 
Visit 2 (Week 1) 
Visit 2A (Week 1) 
Second eye: Post-op Days 30-60 
Visit 3A (Month 1) 
Second eye: Post-op Days 90-120  
Visit 4A (Month 3) 
Second eye: Post-op Days 180-210 
Visit 5A (Month 6) 
Second eye: Post-op Days 360-390 
Visit 6A (Month 12) 
* The second eye implantation occurs at 7-28 days after the first eye implantation.  
Statistical 
Sample size calculation:  

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
Considerations 
• 
Enrolled: 158 subjects 
• 
Implanted: 142 subjects (284 eyes) 
• 
Completed: 127 evaluable subjects (254 eyes) 
 
 
Analysis plan: 
• 
There are no statistical hypotheses for the safety and effectiveness objectives in 
this study. 
• 
Planned analyses include a descriptive summary of all effectiveness and safety 
endpoints. Monocular effectiveness and safety endpoints will be presented 
separately by the first and second implanted eyes and all eyes. 
• 
Descriptive statistics generated for all endpoints will be based upon the data type 
(i.e., whether the data are categorical or continuous) being analyzed. For 
categorical endpoints, sample size, number in the category, and percent in the 
category will be presented. For continuous endpoints, sample size, mean, median, 
standard deviation, minimum, maximum, and two-sided 90% confidence 
intervals will be presented. 
• 
Visual acuity will be summarized as a continuous variable. Additionally 
proportion of subjects who achieve BCDVA of 0.3 logMAR or better will be 
presented. 
 
 
 
 
• 
An interim analysis of all data is planned at approximately 6 months after the 
second eye had been implanted for all subjects. 
 
Table 3-2 shows the acronyms and abbreviations used in this protocol 
Acronym English name 
Chinese name 
ACD 
Anterior chamber depth 
前房深度 
ADE 
Adverse device effect 
医疗器械不良反应 

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Protocol version number: V 2.0 
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AE 
Adverse event 
不良事件 
AL 
Axial length 
眼轴长度 
ARMD 
Age-related macular degeneration 
年龄相关性黄斑变性 
BCDVA 
Best corrected distance visual acuity 
最佳矫正远视力 
cm 
Centimeter 
厘米 
CRF 
Case report form 
病例报告表 
D 
Diopter 
屈光度 
DCIVA 
Distance corrected intermediate visual acuity 
远距离矫正下中距离视力 
DCNVA 
Distance corrected near visual acuity 
远距离矫正下近视力 
DD 
Device deficiency 
器械缺陷 
DEP 
Deviations and evaluability plan 
方案偏离和可评估性计划 
DFU 
Directions for use 
使用说明书 
EDC 
Electronic data capture 
电子数据采集 
FLACS 
Femtosecond laser-assisted cataract surgery 
飞秒激光辅助下白内障手术 
FAS 
Full analysis set 
全分析集 
GCP 
Good Clinical Practice 
临床试验质量管理规范 
GPCMS 
Global Product Complaint System 
全球产品投诉管理系统 
ICF 
Informed consent form 
知情同意书 
IEC 
Independent ethics committee 
伦理委员会 
IOL 
Intraocular lens 
人工晶状体 
 
 
 
IOP 
Intraocular pressure 
眼内压 
IP 
Investigational product 
研究产品 
ISO 
International Organization for Standardization 
国际标准化组织 
m 
Meter 
米 
μm 
Micrometer 
微米 
mm 
Millimeter 
毫米 
mmHg 
Millimeters of mercury 
毫米汞柱 
MIOL 
Multifocal intraocular lens 
多焦点人工晶状体 
N/A 
Not applicable 
不适用 
Nd:YAG 
Neodymium-doped yttrium aluminium garnet 
掺效乙铝石榴石激光 
OD 
Right eye 
右眼 

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OS 
Left eye 
左眼 
OVD 
Ophthalmic viscosurgical devices 
粘弹剂 
PC 
Posterior capsulotomy 
后囊切开术 
PCO 
Posterior capsular opacification 
后囊膜混浊 
PI 
Principal Investigator 
主要研究者 
PP 
Per protocol  
 符合方案集 
QUVID 
Questionnaire for Visual Disturbances 
视觉干扰症状调查问卷 
RD 
Retinal detachment 
视网膜脱离 
SADE 
Serious adverse device effect 
器械严重不良反应 
SAE 
Serious adverse event 
严重不良事件 
SAS 
Safety analysis set 
安全性分析集 
SD 
Standard deviation 
标准差 
SOP 
Standard operating procedures 
标准操作流程 
SSI 
Secondary surgical intervention 
二次手术介入 
 
 
 
 
 
 
 
 
 
 
UNSV 
Unscheduled visit 
计划外访视 
US 
United States 
美国 
USADE 
Unanticipated serious adverse device effect 
非预期的严重不良反应 
VA 
Visual acuity 
视力 
 
IV. Background Information of the Clinical Trial 
Cataract is the leading blinding eye disease worldwide, and surgery is currently the only 
effective treatment. In recent years, with the increasing improvement of cataract extraction 
techniques and the application of a variety of new functional IOLs in clinical practice, patients 
also have higher requirements for visual quality after cataract extraction, including 
postoperative distance, intermediate and near vision, spectacle independence rate, etc. 
Therefore, cataract extraction has entered the era of refractive surgery from the era of blindness 
prevention surgery. 
In recent years, the design and materials of multifocal intraocular lenses (MIOL) have been 
continuously improved, and MIOL is thus more and more clinically used, thereby greatly 
improving the accuracy of distance, intermediate and near vision after surgical treatment of 
cataract patients [1]. 

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Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
The investigational product PanOptix IOL used in this study is a multifocal intraocular 
lens. It was approved by the National Medical Products Administration on December 26, 2019. 
At the same time, after registration, the production enterprises still need to complete the 
following tasks: clinical follow-up should be carried out after the product is marketed, focusing 
on the visual acuity and adverse events related to vision (visual disturbance) of Chinese patients 
after implantation. Statistical analysis of the follow-up data should also be conducted to form a 
clinical follow-up report, which should be submitted when renewing the registration. 
At present, PanOptix IOL has been approved for marketing in the United States, Australia, 
Japan, Europe and other countries and its safety and effectiveness have been widely recognized 
internationally. PanOptix IOL provides patients with good visual acuity at far distance, 
intermediate distance of 60 cm and near distance of 40 cm by creating an addition power of 
+2.17 D IOL plane intermediate vision (equivalent to +1.64 D spectacle plane) and an addition
power of +3.25 D IOL plane near vision (equivalent to +2.48 D spectacle plane). 
PanOptix IOL has the same material and overall dimensions as AcrySof IQ ReSTOR +3.0 
D IOL which has been approved globally, but there are differences in the diffraction optical 
design of the optical zone. PanOptix IOL is a non-sequential diffraction design to provide 
distance and near vision equivalent to ReSTOR +3.0 D, as well as better intermediate vision. 
From the current global clinical data, PanOptix IOL can effectively provide continuous vision 
from near to distance, and no unanticipated risks related to IOL optical design have been found. 
This study aims to assess the clinical performance of PanOptix IOL in Chinese population, 
especially the observation of visual acuity and adverse visual reactions, so as to prove that it 
has good distance, intermediate and near vision in Chinese population, can reduce the spectacle 
dependence, and have tolerable and acceptable adverse reactions related to vision.   
V. Product Characteristics, Structural Composition, Working Principle, Mechanism of
Action and Test Scope
(I) Product Characteristics
PanOptix IOL (model and specification: TFNT00) is an ultraviolet and blue light filtering 
foldable multifocal IOL. The intraocular lens adopts a single-piece design, including a central 
optical zone and two open-loop intraocular lens loops (Figure 5-1). The optical part is composed 
of a proprietary hydrophobic acrylate material with a blue light filtering chromophore, which 
can filter light in the blue wavelength range of 400-475 nanometers in a manner close to the 
human lens (Boettner and Wolter, 1962). The biconvex optical zone is made of a soft acrylic 
material, which can be folded before implantation, so it can be implanted into the eye through 
an incision smaller than the optical diameter of the lens. The optical zone diameter of the 
intraocular lens is 6.0mm. The total diameter is 13.0mm. Its power range is 6.0-30.0D (in 
increments of 0.5 D) and 31.0 D-34.0 D (in increments of 1.0 D). After being surgically 
implanted into the eye, the intraocular lens is gradually fully deployed. The optical diffraction 

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Mode of action 
The AcrySof IQ PanOptix IOL Model TFNT00 is intended to be positioned in the lens 
capsule in the posterior chamber of the eye, replacing the Natural crystalline lens. This position 
allows the lens to function as a refractive medium in the correction of aphakia. This IOL has a 
biconvex optic containing an aspheric design and a diffractive structure on the anterior surface. 
The diffractive structure divides incoming light to provide a range of vision from distance to 
intermediate to near. This IOL provides an option for clinicians to provide patients an 
intermediate add power of +2.17 D and a near add power of +3.25 D.  
(III) Trial Scope 
The study population of this trial includes adult Chinese subjects, 18 years of age or older, 
who require primary implantation of an intraocular lens in the capsular bag in the posterior 
chamber after cataract extraction with distance, intermediate and near visual acuity 
requirements so as to improve near, intermediate and distance visual acuity and reduce spectacle 
dependence. The preoperative regular corneal astigmatism in each eye of the subject is less than 
1.0 D. The calculated IOL power needs to be between +6.0 D and +34.0 D (when targeted for 
emmetropia 0.0 D). The preoperative best-corrected distance visual acuity in each eye is worse 
than or equal to 0.3 LogMAR. The potential postoperative best corrected distance visual acuity 
is better than 0.3 logMAR in both eyes. Planned cataract removal by routine 
phacoemulsification. Able to complete all study visits required in the protocol. Able to 
comprehend and sign an informed consent form.  
 
VI. Indications and Contraindications, Precautions of the Product  
Scope of application 
This product is suitable for adult patients who require primary implantation of an 
intraocular lens in the capsular bag in the posterior chamber after cataract extraction with 
distance, intermediate and near visual acuity requirements so as to improve near, intermediate 
and distance visual acuity and reduce spectacle dependence. 
Contraindications 
There are no known contraindications when using PanOptix intraocular lenses as 
recommended. 
Precautions 
For details, see the product instructions: warnings, reminders and instructions for use. 
VII. Overall Design 
(I) Trial Design 
1. Trial Objective 
The primary objective of this clinical study is to assess the clinical performance of 
PanOptix Intraocular Lens (model: TFNT00) in Chinese population, especially the observation 

Page 17 of 76 
 
Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
of visual acuity and adverse events related to vision (visual disturbance). 
2. Test Method Selection and Justification 
This clinical study is a prospective, single-arm, multi-center, post-marketing clinical study. 
The study is designed based on the Guidelines for Clinical Trials of Intraocular Lenses 
【2】
(hereinafter referred to as the Guidelines), and refers to the content about clinical trials in 
ISO11979-7: 2018
【3】.  
3. Measures to Reduce and Avoid Bias 
(1) Qualified clinical study institutions will be invited to carry out the multi-center clinical 
trial to control the central effect in sample size allocation. Before the start of the 
experiment, the study staff will be trained in the protocol and the standard operating 
procedures. 
(2) The surgeon at each site is the investigator himself/herself, who has rich and mature 
cataract surgery experience, and can ensure that patients undergo high-standard cataract 
surgery. 
(3) A unified distance, intermediate and near visual acuity chart will be used to detect 
visual acuity 
. 
(4) Unified questionnaire  
 QUVID) will be used for subjective survey 
assessment.  
(5) Subjects will be selected in strict accordance with the inclusion and exclusion criteria. 
(6) A verifiable and traceable data collection management system will be established to 
ensure that the data is true and reliable. Qualified monitors will be employed to check 
the original data to ensure that the data is true and complete, and that the research 
process is standardized and recorded. 
4. Investigational Medical Device 
The investigational medical device used in this study is: AcrySof IQ PanOptix Intraocular 
Lens. There is no control medical device. 
Table 7-1 Investigational medical device 
Item name 
Intraocular Lens 
AcrySof IQ PanOptix Presbyopia Correcting Intraocular Lens (model: TFNT00) 
Manufacturer 
6065 Kyle Lane  
Huntington WV, 25702 
USA 
Indication 
This product is suitable for adult patients who require primary implantation of an 
intraocular lens in the capsular bag in the posterior chamber after cataract extraction 
with distance, intermediate and near visual acuity requirements so as to improve 
near, intermediate and distance visual acuity and reduce spectacle dependence. 

Page 18 of 76 
 
Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 
Product description 
and parameters 
• 
Optical type: Single-piece IOL with diffractive aspheric optic  
• 
Intraocular lens material (optic + loop structure): Ultraviolet and blue light 
filtering Acrylate/Methacrylate Copolymer 
• 
Optic power: +6.0D~+30.0D (in increments of 0.5 D), +31.0~+34.0D (in 
increments of 1.0 D), +2.17 D intermediate and a +3.25 D near add power 
• 
Refractive index: 1.55 
• 
Haptic Configuration: STABLEFORCE* Modified-L Haptics 
• 
Optic diameter (mm): 6.0 
• 
Overall length (mm): 13.0 
• 
Haptic Angle: 0° 
Usage 
IOLs are implantable medical devices and intended for long-term use over the 
lifetime of the pseudophakic subject. 
Number/Amount of 
product to be 
provided to the 
subject 
Each subject is planned to be bilaterally implanted with the test articles.  
Packaging 
description 
Alcon standard commercial packaging contains the following items: 
• 
IOL 
• 
Subject registration card (lens implantation response card)  
• 
Subject identification card (implant card) provided to the patient 
• 
Self-adhesive label with IOL information and unique serial number 
• 
eIFU reference card, which provides IFU access information. See 
ifu.alcon.com 
Label description 
Packed in standard Alcon IOL cartons. The carton is marked with the following 
information: lens name, model, total diameter, optical zone diameter, degree, serial 
number, manufacturer's name, storage conditions, expiration date, sterility and 
single use. 
Additional 
information 
In order to successfully implant the IOL in the eyes of study subjects, the surgeons 
participating in the study must be licensed ophthalmologists, have experience in 
cataract surgery, and have received protocol training. 
 
 
 

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5. Subject Selection 
(1) Inclusion criteria 
1 
Able to comprehend and sign an informed consent form.  
2 
Adults aged at and above 18 years, diagnosed with bilateral cataracts. 
3 
Pre-operative regular corneal astigmatism of less than 1.0 D. 
4 
Planned cataract removal by routine phacoemulsification.  
5 
Calculated IOL power between +6.0 D and +34.0 D (when targeted for emmetropia 0.0 D) 
6 
Able to complete all study visits required in the protocol.  
7 
Pre-operative best corrected distance visual acuity worse than or equal to 0.3 LogMAR in each eye. 
8 
Potential postoperative best corrected distance visual acuity of 0.3 logMAR or better in both eyes 
based on the investigator expert medical opinion.  
 
(2) Exclusion criteria 
1 
History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-
retinal) pathologic change including retinal vascular occlusive disease, retinal detachment or 
peripheral retinal laser photocoagulation, ARMD, glaucoma, diabetic retinopathy, retinitis 
pigmentosa and any pathologic changes associated with the optic nerve. 
2 
Corneal Endothelial Cell Count less than 2000 cells/mm2. 
3 
History of recurrent anterior segment/posterior segment inflammation. 
4 
Clinically significant corneal diseases (epithelium, stromal, and/or endothelium) may, according to 
the investigator's medical opinion, adversely affect visual outcomes. These ocular pathologies 
include but are not limited to old significant corneal scars (including Salzman’s nodular 
degeneration), active or inactive keratitis with compromise of the refractive capability of the cornea, 
keratoconjunctivitis sicca with compromise of visual function, active keratouveitis, endothelial 
dystrophy (Fuch’s and non-guttate), keratoconus, etc. (Note: Patients with any pathological 
manifestations that may potentially affect postoperative visual acuity should not be included in this 
study) 
5 
Clinically significant severe dry eye that would affect study measurements based on the 
investigator’s expert medical opinion. 
6 
History of previous intraocular or corneal (refraction or trauma related) surgery. 
7 
Currently or planning to be pregnant/lactating or has another condition with associated fluctuation 
of hormones that could lead to refractive changes. 
8 
Current or past history of amblyopia or monofixation syndrome with poor stereoscopic vision. 
9 
Systemic medications that, in the opinion of the investigator, may confound the outcome or increase 
the risk to the subject (e.g. Tamsulosin Hydrochloride – Flomax) or other medications including 
anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g. small pupil/floppy 
iris syndrome) 
10 
Any subject currently participating in another investigational drug or device study that may confound 
the results of this investigation. 

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Protocol version number: V 2.0 
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11 
Any other ocular or systemic co- morbidity that, in the investigator’s medical opinion, may confound 
the results of this study or prohibit the completion of the study assessments or increase the risk for 
the subject. 
12 
Subjects with conditions that increase the risk of zonular rupture during cataract extraction procedure 
that may affect the postoperative centration or tilt of the IOL (e.g., patients of exfoliation Syndrome, 
Marfan syndrome). 
13 
Any other planned ocular surgical procedures including but not limited to limbal relaxing incision 
(LRI)/Astigmatic Keratotomy and laser-assisted in situ keratomileusis (LASIK). 
14 
Subjects who desire monovision correction.  
 
(3) Criteria and procedure for stopping the trial/trial treatment 
1) Termination of clinical trial 
The trial may be terminated in the following cases: a) If there is new safety 
information indicating that continuing the trial or operation may endanger the safety of the 
subjects; b) the sponsor’s administrative decision. 
The ethics committee should follow up and supervise the clinical trial of the clinical 
trial institution, and may require the suspension or termination of the clinical trial in writing 
at any time if it finds that the rights and interests of subjects cannot be guaranteed or other 
situations alike. 
The sponsor should ensure that all investigators who conduct the clinical trial strictly 
abide by the clinical trial protocol. If the sponsor finds that the clinical trial institution and 
investigator do not comply with relevant laws and regulations, the GCP and the clinical 
trial protocol, the case should be pointed out and corrected; if the case is serious or persists 
without correction, the sponsor should terminate the trial at that site. 
Suspended clinical trials shall not be resumed without the consent of the ethics 
committee. If deciding to suspend or terminate the clinical trial, the sponsor should inform 
the medical device clinical trial management department of all clinical trial institutions 
within 5 days, and explain the reason in writing. The medical device clinical trial 
management department of clinical trial institutions should timely notify the corresponding 
investigators and ethics committees. After the completion of the clinical trial, the sponsor 
should inform the food and drug regulatory authority of the province, autonomous region, 
or municipality directly under Central Government where the sponsor is located.  
2) Subjects’ withdrawal from the clinical trial 
Subjects can stop the study or study treatment at any time for any reason. For the best 
interests of the subjects, the investigator can terminate the subjects’ participation in the trial 
at any time during the trial. 
Subjects can be discontinued from the study or study treatment due to special 
circumstances during the operation. 

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a. Surgical complications including but not limited to loss of zonular 
integrity/zonular weakness, zonular rupture, anterior or posterior capsule rupture 
interfering with the stability of the IOL, any evidence of fluid misdirection during 
the cataract procedure with progressive shallowing of the anterior chamber, 
uncontrollable IOP.  
b. Mechanical or Surgical manipulation of the pupil.  
c. Excessive iris mobility. 
d. Inability to place the IOL in the capsular bag due to surgical complications. 
If 1st eye implantation was aborted and the IOL did not touch the eye, then the 
subject is required to discontinue from the study and standard of care for IOL 
implantation is followed. If the implantation was aborted and the IOL did touch the 
eye, then the subject is encouraged to attend all follow-up study visits for safety 
evaluation on this eye only..  
See the text below: Table 7-6 Subject Status after Reasons for Non-implantation.  
3) Procedures to stop the trial 
Subjects who discontinue the study refer to individuals who voluntarily withdraw 
from the study after signing the informed consent form or are required to withdraw from 
the study by the investigator. 
Except for screening failure, if the subject withdraws from the study, the investigator 
should complete the early withdrawal procedure in accordance with the "Research 
Procedures and Assessment Timetable" and record the reason for withdrawal in the 
subject's original medical record. To ensure the safety of all subjects who withdrew early, 
the investigator should assess each subject and, if necessary, provide them with 
recommendations for any treatment and/or medical procedures that may be needed to 
maintain their health. 
(4) Enrollment time 
This clinical study is expected to start recruiting subjects in the second quarter of 2021, 
and complete the enrollment of subjects in the fourth quarter of 2021. 
(5) The expected overall duration of the clinical trial and justification for its 
determination 
The enrollment time of this clinical study is expected to be 6 months, and the follow-
up time will be 12 months after the final second implant. The statistical analysis and writing 
of clinical trial report will take about 6 months, and the total duration will be about 26 
months. 
(6) Expected duration of participation of each subject 
The follow-up time for each subject is 12 months, and the total expected duration of 

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Protocol version number: V 2.0 
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participation in the study is 14 months. 
The expected duration of participation and follow-up schedule all comply with the 
Guidelines for Clinical Trials of Intraocular Lenses, and refer to the content about clinical 
trials in ISO11979-7. 
(7) Number of subjects required for the clinical trial 
• 
Enrolled: 158 subjects 
• 
Implanted: 142 subjects (284 eyes) 
• 
Completed: At least 127 subjects available for evaluation (254 eyes) 
6. Effectiveness Evaluation Method 
(1) Explanation of effectiveness parameters 
This study set 4 primary effectiveness endpoints 
 
All effectiveness endpoints will be recorded in the corresponding follow-up (see Table 7-2 for 
the specific recording time), with Month 6 postoperative results being the most critical endpoint.  
Primary effectiveness endpoints: 
1) The percentage of eyes with BCDVA equal to or better than 0.3 logMAR 
According to China Monofocal IOL Guideline, effectiveness indicator: best 
corrected visual acuity. The primary evaluation indicator is the effective rate of the 
product at six months. Definition of effectiveness: the IOL implantation eye’s best 
corrected visual acuity reaches 4.7 (standard logarithmic visual acuity chart). 
Therefore, we aim to study the percentage of eyes with BCDVA equal to or 
better than 0.3 logMAR.  
2) Mean monocular and binocular Best Corrected Distance Visual Acuity (BCDVA) 
3) Mean monocular and binocular Distance Corrected Intermediate Visual Acuity 
(DCIVA) (60 cm) 
4) Mean monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) 
(40 cm) 
 
  
 
 
 
 
 

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(2) Method and time selection for evaluating, recording and analyzing effectiveness 
parameters 
 
 

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Table 7-2 Method and time selection for evaluating, recording and analyzing effectiveness parameters 
Effectiveness endpoints 
Method for evaluating, recording and analyzing 
Time selection 
Primary Effectiveness Endpoints 
The percentage of eyes with 
BCDVA equal or better than 
0.3 LogMAR 
“Tumbling E ETDRS VA Charts” or “Chinese Standard 
Logarithmic VA Charts” will be used in this study for distance, 
intermediate and near VA test. Final direction on VA Charts 
will be provided in the “Operations Manual” provided to the 
site. 
For both DCIVA and DCNVA, the intermediate and near 
visual acuity is measured under the premise of the best 
correction of distance visual acuity.  
1 week (7~14 days) after surgery, 1 month (30~60 days) after 
surgery 
3 months (90~120 days) after surgery, 6 months (180~210 
days) after surgery 
12 months after surgery (360~390 days) 
Mean monocular and binocular 
Best Corrected Distance Visual 
Acuity (BCDVA) 
Monocular BCDVA: 
1 week (7~14 days) after surgery, 1 month (30~60 days) after 
surgery 
3 months (90~120 days) after surgery, 6 months (180~210 
days) after surgery 
12 months after surgery (360~390 days) 
Binocular BCDVA: 
6 months (180~210 days) after surgery, 12 months (360~390 
days) after surgery 
Mean monocular and binocular 
Distance Corrected 
Intermediate Visual Acuity 
(DCIVA) （DCIVA）
（60cm） 
Monocular DCIVA: 
1 month (30~60 days) after surgery, 3 months (90~120 days) 
after surgery 
6 months (180~210 days) after surgery, 12 months (360~390 
days) after surgery 
Binocular DCIVA: 
6 months (180~210 days) after surgery, 12 months (360~390 
days) after surgery 

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Protocol version number: V 2.0 
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Mean monocular and binocular 
Distance Corrected Near 
Visual Acuity (DCNVA) (40 
cm) 
Monocular DCNVA: 
1 month (30~60 days) after surgery, 3 months (90~120 days) 
after surgery 
6 months (180~210 days) after surgery, 12 months (360~390 
days) after surgery 
Binocular DCNVA: 
6 months (180~210 days) after surgery, 12 months (360~390 
days) after surgery 

Protocol version number: V 2.0 
Protocol version date: Nov 5, 2020 

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7. Safety Evaluation Method 
(1) Explanation of safety parameters 
This study sets 3 primary safety endpoints 
. All safety 
endpoints will be recorded in the corresponding follow-up (see Table 7-3 for the specific 
recording time), with the Month 6 and Month 12 results being the most critical endpoints. 
Primary safety endpoints: 
1) Evaluate the rates of ocular adverse events 
2) Evaluate the rates of secondary surgical interventions (SSIs) 
3) Estimate rates of severe and most bothersome visual disturbances as reported by the 
subjects using a questionnaire (QUVID) 
 
(2) Method and time selection for evaluating, recording and analyzing safety parameters 
 
 
 

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Protocol version date: Nov 5, 2020 
Table 7-3 Method and time selection for evaluating, recording and analyzing safety parameters 
Safety endpoints 
Method for evaluating, recording and analyzing 
Time selection 
Primary Safety Endpoints 
Evaluate the rates of ocular adverse 
events 
Assess and record all adverse events observed or reported, the ocular related AEs are 
primary safety endpoint. 
Each visit 
Evaluate the rates of secondary 
surgical interventions (SSIs) 
Assess and record all secondary surgical interventions (excluding posterior 
capsulotomy) 
Each postoperative visit 
Estimate rates of severe and most 
bothersome visual disturbances as 
reported by the subjects using a 
questionnaire (QUVID) 
See the attachment for the preoperative and postoperative QUVID questionnaire. 
Preoperative screening 
6 months (180~210 days) after 
surgery 
12 months after surgery (360~390 
days) 

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elastic layer wrinkles 
Grade 3 
Severe 
Corneal center opacity, with invisible pupil borders and 
obvious posterior elastic layer wrinkles 
Note: This classification refers to the Guidelines for Clinical Trials of Soft Contact 
Lenses (No. 51 of 2018) [4]. 
Anterior chamber inflammation-graded using the following method: 
Level 0 
None 
No anterior chamber planktonic cells or 
aqueous flare 
Grade 1 
Faint 
Slight anterior chamber imflammation 
Grade 2 
Moderate 
Iris and lens details clear 
Grade 3 
Marked 
Iris and lens details hazy 
Grade 4 
Intense 
Fibrin or plastic aqueous 
Note: No relevant regulations or standards have been found to describe the grading 
criteria for anterior chamber inflammation. The above classification methods 
refer to the evaluation classification of aqueous flare in the reference [5].  
Each visit 
Hypopyon-graded using the following method: 
Yes 
With hypopyon 
No 
Without hypopyon 
Note: This classification only records the presence or absence of anterior chamber 
empyema. (No reference standard) 
Each visit 
Endophthalmitis-graded using the following method: 
Yes With endophthalmitis 
No 
Without endophthalmitis 
Note: This classification only records the presence or absence of endophthalmitis. 
(No reference standard) 
Each visit 

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Intraocular lens decentration  
Examine the IOL with a slit lamp, and subjectively assess whether the IOL has 
changed position and decentration has occurred since the last visit. If IOL decentration 
has occurred, please record the size of the decentration in millimeters and in 
increments of 0.50 mm. 
Note: IOL decentration is not cumulative. Only record changes since the last visit. 
(This assessment method refer to Alcon PanOptix US IDE Study) 
Each postoperative visit 
Intraocular lens tilt 
Examine the IOL with a slit lamp, and subjectively assess whether the IOL has tilted 
since the last visit. If IOL tilt occurs, please record the degree of tilt in increments of 
1°.  
(This assessment method refer to Alcon PanOptix US IDE Study) 
Each postoperative visit 
Intraocular lens dislocation-graded using the following method: 
Yes With intraocular lens dislocation 
No 
Without intraocular lens dislocation 
Note: This classification only records the presence or absence of intraocular lens 
dislocation. (No reference standard) 
Each postoperative visit 
Intraocular lens opacity-graded using the following method: 
Yes With intraocular lens opacity 
No 
Without intraocular lens opacity 
Note: This classification only records the presence or absence of intraocular lens 
opacity. (No reference standard) 
Each postoperative visit 
To observe the subject's posterior 
capsule opacity and whether to 
undergo laser posterior capsulotomy 
Examine with a slit lamp, and assess the presence of PCO. If PCO exists, classify 
using the following method:  
Clinically Non-
Early development of PCO, including fibrosis and 
1 month (30~60 days) after surgery 
3 months (90~120 days) after surgery 
6 months (180~210 days) after 

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significant 
proliferation of lens epithelial cells, observable by slit-lamp 
biomicroscopy. Causes no apparent decrease in VA 
subjectively (e.g., glare) or objectively (e.g., decrease in visual 
acuity). 
Clinically 
Significant 
Increased PCO with early subjective and objective VA 
changes but not require posterior capsulotomy.  
Clinically 
Significant 
Requiring YAG 
Clinically significant PCO adversely affecting subjects’ visual 
acuity and requiring posterior capsulotomy. 
Note: For posterior capsulotomy assessment, indicate whether a posterior 
capsulotomy was performed since the last visit. If performed, report the date of the 
procedure and the size of the capsulotomy (largest diameter in mm). 
This classification method refers to the routine evaluation standards for Alcon's 
internal clinical studies. (This assessment method refer to Alcon PanOptix US IDE 
Study) 
surgery 
12 months after surgery (360~390 
days) 
 
Dilated fundus examination, pay 
attention to whether there is cystoid 
macular edema, retinal detachment, 
etc. 
Perform dilated fundus examination, assess and record the vitreous body, retina, 
macula, optic nerve and cup-to-disk ratio. 
Preoperative screening 
1 week (7~14 days) after surgery 
1 month (30~60 days) after surgery 
6 months (180~210 days) after 
surgery 
12 months after surgery (360~390 
days) 
Intraocular pressure 
Use equipment commonly used by the investigator to measure IOP. 
Note: The intraocular pressure measurement equipment must be calibrated according 
to the manufacturer's instructions. 
The IOP of each subject should be measured with the same type of equipment at all 
follow-ups. The recording unit of the measurement result is mmHg. 
All visits except the day of surgery 

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OCT examination to clarify the 
condition of the macular retina 
Perform mydriatic or non-mydriatic OCT examination, assess and record the 
condition of the macular retina, and observe whether there is cystoid macular edema. 
Use the following method to record: 
No 
Without cystoid macular edema 
Yes With cystoid macular edema 
If there is cystoid macular edema, it is necessary to describe the specific conditions 
such as the height of the edema; if there are other macular lesions, a description 
should be provided. 
Note: This classification method is formulated in accordance with the requirements 
of the Guidelines for Clinical Trials of Intraocular Lenses.  
Preoperative screening 
1 month (30~60 days) after surgery 
Corneal endothelial cell count 
Use equipment commonly used by the investigator to measure and record corneal 
endothelial cell counts. The corneal endothelial cell count of each subject should be 
measured with the same type of equipment at all follow-ups. The recording unit of the 
measurement result is (cells)/mm2. 
Preoperative screening 
3 months (90~120 days) after surgery 
6 months (180~210 days) after 
surgery 
12 months after surgery (360~390 
days) 
Device deficiencies 
Assess and record all device deficiencies reported or observed since the last visit. (for 
specifics, refer to Section 13 Provisions on the Reporting of Adverse Events and 
Device Deficiencies) 
Each visit except preoperative visit 
(Visit 0) 
Evaluate the rates of adverse events 
Assess and record all adverse events observed or reported, including events 
accompanied by changes in drug dosage since the last visit. (for specifics, refer to 
Section 13 Provisions on the Reporting of Adverse Events and Device Deficiencies) 
Each visit 
Safety evaluation indicators:  
Symptoms, signs, complications 
Assess and record the observed symptoms, signs, and complications. If it meets the 
product complaint and/or AE criteria, it should be reported as required by the protocol. 
Each visit 

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(1) Process for assessment of subjects’ basic conditions: 
1) Informed consent, screening and numbering of subjects 
The investigator will evaluate potential study candidates based on eligibility criteria. 
Candidates must sign an informed consent form before conducting any study-related 
screening examinations that are beyond the usual standard diagnosis and treatment 
procedures. Routine standard diagnosis and treatment assessments (such as slit lamp 
examination, dilated fundus examination, bio-measurement, IOL calculation, and IOP 
measurement, etc.) performed on all subjects due to cataract surgery are not considered as 
specific study assessments. 
Note: If the subject has undergone these routine standard diagnosis and treatment 
assessments within 30 days before signing the informed consent, there is no need to repeat 
the measurement, and the results of these inspections can be used directly (based on the 
judgment of the investigator). 
Signing the informed consent form indicates that the subject is enrolled in the study. 
Enter the subject into the electronic data capture (EDC) system to generate a subject 
number. 
Complete the research process and assessments according to the protocol. Verify 
whether the subject meets all the inclusion criteria. If the subject does not meet the 
inclusion criteria, it will be deemed as a subject screening failure and the subject will be 
notified that he/she does not meet the criteria for participating in the study. 
Note: Subjects who fail the inclusion criteria shall not be subjected to secondary 
screening (that is, if a subject does not meet the research criteria, he/she will still be 
ineligible to participate in the study). 
Subjects who meet the inclusion criteria may not meet the criteria for intraocular lens 
implantation. If these situations occur, see the section "Table 7-6 Subject Status after 
Reasons for Non-implantation” below.  This section will clearly indicate how to follow 
up such subjects during the study. 
2) Demographics 
During the preoperative visit (Visit 0), record the demographic data of the subjects, 
including age, gender and nationality. 
3) Medical history 
The medical history includes ocular and non-ocular diseases. 
During the screening/preoperative visit (Visit 0), record the subject’s medical history 
as follows: 
• 
All ocular and non-ocular specific diseases* (chronic, intermittent or recurrent) 
that have occurred or recovered within 30 days prior to the signing of the informed 
consent. 

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*Specific diseases are defined as the history of non-ocular diseases recorded on 
the CRF. 
• 
Any previous history of eye surgery, including laser surgery. 
4) Concomitant medications 
Concomitant medications can be divided into ocular and non-ocular medications. 
Both must be reported according to the following requirements: 
During the screening/preoperative visit (Visit 0), record all ocular and non-ocular 
medications (prescription or over-the-counter drugs, including vitamins and herbal 
preparations) received within 30 days before the signing of informed consent. Record the 
diseases related to drug treatment, the start and end dates of drug treatment, and the route 
of administration. If necessary, update the concomitant medications (for example, new drug 
treatment, end date of drug treatment) at each study visit. Record this information in the 
source documents.  
Enter the concomitant medication information into the EDC as follows: 
• Medical history in the CRF 
o Medicines related to medical history 
• Adverse events in the CRF 
o Drugs for AE treatment 
Drugs routinely used during cataract surgery: 
Record all routine surgical medications (including preoperative, intraoperative, and 
immediate postoperative medications) and all household medications (that is, the 
medications that the subjects take home for their own use) in the source documents of each 
subject. This information is not collected in the EDC. 
Drugs non-routinely used during cataract surgery: 
Record drugs non-routinely used during cataract surgery (for example, medications 
provided due to adverse events (AE)) in the EDC. Note: All medications must be recorded 
in the source documents. 
5) Inclusion/exclusion 
The enrollment criteria are divided into eye-related and non-eye-related. Check the 
enrollment criteria as follows. 
During the screening/preoperative visit (Visit 0), according to the inclusion criteria 
and exclusion criteria in the protocol, verify whether the subject meets all the enrollment 
criteria. If the subject does not meet the inclusion criteria, it will be deemed as a subject 
screening failure and the subject will be notified that he/she does not meet the criteria for 
participating in the study. If the subject meets all the enrollment criteria and is willing to 
continue to participate in the study, determine the first surgical eye and continue to arrange 
the first surgical eye visit (Visit 00). 

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Second eye 
• 
Reason for non-implantation 
• 
IOL did not touch the eye 
• 
The subject can continue to participate in 
the study for the first eye 
• 
First surgical eye: Monocular safety and 
effectiveness assessment at postoperative 
visits 
• 
Do not perform binocular assessments or 
any other assessments on the second eye. 
• 
Reason for non-implantation 
• 
IOL did touch the eye 
• 
Non-implantation of IOL or 
IOL be removed later 
• 
Finally implant another 
suitable non-study lens per 
standard of care 
• 
The subject can continue to participate in 
the study 
• 
First surgical eye: 
○ 
Monocular safety and effectiveness 
assessment at postoperative visits 
• 
Second surgical eye: Safety assessment at 
postoperative visits 
• 
Do not perform binocular assessments 
*Note: Implanting a study lens when a reason for discontinuation during surgery is observed is a protocol 
deviation, and should not occur. If an exclusion occurs after the IOL is already implanted, the surgeon should 
use his best judgement for the safety of the subject to leave the study IOL implanted or to replace with a non-
study IOL. 
(2) Process for assessment of subjects’ eye conditions: 
1) Eye bio-measurement 
Use the standard optical biometer of the site (ie IOL Master biometer and/or 
LenStar biometer, Corneal Topography biometer etc.) for bio-measurement. And record 
the following measurement results in the EDC: anterior chamber depth (ACD) and axial 
length (AL). 
Save the results printed by the biometer as source documents. 
2) Corneal curvature measurement 
Use an optical biometer (ie IOL Master biometer and/or LenStar biometer, Corneal 
Topography biometer, etc.) to measure corneal curvature. Record the curvature (D) and 
axis position of the flat meridian (K1) and the steep meridian (K2) in the EDC. 
3) IOL diopter calculation-target (expected) residual refractive diopter (spherical and 
cylindrical powers) 
Formula: 
It is recommended that investigators use the most experienced new-generation 
intraocular lens calculation formula (for example, SRK/T formula, Haigis formula) in 
their daily work, and use the Barrett Universal II formula for comparison and 
verification. 

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5) Questionnaire 
The questionnaires include QUVID 
  
The Chinese study questionnaire will be provided so that the subjects can complete the 
study by themselves. Instruct the subject to fill out the questionnaires completely in the 
following order: 
o 
QUVID 
 
 
Preoperative questionnaire: Provide the questionnaire after assessing and confirming the 
eligibility of the subjects. Postoperative questionnaire: Provide at Visits 5A and 6A after a 
simple greeting and before the following operations: 
1. Any questionnaire regarding the health and/or visual acuity status of the subject, and 
2. Any other assessments performed. 
Even if the subjects request, no explanation is allowed. If the subjects need interpretation 
or explanation, it must not be provided, and it is recommended that they try their best to answer 
the questions. 
After the subject completes the questionnaire, please review its completeness and the 
accurate completion of skipping different questions. Do not comment on the subjects’ answers. 
If any question is left blank, instruct the subject to fill it out. If skipping different questions is 
not correctly completed, instruct the subject to review his/her answers again and fill in 
accordingly. Finally, review the strikethrough/correction of the questionnaire. If the subject 
corrects a mistake, instruct the subject to sign his/her name and indicate the date of change. 
6) Corneal endothelial cell count 
During the visit, each subject used the same instrument to measure the corneal endothelial 
cell count. The recording unit of the measurement result is: cells/mm2.  
Note: The equipment must be calibrated according to the instrument manufacturer's 
instructions. 
7) Posterior segment OCT examination 
The same instrument should be used for the fundus OCT examination of each subject 
during the visits. Perform mydriatic or non-mydriatic OCT examination, assess and record the 

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condition of the macular retina, and observe whether there is cystoid macular edema. Use the 
following method to record: 
No 
Without cystoid macular edema 
Yes 
If there is cystoid macular edema, please describe the specific 
conditions such as the height of the edema.  
If there is cystoid macular edema, it is necessary to describe the specific conditions such as the height 
of the edema; if there are other macular lesions, a description should be provided. 
Note: The equipment must be calibrated according to the instrument manufacturer's 
instructions. 
 
The equipment used to measure visual acuity 
, assessment distance, 
lighting requirements, assessment management and scoring, please refer to the "Operation 
Manual". 
Requirements for examination of visual acuity: 
Measure VA 
 before measuring IOP, instilling mydriatic or anesthetic 
eye drops, or before any examination that requires eye contact. 
1. 
Perform visual acuity measurement in accordance with the requirements of the 
“Operation Manual”. 
2. 
Ask subjects to sit in front of the visual acuity chart to ensure that they are at an 
appropriate distance from the visual acuity chart, and the height of the line of sight is 
approximately aligned with the middle of the visual acuity chart. 
3. 
Provide preliminary guidance to subjects. 
a. 
Inform subjects that their distance/intermediate/near/defocused visual acuity 
will be assessed. 
b. 
Explain that they should read slowly to best identify each letter when answering, 
and explain that they should not continue to read the next letter until they are 
clearly responded. 
4. 
During the assessment, remind subjects to maintain an appropriate position and close 
the contralateral eye (if applicable). Also pay attention to squinting, excessive blinking, 
and head tilt. If these situations are found, correct the subject immediately. Do not 
point to the visual acuity chart or specific letters on the visual acuity chart. Do not 
comment on the accuracy of the answers. Encourage subjects to do their best to 
identify each letter, and encourage them to guess when necessary. 
9) Slit lamp examination 
Perform a slit lamp examination before IOP measurement and fundus 
examination. Observe corneal, anterior and posterior segment inflammation and 
intraocular lens performance under slit lamp (record corneal edema, corneal folds and 

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other related information; anterior and posterior segment inflammation, such as 
anterior chamber planktonic cells, aqueous flare, anterior chamber empyema and 
endophthalmitis manifestations; intraocular lens decentration, tilt, dislocation and 
opacity, etc.) 
Record all baseline clinical observation results. Continue to record the 
observation results during the postoperative visits until resolved.  
10) Dilated fundus examination 
Perform a dilated fundus examination (indirect or direct ophthalmoscopy). Assess 
the vitreous body, retina, macula, choroid, optic nerve, and cup-to-disk ratio. Record 
all baseline clinical observation results. And record the observation results until 
resolved. 
If fundus observations were not observed at Screening/Preoperative Visit (Visit 
0), it may become apparent under the microscope prior to surgery. In these instances, 
document the findings and update the Screening/Preoperative Visit (Visit 0) fundus 
exam panel in EDC. Observations made under the microscope during surgery or at the 
conclusion of surgery must be captured as AEs (ie, iatrogenic events, operative 
complications, etc.). Additionally, pathologic conditions observed after surgery must 
be documented and may be reported as a Screening/Preoperative Visit (Visit 0) finding. 
11) Intraocular pressure 
The IOP of each subject will be measured with the same instrument during each 
visit. The recording unit of the measurement result is mmHg.  
Note: The equipment must be calibrated according to the instrument 
manufacturer's instructions. 
12) Subjective PCO Including Posterior Capsulotomy 
During the slit lamp examination, assess the presence of PCO. If PCO exists, 
grade as clinically non-significant, clinically significant or clinically significant 
requiring YAG according to Table 7-3 Method and time selection for evaluating, 
recording and analyzing safety endpoints above. 
13) IOL observation 
During the slit lamp examination, observe and record the IOL conditions, 
including dislocation, opacity, etc. 
14) IOL position change (decentration/tilt) 
Examine the IOL via the slit lamp and subjectively assess whether the lens has 
changed position and tilted, since the last visit. If the IOL decentration has occurred, 
the size of the decentration shall be recorded in millimeters (0.50 mm increments). If 
the IOL has tilted, record the degree of tilt (in 1° increments). 
Note: Tilt and deviation are not accumulated. Only record changes since the last visit. 

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(3) Surgery-related assessment 
1) 
Operative eye 
In the EDC, record the first and second surgical eyes as OD or OS. 
Regardless of the investigative site’s standard operating procedure, the 1 st 
operative eye must be selected as described here: the first surgical eye is defined as the 
eye with the worst BCDVA at the screening visit. If the BCDVA is the same in both 
eyes, identify the right eye (OD) as the first operative eye. 
2) 
IOL information, model, power, serial number 
For each successful lens implantation, retain the IOL adhesive label which 
documents the lens model, lens power and unique serial number in the subject’s source 
documents.  
For each aborted lens implantation, assess the lens for device deficiency. If a 
defect is found, report the deficiencies as an adverse event or device defect in the 
protocol. In the subject’s source documents, note the reason for the failed implantation 
and retain the IOL adhesive label (which documents the lens model, lens power and 
unique serial number). 
Study staff must document the implanted lens model and serial number in EDC. 
3) 
Incision position and final incision size 
Perform routine phacoemulsification cataract surgery according to the 
investigator's standard procedure. According to the IOL DFU and study protocol, 
implant the IOL into the assigned subject. It is recommended that investigators have at 
least two IOLs of the same model and required power in the operating room during 
surgery. 
The following standard information should be recorded in the original medical 
record: 
• Incision size 
• Incision position 
• IOL injector and cartridge utilized 
• OVD(s) utilized 
• Surgical complications or other procedures 
• Medications used 
• Phacoemulsification and/or femtosecond laser used 
4) 
Problems during surgery 
Document whether any problems arose during surgery. 
Problems include anterior capsular tear, poorly dilated pupils during surgery, and 
the lens loop stuck in the ciliary sulcus. Evaluate whether the problem meets the 
definition of an AE and report accordingly. Refer to the "Adverse Events and Device 

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Deficiencies" section of the protocol for definitions and reporting requirements. 
Note: If problems arise during surgery, prior to implanting the IOL determine 
whether the lens should be implanted. Please refer to the "Reason for Discontinuation 
(Intraoperative)" section of the protocol for the criteria for not implanting the IOL for 
the study. 
5) 
Record other surgical procedures 
In cataract surgery, record whether any additional surgery (for example, anterior 
vitrectomy, capsular tension ring) is performed. Valuate whether the surgery meets the 
definition of AE and report accordingly. Refer to the "Adverse Events and Device 
Deficiencies" section of the protocol for definitions and reporting requirements. 
Note: If other surgical procedures are performed, prior to implanting the IOL 
determine whether the lens should be implanted as recommended in the product DFU. 
Please refer to the "Reason for Discontinuation (Intraoperative)" section of the 
protocol for the criteria for not implanting the IOL for the study. 
(4) Adverse events and device deficiencies 
1) Adverse events 
The collection of AEs starts when the subject signs the informed consent form. 
AEs may be ocular or non-ocular (eg, seasonal allergies, hip replacement surgery).  
2) Device deficiencies 
Refer to the "Adverse Events and Device Deficiencies" section of the protocol for 
the reporting requirements related to deficient devices. Return the product to the study 
sponsor as described below. 
Unless otherwise arranged by the sponsor, products involving device deficiencies 
should be returned to the study sponsor for investigation. 
 
 

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2. Specification for Device Use 
The study product is a regular commercially available product, and the method of use is 
shown in the product instructions. Throughout the research process, the investigator or 
designated personnel should keep a record of the IOL implanted in each subject. 
(III) Monitoring Plan 
The monitors appointed by the sponsor should formulate a complete and applicable 
monitoring plan according to the requirements of the trial, and conduct trial quality monitoring 
according to the monitoring plan. 
1. Site’s qualification confirmation visit 
Before selecting investigators to participate in the study, a qualification visit is required. 
The purpose of the visit is to confirm that the investigator/site has sufficient staff (including the 
designated research coordinator) and facilities for conducting the study in accordance with the 
requirements of the trial protocol. The relevant personnel of the trial fully understand the 
protocol, process, responsibilities, and clinical trial-related regulations.  
2. Study initiation visit 
Before the site recruits subjects, a site initiation visit should be implemented. The purpose 
of the visit is to confirm that the site is still eligible to participate in the study and to review the 
responsibilities of and research requirements for the investigator/site. Site training should be 
implemented, including but not limited to: 
(1) Clinical trial protocol and data collection procedure 
(2) Monitoring requirements 
(3) Ethical requirements 
(4) Informed consent procedures 
(5) Review of the site’s records 
3. Regular monitoring visits 
The designated study monitors entrusted by the sponsor should pay regular monitoring 
visits to the site during the research process. The purpose of the visit is to confirm the 
compliance with the trial protocol, review the regulatory documents, keep accurate and 
complete records, and compare the source documents with the completed CRF for 
considerations of completeness and consistency. Determine the timetable for the initial 
monitoring visit to the site as soon as possible after 1 to 2 subjects are recruited for the study. 
The frequency of follow-up visits is determined by the recruitment rate and the performance of 
the site (the performance of the site is determined according to previous monitoring visits). 
Special assessments conducted during monitoring visits include: 
(1) Continued acceptability of the site 
(2) Compliance with the protocol 
(3) Ethical approval status 

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(4) Use of approved informed consent form 
(5) Adequacy of source documents 
(6) Complete and accurate CRFs 
(7) Adverse event reports 
(8) Protocol deviations 
(9) Site’s records 
If it is determined during the monitoring visit that the site has major non-compliance issues 
(including compliance with the trial protocol or applicable regulatory requirements), these 
issues should be discussed with the investigator and research coordinator, and guidance on how 
the site can comply should be given. If non-compliance is still found during follow-up 
monitoring visits, the site should be considered to stop participating in this study.  
4. Site closure visit 
A closure visit should be conducted at the end of the last follow-up visit at each site. 
Purpose of the visit: 
(1) Check all unresolved data queries 
(2) Recheck the requirements for research record keeping 
(3) Arrange to return all study-related materials to the sponsor 
(4) Recheck the final ethical requirements for the study 
 
VIII. Statistical Considerations 
(1) Statistical Design, Methods and Analysis Procedures 
1. Statistical design 
This clinical study is a prospective, single-arm, multi-center, post-marketing clinical study. 
2. Statistical methods and procedures 
Continuous variables will be summarized using sample size, mean, standard deviation (SD), 
median, minimum, and maximum, and confidence intervals (CIs) or confidence limits (if 
applicable). The count and percentage classification variables for each category will be 
summarized; any deviations in the analysis plan will be updated as part of the protocol revisions 
during the research process or will be detailed in the clinical study report. 
 
2.1 Subject evaluability  
The final subject evaluability must be determined prior to locking the database, depending 
on the protocol deviation and evaluability plan (DEP). 
2.2 Analysis data sets 
(1) Safety analysis set: This analysis set includes all subjects who have tried the 
implantation of IOL (successfully implanted or aborted after IOL contact with the eye). 

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(2) Full analysis set: The full analysis set (FAS) includes all subjects who have had IOL 
successfully implanted in at least one eye and have undergone at least one postoperative 
effectiveness assessment (BCDVA, UCDVA). 
(3) Per protocol set: The per protocol (PP) analysis set is a subset of FAS and excludes all 
data/subjects that meet any key deviation or evaluability criteria identified in the DEP. 
2.3 Demographics and baseline characteristics 
Demographics and baseline characteristics will be summarized using FAS and PP. 
Demographics include age and gender. Baseline characteristics include anterior chamber depth, 
axial length, corneal curvature (curvature (D) and axial position of flat meridian (K1) and steep 
meridian (K2), monocular BCDVA and binocular BCDVA. Counts and percentages will be used 
for categorical variables such as gender, age group (< 65 years; ≥ 65 years). The observed 
sample size, mean, standard deviation (SD), median, minimum, and maximum will be used to 
report continuous variables such as age. 
2.4 Effectiveness analysis 
This study defines 4 primary effectiveness endpoints 
 
he primary effectiveness endpoints will be statistically discribed in the FAS and PP 
analysis sets.  
 
(1) Analysis of the primary effectiveness endpoints 
The primary effectiveness endpoints of this study include the following, with the Month 6 
results as the most critical endpoints: 
• Percentage of eyes with BCDVA equal to or better than 0.3 logMAR. 
• Mean monocular and binocular Best Corrected Distance Visual Acuity (BCDVA)  
• Mean monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) 
(60 cm) 
• Mean monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) (40 
cm). 
1) Statistical hypotheses and models 
No inference is made about the primary effectiveness endpoints. Therefore, no hypotheses 
are made. 
2) Analytical methods 
All primary effectiveness endpoints will be descriptively statistically summarized. The 
percentage of eyes with BCDVA equal to or better than 0.3 logMAR will be used as a 
categorical variable for summary: 0.0 LogMAR and better, 0.1 LogMAR and better, 0.2 
LogMAR and better, and 0.3 LogMAR and better, including counts and percentages. Monocular 
BCDVA, DCIVA and DCNVA are presented by the first eye, the second eye and all implanted 
eyes; binocular BCDVA, DCIVA and DCNVA are presented by subject, including sample size, 

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mean, median, standard deviation, maximum and minimum, and two-sided 90% confidence 
interval. Listings will be provided as needed.  
2.5 Safety analysis 
The primary safety endpoints of this study include:  
The rates of ocular adverse events, the rates of secondary surgical interventions (SSIs), 
and ratesof severe and most bothersome visual disturbances as reported by the subjects using a 
questionnaire (QUVID) 

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All AEs that occur from the day when the subject signs the informed consent form to the 
subject‘s withdrawal from the study will be included in the report. Subjects who have had AEs 
after signing the informed consent form and before exposure to IP will be displayed in the form 
of a list; the AEs after exposure to IP will be summarized as follows: 
1. All adverse events (combined serious and non-serious) form 
a. Ocular 
b. Non-ocular 
2. Device/surgery-related adverse events form 
a. Ocular 
b. Non-ocular 
3. All serious adverse events (including device/surgery-related adverse events) form 
a. Ocular 
b. Non-ocular 
4. List of subjects with adverse events 
a. Non-serious ocular 
b. Non-serious non-ocular 
c. Serious ocular 
d. Serious non-ocular 
The descriptive table of AEs (counts and percentages) will report the preferred terms 
provided in the Medical Dictionary for regulatory activities, and AEs that have caused 
discontinuation of the study should be identified. 
The incidence of severe and most bothersome visual disturbances in the QUVID 
questionnaire survey will be presented as count, incidence, and two-sided 90% CI for incidence. 
The intraocular pressure and its changes from baseline will be classified and summarized 
by observing the number, mean, median, standard deviation, minimum and maximum based on 
the surgical eye: IOP increases/decreases include > 30 mmHg, 21～30 mmHg, 11～20 mmHg 
and 6～10 mmHg, and the normal range is -5～5 mmHg. The baseline is defined as the last 
measurement taken before the IOL is implanted. A list of subjects' intraocular pressure and 
changes from baseline will be provided. 
The OCT examination will use (no/with) cystoid macular edema to perform categorical 
variable statistics, and provide a list of the height of cystoid macular edema and a list of other 
macular lesions. 
The results of slit lamp examination, fundus examination and IOL observation will be 
listed with descriptive statistics. Among them, count and percentage will be provided, and the 
changes in corneal endothelial count from baseline will be summarized. The number and 
percentage of eyes with IOL position changes (tilt≥ 1° and/or decentration ≥ 0.5 mm) will be 

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provided based on the surgical eye, and a list of eyes with IOL position changes will be 
provided. 
The types of device deficiencies will be tabulated and a listing will be provided. 
2.6 Interim analysis and report 
This study plans to conduct an interim analysis of all data 6 months after all subjects have 
their second eye implanted. 
(II) Calculation of Sample Size 
1. Overall Sample Size 
The study plans to recruit (signing of informed consent form) approximately 158 subjects 
at no more than 8 sites in China in order to include 142 subjects (284 eyes). It is expected that 
127 subjects (254 eyes) will complete the study.  
2. Number of Cases for the Clinical Trial of Each Disease and its Justification 
1) Number of cases for the clinical trial of each disease 
The study is a single-disease study, so the number of cases is the same as the total sample 
size.  
2) Justification  
According to the CSRs summarized in PanOptix DL Response for China registration, the 
ocular? SAE rate is 1.80%. A sample size of 127 subjects would ensure more than a 90% 
probability of observing at least one AE for any event that has a true incidence of 1.8% or 
greater. 
Allowing for a 10% screening failure rate, approximately 158 subjects will be enrolled to 
obtain about 142 subjects who will undergo IOL implantation in both eyes. Assuming a further 
10% dropout rate at Month 12 of follow-up, it is expected that 127 subjects (254 eyes) will 
complete the study.  
3. 
In a multi-center clinical trial, the minimum and maximum number of subjects and 
reasons for each clinical trial institution and site-specific targets may vary based upon 
individual site capabilities. In order to control the central effect of the trial, in principle, 
the single-site enrollment should not exceed 1/3 of the total enrolled cases. 
(III) Significance Level and Power of the Clinical Trial 
In this study, there are no statistical hypotheses about the effectiveness and safety 
objectives, and the sample size is not calculated based on power. 
(IV) Expected Dropout Rate 
It is estimated that the screening failure rate is 10% and the dropout rate is 10%. 
(V) Criteria for Qualified/Unqualified Clinical Trial Results 
The trial is considered as successful as long as the data are true and credible.   

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(VI) Criteria for Terminating the Trial Based on Statistical Reasons and Justification 
This trial will not be terminated based on statistical reasons. 
(VII) Statistical Methods for All Data, as well as Processing Methods for Missing, Unused or 
Erroneous Data (Including Halfway Exit and Withdrawal) and Unreasonable Data  
1. Data statistical methods 
Descriptive statistics will be used, and lists provided when necessary. 
2. Processing methods for missing, unused or erroneous data (including halfway exit and 
withdrawal) and unreasonable data 
1) Processing of missing values:  In this trial, missing values will not be processed. 
2) Processing of unused or erroneous data: If the subject exits or withdraws from the trial 
halfway, the reason should be recorded and the missing data will not be processed. Before 
database locking, the data in the database should be cleaned up. If any erroneous data is found, 
the investigator will be questioned, and the data will be corrected according to the investigator's 
reply. 
3) Processing of unreasonable data: Before database locking, the data in the database 
should be cleaned up. If any erroneous data is found, the investigator will be questioned, and 
the data will be corrected according to the investigator's reply. 
(VIII) Procedures for Reporting Deviations from the Original Statistical Plan 
The statistical analysis plan needs to be confirmed by the sponsor and the principal 
investigator, and finalized before the database is locked. Before finalization, the initial analysis 
plan can be modified according to the actual situation in the trial process. In principle, the main 
analysis principles, methods, and analysis sets will not be modified, and all modifications will 
be recorded. 
(IX) Selection Criteria for the Subjects Included in the Analysis and Justification 
The full analysis set (FAS) includes all subjects who have had IOL successfully implanted 
in at least one eye and have undergone at least one postoperative effectiveness assessment 
(BCDVA, UCDVA). 
The per protocol (PP) analysis set is a subset of FAS and excludes all data/subjects that 
meet any key deviation or evaluability criteria identified in the DEP. 
The safety analysis set includes all subjects who have tried the implantation of IOL 
(successfully implanted or aborted after IOL contact with the eye). 
(X) Special Information Excluded from Hypothesis Verification and Justification (If Applicable) 
Not applicable. 
 
IX. Data Management 

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(I) Data Collection 
The Electronic Data Capture (EDC) system is used to collect trial data. Before the system 
is officially launched, relevant users need to be trained and tested to ensure that the system 
meets the trial requirements. After the system is officially launched, the relevant personnel will 
be given the account number and password. The account is tied to the user's role and authority. 
The account information must be properly kept and the account information must not be 
disclosed to others or the corresponding rights shall be exercised on behalf of others. 
The EDC will directly transmit data from the client to the server via the Internet. The 
investigator is responsible for the quality of the entered data, and should ensure the authenticity 
and completeness of the data. CRFs must be completed regularly in accordance with the clinical 
research visit plan. It is expected that all reported data will have corresponding entries in the 
source documents. 
(II) Data Verification and Modification 
When an investigator enters an abnormal data, the EDC system will issue a real-time 
warning to remind the investigator to check the data; the data administrator will perform logic 
check on the data stored on the server, and issue erroneous data through the EDC in the form 
of manual questioning. The investigator should answer the questions posted. The monitors 
should remind and assist the investigator to answer questions on a regular basis to ensure that 
every question is dealt with correctly. The system will record all questions and their 
corresponding answers. 
(III) Database Locking 
When all data are entered and submitted, and all queries are answered, the system enters 
the soft lock state. The statistician will generate a blind audit report based on the database. If it 
is confirmed that the data will no longer be modified, the sponsor, the person in charge of data 
management, and the person in charge of statistics need to sign the database locking form, and 
the data administrator will complete the database locking operation based on this form. The 
locked database cannot be modified again. If there are errors that affect the primary 
effectiveness indicators or safety indicators, the sponsor, the person in charge of data 
management, and the person in charge of statistics must confirm the unlocking modification 
and sign the database unlocking form. The data administrator will modify the erroneous data 
according to the reason for unlocking and carry out quality control. After the error is corrected, 
the sponsor, the person in charge of data management, and the person in charge of statistics 
need to sign the database locking form again. 
(IV) Completed Source Documents and Case Report Forms 
The nature and location of all source documents will be identified to ensure that the 
original data required to complete the CRF does exist and can be accessed for verification by 
the monitors at the site. All discrepancies shall be appropriately documented via the query 
resolution process. Site monitors are appointed by the Study Sponsor and are independent of 
study site staff. 

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If electronic records are maintained, the method of verification must be determined in 
advance of starting the study. 
At a minimum, source documents include the following information for each subject: 
• 
Subject identification (name, sex, age) 
• 
Documentation of subject eligibility 
• 
Date of informed consent   
• 
Dates of visits 
• 
Documentation that protocol specific procedures were performed 
• 
Results of the research indicators required by the protocol 
• 
Test article accountability records (if applicable) 
• 
Documentation of AEs and other safety parameters (if applicable) 
• 
Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• 
Date of study completion and reason for early discontinuation, if applicable 
It is required that the author of an entry in the source documents be identifiable. Direct 
access to source documentation (medical records) must be allowed for the purpose of verifying 
that the data recorded on the CRF are consistent with the original source data. 
Only individuals designated by the site will complete the CRFs. The CRFs must be 
completed at regular intervals following the clinical study visit schedule. It is expected that all 
data reported have corresponding entries in the source documents. The Principal Investigator is 
responsible for reviewing and certifying that the CRFs are accurate and complete. The only 
subject identifiers recorded on the CRFs will be subject number, and subject demographic 
information. 
(V) Data Review and Clarification 
A review of CRF data to the subject’s source data will be completed by the site monitor to 
ensure completeness and accuracy. After the CRFs have been completed, additional data 
clarifications and/or additions may be needed as a result of the data cleaning process. Data 
clarifications are documented and are part of each subject’s CRF. 
 

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X. Feasibility Analysis 
(I) Analysis of the Possibility of Success 
PanOptix Intraocular Lens has been approved in many countries and regions, which meets 
the safety and effectiveness objectives of product design according to the obtained clinical 
application. The study design complies with the relevant guidelines, and it is a prospective, 
single-arm, multi-center, post-marketing clinical study. The study is designed based on the 
Guidelines for Clinical Trials of Intraocular Lenses (hereinafter referred to as the Guidelines), 
and refers to the content about clinical trials in ISO11979-7. The design is rigorous, and the 
method is scientific, and can reduce unnecessary biases. In summary, we expect that the study 
will confirm the safety and effectiveness of the product in the Chinese population. 
(II) Analysis of the Possibility of Failure 
The main possibilities of failure include slower than expected enrollment speed and failure 
to complete the enrollment targets. Problems may arise during the research process, such as 
bias, poor compliance of subjects, inaccurate inspection data, and non-repeatability. Targeted 
preventive considerations for the above possibilities have been made in the "Measures to reduce 
and avoid bias” section above.  
 
XI. Quality Control of the Clinical Trial 
During the research process, the clinical monitors appointed by the sponsor will regularly 
pay on-site monitoring visits to the site to ensure that all the contents of the study protocol are 
strictly followed and the research materials are filled in correctly. All personnel participating in 
the study must receive unified training to unify the recording methods and judgment standards. 
The entire clinical trial process should be carried out under strict operation. 
The investigator or authorized personnel should record various contents in the eCRF 
truthfully, thoroughly and carefully according to the CRF filling requirements, and ensure that 
the contents of the case report forms are complete, true and reliable. All observations and 
findings in the clinical study should be verified to ensure the reliability of the data and ensure 
that the conclusions in the clinical study are derived from the original data. There should be 
corresponding data management measures in the clinical research and data processing stages. 
The original materials of this study, including the signed informed consent forms, research 
supplies distribution and use records (if applicable), relevant laboratory test reports, auxiliary 
examination reports, medical records and other related records, etc. They should be kept in the 
clinical trial institution of the hospital where each site is located for 10 years after the end of 
the clinical trial, and the sponsor should save the clinical trial data until the investigational 
medical device is no longer used. 
 
 

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XII. Ethical Issues of the Clinical Trial and Informed Consent 
 
(I) Ethical considerations 
This clinical study must be conducted in accordance with the ethical principles contained 
within: 
(1) The Declaration of Helsinki, and in compliance with the ICH E6 GCP Consolidated 
Guideline, ISO 14155:2011, and the applicable US FDA 21 CFR Regulations. 
(2) Good Clinical Practice for Medical Devices (Decree No. 25 of the National Medical 
Administration and the National Health and Family Planning Commission of the People's 
Republic of China) 
(3) SOPs of the Study Sponsor and contract research organizations participating in the 
conduct of the clinical study and all other applicable regulations. 
(II) Approval of the trial protocol 
Before clinical study initiation, this protocol, the informed consent form, any other written 
information given to subjects, and any advertisements planned for subject recruitment must be 
approved by the ethics committee. The Investigator must provide documentation of the ethics 
committeeapproval to the Study Sponsor. The approval must be dated and must identify the 
applicable protocol, amendments (if any), informed consent form, consent form amendment (if 
any), all applicable recruiting materials, written information for subject, and subject 
compensation programs. A copy of the clinical investigator's brochure, PanOptix package 
insert, any periodic safety updates, and all other information required by local regulations 
and/or the ethics committee must be provided to the ethics committee. At the end of the study, 
the Investigator must notify the ethics committee about the study’s completion. The ethics 
committee also must be notified if the study is terminated prematurely. Finally, the Investigator 
must report to the ethics committee on the progress of the study at intervals stipulated by the 
ethics committee. 
(III) Informed Consent Process and Informed Consent Form Text 
Voluntary informed consent must be obtained from each subject and this process must be 
completed prior to the subject proceeding to the specific procedure for the clinical study. The 
investigator must clearly document the process of obtaining informed consent. Specifically, the 
investigator or his/her authorized personnel must explain the clinical research process to each 
potential subject, and the subject must sign an approved informed consent form and date it to 
indicate voluntary consent. The subject should have the opportunity to raise questions to the 
investigator, and should also be able to ask other qualified personnel if required by local 
regulations. The investigator must provide the subject with a copy of the consent form, and the 
subject should be able to understand the content of the consent form. The consent form must 
comply with all applicable local laws and provide the subjects with information about the 
objectives, procedures, requirements, and restrictions of the study, all known risks and potential 
benefits related to IP and the study, compensation that the subjects can get, and existing 

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provisions on the protection of confidentiality of their personal health information. The subject 
must be informed of the voluntary nature of participating in the study, and must be provided 
with the contact information of the relevant personnel in case that the subject has questions or 
concerns during the study. The investigator must also inform the subject that the relevant 
authorities and personnel designated by the sponsor can access their records. The investigator 
must retain the original signed copy of the consent form (archived in the subject's medical 
record) and must provide a copy to each subject in accordance with local regulations. 
The ethics committee must review and approve the informed consent form dedicated for 
this study. As long as new information that may affect the subject’s consent is obtained, the 
written informed consent form (and any other written information provided to study subjects) 
should be updated. Any such revisions or updates must be approved by the review ethics 
committee before being provided to study subjects. 
The study will be registered at the website of 
http://www.chictr.org.cnwww.clinicaltrials.gov.  
 
XIII. Provisions on the Reporting of Adverse Events and Device Dfficiencies 
(I) Adverse events and serious adverse events 
1. 
Overview 
    Adverse event refer to adverse medical events occur during the process of clinical trial, no            
matter they are relevant to investigational medical devices or not.  
    Serious adverse event refer to events occurred during the process of clinical trial that cause 
death or serious deterioration of health condition, including fatal diseases or injuries, 
permanent deficiency of body structure or body functions, demands of hospitalization or 
extending the duration of hospital stays, demands of medical or surgical intervention so as to 
avoid causing permanent deficiency to body structure or body functions, and events leading to 
fetal distress, fetal death or congenital anomaly and congenital defect.  
Note: Planned hospitalization for a pre-existing condition, without seriousdeterioration in 
health, is not considered a serious adverse event. In general, hospitalization signifies that the 
individual remained at the 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-patient setting. Complications that occur during hospitalization are adverse 
events. If a complication prolongs hospitalization or fulfills any other seriouscriteria, the event 
is serious. When in doubt as to whether “hospitalization” occurred, the event should be 
considered serious. 
Please refer to the figure below for the classification of adverse event and serious adverse 
event. 
 
Figure 13-1 Classification of all adverse events 

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ADE
Device /
procedure-
related?
Meets 
seriousness 
criteria?
SAE
All AEs
AE
No
No
Yes
Yes
 
 
Figure 13-2 Classification of all serious adverse events 
 
All SAEs
Device /
procedure 
related?
SAE
SADE
No
Yes
 
 
2. Specific Events Relevant to this Protocol 
In addition to reporting all AEs (serious and non-serious) meeting the definitions, the 
Investigator must report any occurrence of the following as an SAE: 
o 
Cystoid macular edema 
o 
Hypopyon 

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o 
Endophthalmitis 
o 
Lens dislocation 
o 
Pupil block 
o 
Retinal detachment 
o 
Secondary surgical intervention (excluding posterior capsulotomy) 
Any other potentially sight-threatening event may also be considered serious based on the 
judgment of the Investigator and must be reported appropriately as described in the reporting 
procedure below. 
(II) Device deficiencies 
Device deficiency refer to unreasonable risks of medical devices under normal use during 
the process of clinical trial that may endanger human health and life safety, such as labeling 
mistake, quality problem and malfunctions. In case of malfunctions or other efficiencies, the 
study device should be returned to the sponsor for further investigation. 
The investigator should record all adverse events that occur during the clinical trial and 
device deficiencies found, analyze the cause with the sponsor, form a written analysis report, 
and put forward his/her opinions for continuing, suspending or terminating the trial. Then the 
opinions should be reported to the ethics committee for review through the medical device 
clinical trial management department of the clinical trial institution. 
Examples of device deficiencies include the following: 
1) Incompliance with product quality specification (for example, inaccurate IOL powers) 
2) IOL defect 
3) Broken IOL optic 
4) Broken IOL haptic 
5) Scratched IOL optic 
6) Unsealed device packaging 
7) Suspected product contamination 
8) Lack of effectiveness 
(III) Reporting procedures and contact person’s information 
The collection of AEs starts from the signing of informed consent. Any pre-existing 
medical conditions or signs/symptoms present in a subject prior to the start of the study (ie, 
before informed consent form is signed) are not considered AEs in the study and should be 
recorded. In addition, anterior chamber planktonic cells and flare, corneal edema, raised IOP, 
and superficial punctate keratitis are examples of early postoperative findings that are typically 
observed following ocular surgery. These are not considered AEs if they can be reasonably 
expected to resolve within a week and not result in any untoward long term visual outcome 
impact. 
Each recorded event should include: date of occurrence, severity, treatment (if applicable), 

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outcome, and assessments of the severity and causality. 
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking the standard questions such as:  
• 
“Have you had any health problems since your last study visit?” 
• 
“Have there been any changes in the medicines you take because of a new health issue 
since your last study visit?” 
Changes in any protocol-specific ocular or systemic parameter evaluated during the study 
are to be reviewed by the Investigator. In addition, the subject’s responses to any questionnaire 
utilized during the study are to be reviewed by the Investigator. Any untoward (unfavorable 
and unintended) change in a protocol-specific parameter or questionnaire response that is 
clinically relevant, in the opinion of the Investigator, is to be reported as an AE. These clinically 
relevant changes will be reported regardless of causality. Subjects with adverse events should 
be followed up clinically until the adverse event has recovered (returned to a normal state or to 
a baseline state), or until the condition is stable, or there is a reasonable explanation. 
If any serious adverse event occurs in the clinical study, no matter whether it is related to 
the test device, the Investigator should immediately take appropriate treatment measures to the 
subject, and at the same time, report in writing to the medical device clinical trial management 
department of the clinical trial institution to which it belongs. The sponsor will be notified in 
writing by the medical device clinical trial management department. The medical device 
clinical trial management department should report in writing to the corresponding ethics 
committee, the medical products administration departments and the competent health and 
family planning authority of the province, autonomous region, or municipality directly under 
Central Government where the clinical trial institution is located within 24 hours. For death 
events, the clinical trial institution and the investigator should provide all necessary materials 
to the ethics committee and the sponsor. 
The sponsor should quickly investigate the serious adverse events that have occurred with 
the investigator, take necessary measures to ensure the safety and rights of the subjects, and 
report to the medical products administration department and the competent health and family 
planning authority at the same level within 5 working days after being informed. At the same 
time, the sponsor should notify other clinical trial institutions and investigators participating in 
the trial, and inform the ethics committees of the clinical trial institutions through their medical 
device clinical trial management department. 
In addition, the Investigator must record all device deficiencies reported or observed in 
the study product in the device efficiency eCRF. The site must immediately submit all available 
information about SADE, SAE and device deficiencies to the study sponsor: 
• 
All SAEs are documented on the Adverse Device Effect and Serious Adverse Event eCRF 
within 24 hours of the Investigator’s or site’s awareness. 
• 
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10 calendar days after the investigator or research center is notified. 
• 
Additional relevant information after initial reporting is to be entered into the eCRF as soon 
as the data become available. 
• 
Document any changes to concomitant medications on the appropriate eCRFs. 
• 
Document all relevant information from Discharge Summary, Autopsy Report, Certificate 
of Death, etc., if applicable, in narrative section of the Adverse Device Effect (for related AEs) 
and Serious Adverse Event eCRF. 
 
The Investigator must also report all AEs and device deficiencies that could have led to a 
SADE according to the requirements of regulatory agencies or the ethics committee. 
 
 

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(IV) Severity and causality assessment 
The Investigator should assess the severity of the AE as mild, moderate, or severe based 
on medical judgment with consideration of any subjective symptom(s), as defined below: 
Severity 
o Mild: An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
o Moderate: An AE is moderate if the sign or symptom results in discomfort 
significant enough to cause interference with the subject’s usual activities. 
o Severe: An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
Causality  
For every AE in the study, the Investigator must assess the causality (Related or Not 
Related to the medical device or test procedure). An assessment of causality will also be 
performed by the Study Sponsor utilizing the same definitions, as shown below: 
o Related: An AE classified as related may be either definitely related or possibly 
related where a direct cause and effect relationship with the medical device or study 
procedure has not been demonstrated, but there is a reasonable possibility that the 
AE was caused by the medical device or study procedure. 
o Not Related: An AE classified as not related may either be definitely unrelated or 
simply unlikely to be related (ie, there are other more likely causes for the AE). 
The Study Sponsor will assess the AEs and may upgrade the Investigator’s assessment of 
severity and/or causality. The Study Sponsor will notify the Investigator of any AEs that is 
upgraded from non-serious to serious or from unrelated to related. 
 
XIV. Deviations from the Clinical Trial Protocol and Provisions on the Modification of 
the Clinical Trial Protocol 
(I) Deviations from the clinical trial protocol 
Definition: Events where the Investigator or the staff of the site fails to carry out the study 
in accordance with the clinical study protocol, corresponding laws, corresponding management 
regulations or research contracts. 
The Investigator should strictly abide by the clinical trial protocol, and shall not deviate 
from the protocol or change the protocol substantially without the consent of the sponsor and 
the ethics committee, or without the approval of the National Medical Products Administration 
as stipulated. However, there are exceptions for emergency situations that require protection of 
the life or health of the subjects. Such approval should have written records and kept in the trial 
record file. Prior approval is usually impossible for situations that the Investigator cannot 

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anticipate and control (such as the subject's failure to undergo follow-up as planned), but the 
event itself is still considered a deviation. 
After a deviation event occurs, the study staff should promptly report the above-mentioned 
research deviation to the sponsor. The study staff should report the handling of deviations from 
the trial in accordance with the requirements of the ethics committee. 
(II) Revision of clinical trial protocol 
All modifications made to the protocol must be approved by the sponsor and the 
Investigator, and submitted to the ethics committee for review and approval by the medical 
device clinical trial management department of the clinical trial institution. Amendments may 
require changes to informed consent and other study-related materials. If the informed consent 
form is revised, all subjects currently participating in the study must sign an approved and 
revised informed consent form (re-consent) in accordance with the requirements of the ethics 
committee. 
When clinical trial institutions and investigators have changed compared with the original 
list, the list can be updated for each change without using a formal amendment, but the final 
report must provide the final list of all clinical trial institutions and investigators. 
 
XV. Direct Access to Source Data and Documents 
(I) Definition of source data and source documents 
Source data refers to the original records of clinical findings, observations, and other 
activities in clinical trials and all the information in their approved copies, which can be used 
for clinical trial reconstruction and evaluation. 
Source documents refer to printed documents, visual documents or electronic documents 
that contain source data. 
(II) Provisions on direct access to source data and documents 
The investigator should truthfully and accurately record and save the source data and 
source documents in the clinical trial process. 
The clinical trial institution and the investigator should accept the sponsor’s monitoring 
and audits, and the ethics committee’s supervision, and provide all required trial-related 
records. Where the medical products administration and the competent health and family 
planning authority dispatch monitors to carry out inspections, the clinical trial institution and 
the investigator shall cooperate. 
The original data of this trial will be preserved in accordance with the data preservation 
provisions required by the by the Good Clinical Practice for Medical Devices (Decree No. 25), 
that is, the clinical trial institution shall preserve the clinical trial data for 10 years after the end 
of the clinical trial. The sponsor should save the clinical trial data until the medical device is 
not used any more. 
 
 

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XVI. Finance and Insurance 
Before the enrollment of subjects, the sponsor, the clinical trial institution and the 
investigator should reach a written agreement on the trial design, trial quality control, division 
of responsibilities in the trial, clinical trial-related expenses borne by the sponsor, and principles 
for the handling of harms that may occur in the trial. 
This trial stipulates that the sponsor shall bear the cost of treatment and corresponding 
financial compensation for subjects who suffer injuries or deaths associated with the clinical 
trial, except for damages caused by the fault of the medical institution and its medical staff in 
the diagnosis and treatment activities. The sponsor has purchased medical device clinical trial 
liability insurance for this trial. 
See the Clinical Research Contract for specific provisions.  
 
XVII. Contents to Be Covered by the Clinical Trial Report  
The investigator should verify or validate the safety and effectiveness of the investigational 
medical device in accordance with the design requirements of the clinical trial protocol, and 
complete the clinical trial report. The clinical trial report of a multi-center clinical trial should 
include the clinical trial summary of each sub-site. 
For multi-center clinical trials, the clinical trial summary of each sub-site should at least 
include the clinical trial overview, general clinical data, information description of the 
investigational medical device, safety and effectiveness data sets, incidence and treatment of 
adverse events, and description of protocol deviations, with case report forms attached. 
The clinical trial report complies with the relevant requirements of Good Clinical Practice 
for Medical Devices, and will be formulated by referring to the Sample Medical Device Clinical 
Trial Report and Guidelines for Clinical Trials of Intraocular Lenses.  
 
XVIII. Confidentiality Principle 
All data obtained in the clinical trial are subject to data protection. The investigator shall 
not disclose the subject’s name and other personal information (excluding date of birth/age and 
sex). It must be ensured that the CRF or other documents sent to the sponsor (such as copies of 
reports on special findings) do not contain names, but only the subject's study code (number, 
date of birth and/or random number). 
Similarly, data storage for statistical evaluation can only be performed under the subject's 
study code. Only the investigator can identify the subject’s name/other personal details by the 
study code. 
During the clinical trial, if the name of the subject needs to be identified due to medical 
reasons, all relevant personnel are obliged to keep it confidential. 
 
 

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The sponsor can publish anonymous research data to external investigators for future 
research directly related to the study objective, or future research beyond the scope of the 
current study objective. The informed consent form explains this point to the study subjects. 
Anonymity means that all identifiable information will be deleted from the data sets and all 
links to subjects in the study will be deleted. Data confidentiality can ensure the confidentiality 
of the subjects participating in the study, so that they cannot be identified by external 
investigators. The anonymized data sets will contain the records of all subjects in the current 
study, but the anonymization process may change the data sets in some way, so external 
investigators will be informed that they cannot copy some results of the study.  
 
XIX. Agreement on Publication of Test Results 
An interim analysis will be performed on all research data after the last subject completes 
the follow-up at Month 6 after surgery. 
The final results of this study will be submitted by the sponsor to the National Medical 
Products Administration for renewal of registration approval. The sponsor has obtained the 
product registration certificate granted by the National Medical Products Administration. All 
sites can publish articles on their own research, but the data and results of their published 
articles must be consistent with the summary report of this trial and the sub-site summary 
reports, and the sponsor must be notified in writing. 
 
XX. Responsibilities Assumed by Each Party  
The responsibilities stipulated in the Good Clinical Practice for Medical Devices are as 
follows:  
(I) Responsibilities of Sponsors 
Article 38 The sponsor is responsible for initiating, applying for, organizing and 
monitoring clinical trials, and shall be responsible for the authenticity and reliability of clinical 
trials. The sponsor is usually a manufacturer of medical devices. If the sponsor is an overseas 
institution, it shall appoint an agent within the territory of China.  
Article 39 The sponsor is responsible for organizing the formulation and modification of 
the Investigator’s Brochure, clinical trial protocol, informed consent form, case report form, 
relevant standard operating procedures, and other relevant documents, and is responsible for 
organizing the implementation of the training necessary for clinical trials.  
Article 40 The sponsor shall choose clinical trial institutions and investigators in qualified 
medical device clinical trial institutions according to the characteristics of the investigational 
medical device. Before the sponsor signs the clinical trial agreement with clinical trial 
institution, the latest Investigator’s Brochure and other relevant documents shall be provided to 
the clinical trial institution and investigator for them to decide whether they can undertake the 
clinical trial or not.  

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Article 41 The Investigator’s Brochure shall contain the following main contents: 
(1) Basic information of the sponsor and investigator; 
(2) Summary of the investigational medical device; 
(3) Summary and evaluation supporting the intended use of the investigational medical 
device and justification for the clinical trial design;  
(4) Declaration that the manufacturing of the investigational medical device meets the 
requirements of applicable quality management system of medical devices. 
Article 42 The sponsor shall not exaggerate to publicize the mechanism and efficacy of 
the investigational medical device when organizing the formulation of the clinical trial protocol.  
Article 43 In the process of clinical trials, the sponsor shall modify the Investigator’s 
Brochure and relevant documents in a timely manner when obtaining important information 
that affects the clinical trial, and submit the modified documents to the ethics committee for 
review and approval through the medical device clinical trial management department of the 
clinical trial institution.  
Article 44 The sponsor shall reach a written agreement with the clinical trial institution 
and investigator on the following issues: 
(1) Implement clinical trials according to relevant laws and regulations and clinical trial 
protocol, and accept monitoring, audit and inspection;  
(2) Comply with data recording and reporting procedures; 
(3) Keep the basic documents related to the trial for no less than the statutory period, until 
the sponsor informs the clinical trial institution and investigator that the documents are no 
longer needed; 
(4) The sponsor is responsible for providing investigational medical devices to clinical 
trial institutions and investigators after being approved by the ethics committee, and 
determining the transportation conditions, storage conditions, time of storage, validity period, 
etc.;  
(5) Investigational medical devices shall be qualified and have special identification for 
easy recognition and with correct coding and marking with “for trial”, and shall be properly 
packaged and stored in accordance with the requirements of the clinical trial protocol;  
(6) The sponsor shall establish standard operating procedures related to the quality control 
of clinical trials, such as transportation, reception, storage, distribution, handling and recovery 
of medical devices used in the trials, which shall be followed by the clinical trial institutions 
and investigators. 
Article 45 The sponsor is responsible for the safety of the investigational medical device 
in the clinical trial. When it is found that the safety of subjects may be affected or the 
implementation of the trial may change the approval of the ethics committee to continue the 
trial, the sponsor shall immediately notify all clinical trial institutions and investigators, and 
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Article 46 If deciding to suspend or terminate the clinical trial, the sponsor shall inform 
the medical device clinical trial management department of all clinical trial institutions within 
5 days, and explain the reason in writing. The medical device clinical trial management 
department of clinical trial institutions should timely notify the corresponding investigators and 
ethics committees. Suspended clinical trials shall not be resumed without the consent of the 
ethics committee. After the completion of the clinical trial, the sponsor should inform the food 
and drug regulatory authority of the province, autonomous region, or municipality directly 
under Central Government where the sponsor is located.  
Article 47 The sponsor shall ensure that all investigators who conduct the clinical trial 
strictly abide by the clinical trial protocol. If the sponsor finds that the clinical trial institution 
and investigator do not comply with relevant laws and regulations, the GCP and the clinical 
trial protocol, the case shall be pointed out and corrected; if the case is serious or persists 
without correction, the trial should be terminated and a report should be made to the medical 
products administration departments of the province, autonomous region, or municipality 
directly under the Central Government where the clinical trial institution is located and the 
National Medical Products Administration. 
Article 48 The sponsor shall bear the cost of treatment and corresponding economic 
compensation for subjects that suffer injuries or deaths associated with the clinical trial, except 
for harms caused by the fault of the medical institution and its medical staff in the diagnosis 
and treatment activities.   
Article 49 The sponsor shall assume the responsibility for the monitoring of clinical trials, 
and select qualified supervisors to perform the supervision responsibilities. 
The number of monitors and times of monitoring depend on the complexity of the clinical 
trial and number of clinical trial institutions participating in the trial.  
Article 50 The monitor shall have the relevant professional background such as clinical 
medicine, pharmacy, biomedical engineering and statistics, and shall have received necessary 
training, be familiar with the relevant regulations and the GCP, familiar with the non-clinical 
information of the investigational medical device and clinical information of similar products, 
the clinical trial protocol and related documents.  
Article 51 The monitor shall comply with the standard operating procedures for monitoring 
the clinical trials of the investigational medical device formulated by the sponsor, supervise and 
urge the implementation of clinical trials in accordance with the clinical trial protocol. The 
specific responsibilities include:  
(1) Confirming that the clinical trial institution has had appropriate conditions, including 
the staffing and training meet the requirements, the laboratory is fully equipped and working in 
good condition, it is expected that there will be a sufficient number of subjects, and the 
participating study staff is familiar with the test requirements. 
 
 

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(2) Monitoring whether the clinical trial institutions and investigators comply with relevant 
regulations, the GCP and the clinical trial protocol in the early, middle, and late stages of the 
trial.  
(3) Confirming that each subject has signed the informed consent form before participating 
in the clinical trial, and knowing the inclusion of subjects and the progress of the trial; clearly 
and truthfully recording the follow-ups, tests and examinations that the investigator have not 
done, and whether mistakes and omissions have been corrected; confirming that subjects who 
are affected but have not ended the participation of clinical trial re-sign the modified informed 
consent form.  
(4) Confirming that all case report forms are filled out correctly and consistent with the 
source data; all mistakes and omissions have been corrected or noted, and signed and dated by 
the investigator; the disease type, total number of cases, and the sex, age, therapeutic effect of 
all cases shall be confirmed and recorded.  
(5) Confirming that cases where the subject withdraws from the clinical trial or does not 
comply with the requirements of the informed consent form are documented, and discussing 
the cases with the investigator.  
(6) Confirming that all adverse events, complications, and other device efficiencies are 
documented, and that serious adverse events and device deficiencies that may lead to serious 
adverse events are reported and documented within the specified time limit.  
(7) Monitoring the supply, use, maintenance as well as transportation, receiving, storage, 
distribution, handling and recovery of the investigational medical device.  
(8) Supervising the regular maintenance and calibration of the equipment in the course of 
clinical trials.  
(9) Ensuring that all the documents related to the clinical trial received by the investigators 
are the latest version.  
(10) A written report shall be submitted to the sponsor after each monitoring. The report 
shall include the name of the monitor, the date, time, place and contents of monitoring, the name 
of the investigator, project completion status, existing problems, conclusions, and correction of 
mistakes and omissions.  
Article 52 The sponsor may organize auditors dependent from the clinical trial who have 
relevant training and experiences to audit the progress of the clinical trial and assess whether 
the clinical trial meets the requirements of the clinical trial protocol so as to ensure the quality 
of the clinical trial.  
Auditing can be a part of the routine clinical trial quality management work of the sponsor, 
and also can be used to assess the effectiveness of monitoring activities, or audit serious and 
repeated deviations from the clinical trial protocol, suspected fraud and other cases.  
Article 53 The auditor shall formulate an audit plan and audit procedures according to the 
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and the risk level for subjects.  
Article 54 For serious adverse events and device deficiencies that may lead to serious 
adverse events, the sponsor shall report to the medical products administration department that 
the sponsor has filed to and the competent health and family planning authority at the same 
level within 5 working days after knowing them. At the same time, the sponsor shall notify 
other clinical trial institutions and investigators participating in the trial, and inform the ethics 
committees of the clinical trial institutions through their medical device clinical trial 
management department.  
Article 55 If the sponsor uses electronic clinical databases or remote electronic clinical 
data systems, it shall ensure that the clinical data is controlled and truthful, and that complete 
validation documents are formed.  
Article 56 For multi-center clinical trials, the sponsor shall ensure that the documents have 
been formulated before the clinical trial to clarify the division of responsibilities of coordinating 
investigators and other investigators.   
Article 57 For multi-center clinical trials, the sponsor shall organize the formulation of 
standard operating procedures according to the clinical trial protocol, and organize the training 
of all investigators participating in the trial on the clinical trial protocol and the usage and 
maintenance of the investigational medical device to ensure the consistency of the 
implementation of the clinical trial protocol and the usage of the investigational medical device.  
Article 58 In multi-center clinical trials, the sponsor shall ensure that the case report form 
is designed rigorously and reasonably and enables the coordinating investigators to obtain all 
data of the clinical trial institution of each sub-site.  
(II) Responsibilities of Clinical Trial Institutions 
Article 59 Before accepting a clinical trial, clinical trial institutions shall assess their 
relevant resources according to the characteristics of the investigational medical device to 
decide whether they should accept the clinical trial.  
Article 60 Clinical trial institutions shall properly keep the records and essential 
documents of the clinical trial in accordance with the agreement with the sponsor.  
Article 61 The investigator responsible for the clinical trial shall meet the following 
conditions:  
(1) With relevant professional technical title and qualification, such as associate chief 
physician, associate professor, associate researcher, and other titles above associate senior;  
(2) With the professional knowledge and experiences required for investigational medical 
devices, and having received the relevant training if necessary;  
(3) Be familiar with the requirements of the sponsor and the documents and literature 
related to the clinical trial provided by the sponsor;  
(4) Having the ability to coordinate, dominate and use the personnel and equipment for 
conducting the trial, and having the ability to deal with the adverse events and other associated 

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events of the investigational medical device;  
(5) Be familiar with the relevant Chinese laws, regulations and the GCP.  
Article 62 Before the clinical trial, the medical device clinical trial management 
department of clinical trial institutions shall cooperate with the sponsor to apply to the ethics 
committee, and submit relevant documents in accordance with relevant provisions.  
Article 63 The investigator shall ensure that the relevant personnel participating in the trial 
are familiar with the principle, scope of application, product performance, operation method, 
requirements for installation and technical indicators of the investigational medical device, 
understand the pre-clinical research data and safety data of the investigational medical device, 
and master the prevention and emergency handling of possible risks that may arise from the 
clinical trial.  
Article 64 The investigator shall ensure that all personnel participating in the clinical trial 
fully understand the clinical trial protocol, relevant provisions, the characteristics of the 
investigational medical device and the responsibilities related to the clinical trial, ensure that a 
sufficient number of subjects that meet the inclusion criteria of the clinical trial protocol will 
participate in the clinical trial, and ensure that there is enough time to safely implement and 
complete the clinical trial in accordance with the relevant provisions during the trial period 
agreed in the agreement.  
Article 65 The investigator shall ensure that the investigational medical device will only 
be used by the subjects in this clinical trial, and no fee may be charged.  
Article 66 The investigator shall strictly abide by the clinical trial protocol, and shall not 
deviate from the protocol or change the protocol substantially without the consent of the sponsor 
and the ethics committee, or without the approval of the National Medical Products 
Administration as stipulated. However, in case of an emergency such as immediate danger to 
the subject, which needs to be eliminated immediately, it may also be reported in writing 
afterwards. 
Article 67 The investigator is responsible for recruiting subjects and talking to the subjects 
or their guardians. The investigator is also responsible for explaining the details related to the 
investigational medical device and the clinical trial, informing subjects of the possible benefits 
and known and foreseeable risks, and obtaining the informed consent form signed and dated by 
subjects or their guardians.  
Article 68 The investigator and other personnel participating in the trial shall not force or 
induce subjects by unfair means to participate in the trial.  
Article 69 When the investigator finds an unexpected adverse event of the investigational 
medical device in the clinical trial, he/she shall modify the relevant contents of the informed 
consent form together with the sponsor. After the modified informed consent form is reviewed 
and approved by the ethics committee according to the relevant work procedures, the affected 
subjects or their guardians shall re-sign and confirm the modified informed consent form.  

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Article 70 The investigator is responsible for making medical decisions related to the 
clinical trial. When any clinical trial-related adverse event occurs, the clinical trial institution 
and the investigator shall ensure that the subjects are provided with adequate and timely 
treatment and care. The investigator shall timely inform subjects in a timely manner when the 
subject has a concurrent disease requiring treatment and care. 
Article 71 If serious adverse events occur in the clinical trial, the investigator shall take 
appropriate treatment measures for subjects immediately, and report in writing to the medical 
device clinical trial management department of the clinical trial institution which will notify the 
sponsor in writing. The medical device clinical trial management department should report in 
writing to the corresponding ethics committee, the medical products administration departments 
and the competent health and family planning authority of the province, autonomous region, or 
municipality directly under Central Government where the clinical trial institution is located 
within 24 hours. For death events, the clinical trial institution and the investigator should 
provide all necessary materials to the ethics committee and the sponsor. 
Article 72 The investigator shall record all adverse events that occur during the clinical 
trial and device deficiencies found, analyze the cause with the sponsor, form a written analysis 
report, and put forward his/her opinions for continuing, suspending or terminating the trial. 
Then the opinions shall be reported to the ethics committee for review through the medical 
device clinical trial management department of the clinical trial institution.  
Article 73 The investigator shall ensure that the clinical trial data will be recorded in the 
case report form accurately, completely, clearly and timely. The case report form shall be signed 
by the investigator, and any modification of data shall be signed and dated by the investigator. 
At the same time, the original records shall be kept, and the original records shall be clearly 
identifiable. 
Article 74 The clinical trial institution and the investigator shall ensure that the data, 
documents and records formed in the clinical trial are true, accurate, clear and secure.  
Article 75 The clinical trial institution and the investigator shall be subject to the sponsor's 
supervision, verification, and oversight by the ethics committee, and shall provide all necessary 
records related to the trial. Where the medical products administration department and the 
competent health and family planning authority dispatch monitors to carry out inspections, the 
clinical trial institution and the investigator shall cooperate.  
Article 76 If the clinical trial institution and the investigator find that the risks overweight 
the potential benefits, or obtain results sufficient to determine the safety and effectiveness of 
the investigational medical device, which requires to suspend or terminate the clinical trial, the 
subjects shall be notified, and it shall be ensured that the subjects will receive appropriate 
treatment and follow-up. At the same time, the situation shall be reported in accordance with 
the provisions, and a written explanation shall be provided. If necessary, the situation shall be 
reported to the local medical products administration department of the province, autonomous 
region and municipality directly under the Central Government.  

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The investigator shall inform the subjects in time after receiving the notification to suspend 
or terminate the clinical trial from the sponsor or the ethics committee, and ensure that the 
subjects will receive appropriate treatment and follow-up. 
Article 77 If the sponsor violates the relevant provisions or demands to change the trial 
data or conclusion, the clinical trial institution and the investigator shall report to medical 
products administration department of the province, autonomous region and municipality 
directly under the Central Government where the sponsor is located, or the National Medical 
Products Administration.   
Article 78 At the end of the clinical trial, the investigator should ensure that all records and 
reports are completed. At the same time, the investigator shall also ensure that the number of 
received investigational medical devices is consistent with the number of used, obsolete or 
returned devices, and ensure that the remaining investigational medical devices are disposed of 
properly, recorded and archived.  
Article 79 The investigator may authorize relevant personnel to recruit subjects, 
communicate with subjects, record clinical trial data and manage investigational medical 
devices according to the needs of the clinical trial. The investigator shall offer related training 
to the authorized personnel and form relevant documents. 
 
XXI. References 
 
1. 
Expert Consensus on the Clinical Application of Multifocal Intraocular Lenses in China (2019), 
Cataract and Intraocular Lens Group of Chinese Ophthalmological Society, CMA. Chinese 
Journal of Ophthalmology, July 2019, Vol. 55, No. 7, 491-494. 
2. 
Guidelines for Clinical Trials of Intraocular Lenses. No. 13 of 2019. 
3. 
Ophthalmic implants – Intraocular lenses – Part 7: Clinical investigations of intraocular lenses for 
the correction of aphakia (ISO 11979-7: 2018). 
4. 
Guidelines for Clinical Trials of Soft Contact Lenses No. 51 of 2018.  
5. 
SUN Working group (2005) Standardization of uvieitis nomenclature for reporting clinical data. 
Results of the first international workshop. Am J Ophthalmol 140: 509-516. 
 
Investigator’s statement 
I agree: 
1. I will carry out this clinical trial in strict accordance with the Declaration of Helsinki, 
China's current regulations, and the requirements of the trial protocol.  
2. I will accurately record all required data in the case report form (CRF), and complete 
the clinical trial report on time.  
3. The investigational medical device will only be used for this clinical trial. I will 
completely and accurately record the receiving and use of the investigational medical device in 

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the course of the clinical trial, and keep the records.  
4. I will allow the monitors, auditors authorized or dispatched by the sponsor and the 
regulatory authority to monitor, audit, and inspect the clinical trial.  
5. I will strictly perform the terms of clinical trial contract/agreements signed by all parties.  
 
I have completely read the clinical trial protocol, including the above statement, and I 
agree to all contents above.  
 
 
 
 

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