Evaluation and Clinical Outcomes After Routine Cataract Surgery With the Quatera® 700 and the Centurion® Vision System
Phase: NA
Conditions: Cataract
Sponsor: Carolina Eyecare Physicians, LLC

 
Solomon KD, DeOliveira A, Sandoval HP 
 
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CONFIDENTIAL 
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Version 1.1/10Apr2024   
 
Evaluation and Clinical Outcomes After Routine Cataract Surgery with the 
Quatera® 700 and the Centurion® Vision System 
 
 
 
 
Sponsor:  
 
 
Carolina Eyecare Physicians, LLC 
 
 
 
 
1101 Clarity Rd., Suite 100 
 
 
 
 
Mt. Pleasant, SC 29464 
(843) 881 3937 
Kerry D. Solomon, MD, Principal Investigator 
Helga P. Sandoval, MD, MSCR, Director of Research 
 
Study Product:  
Zeiss Quatera® 700 
 
Alcon Centurion® Vision System 
 
Protocol Number: 
 
CEP-23-002 
 
 
 
 
Initial version date: 13Jun2023 
 
 
 
 
Final version date: 27Jul2023 
 
 
 
 
Amendment #1: version 1.1 date: 10Apr2024 
 
 
 
 
 
 
 
 
 
 
 
 
Investigator Agreement: 
I have read the clinical study described herein, recognize its 
confidentiality and agree to conduct the described trial in 
compliance with Good Clinical Practices (GCP), the Declaration of 
Helsinki, this protocol and all applicable regulatory requirements. 
Additionally, I will comply with all procedures for obtaining 
informed consent, data recording and reporting, will permit 
monitoring, auditing, and inspection of my research center, and 
will retain all records until notified by the sponsor. 
 
Name of the Investigator: 
_________________________________________________ 
Name of the Institution: 
_________________________________________________ 
Address: 
 
 
_________________________________________________ 
 
 
 
 
_________________________________________________ 
 
 
Investigator: 
______________________________________________________ 
Signature 
 
 
 
 
 
Date 

 
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Evaluation and Clinical Outcomes After Routine Cataract Surgery with the 
Quatera® 700 and the Centurion® Vision System 
 
 
INTRODUCTION 
Accordingly with the last report from Word Health Organization (WHO) at least 2.2 billion people 
globally have a near or distance vision impairment and almost 94 million of those people present 
age–related cataract, considered the second cause of visual impairment1 and the main cause for 
reversible blindness worldwide. Characterized by the darkening and solidification of a previously  
transparent crystalline lens; the condition is responsible for both vision impairment and also for 
a decreased quality of life, due to restriction to independent living; and increased risk of body 
injuries2, anxiety and depression levels; in individuals with non–operated cataracts3.   
 
At the early stages the cataracts can be managed by changing the prescribed glasses, however 
their progression is unpredictable, and sometimes changes associated with the progression 
could lead to rapidly increasing refractive errors, significant anisometropia and to lower visual 
acuity, leading to the necessity of a surgical procedure to restore the visual capacity to patients 
with age-related cataract.   
 
Phacoemulsification is the most common treatment for cataract surgery in the developed 
countries and over the years it gained importance due to several factors: small incision, surgery 
performed under topical anesthesia - which reduce injection-related complications – short 
recovery time, low post operatory induced astigmatism, and low incidence of surgical 
complications, when compared to the conventional surgeries.  
 
Although phacoemulsification has fewer complications when compared to previous types of 
cataract surgeries, it still burdens undesirable side effects, in the form of intraoperative and/or 
post–operative complications.4 Anterior segment changes occur after phacoemulsification 
surgery, and corneal endothelium seems to be the most adversely affected structure with 
significant loss of corneal endothelial cells density and corneal thickness during cataract surgery.5  
Corneal endothelial cell loss can be caused by the heat originated from the ultrasound, excessive 
irrigation, turbulence of fluid, bubble generation in the anterior chamber, and direct trauma, 
leading to a reduced corneal metabolism postoperatively. In severe cases, corneal 
decompensation may occur, following an ineffective endothelial pumping, resulting in persistent 
corneal edema, and decreased vision leading to subsequent corneal transplantation.6 Some 
factors act as adjuvants to increase the risk of cell damage like intraoperative 
phacoemulsification time, shorter eyes, and a shallow anterior segment, and because of all that 
it is important to perform surgery as effectively and safely as possible to avoid disrupting the 
delicate balance of the eye. 

 
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 Corneal thickness changes after phacoemulsification can be used to assess surgically induced 
corneal edema and it was already observed that the degree of permanent corneal endothelial 
damage is related to the degree of early postoperative corneal swelling.7 Moderate damage of 
the corneal endothelium during surgery may lead to a transient increase in corneal thickness, 
although data about it are contradictory since some authors reported that all patients recovered 
preoperative values after 4 weeks8,9, while others reported sustained increases up to 6 months 
or even 1 year postoperatively; however, those discrepancies may reflect inadequate 
measurement of central corneal thickness (ultrasonic pachymetry) and in the estimation of 
endothelial cell numerical density.  Nowadays modern technology, such as optical low coherence 
reflectometry, allows more precise measurements of the central corneal thickness and published 
data show that a moderate decrease in the endothelial cell numerical density does not influence 
the central corneal thickness, if accurately determined, at various time intervals up to 1 year 
after surgery.10 
 
The purpose of this study is to evaluate and compare the performance of 2 different 
phacoemulsification systems: the Zeiss Quatera® 700 and the Centurion® Vision System, when 
using the optimized settings for each device, in patients undergoing routine cataract surgery.  
 
1. OBJECTIVE: 
 
The purpose of this study is to evaluate the Zeiss Quatera® 700 and compare it to the 
Centurion® Vision System using the optimized settings for each device in patients undergoing 
uneventful routine cataract surgery. Main end points include central corneal thickness at day 
1 postoperatively and lens removal time (from end of rhexis to complete nucleus removal) as 
measured digitally by the Zeiss Surgery Optimizer and manually with a stopwatch. 
 
2. STUDY DESIGN AND METHODS: 
 
A. Test article: Zeiss Quatera® 700 and Alcon Centurion® Vision System 
 
B. Study Design:  Prospective, randomized, double-masked contra lateral eye study. 
 
C. Subjects: A total of 40 subjects who met the Inclusion/Exclusion criteria will be enrolled. 
1. 
Inclusion Criteria: 
Subjects MUST fulfill the following conditions to qualify for enrollment into the trial 
1. Subject is undergoing bilateral lens extraction with implantation of a posterior chamber 
intraocular lens.  
2. Gender: Males and Females.  
3. Age: 40 years or older. 

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4. Willing and able to provide written informed consent for participation in the study
5. Willing and able to comply with scheduled visits and other study procedures.
6. Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes
within 1 to 15 days between surgeries
7. Subjects requiring an IOL power in the range of +10.0 D to +30.0 D only.
8. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both
eyes.
2.
Exclusion Criteria:
Subjects with ANY of the following conditions on the eligibility exam (Visit 0) may NOT be
enrolled into the trial.
1. Severe preoperative ocular pathology:  amblyopia, rubella cataract, proliferative 
diabetic retinopathy, shallow anterior chamber, macular edema, retinal detachment, 
aniridia or iris atrophy, uveitis, history of iritis, iris neovascularization, medically 
uncontrolled glaucoma, microphthalmos or macrophthalmos, optic nerve atrophy, 
macular degeneration (with anticipated best postoperative visual acuity less than 
20/30), advanced glaucomatous damage, etc.
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Contact lens use during the active treatment portion of the trial.
5. Any concurrent infectious/non-infectious conjunctivitis, keratitis or uveitis.
6. Clinically significant corneal dystrophy.
7. Corneal irregularities potentially affecting visual acuity:  keratoconus, corneal 
dystrophy, corneal opacities.
8. Endothelial cell count less than 1500 cells/mm2
9. History of chronic intraocular inflammation.
10. History of retinal detachment.
11. Femtosecond arcuates at time of surgery.
12. Femtosecond laser assisted cataract surgery in one eye only.
13. Pseudoexfoliation syndrome or any other condition that has the potential to weaken 
the zonules.
14. Previous intraocular surgery.
15. Previous radial keratotomy (RK).
16. Previous keratoplasty
17. Pupil abnormalities
18. Subject who may reasonably be expected to require a secondary surgical intervention 
at any time during the study (other than YAG capsulotomy, i.e. LASIK)
19. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc).
20. Other ocular procedures at the time of the cataract extraction (i.e., iStent)

 
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21. Any clinically significant, serious or severe medical or psychiatric condition that may 
increase the risk associated with study participation or may interfere with the 
interpretation of study results. 
22. Participation in (or current participation) any ophthalmic investigational drug or 
ophthalmic device trial within the previous 30 days prior to the start date of this trial. 
 
The principal investigator reserves the right to declare a patient ineligible or non-
evaluable based on medical evidence that indicates the patient is unsuitable for the trial. 
 
3. 
Exclusion Criteria during surgery 
 
If any of the following exclusion criteria are applicable to the study eye, the subject 
should not continue in the study. 
 
1. Different surgical technique in each eye (traditional/femtosecond laser) 
2. Other planned ocular surgery procedures, i.e iStent. 
3. Significant vitreous loss. 
4. Significant anterior chamber hyphema. 
5. Uncontrollable intraocular pressure. 
6. Zonular or capsular rupture. 
7. Bag-sulcus, sulcus-sulcus or unknown placement of the haptics. 
8.  
9. Intraocular lens tilt or decentration 
10. Significant sedation or retrobulbar block during surgery. 
11. Other procedure, such as pupil stretch, expanders, iris hooks, capsular tension ring, 
etc. during surgery.   
 
Note: Any subject in which surgery has been aborted for either eye should immediately 
be discontinued from the study and an exit form completed for that subject. These 
subjects will be followed up as per the clinic standard of care, monitored for safety, and 
their data will be excluded from the study efficacy analysis (obtained from FDA Database 
Research Results Feb 05, 2009). All adverse events will be appropriately documented and 
reported. 
 
Additionally, participants who are considered to be a vulnerable subject population are 
not to be enrolled into the study without prior written authorization from both the 
Sponsor and the IRB to ensure that a description of additional safeguards are in place 
during the consenting and enrollment processes. Vulnerable populations include, but are 
not limited to, the following: 
1. 
Prisoners 
2. 
Nursing home residents /institutionalized individuals 

 
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3. 
Mentally disabled /cognitively impaired individuals 
4. 
Sponsor employees and their family members 
5. 
Site employees and their family members that are directly and indirectly involved 
with the study 
6. 
Students of the university or the principal investigator participating in the study 
7. 
Economically and/or educationally disadvantaged individuals 
8. 
Comatose individuals / traumatized individuals 
9. 
Adults who do not read and/or write 
10. 
Hearing impaired individuals 
11. 
Terminally ill individuals / individuals with life-threatening conditions 
 
3. Study Procedures 
 
A. Informed Consent / Subject enrollment 
Potential subjects will be identified from the patients presenting at the clinic. 
Additionally, an ad will be placed in social media and in the practice website, if deemed 
necessary. Once identified as a study candidate, the patient will be asked if he/she 
would like to participate. The sub-investigator, study coordinator or an appropriately 
trained staff member will answer any and all questions and will obtain informed consent. 
A copy of the signed informed consent document will be given to the subject. The 
principal investigator will be available if the subject wants to discuss further details with 
him.  Any testing that is part of the investigative site’s standard preoperative cataract 
evaluation may be performed prior to the informed consent being signed, provided 
these tests are conducted within 90 days of surgery. The patient will understand that 
participation in the study, or declining to participate, will not affect his/her quality of 
care. 
 
No subject will be enrolled into the study that does not meet the inclusion/exclusion 
criteria and does not sign the current approved informed consent document. Informed 
consent will be obtained prior to collecting any data for the study. The original signed 
documents will be maintained by the investigator as a permanent part of the subject's 
research records. 
 
B. Surgery Procedures: 
The first eye undergoing surgery will be randomized to either the Quatera® 700 or the 
Centurion® Vision System. The fellow eye will receive the alternate treatment. The first 
operative eye will be the eye with the worse cataract. If the cataract is the same in both 
eyes, the clinic’s standard of care will be followed. The randomization list will be provided 
by a third-party consultant. Research staff not attending or participating in surgery will be 
masked to the extent possible.  

 
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C. Study Visit Schedule and Assessments (Table 1). 
 
1. 
Visit Schedule: Subjects will be examined at the following intervals: 
 
1. Visit 0: Screening and enrollment: Preoperative evaluation completed not more 
than eight weeks before surgery 
2. Visit 1: Day of Surgery each eye 
3. Visit 2: Day 1: (12 to 48 hours) after surgery each eye 
4. Visit 3: Week 1: 7 ±2 days after surgery each eye 
4. Visit 3: Month 1: 30 ±7 days postoperative after second eye surgery 
4. Visit 4: Month 3: 90 ±15 days postoperative after second eye surgery 
 
 
D. Measurements and evaluations 
 
1. 
Visit 0:  Informed consent process will be conducted at this visit. Assessments include 
best-corrected distance visual acuity (BCDVA, Snellen chart), manifest refraction, 
intraocular pressure (IOP, Goldman), corneal tomography (Pentacam), ultrasound 
pachymetry, specular microscopy, macular OCT, slit lamp examination including 
dilated fundus exam, cataract density and type (LOCS III). Any testing that is part of 
the site’s standard of care preoperative cataract surgery evaluation may be 
performed prior to the informed consent being signed provided these tests are 
conducted within 90 days of the surgery and notation of the date performed is 
entered onto the CRF. The surgeon’s standard pre cataract surgery treatment will be 
used in all his patients 
 
First eye undergoing surgery will be randomized to Group A (Quatera 700) or B 
(Centurion).  
 
2. Visit 1: The surgeon may use his preferred small incision cataract extraction 
technique (manual phacoemulsification or laser assisted). The same technique must 
be used in both eyes. The intraocular lens will be implanted in the bag.  The following 
information will be captured the day of surgery: phaco metrics, lens removal time, 
duration of surgery, incision size (prior to lens implantation), estimated fluid used, 
lens implanted and power, target refraction for IOL power implanted, additional 
surgical procedures, intraoperative complications, and any device deficiencies.  
Additionally, the surgery will be recorded, and the videos will be analyzed digitally 
using the Surgery Optimizer and manually using a stopwatch. The surgeon’s standard 
post cataract surgery treatment will be used in all patients.   
 

 
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3. Visit 2: monocular pinhole uncorrected visual acuity (UCVA), slit lamp examination, 
IOP, ultrasound pachymetry and Pentacam.  
 
4. Visit 3: Manifest refraction, best distance corrected visual acuity (BCVA), IOP, slit lamp 
examination, ultrasound pachymetry, Pentacam and macular OCT. 
 
5. Visit 4: Manifest refraction, best distance corrected visual acuity (BCVA), IOP, slit lamp 
examination, ultrasound pachymetry, Pentacam, macular OCT, and dilated fundus 
exam if deemed necessary by the investigator. 
 
6. Visit 5: Manifest refraction, best distance corrected visual acuity (BCVA), IOP, slit lamp 
examination, ultrasound pachymetry, Pentacam macular OCT will be performed. 
Dilated fundus exam to be performed if deemed necessary by the investigator. 
 
All adverse events and complaints will be monitored and recorded at all study visits. 
 
Table 1.  Visits and Study Assessments 
 
 
Visit 0 
Screening 
Visit 1/1A 
DOS 
Visit 2/2A 
1-day 
 
Visit 3/3A 
1-week 
7 ±2 days 
Visit 4/4A 
1-Month 
30 ±5 days 
Visit 5/5A 
3-Month 
90 ±15 days 
Informed Consent 
X 
 
 
 
 
 
Inclusion/Exclusion 
X 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
 
Past medical & ocular 
history 
X 
 
 
 
 
 
Concomitant 
medications 
X 
 
 
 
 
 
BCVA Snellen 
X 
 
 
 
 
 
Pinhole uncorrected 
distance VA (ETDRS) 
 
 
X 
 
 
 
Manifest refraction 
X 
 
 
X 
X 
X 
Best corrected distance 
VA (ETDRS) 
 
 
 
X 
X 
X 
Intraocular Pressure 
(Goldman) 
X 
 
X 
X 
X 
 
Specular microscopy 
X 
 
 
 
 
X 
Ultrasound Pachymetry 
X 
 
X 
X 
X 
X 
Pentacam 
X 
 
X 
X 
X 
X 
SLE 
X 
 
X 
X 
X 
X 

 
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Signs of inflammation 
(cells and flare) 
X 
 
X 
X 
X 
X† 
Dilated fundus exam 
X 
 
 
 
X†† 
X†† 
Macular OCT  
X 
 
 
X 
X 
X 
Cataract density / type 
(LOCS III) 
X 
 
 
 
 
 
Phaco metrics 
 
X 
 
 
 
 
Lens removal time 
 
X 
 
 
 
 
Duration of surgery 
 
X 
 
 
 
 
Incision size 
 
X 
 
 
 
 
Surgical optimizer 
 
X 
 
 
 
 
Estimated fluid use 
 
X 
 
 
 
 
Adverse events 
X 
X 
X 
X 
X 
X 
 
X To be performed as scheduled 
† To be performed if cells and flare still present at the 1-month visit 
†† To be performed as deem necessary by the investigator. 
 
BCVA, best corrected visual acuity 
ETDRS, Early Treatment Diabetic Retinopathy Study 
SLE, Slit lamp exam 
OCT, Optical Coherence Tomography 
LOCS, The Lens Opacities Classification System 
 
4. Study endpoint criteria 
 
A. Patient Completion of Study: If a study patient has completed the final visit (Visit 5) of 
the study, he/she is considered to have completed the study. 
 
B. Patient Discontinuation: Each study patient may voluntarily discontinue the study at any 
time they choose.  Study patients who cannot complete the study for administrative 
reasons (e.g., non-compliance, failure to meet visit schedule, etc.) will be discontinued 
from the study.  Study patients discontinued during the enrollment phase (prior to 
surgery) of the study will be replaced. 
 
C. Patient Termination: A study patient will be terminated if the study patient develops any 
severe adverse event that may be related to the study.  A study patient will receive 
appropriate treatment at the discretion of the investigator.  Notification of termination 
will be clearly documented.  These study patients are considered to have completed the 
study and will not be replaced. 

 
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D. Study Termination: The investigator with appropriate notification may terminate the 
study.  If, after clinical observations, the investigator feels that it may be unwise to 
continue the study, he may stop the study. 
 
E. Study Completion: The study will be complete when all enrolled patients have 
completed Visit 5 or have been terminated from the study. 
 
5. STATISTICAL CONSIDERATIONS 
 
A. Sample size 
A total of 40 subjects will be enrolled. In order to calculate the sample size, we need to 
know an accurate estimate of the standard deviation of the outcome measure which we 
do not know; therefore, we consider this study a pilot trial.  When estimating the sample 
size for a pilot study, the simplest method is to apply a sample size rule of thumb. 
Browne suggests a general flat rule to ‘use at least 30 subjects or greater to estimate a 
parameter’. However, since analysis comparing manual phaco vs. femtosecond laser 
assisted cataract surgery will be conducted, at least 20 subjects will be enrolled in each 
surgical technique (femtosecond laser/manual phaco) 
 
B. Statistical Analysis  
All data will be collected by the site and entered into a database.  Subjects will be 
assigned an ID number. Data analysis will be performed without patient identification. 
Statistical analysis will be performed using standard descriptive statistics and other tests 
as deemed appropriate based on the characteristics of the data to be analyzed. All 
statistical tests will be two-sided and interpreted at a 5% significance level.  Comparisons 
between the groups will be made.  Data analysis will be conducted by a third-party 
consultant. 
 
C. Study Endpoints:  
 
1. 
Primary Endpoints:  
a. Central corneal thickness at day 1 postoperatively 
b. Lens removal time (from end of rhexis to complete nucleus removal) 
 
2. 
Secondary Endpoints: 

 
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a. Duration of surgery (from incision to wound hydration)  
b. Incision size (prior to intraocular lens implantation) 
c. Estimated fluid use 
d. Subjective signs of inflammation (cells and flare) at day 1, 7 and 30. 
e. Endothelial cell density at 3 months 
f. Central corneal thickness at day 7, 30 and 90 
g. Best corrected distance visual acuity at day 7, 30 and 90 
h. Intraocular pressure at day 1, 7, and 30 
i. Macular thickness day 7, 30 and 90 
j. Intraoperative complication rate 
 
 
3. 
Exploratory Endpoint: 
a. Accuracy of the Surgical Optimizer 
 
D. Safety Analyses 
The type, severity, duration and frequency of reported ocular adverse events will be 
tabulated for each group.  Adverse events will also be summarized for events that were 
considered treatment-related.  Comparison of treatment groups with respect to the 
proportion of study patients reporting adverse events will be made using Fisher’s Exact 
Test. 
 
 
6. DATA HANDLING AND RECORD KEEPING 
 
A. Confidentiality 
To ensure confidentiality in this study, records of the participants will be examined only by 
the principal investigator, sub-investigators and research staff involved in the study.  Study 
records will be kept on file.  Any statistical analysis and publication will not include any 
subject identifiers.  Medical records will be made available only for review by the 
investigators, or Research Institution, the IRB, and other State or Federal Regulatory 
Agencies, if necessary.  All information in these records will be kept confidential. 
 
B. Records Retention 
The PI is accountable for the integrity, retention and security of all study related data. The 
investigator must maintain accurate, complete and current records relating to the clinical 

 
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study. The investigator must maintain the required records during the investigation and for a 
period of 3 years after the date on which the investigation is terminated, completed or 
published. 
 
7. STUDY MONITORING, AUDITING, AND INSPECTING 
 
The nature and location of all source documents will be identified to ensure that original data 
required to complete the case report forms (CRFs) exist and are accessible for verification by 
the monitor.  If electronic source records are maintained, these records must be 21 CFR Part 
11 compliant and will be printed and certified for verification by the monitor as needed.  
 
The required examination must be recorded on the CRFs. Provided CRFs can be used as 
source document.  All data reported must have corresponding entries in the source 
documents. The principal investigator or sub-investigator must review the reported data and 
certify that the CRFs are accurate and complete. No subject identifiers should be recorded on 
the CRFs beyond subject number, subject initials and study specific identifiers. 
 
Data from CRFs will be entered into a database created specifically for this study. Project 
manager or designee will monitor the data entered throughout the study. 
 
Upon completion of the CRFs, the data will be reviewed by study manager and statistician for 
accuracy and completeness. If corrections and/or any additions to the data are deemed 
necessary, queries will be generated and forwarded to the site staff for resolution. 
Designated research staff is expected to respond to data queries in a timely manner and 
ensure that the corrections and changes made to the data in the database are reflected in 
the subjects’ source documentation. Any changes will need to be initialed and dated by the 
authorized personnel making such changes. 
 
Data will not be sold to third parties but may be used for future research. 
 
Electronic data will be stored and accessed on a secured server.  
 
8. INVESTIGATIONAL PRODUCT  
 
A. Description  

 
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Zeiss Quatera® 700 (Zeiss – Germany) is a phacoemulsification unit for use in cataract 
procedures with a synchronized fluid exchange system that directly measures and 
simultaneously controls both infusion and aspiration volumes in real-time, actively 
compensating for incision leakage volume and, according to the manufacturer, providing 
chamber stability independent of IOP and flow.11 
 
Centurion® Vision System (Alcon – Fort Worth -TX) is a phacoemulsification unit for use 
in cataract and vitrectomy procedures and, according to the manufacturer, this unit 
automatically adapts to the eye’s changing conditions, while also provides smoother 
fluidics, anterior chamber stability, and surgical precision.11 
 
B. Treatment/Dosing Regimen 
The phacoemulsification devices are used at the time of surgery to remove the 
cataractous lens. The first eye undergoing surgery will be randomized to either the 
Quatera® 700 or the Centurion® Vision System. The fellow eye will receive the alternate 
treatment. The first operative eye will be the eye with the worse cataract. If the cataract 
is the same in both eyes, the clinic’s standard of care will be followed. The randomization 
list will be provided by a third-party consultant. Research staff not attending or 
participating in surgery will be masked to the extent possible. 
 
C. Method for Assigning Subjects to Treatment/Dosing Groups 
Randomization envelopes will be provided to staff attending surgery. The envelopes will be 
sequentially numbered. 
 
D. Subject Compliance Monitoring  
Since the devices are used at the time of surgery to remove the cataract, subject compliance 
will not be an issue in this particular study. 
 
E. Packaging, Receiving, Storage, Dispensing and Return 
N/A 
 
9. ETHICAL CONSIDERATION 
 
This clinical trial will be conducted in accordance with the principles of the Declaration of 
Helsinki, and Good clinical practice.  The Investigator and all clinical trial staff will conduct the 
clinical trial in compliance with this protocol. The Investigator will ensure that all personnel 

 
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involved in the conduct of the clinical trial are qualified to perform their assigned duties 
through relevant education, training, and experience. Deviations from the clinical protocol 
must be documented in each subject’s study records including the dates and reasons for 
each deviation. The PI must ensure that all aspects of the trial are in compliance with the 
applicable regulatory laws and conditions of approval imposed by the IRB. 
 
10. RISKS AND BENEFITS 
 
The risk of being in the study is not greater than the risk of undergoing routine cataract 
surgery with implantation of an intraocular lenses. However, there is always the risk that 
uncommon or previously unknown side effects may occur.  The study includes additional 
postoperative examinations at no cost. 
 
11. IN CASE OF AN INJURY RELATED TO THIS RESEARCH STUDY 
 
Every effort to prevent study-related injury will be taken by the study doctor and staff. In the 
event a patient is injured as a direct result of the study while following the study instructions 
and requirements, the patient will be instructed to immediately contact the principal 
investigator and/or study staff.  Treatment will be provided as needed for those injuries 
caused directly by this research study. In the event of injury or illness caused by or occurring 
during the participation in this study, all charges for medical care provided will be billed to 
the patient’s insurance company. The medical care costs for injuries or illnesses that are not 
caused directly by the research study will not be covered. 
 
12. CONFIDENTIALITY/PUBLICATION OF THE STUDY 
The existence of this Study is confidential and should not be discussed with people outside of 
the Study.  Results will be submitted for publication and presentation at national and/or 
international meetings. A manuscript will be submitted to peer-review journals for 
publication but there is no guarantee of acceptance. 
 
13. REFERENCES 
1.  
Vision impairment and blindness. Accessed November 17, 2022. 
https://www.who.int/news-room/fact-sheets/detail/blindness-and-visual-impairment 
 
2.  
Ivers RQ, Cumming RG, Mitchell P, Simpson JM, Peduto AJ. Visual risk factors for hip 
fracture in older people. J Am Geriatr Soc. 2003; 51:356-363.  

 
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3.  
Taylor HR, Pezzullo ML, Keeffe JE. The economic impact and cost of visual impairment in 
Australia. British Journal of Ophthalmology. 2006; 90:272-275.  
 
4.  
de Silva SR, Riaz Y, Evans JR. Phacoemulsification with posterior chamber intraocular lens 
versus extracapsular cataract extraction (ECCE) with posterior chamber intraocular lens for age-
related cataract. Cochrane Database Syst Rev. 2014;(1):CD008812.  
5.  
Bamdad S, Bolkheir A, Sedaghat MR, Motamed M. Changes in corneal thickness and 
corneal endothelial cell density after phacoemulsification cataract surgery: a double-blind 
randomized trial. Electron Physician. 2018; 10:6616-6623.  
 
6.  
Thakur SK, Dan A, Singh M, Banerjee A, Ghosh A, Bhaduri G. Endothelial cell loss after 
small incision cataract surgery. Nepal J Ophthalmol. 2011; 3:177-180.  
 
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Lundberg B, Jonsson M, Behndig A. Postoperative Corneal Swelling Correlates Strongly to 
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11. ZEISS QUATERA 700 a new experience in phaco surgery. Accessed June 14, 2023. 
https://www.zeiss.com/meditec/en/products/phaco-vitrectomy-lensfragmentation/zeiss-quatera-
700.html. Accessed 14Jun2023. 
 
12. 510(k) Premarket Notification.  
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121555. Accessed June 
14, 2023.