Clinical Investigation of Healon EndoCoat Ophthalmic Viscosurgical Device (OVD)
Phase: NA
Conditions: Cataracts
Sponsor: Johnson & Johnson Surgical Vision, Inc.

 
 
 
Study Protocol 
 
 
 
Clinical Investigation of the Bacterially-Derived Healon 
EndoCoat PRO Ophthalmic Viscosurgical Device (OVD) 
 
PROTOCOL NUMBER: VSCO-110-LOKE 
 
NCT Number: NCT 05575063 
 
Document Date: March 01, 2024 

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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Johnson & Johnson Surgical Vision 
Clinical  Investigation  of the  
Bacterially -Derived Healon EndoCoat  PRO Ophthalmic Viscosurgical Device 
(OVD) 
 
IDE Number: G220153  
 
PROTOCOL NUMBER: VSCO-110-LOKE 
 
SPONSOR: Johnson & Johnson Surgical Vision, Inc. 
31 Technology Dr., Suite 200 
Irvine, CA 92618 
 
 
Investigator Agreement
 
 
As an Investigator, I agree to
: 
• Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812, ISO 14155 and all 
other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB), FDA or other regulatory authorities; 
and all other applicable laws and regulations. 
• Supervise all testing of the device where human subjects are involved. 
• Ensure that the requirements for obtaining informed consent are met. 
• Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
• Maintain all information supplied by Johnson & Johnson Surgical Vision in 
confidence and, when this information is submitted to an independent IRB or any 
other group, it will be submitted with a designation that the material is 
confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
 
 
 
 
 
Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 
 
 
 
 
 
Sub-Investigator Printed Name 
Signature 
Date 
 
 

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PERSONNEL AND FACILITIES 
SPONSOR: 
Johnson & Johnson Surgical Vision, Inc. 
31 Technology Dr., Suite 200 
 
Irvine, CA 92618 
 
 
SPONSOR PERSONNEL: 
 
 
Medical Monitor:  
Leslie Patch, M.D., M.B.A., F.A.C.S. 
 
Medical Director, Cataract Surgery Implants 
 
Cell: (445) 227-5545  
 
Medical Safety Officer:   
   Ritchie Yuson, M.D. 
   Medical Safety Officer 
   Office: (714) 227-9191 
 
 
Director, Clinical Science : 
Priya Janakiraman, O.D. 
 
Director, Clinical Science 
 
Office: (408) 300-3442 
 
Clinical Scientist: 
Eric Li, O.D., Ph.D. 
 
Principal Clinical Research Scientist 
 
Mobile: (650) 732-1467 
 
Study Manager:  
Joann Nilplub, M.B.S. 
 
Clinical Research Manager 
 
Mobile: (714) 478-1176  
 
Clinical Study Management 
       Amanda Policastro, M.B.A. 
Lead: 
 
   Senior Manager, Clinical Operations  
 
   Office: (714) 721-8682 
 
Biostatistician s: 
Linda Tsai, M.P.H. 
 
Principal Biostatistician 
 
Office: (714) 247-8850 
 
 
Wuchen Zhao M.S. 
 
Senior Biostatistician 
 
Office: (732) 494-2005 ext. 108 
 
 
EMERGENCY TELEPHONE NUMBERS: 
Joann Nilplub 
Mobile: (714) 478-1176 
 
 
 

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1. 
SYNOPSIS 
PROTOCOL: 
Clinical Investigation of the Bacterially-Derived Healon 
EndoCoat PRO Ophthalmic Viscosurgical Device (OVD) 
 
Protocol Number: VSCO-110-LOKE 
 
STUDY TREATMENTS: 
Test Product: Healon EndoCoat PRO (“EndoCoat PRO”) 
(Johnson & Johnson Vision) 
 
Control Product:  Commercially-available Healon EndoCoat 
(“EndoCoat”) (Johnson & Johnson Vision) 
 
STUDY OBJECTIVE:  
The purpose of this clinical trial is to evaluate the safety and 
effectiveness of the Healon EndoCoat PRO OVD as 
compared to the Healon EndoCoat OVD. 
 
CLINICAL HYPOTHESIS:  
The Healon EndoCoat PRO OVD will be statistically non-
inferior to the currently-available Healon EndoCoat OVD 
with regard the cumulative rate of IOP spikes ≥ 30 mmHg 
and mean endothelial cell count (ECC) change at 3 months 
postoperatively. 
 
OVERALL STUDY DESIGN: 
Structure:  
Prospective, 
multicenter, 
paired-eye, 
randomized, 
subject/evaluator-masked clinical investigation of the 
Healon EndoCoat PRO OVD versus the current Healon 
EndoCoat OVD control. 
 
Number of sites:  
Up to 10 sites in the USA.  
 
Duration:  
3 months 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 

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Number of Subjects:  
Up to 195 subjects will be enrolled 
 
 
 
 
 
  
 
Inclusion Criteria (all criteria apply to each study eye): 
• 
Minimum 22 years of age 
• 
Cataracts for which extraction and posterior chamber IOL implantation have been 
planned in both eyes 
• 
Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 
Snellen or better 
• 
Clear intraocular media, other than cataract  
• 
Availability, willingness, and sufficient cognitive awareness to comply with examination 
procedures 
• 
Signed informed consent and HIPAA authorization  
 
Exclusion Criteria (all criteria apply to each study eye): 
• 
Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)  
• 
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical 
outcomes or increase risk to the subject 
• 
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery  
• 
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or 
other retinal disorders) that are predicted to cause visual acuity losses to a level worse 
than 20/40 Snellen during the study.  
• 
Prior, current, or anticipated use during the course of the 3-month study of tamsulosin 
or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the 
investigator, confound the outcome or increase the risk to the subject (e.g., poor 
dilation or a lack of adequate iris structure to perform standard cataract surgery)  
• 
Conditions associated with increased risk of zonular rupture, including capsular or 
zonular abnormalities that may lead to IOL decentration or tilt, such as 
pseudoexfoliation, trauma, or posterior capsule defects 
• 
Use of systemic or ocular medications that may affect vision or IOP 
• 
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are 
predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the 
study, or in the opinion of the investigator, may confound the outcome(s) of the study  
• 
Poorly-controlled diabetes  
• 
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion 
of the investigator, would increase the operative risk or confound the outcome(s) of 
the study (e.g., immunocompromised, connective tissue disease, suspected 
glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, 
etc.).   

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• 
Known steroid responder 
• 
Ocular hypertension of ≥ 20 mmHg, medically-controlled ocular hypertension 
(regardless of IOP value), or glaucomatous changes in the optic nerve 
• 
Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the 
average of the three cell counts as taken by the Konan Specular Microscope)  
• 
Known ocular disease or pathology that may affect visual acuity or that may be 
expected to require retinal laser treatment or other surgical intervention during the 
course of the study (macular degeneration, cystoid macular edema, diabetic 
retinopathy, etc.)  
• 
Patient is pregnant, plans to become pregnant, is lactating or has another condition 
associated with the fluctuation of hormones that could lead to refractive changes 
• 
Concurrent participation or participation within 60 days prior to preoperative visit in any 
other clinical trial 
 
 
 
 
  
 
 
 
 
 
 
DATA ANALYSIS: 
The investigational OVD will be compared to the control OVD.   The 3-month postoperative 
visit is the key analysis time point for cumulative IOP spikes and ECC. 
 
 
 
 
 
  
 
 
  

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2. 
BACKGROUND/INTRODUCTION 
Viscoelastic devices are indicated for use as a surgical aid in anterior segment procedures 
including cataract surgery with or without an intraocular lens, secondary intraocular lens 
implantation, corneal transplant surgery, and glaucoma filtration surgery.  Some 
established benefits of using viscoelastic materials in cataract surgery are endothelial cell 
protection and maintenance of intraocular space.1 The protection these materials provide 
result in reduced trauma to the cornea from inadvertent “touch” during intraocular surgery, 
therefore minimizing endothelial cell loss.2   
Viscoelastic devices traditionally have been produced using animal-derived components 
but the use of animal-derived components have been losing favor in many parts of the 
world. JJSV has transitioned most of their OVDs to bacterially-derived NaHA (i.e., Healon5 
PRO) with Healon EndoCoat being the remaining OVD that utilizes animal-derived 
components. The OVD under investigation is an animal-free, bacterially-derived sodium 
hyaluronate version of the currently available, bacterially-derived Healon EndoCoat, which 
is named Healon EndoCoat PRO.  This clinical study will evaluate the performance of the 
bacterially-derived Healon EndoCoat PRO OVD under normal-use conditions during the 
cataract surgical procedure.  
3. 
CLINICAL HYPOTHESIS 
The Healon EndoCoat PRO OVD will be statistically non-inferior to the currently available 
Healon EndoCoat OVD with regard to the cumulative rate of IOP spikes ≥ 30 mmHg and 
mean endothelial cell count (ECC) change at 3 months postoperatively.  
4. 
STUDY DESIGN 
This study is a 3-month, prospective, multicenter, paired-eye, two-armed, masked, 
randomized clinical investigation of the bacterially-derived Healon EndoCoat PRO versus 
the currently available, Healon EndoCoat control.  
The study will be conducted at up to 10 sites in the USA and will include 195 enrolled 
subjects 
 
 Subjects will be randomly assigned to receive the 
test OVD in one eye and the control OVD in the fellow eye. 
 
 
 
 
 
 

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5. 
ACRONYMS 
The following acronyms are used throughout the document:   
• 
OVD: Ophthalmic viscosurgical device 
• 
ECC: Endothelial Cell Count 
• 
IOP: Intraocular pressure 
• 
BCDVA: Best corrected distance visual acuity 
• 
SAE: Serious Adverse Event 
• 
JJSV: Johnson & Johnson Surgical Vision, Inc.  
 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The purpose of this clinical trial is to evaluate the safety and effectiveness of the Healon 
EndoCoat PRO OVD as compared to the Healon EndoCoat OVD.   
6.1 
PRIMARY ENDPOINTS 
SAFETY: CUMULATIVE RATES OF IOP SPIKES 30 MMHG OR GREATER MEASURED 
POSTOPERATIVELY 
Success criteria: The cumulative rate of IOP spike for the Healon EndoCoat PRO OVD 
will be statistically non-inferior to that for control eyes using a non-inferiority margin of 10% 
EFFECTIVENESS: MEAN PERCENT ECC CHANGE PREOPERATIVELY VS. 
POSTOPERATIVELY 
Success criteria: The mean percent ECC change for Healon EndoCoat PRO will be 
statistically non-inferior to that for control eyes using a non-inferiority margin of 5%.  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

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• 
 
• 
Monocular BCDVA  
• 
Monocular UCDVA 
7. 
STUDY PRODUCTS 
7.1 
OPHTHALMIC VISCOSURGICAL DEVICES 
The two OVDs used in this study include the investigational, animal-free, bacterially-
derived Healon EndoCoat PRO and the commercially available, bacterially-derived 
Healon EndoCoat control. Both are considered dispersive viscoelastic devices.  
Investigational Healon EndoCoat PRO OVD 
Healon EndoCoat PRO is a sterile, nonpyrogenic, viscoelastic preparation of a highly 
purified sodium hyaluronate (NaHA) in a physiological sodium chloride phosphate buffer 
solution for intraocular use. This polymer is made up of repeating disaccharide units of 
glucuronic acid and N-acetyl-β-glucosamine. The ophthalmic viscoelastic contains 3% 
NaHA that is obtained from a bacterial fermentation source and it has a viscosity of 
approximately 30 - 90 Pas, a molecular weight of 800,000-1,000,000 Daltons, a pH of 6.8 
- 7.6 and an osmolarity of 320 mOsm/kg. The HA of the Healon EndoCoat PRO OVD is 
derived from an animal-free bacteria-fermentation process.  
Healon EndoCoat Control OVD 
Healon EndoCoat is a sterile, nonpyrogenic, viscoelastic preparation of a highly purified 
sodium hyaluronate (NaHA) in a physiological balanced salt solution for intraocular use. 
This polymer is made up of repeating disaccharide units of glucuronic acid and N-acetyl-
β-glucosamine. The ophthalmic viscoelastic contains 3% NaHA that is obtained from a 
bacterial fermentation source and it has a viscosity of approximately 30-62 Pas, a 
molecular weight of 800,000 Daltons, a pH of 6.8-7.6 and an osmolarity of 320 mOsm/kg. 
The HA of the current EndoCoat OVD is derived from a bacteria-fermentation process.  
Although no animal-origin materials remain in the finished product, casein hydrolysate is 
used as nutrient source of bacterial fermentation.  Casein hydrolysate, originating from 
bovine milk, is an extensively processed and modified material of animal origin. 
    
 
 
 
 
 
  

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8. 
STUDY POPULATION 
All study subjects will be enrolled from the surgical cataract population at up to 10 sites in 
the USA.  Up to 195 subjects will be enrolled 
 
.   
 
 
 
 
 
 
 

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8.1 
INCLUSION CRITERIA (ALL CRITERIA APPLY TO EACH STUDY EYE): 
• 
Minimum 22 years of age 
• 
Cataracts for which extraction and posterior chamber IOL implantation have been 
planned in both eyes 
• 
Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/40 
Snellen or better 
• 
Clear intraocular media, other than cataract  
• 
Availability, willingness, and sufficient cognitive awareness to comply with examination 
procedures 
• 
Signed informed consent and HIPAA authorization  
 
8.2 
EXCLUSION CRITERIA (ALL CRITERIA APPLY TO EACH STUDY EYE): 
• 
Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils)  
• 
Recent ocular trauma or ocular surgery that is not resolved/stable or may affect clinical 
outcomes or increase risk to the subject 
• 
Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery  
• 
Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or 
other retinal disorders) that are predicted to cause visual acuity losses to a level worse 
than 20/40 Snellen during the study.  
• 
Prior, current, or anticipated use during the course of the 3-month study of tamsulosin 
or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of the 
investigator, confound the outcome or increase the risk to the subject (e.g., poor 
dilation or a lack of adequate iris structure to perform standard cataract surgery)  
• 
Conditions associated with increased risk of zonular rupture, including capsular or 
zonular abnormalities that may lead to IOL decentration or tilt, such as 
pseudoexfoliation, trauma, or posterior capsule defects 
• 
Use of systemic or ocular medications that may affect vision or IOP 
• 
Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are 
predicted to cause visual acuity losses to a level worse than 20/40 Snellen during the 
study, or in the opinion of the investigator, may confound the outcome(s) of the study  
• 
Poorly controlled diabetes  
• 
Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion 
of the investigator, would increase the operative risk or confound the outcome(s) of 
the study (e.g., immunocompromised, connective tissue disease, suspected 
glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, 
etc.).   
• 
Known steroid responder 

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• 
Ocular hypertension of ≥ 20 mmHg, medically controlled ocular hypertension 
(regardless of IOP value), or glaucomatous changes in the optic nerve 
• 
Endothelial cell count (ECC) lower than 1800 cells/mm2 preoperatively (based on the 
average of the three cell counts as taken by the Konan Specular Microscope)  
• 
Known ocular disease or pathology that may affect visual acuity or that may be 
expected to require retinal laser treatment or other surgical intervention during the 
course of the study (macular degeneration, cystoid macular edema, diabetic 
retinopathy, etc.)  
• 
Patient is pregnant, plans to become pregnant, is lactating or has another condition 
associated with the fluctuation of hormones that could lead to refractive changes 
• 
Concurrent participation or participation within 60 days prior to preoperative visit in any 
other clinical trial 
 
9. 
INVESTIGATOR SELECTION 
9.1 
INVESTIGATOR QUALIFICATIONS 
JJSV will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent) and are licensed to practice medicine and perform surgery 
at his/her investigative site.  
Investigators will be selected from surgeons who are experienced in small-incision, 
phacoemulsification and IOL implantation in cataract patients.  All sites are required to 
have adequate staff support for reporting and subject follow-up, as well as the necessary 
instrumentation to conduct study testing. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• 
Conduct the study in accordance with the relevant and current protocol.  Investigator 
will only make changes to a protocol after notifying and obtaining approval from JJSV, 
the FDA or other governing agencies, and the Investigational Review Board (IRB), 
except when necessary to protect the safety, rights, or welfare of subjects 
• 
Personally conduct and supervise the study 
• 
Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
• 
Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the devices 
under investigation 

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• 
Inform patients that the device(s) are being used for investigational purposes and that 
requirements relating to obtaining informed consent and IRB approval are met 
according to 21CFR50, 21CFR56, 21CFR812 and all other applicable laws and 
regulations 
• 
Maintain confidentiality as required by HIPAA or similar laws and regulations 
• 
Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining FDA and IRB approval  
• 
Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 
• 
Report to JJSV and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations 
• 
Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either JJSV, duly authorized regulatory agencies (e.g., FDA) and/or the 
IRB 
• 
Submit progress reports on the investigation to JJSV and the reviewing IRB at regular 
intervals, but no less often than yearly as required by 21CFR812.150  
• 
Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
• 
Report all changes in research activity and all unanticipated problems involving risks 
to patients to the IRB and JJSV 
• 
Supervise and permit investigational device use and disposition in accordance with 
applicable regulations and protocol requirements.  Upon completion of enrollment or 
termination of the study or the investigator’s part of the study, or at JJSV’s request, 
return to JJSV any remaining supply of the investigational device 
• 
Provide sufficient accurate financial information to JJSV to allow JJSV to submit 
complete and accurate certification or disclosure statements as required by 21CFR54.  
Promptly update this information if any relevant changes occur during the course of 
the investigation or for up to one year following completion of the study 
• 
Comply with all other obligations of clinical investigators and requirements according 
to all applicable FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB, the FDA and 
the regulatory agency of the country in which the study is being conducted 
• 
Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are adequately informed about the protocol, the investigational device, their 

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study-related duties and functions and agree to fulfill their obligations in meeting the 
above commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study. The Investigator, or delegate, shall notify JJSV of any change in the conduct of the 
study including changes in study personnel assigned to the study project, location of the 
investigational device(s), or maintenance of study records, etc.  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB submissions and 
approvals should be forwarded to JJSV.  Study sites will obtain IRB approvals and fulfill 
any other site-specific regulatory requirements.  The investigator is required to report to 
JJSV within five working days any withdrawal of approval by the reviewing IRB for his/her 
participation in the investigation. 
Prior to the start of subject enrollment, the following documents must be signed and 
returned to JJSV: 
• 
Confidentiality Agreement 
• 
Clinical Trial Agreement 
• 
Investigator Agreement/Protocol Signature page 
• 
Clinical Investigator Brochure Signature page 
• 
Financial Disclosure form 
• 
Signed and dated copy of investigator’s current curriculum vitae 
• 
Copy of the investigator’s current medical license  
• 
Hospital/Ambulatory Surgery Center Clinical Study Acknowledgement, if required 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
9.4 INVESTIGATOR INFORMATION 
Information on the principal investigator at each investigative site, the coordinating 
investigator, the address details for each investigative site and the emergency contact 
details for the principal investigator of each site are listed in a separate document - Study 
Investigator Information. 

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10. 
EXPERIMENTAL PLAN 
10.1 
OVERVIEW 
This study will be conducted in accordance with the ethical principles that have their origin 
in the Declaration of Helsinki, ISO 14155:2020 and all other applicable regional laws and 
regulations.  The study will not begin until regulatory and IRB approvals have been 
obtained. Any additional requirements imposed by the IRB or regulatory authority will be 
followed.  
This study will be a prospective, multicenter, paired-eye, randomized, two-arm, subject- 
and evaluator-masked clinical investigation conducted at up to 10 sites. Up to 195  
subjects will be enrolled to achieve approximately 114 contralaterally-treated and 
evaluable subjects at 3 months. After informed consent is obtained and confirmation that 
all inclusion/exclusion criteria are met, the eyes may be randomized.  
After signing the informed consent, eyes meeting all inclusion and exclusion criteria will 
be randomly assigned in a 1:1 ratio to receive either the Healon EndoCoat PRO OVD or 
the Healon EndoCoat OVD control for the first-eye surgery and the other study product for 
the second-eye surgery. 
 
 
 
 
 
 All subjects will be examined through 
3 months postoperatively 
 
  
 
 
  
 
 
 
 
 
 
 
 
 
   

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As the Informed Consent Form is signed at the beginning of the preoperative study exam, 
some subjects may not qualify after study-specific testing is performed. Subjects will be 
considered screen-failures if they do not qualify or otherwise decide not to proceed with 
surgery or study participation. These subjects will be exited from the study.  
    
  
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
  
 
  
 
  
 
  
 
 
 
 
 
 
 
 
 
 
 

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10.4 
RANDOMIZATION AND MASKING 
A randomization list stratified by investigational sites will be created 
 
 Subjects will be 
randomly assigned to receive either the Healon EndoCoat PRO or the Healon EndoCoat 
control in the first operative eye in a 1:1 ratio; subjects will then receive the OVD not used 
in the first-eye surgery in the fellow eye.  Unmasked study personnel at the site will be 
trained in the randomization process through the EDC system and will randomize subjects 
as they are enrolled. Randomization will take place after the subject has signed the 
informed consent document, has met all inclusion and exclusion criteria, and the 
investigator has documented which eye will be the first to undergo surgery.  
As part of the informed consent process, the investigator or delegate will explain to the 
subject the requirements of a randomized study and the differences between the two 
OVDs: the Healon EndoCoat PRO investigational OVD and the Healon EndoCoat control 
OVD. 
 
 
 
 
 
The subjects, investigators, and the study technicians performing the postoperative exams 
are to be masked through study completion.  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
   
 
 
 
 
 
 

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Unmasked Clinical Research Associates (CRAs) will visit the site to confirm OVD 
traceability and to monitor Operative visit forms and source documents.  All other JJSV 
study personnel will remain masked through the final study visits.  
10.5 
STUDY OVD SUPPLY 
The investigational OVD will be obtained from a site consignment that is supplied by the 
Sponsor following IRB approval for a given site. 
 
 
 
 
 
 
   
The control OVD will also be obtained from a site consignment that is provided by the 
Sponsor specifically for use in the study.  
 
  
 
 
 
  
  
 
 
 
 
  
  
  
 
  
 
  
  
 
 
 
  

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10.7 
OPERATIVE PROCEDURES  
Both the investigational and the control OVDs should be generally used as the investigator 
would use his/her standard OVD(s) during the cataract removal and lens implantation 
procedure.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10.8 
POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule 
 
  

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ADVERSE EVENTS 
Subjects should be assessed at each visit for occurrence of and/or change in status of 
any adverse events, particularly serious and/or device-related adverse events.  
 
  
10.9 
EXIT OF SUBJECTS  
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.   
 
It is the responsibility of the investigator to provide complete follow-up data to JJSV for 
each subject, and every attempt should be made to gather that complete follow-up data 
for all subjects enrolled as missing data can have a negative effect on the study results. 
Patients who would be traveling, relocating or otherwise unavailable for postoperative 
follow-up visits should not be chosen for this clinical study. 
 
Subjects will be discontinued/early terminated from the study if the subject dies, or if the 
subject is irretrievably lost for unavoidable reasons such as: subject moved/unable to 
locate, subject uncooperative/refuses further study participation, subject ill/unable to 
travel. Documentation of efforts to trace subjects that are lost to follow-up and possible 
reasons are required.  In the event of subject relocation, efforts must be made by the 

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investigator to secure follow-up information (i.e., slit-lamp findings and general visual 
acuity, etc.) from the subject’s new physician.   
 
A subject will be considered a non-randomized screen failure if he/she does not meet the 
inclusion/exclusion criteria, if consent is withdrawn prior to randomization or death occurs 
prior to treatment.   
 
A subject will be considered a randomized screen failure if the subject is randomized but 
does not undergo surgery or does not receive a study/control OVD for various reasons 
including: subject does not meet the inclusion/exclusion criteria, the planned implant was 
aborted due to surgical complications, the subject withdrew consent prior to treatment or 
the subject died prior to treatment.  If a subject receives the study or control OVD in at 
least one eye, he/she is to be followed according to the protocol.   
 
If a subject is exited early from the study, the investigator will complete an Exit Case 
Report Form in EDC indicating the reason for study exit.  In the event of a lens removal or 
other serious adverse event, the subject may be exited from the study; however, efforts 
must be made by the investigator to follow the subject until resolution of the adverse event. 
 
Following study completion or early exit, subjects may be informed about which OVD 
model they received.  Additionally, all study subjects are to be instructed to undergo 
regular eye examinations at least yearly and also to return to their doctor if any eye 
complications are experienced in the interim.   
 
 
 
 
10.10 UNSCHEDULED VISITS  
During the study period, if a non-protocol-required visit is done for the purpose of 
medically-indicated follow-up for either study eye, data from this visit should be submitted 
using the Unscheduled Visit CRF.  The need for unscheduled visits is at the investigator’s 
discretion.  Specific examinations to be performed at unscheduled visits are also at the 
discretion of the investigator (based on the reason for the unscheduled visit), and data are 
to be recorded in the appropriate section of the case report form. 
Data to be collected may include: 
• 
Uncorrected and best corrected distance visual acuity 
• 
Manifest refraction 
• 
Intraocular pressure 
• 
Slit-lamp examination for medical and/or lens findings  
• 
Dilated fundus exam 
• 
Adverse events 
• 
Ocular Medications 

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10.11 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented, and corrective 
actions will be implemented as appropriate. Any deviation made to protect the life or 
physical well-being of a subject in an emergency as well as any use of the investigational 
device without obtaining informed consent must be reported to JJSV within 5 working 
days. Protocol deviations will be monitored by JJSV, and if the non-compliance is 
persistent or egregious, JJSV may take action, including but not limited to termination of 
the investigator’s participation in the study.  The investigator is also responsible for 
informing the reviewing IRB of instances of protocol non-compliance in accordance with 
the IRB requirements. JJSV cannot grant permission to use waiver from the study 
protocol. 
11. 
ADVERSE EVENTS AND PRODUCT COMPLAINTS  
11.1 
ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
• 
is sight- or life-threatening,  
• 
results in death,  
• 
requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition without a serious deterioration in health is 
not considered a serious adverse event), 
• 
results in permanent impairment of a body structure or body function including chronic 
diseases,  
• 
necessitates medical or surgical intervention to prevent permanent impairment to a 
body structure or function, or 
• 
results in fetal distress, fetal death or a congenital abnormality or birth defect including 
physical or mental impairment 
Device-Related Adverse Event/Adverse Device Effect (ADE) 
A device-related adverse event is defined as any adverse even that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 11.4, Causal Relationship).  A device-related event is also considered an adverse 

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device effect (ADE; following ISO 14155) resulting from the use of the study device that 
may result from user error, insufficiencies or inadequacies in the instructions for use, 
deployment, implantation, installation, operation of any malfunction of the device.   
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular adverse events that are 
anticipated and must be reported to JJSV for this study.  Any events that are unlikely but 
anticipated (i.e., endophthalmitis) will be reported to the FDA and other appropriate 
regulatory agencies. 
• 
Endophthalmitis/Intraocular infection 
• 
Hypopyon 
• 
Hyphema 
• 
IOL dislocation 
• 
Cystoid macular edema 
• 
Pupillary block 
• 
Retinal detachment/tear 
• 
Persistent corneal edema 
• 
Persistent iritis 
• 
Raised IOP requiring treatment (i.e., IOP ≥ 30 mmHg) 
• 
Visual symptoms requiring secondary surgical intervention (e.g., lens removal) 
• 
Tilt and decentration requiring secondary surgical intervention (e.g., repositioning) 
• 
Residual refractive error resulting in a secondary surgical intervention 
• 
Retained lens material resulting in secondary surgical intervention 
NOTE 1: Suture removal, planned blepharoplasty and Nd:YAG capsulotomy (for PCO) 
are not considered adverse events for this study. 
NOTE 2: Corneal edema and iritis will only be considered serious if sight-threatening at 
the time of occurrence.  Treatment merely to hasten the resolution of such conditions (and 
not intended to prevent permanent damage to the eye) will not be reported as serious 
adverse events.   
NOTE 3: Corneal edema, and chronic anterior uveitis/iritis will be considered serious if 
corneal edema results in BCDVA of 20/40 or worse at 1 month or later; and Grade 1+ 
uveitis/iritis persists longer than 3 months. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse Device 
Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 
application (including a supplementary plan or application), or risk assessment, or any 

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other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
Serious Health Threat 
A serious health threat (following ISO 14155) is a signal from any adverse event or device 
deficiency that indicates an imminent risk of death or a serious deterioration in the health 
in subjects, users or other persons, and that requires prompt remedial action for other 
subject, users or other persons.  This would include events that are of significant and 
unexpected nature such that they become alarming as a potential serious health hazard 
or possibility of multiple deaths occurring at short intervals.   
11.2 
PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as any 
alleged deficiency related to the identity, quality, durability, reliability, safety, effectiveness, 
or performance of a device. This may include malfunctions, use error and inadequacies in 
labeling.  Product complaints can pertain to any marketed JJSV device being used in the 
study as well as the investigational device.  The investigator is to assess whether the 
deficiency could have led to a serious adverse event without suitable action or intervention 
or under less fortunate circumstances. 
11.3 
ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any JJSV product, regardless of 
severity and whether or not attributed to the study device(s), are to be reported to JJSV 
and recorded on the case report form corresponding to the visit during which awareness 
of the event occurred.  Adverse events are also to be reported to the reviewing IRB as per 
the IRB reporting requirements.  If required, adverse events will be reported to the 
appropriate regulatory agencies (e.g., FDA) according to all applicable laws and 
regulations.   
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812).  
General guidelines are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to JJSV in a timely 
manner.  Notification of non-serious and non-device related adverse events will occur by 
recording events on the CRF when noted.  Such adverse events are also to be reported 
to the reviewing IRB per their reporting requirements.  

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Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to JJSV in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 
complaints on the CRF when the complaint occurred (e.g. operative form) or by a phone 
call to the Sponsor.  Any device deficiency that could have led to a serious adverse event 
without suitable action or intervention, or under less fortunate circumstances, must be 
reported to the sponsor immediately (no later than 24 hours after detection). Device 
deficiencies that could have led to a serious adverse event should also be reported to the 
investigator’s IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
Serious and/or device related events (ADEs) are to be documented using the Detailed 
Adverse Event CRF.  In the event of a serious adverse event (SAE), which may or may 
not be related to use of the study device, JJSV must be notified immediately (no later than 
48 hours after detection).  Any SAE is to be reported by phone (and/or email) and by 
submitting the completed Detailed Adverse Event CRF.  Any SAE or device-related AE 
should also be reported to the investigator’s IRB/IEC per their reporting requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse Device 
Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
device-related and was not previously expected in nature, severity, or degree of incidence, 
the investigator is to report the UADE/USADE to JJSV immediately (no later than 48 hours 
after detection), and to the investigator’s IRB as soon as possible (and no later than 
10 working days after learning of the event for sites in the USA as required by 21CFR812). 
11.4 
CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the study 
device or the use of the study device (i.e., the procedure specific to the initial application 
of the device).  An attempt should be made in every case to determine the causality of the 
event.  The following definitions are to be used as guidelines in determining the 
relationship between the event and the study device and/or use of the device.   
Definitely related: 
If the event is associated with the device and/or the use of the 
device beyond a reasonable doubt, a causal relationship exists 
between the adverse event and the device and/or the use of the 
study device. 
Probably related:   
There is a reasonable possibility of a causal relationship between 
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device and/or the adverse event cannot be reasonably explained 
by another cause. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or the use of the device, but no other cause has been 
identified and the device and/or the use of the study device cannot 
be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between adverse 
event and the device and/or the use of the device could exist, but 
the adverse event can be reasonably explained by another cause. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device and/or the use of the study device 
and/or the adverse event can be attributed to another cause. 
If an adverse event is believed to be definitely, probably or possibly related to the study 
device and/or the use of the device, the event will be considered related to the study device 
and/or the use of the device.   
11.5 
ADVERSE EVENT FOLLOW-UP 
For every adverse event, appropriate measures should be undertaken to treat and/or 
monitor the subject until resolution occurs.  Obtain and maintain in the subject's files all 
pertinent medical data relating to the event including the subject’s medical records and 
medical reports and/or judgments from colleagues or outside specialists who assisted in 
the treatment and follow-up of the subject. The investigator should keep JJSV closely 
informed as to the outcome of serious and/or device-related adverse events, thereby 
allowing JJSV to comply with the appropriate regulatory reporting requirements.  A 
Detailed Adverse Event Update CRF should be completed each time the subject returns 
to the investigator or other specialist(s) for follow-up of serious and/or device-related 
adverse event until resolution of the event.  Any subject who is exited from the study due 
to a serious and/or device-related adverse event will be followed until the outcome is 
determined. 
12. 
PROTOCOL CHANGES/AMENDMENTS  
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from JJSV regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection) require approval 
by the FDA and all other appropriate regulatory agencies, as well as approval of the 
governing IRB prior to implementation.   

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13. 
ETHICS REVIEW AND PATIENT WELFARE 
13.1 
INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to JJSV. 
The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
13.2 
INFORMED CONSENT 
The informed consent document will be provided as a physical or electronic document to 
each study subject for review prior to consenting. If using the electronic document, the 
study subject will be given an electronic tablet with the preloaded IRB-approved study 
specific informed consent. The current version of the IRB-approved study informed 
consent must be signed by each study subject prior to any study-specific examinations 
being performed.  The IRB approved informed consent is to be signed and dated by the 
subject as well as by the person who conducted the informed consent discussion. Consent 
will be documented with required signatures on the physical document or on the electronic 
document. The signed informed consent will be maintained by the investigator as a 
permanent part of the subject’s medical records.  A copy of the signed and dated form is 
to be provided to the subject. If the electronic document is used for consenting, study 
subjects can elect to receive either a printed or electronic copy of the informed consent 
documents.  Signed and submitted informed consent documents will be available as PDFs 
in the electronic consent repository.  The investigator will provide JJSV written 
acknowledgement on the preoperative case report form that a signed agreement of 
informed consent has been obtained and is in the investigator’s possession for each 
subject.  As required by 21CFR812 Part G, the site shall document in the source 
documents that informed consent was obtained prior to participation in the study for each 
subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to medical 
treatment in the governing countries.   
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 

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14. 
DOCUMENTATION 
14.1 
SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include a 
subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the medical 
charts/clinic notes must also include, at a minimum, the following data that will be 
considered source data and will be reviewed by JJSV: 
• 
Subject’s name and study identification number 
• 
Subject’s contact information 
• 
Study protocol number and the Sponsor name (JJSV) 
• 
A statement that informed consent was obtained prior to participation in the study 
(including the date)  
• 
Evidence of subject eligibility 
• 
Dates of all subject visits and surgeries throughout the duration of the study 
• 
OVD serial number identification (NOTE: This is masked information, and may only be 
reviewed by unmasked study staff) 
• 
Concurrent medications 
• 
Corrected and uncorrected distance visual acuity 
• 
IOP 
• 
ECC 
• 
Manifest refraction 
• 
Occurrence and status of any operative complications, postoperative medical or lens 
findings and adverse events 
• 
The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
14.2 
SUBJECT CONFIDENTIALITY 
Subjects will be assigned a unique subject number at the time of enrollment as a means 
of identification on study documents.  Subject confidentiality will be maintained by 
recording only the subject number on the CRFs.  Subject names may possibly be 
disclosed to JJSV or regulatory agencies during inspection of medical records related to 
the study, but reasonable precautions will be taken to protect and maintain confidentiality 
of personal information to the extent permitted by applicable laws and regulations. 

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14.3 
CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system. All study staff responsible for 
entering data into the system must complete certification prior to using the system. The 
investigator is responsible for ensuring that data are properly recorded on each subject’s 
case report forms and related documents.  Prior to database lock, the investigator will 
verify completeness and accuracy of data submitted to JJSV.  
 
 
 
 
  
15. 
MONITORING  
JJSV will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
15.1 
DATA MONITORING 
In order to ensure a well-controlled clinical trial, JJSV will follow specific data monitoring 
procedures, routinely generate reports and periodically review safety and effectiveness 
data. To avoid bias, any analyses generated prior to site closures will not be disseminated 
to any of the investigative sites.   
An electronic data capture (EDC) system will be used to transmit case report forms from 
the investigative site to JJSV. Requests for data clarification will be handled through this 
same system. To minimize data omissions and inconsistencies on clinical reports and to 
ensure that data are accurately transcribed to computer data files, JJSV will follow internal 
data processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed in the EDC system. 
Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff -via online 
conferencing, centralized and/or on-site programs.  In addition, subjects will be 
encouraged at the time of informed consent to avoid missing study visits, as missing data 
may affect the study reliability and diminish the scientific value of their contribution to the 
study.  
15.2 
ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that study devices, subjects, and forms 
can be traced and will allow monitoring of investigator progress and compliance.  

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Accountability and traceability of study devices will be monitored by trained JJSV 
personnel.  
Study Device Accountability 
Complete OVD accountability will be maintained at the investigative site by maintaining 
records of all investigational OVDs received from and returned to JJSV.  A site log will be 
used to track OVDs for date of receipt, use and disposition/return to JJSV.  This site log 
and any other OVD information will be maintained in the operative room study binder and 
monitored by JJSV personnel.  During periodic site monitoring visits, JJSV personnel will 
review inventory records and logs to ensure OVD accountability compliance and complete 
OVD traceability.   
Site Monitoring Plan 
Prior to performing any study surgeries, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a formal study investigator meeting.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with JJSV or have undergone significant 
changes, or have not been visited in the past year.  A study initiation visit will be conducted 
for all sites prior to or at the time of the first study surgery.  
Throughout the duration of the study, site visits to monitor compliance to this protocol will 
be made at each investigative site.  During a routine site monitoring visit, JJSV will review 
informed consent documents and subject eligibility, and the data on study case report 
forms will be verified against subject charts and other source documents to ensure 
complete and accurate reporting.  The subject files will also be reviewed to assure that all 
adverse events and any issues encountered with JJSV products have been reported in a 
timely fashion.   
JJSV will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 14.1, Source Documents, for 
a list of items that are required for source documentation Additionally, study logs will be 
checked to ensure compliance with study procedures.  
Training on study-specific procedures may also be conducted during monitoring visits.   
Upon study completion, a final close-out site visit to each site will be made to monitor the 
last of the subject data records and finalize any outstanding study issues.  
A separate Study Monitoring Plan will be established prior to study start that will define the 
type and frequency of monitoring visits and frequency of record monitoring.  

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15.3 
SAFETY MONITORING 
The Medical Monitor will review and assess any reports of serious and/or device-related 
adverse events as well as device deficiencies that could have led to a serious adverse 
event.  If necessary, the medical monitor will discuss these events with the reporting 
investigator(s), without being specific about OVD type.  If unmasking is required by the 
Medical Monitor to protect the safety of the subject(s), a request will be submitted and 
approved by Head of Clinical Sciences and Head of Biostatistics prior to release of the 
randomization code for only the subject(s) involved and the IRB will be notified. The 
medical monitor will also be available to answer all questions from investigators. The 
medical monitor, as well as any other qualified personnel designated by JJSV, shall also 
review interim progress reports, as applicable. 
The Safety Management Team (SMT) will evaluate participant safety data throughout the 
duration of the trial and provide recommendations to either continue, amend or terminate 
a clinical trial based on this information. The presence of unanticipated device effects 
(UADEs), observed events that raise concern or events highlighted through trending and 
signal detection are all reasons that the SMT might recommend escalation to Product 
Safety Council or additional safety reviews to assess the impact on the study’s benefit/risk 
analysis and/or if appropriate corrective actions are warranted including possible early 
termination of the clinical trial. The individuals comprising the SMT and the frequency of 
SMT review is required to be documented in the Safety Management Plan. 
16. 
RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE BACTERIALLY-DERIVED HEALON ENDOCOAT PRO OVD 
The bacterially-derived Healon EndoCoat PRO OVD is intended for use in anterior 
segment ophthalmic surgical procedures of the human eye. Like the non-investigational, 
Healon EndoCoat OVD, the Healon EndoCoat PRO OVD is designed to create and 
maintain a deep anterior chamber which facilitates manipulation inside the eye with 
reduced trauma to the corneal endothelium and other ocular tissues. The Healon 
EndoCoat PRO OVD can also be used to efficiently separate and control ocular tissues. 
The Healon EndoCoat PRO OVD is not designed to have any pharmacological effect.   
The potential for early and short-term postoperative intraocular pressure (IOP) spikes 
exists with dispersive OVDs, which potentially require more time and care to remove from 
the eye. Therefore, it is recommended that Healon EndoCoat PRO and Healon EndoCoat 
OVD be removed from the eye completely by irrigating and aspirating with sterile irrigation 
solution to reduce the risk of early postoperative IOP spikes. Due to the greater viscosity 
of the Healon EndoCoat PRO OVD, the effect in IOP may be higher with the Healon 
EndoCoat PRO OVD than if the same volume of other sodium hyaluronate viscoelastic 

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products, with lower zero-shear viscosity, is left in the anterior chamber of the eye. Long-
term risks of IOP spikes include secondary glaucoma, visual field loss and optic nerve 
damage. 
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation 
in general. These can include worsening of vision, hemorrhage, loss of corneal clarity, 
inflammation, infections, retinal detachment, pupil changes, glaucoma, etc. Complications 
can result in poor vision, loss of vision or loss of the eye.   
RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration.  The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to JJSV according 
to Section 11.0, Adverse Events and Product Complaints.  Additionally, JJSV will monitor 
incoming data following the procedures outlined in Section 15.0, Monitoring.  The Medical 
Monitor will ensure subjects are not exposed to additional risks by monitoring serious 
adverse events, device-related adverse events, and device-deficiencies that could have 
led to serious adverse events (Section 15.3, Safety Monitoring).  
POTENTIAL BENEFITS 
The general clinical performance of the bacterially-derived Healon EndoCoat PRO OVD 
is expected to be the same as the currently available Healon EndoCoat OVD. Bacterially-
derived Healon EndoCoat PRO is designed to create and maintain a deep anterior 
chamber, which facilitates manipulation inside the eye with reduced trauma to the corneal 
endothelium and other ocular tissues. It can also be used to efficiently separate and 
control ocular tissues. 
CONCLUSION 
The hazards/risks associated with the Healon EndoCoat PRO OVD are acceptable and 
within those of the currently available Healon EndoCoat OVD. The potential clinical 
benefits of the bacterially-derived Healon EndoCoat PRO outweigh the residual risks when 
the device is used as intended.  
17. 
RECORD RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and a copy of the 
electronic case report forms should be maintained by the investigator.   
The investigator must maintain and have access to the following essential documents until 
notified by the Sponsor.   Note: This may be for a minimum of 15 years after completion 

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of the study unless country-specific requirements are longer.  JJSV requires notification if 
the investigator wishes to relinquish ownership of the data so that mutually agreed-upon 
arrangements can be made for transfer of ownership to a suitably qualified, responsible 
person. 
• 
All case report forms 
• 
All adverse event information (detailed adverse event forms, follow-up letters, etc.) 
• 
Investigational supply records/inventory 
• 
IRB and regulatory approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 
• 
Clinical Investigator’s Brochure 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries) 
• 
Subject medical chart/clinic notes 
 
18. 
TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events that are unexpected in nature and/or severity and evaluated as to 
causality relative to the study device.  The clinical investigation may be suspended if the 
Medical Monitor or IRB, upon review and evaluation of the clinical data, finds unacceptable 
clinical performance or the level of single or total complications and/or adverse events 
unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA and governing countries.  The study 
will be terminated if causality is shown to be related to the study device. 
Additionally, the investigator, or JJSV, may stop a subject’s participation at any time.  JJSV 
may also stop the study at any time for reasons it determines appropriate.  However, no 
suspension of the study would be made to disadvantage the study subjects.  Following 
suspension of the study for any reason, all study subjects who have already received 
treatment would continue to be followed through completion of the study visit schedule. 

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19. 
STATISTICAL METHODS 
This section highlights the analyses for the primary and other key endpoints. The detailed 
plan for all analyses will be documented in the Statistical Analysis Plan (SAP). Data from 
the 3-month postoperative visit will be the key timeframe for the primary and key 
endpoints. The operative day visit is the key analysis time point for the user acceptance 
endpoint. Data from other study visits will be reported for supportive analysis.  All 
complications and adverse events will be evaluated at all visits. 
Summary statistics include mean, standard deviation, median, minimum, and maximum 
for continuous variables, and frequency counts and proportions for categorical endpoints. 
In addition to the point estimates, the appropriate 95% confidence interval may be 
calculated. All descriptive summaries will be presented by OVD. 
 
 
 
19.1 
ANALYSIS POPULATION 
• 
mITT: modified ITT population will consist of all randomized subjects who have 
any investigational or control OVD used.  Subjects will be analyzed as per planned 
randomization schema. 
• 
Safety: Safety Population (SP) will consist of all subjects who have any 
investigational or control OVD used or attempted use (defined as either OVD 
system coming into contact with the eye) and analyzed per treatment received.  
• 
Per-Protocol:  Per-Protocol Population will include subjects with an investigational 
or control OVD used, evaluated within the proper study interval and without 
clinically relevant protocol deviations (deviations that could potentially impact the 
primary or secondary endpoints) in both eyes as determined prior to database lock.  
 
 
 
  
 
 
 
  
19.2 
MISSING DATA HANDLING RULES 
The primary analysis will be based on the multiple imputation approach for all primary 
endpoints. For assessing the impact of missing data on primary analyses of the primary 
safety (cumulative rate of IOP spike) and effectiveness (mean percent ECC change) 
endpoints, the following missing data handling rules will be applied.  

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The primary endpoints analyses based on observed case data (i.e., no imputation for 
missing values) will be used to supplement the inspection of the impact of missing data 
on the primary endpoints. 
Full details regarding methods for the imputations will be outlined in the SAP.  
19.3 
STUDY ENDPOINTS 
 
Primary Endpoints  
 
The safety population will be the primary analysis set for the primary safety endpoint; the 
mITT population will be the primary analysis set for the primary effectiveness endpoint.  
 
 
 
  
 
 
 

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SAFETY: CUMULATIVE RATE OF IOP SPIKES 30 MMHG OR GREATER MEASURED 
POSTOPERATIVELY 
 
The cumulative count and proportion of eyes with an IOP spike at 3 months will be reported 
by OVD groups. Cumulative IOP spikes are defined as an IOP of 30 mmHg or greater at 
any visit.  
Hypothesis Testing 
The null and alternative hypotheses for testing the non-inferiority of the test Healon 
EndoCoat PRO OVD compared to the control Healon EndoCoat OVD with respect to 
cumulative IOP spike rate at 3 months (𝑝) are as follows:  
𝐻0: 𝑝𝑡𝑒𝑠𝑡−𝑐𝑜𝑛𝑡𝑟𝑜𝑙≥𝛿 
𝐻𝐴: 𝑝𝑡𝑒𝑠𝑡−𝑐𝑜𝑛𝑡𝑟𝑜𝑙< 𝛿 
 
 
 
 
 
 
  
 
 
 
 
 
 
Success Criteria: the upper bound of the 2-sided 95% confidence interval for 𝑝𝑡𝑒𝑠𝑡−𝑐𝑜𝑛𝑡𝑟𝑜𝑙 
is less than 10%.  
 
 
 
 
 
  
 
 
 
 
 
  

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EFFECTIVENESS: MEAN PERCENT ECC CHANGE PREOPERATIVELY VS. 
POSTOPERATIVELY  
The percent change in ECC from preoperative to 3 months postoperative will be reported 
by descriptive statistics by OVD groups. The percent change in ECC from preoperative to 
postoperative is calculated as followed:  
Percent change in ECC = [(Postop ECC minus Preop ECC)/Preop ECC] *100% 
Hypothesis Testing 
The null and alternative hypotheses for testing the non-inferiority of the test Healon 
EndoCoat PRO OVD compared to the control Healon EndoCoat OVD with respect to 
percent change in ECC at 3 months (𝜇) are as follows:  
𝐻0: 𝜇𝑡𝑒𝑠𝑡−𝑐𝑜𝑛𝑡𝑟𝑜𝑙≤𝛿 
𝐻𝐴: 𝜇𝑡𝑒𝑠𝑡−𝑐𝑜𝑛𝑡𝑟𝑜𝑙> 𝛿 
 
 
 
 
 
 
 
 
Success Criteria: the lower bound of the 2-sided 95% confidence interval for 𝜇𝑡𝑒𝑠𝑡−𝑐𝑜𝑛𝑡𝑟𝑜𝑙 
is greater than -5%.  
 
 
 
 
  
 
 
 
 
 
  

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SITE HETEROGENEITY AND OTHER COVARIATES 
The analysis of site heterogeneity and of the potential impact of other key covariates 
 
 on 
the primary endpoints will be performed using the safety population observed case data 
for primary safety endpoint and using the mITT population observed case data for primary 
effectiveness endpoint.  
 
 
 
  
Other Endpoints  
 
The Safety population will be used for the analyses of all safety and other endpoints. 
 
The percentage of IOP spikes at 8 hours, 1 day, 1 week, 1 month and 3 months 
postoperatively will be summarized by OVD and the corresponding 95% CI of the paired-
eye difference in proportions will be presented.  No adjustment in the confidence level for 
multiple CIs will be made.  
 
   
The change in IOP from preoperative will be presented by descriptive statistics for the 8-
hour 
 1-day, 1-week, 1-
month and 3-month postoperative time points by OVD. The 8-hour visit will also be 
stratified in 2-hour intervals 
   
ECC for preoperative, 3 months postoperative and the difference between preoperative 
and 3 months will be summarized using descriptive statistics.  
The grades of inflammation for epithelial and stromal edema, cells and flare, anterior and 
posterior synechiae, and fibrin presence will be tabulated with the count and proportion of 
eyes with each grading for each event over time and cumulatively will be presented 
descriptively for both OVDs.  
Additional IOP, ECC and inflammation related analysis described in ISO/FDIS 15798:2021 
Annex C will further be detailed in the statistical analysis plan. 

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All SPE types of adverse events reported in the test OVD will be compared to ISO SPE 
rates using a one-sided 95% Clopper Pearson exact confidence interval.  The test AE rate 
is considered not significantly higher than ISO SPE rate if the lower limit of one-sided 95% 
confidence interval is less than the SPE rate. 
The count and proportion of monocular BCDVA will be reported over time by visual acuity 
line. Percentage of eyes with monocular BCDVA 20/40 or better which received the test 
OVD will be compared to ISO SPE rate. The test BCDVA rate is considered not 
significantly lower than ISO SPE rate if the upper limit of one-sided 95% confidence 
interval is greater than the SPE rate. 
The count and proportion of monocular UCDVA at 1 day will be reported by visual acuity 
line.  
19.4 
SAMPLE SIZE CALCULATIONS 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
  
  
 
 
 
 
 
 
 
 

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