Evaluation of the Symfony With Optiblue Intraocular Lens Compared to The Vivity IOL Under Mesopic Conditions
Phase: PHASE4
Conditions: Cataract
Sponsor: Carolina Eyecare Physicians, LLC

 
Solomon KD, Sandoval HP 
 
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Version 1.2 - 22Sep2023 
Evaluation of the Symfony with Optiblue Intraocular Lens Compared to The Vivity IOL Under 
Mesopic Conditions 
 
 
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, Research Manager 
 
Study Product:  
 
Symfony ™OptiBlue®IOL models DXR00V and DXWxxx  
Clareon® Vivity® IOL models CCWET0 and CCWETx 
 
Protocol Number:  
CEP-23-001 
Version 1.0 13June2023 
Version 1.1 14Sep2023 
Version 1.2 22Sep2023 
 
 
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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INTRODUCTION 
Cataract surgery is one of the most frequently performed surgical procedures and offers 
significant improvement to the patients’ quality of life. For refraction correction at the time 
of cataract surgery, the range of intraocular lenses available goes from monofocal intraocular 
lenses to the multifocal ones, including among the options, trifocal and extended depth of 
focus lenses (EDOF).  
Conventional monofocal intraocular lens (IOL) are the most common device implanted1 due 
to their low cost, highly predictable distance visual outcome and low incidence of photic 
symptoms. However, monofocal IOLs have no power to meet the visual expectations for 
those patients that wish to be less dependent on glasses while performing simple activities 
brought to us by modern life, like computer work and cell phone usage, since these activities 
demand an increased need for intermediate or near vision. Trifocal lenses provide the most 
extended range of vision, and could meet the intermediate and near vision expectations, but 
also with limitations. Due to their design, these diffractive lenses split the light to distinct 
foci; as a result, at one focus the indistinct image from the other foci introduces the potential 
for glare and halos. For some patients, even if they notice this phenomenon, it is not 
bothersome to the point to complain about it; to others, on the other hand, glare and halos 
can be so disturbing that they have a very hard time adapting to this new visual reality. 
Another common complaint is the lower contrast sensitivity, reported by patients with 
trifocal lenses implanted.  
Extended depth of focus, or EDOF, lenses were developed as a bridge to cover the gap 
between the monofocal and trifocal or multifocal intraocular lenses. EDOF lenses provide 
spectacle independence for far and intermediate vision and need only a minimal negative 
defocus for optimized near vision; they are considered the best option for patients aiming to 
be less spectacle dependent and, at the same time, to avoid some of the side effects and the 
compromising from trifocal and multifocal IOLs. 
Although the performance of EDOF lenses under photopic conditions has been widely 
investigated,2-7 the question about their performance under mesopic conditions remains 
unanswered.  
 

 
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1. OBJECTIVE: 
The purpose of this study is to evaluate the visual outcomes of the Symfony lens with 
OptiBlue and the Vivity lens under mesopic lighting conditions in patients undergoing 
routine cataract surgery.  
 
2. STUDY DESIGN AND METHODS: 
A. Test article: 
• Symfony ™OptiBlue®IOL models DXR00V and DXWxxx 
• Clareon® Vivity® IOL models CCWET0 and CCWETx 
 
A. Study Design: Prospective, multicenter (up to 2 sites), double masked (subject and 
evaluator) study. 
 
B. Subjects: A total of 64 subjects who meet 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 an EDOF IOL 
with a target refraction of plano OU. 
2. Gender: Males and Females.  
3. Age: 50 years and older. 
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 in both eyes, with 1 to 30 days 
between surgeries. 
7. 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 may NOT be 
enrolled into the trial. 

 
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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 (i.e., keratoconus, 
corneal opacities. 
8. History of chronic intraocular inflammation. 
9. History of retinal detachment. 
10. Pseudoexfoliation syndrome or any other condition that has the potential to 
weaken the zonules. 
11. Previous intraocular surgery. 
12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK). 
13. Subject who declined any type of presbyopia correcting IOL due to concerns 
with visual disturbances (i.e., halos) 
14. Previous keratoplasty 
15. Severe dry eye 
16. Pupil abnormalities 
17. 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) 
18. 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. 
19. 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. 

 
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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. Other planned ocular surgery procedures, i.e., iStent. 
2. Significant vitreous loss. 
3. Significant anterior chamber hyphema. 
4. Uncontrollable intraocular pressure. 
5. Zonular or capsular rupture. 
6. Bag-sulcus, sulcus-sulcus, or unknown placement of the haptics. 
7. Suturing of incision required at time of surgery. 
8. Intraocular lens tilt or decentration 
9. Significant sedation or retrobulbar block during surgery. 
10. Other procedures such as pupil stretch, expanders, or iris hooks 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 
3. Mentally disabled /cognitively impaired individuals 

 
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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 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, a flyer will be placed in the check-in area and an ad will be placed in 
social media and on 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: 
Patients will be randomly assigned to one of two groups: 
• Group A, bilateral Symfony. 
• Group B, bilateral Vivity. 

 
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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 1/1A: Day of Surgery for each eye 
3. Visit 2: Month 3: 90 ±15 days postoperative after second eye surgery 
 
2. Measurements and evaluations 
1. Visit 0 (screening): Informed consent process will be conducted during this 
visit. Assessments include best-corrected distance visual acuity (BCDVA, 
Snellen chart), manifest refraction, halo and glare simulator, slit lamp 
examination including dilated fundus exam, cataract density and type, patient 
satisfaction, visual symptoms and spectacle independence questionnaires, 
Additionally, patients enrolled at one site (CEP) will have an iTrace done. Any 
testing that is part of the site’s standard of care related to 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 
 
2. Visit 1/1A (day of surgery for each eye): The surgeon may use his preferred 
small incision cataract extraction technique (manual phacoemulsification or 
laser assisted). The lens will be implanted in the capsular bag. The following 
information will be captured from the day of surgery: phaco technique (manual 
or laser), lens implanted and power, target refraction for IOL power implanted, 
additional surgical procedures, intraoperative complications, and any device 
deficiencies. The surgeon’s standard post cataract surgery treatment will be 
used in all his/her patients.  
 
3. Visit 2 (Month 3): Monocular and binocular UCDVA and BCDVA at 4 m, 
binocular UCIVA and DCIVA (at 66 cm), binocular UCNVA and DCNVA (at 40 
cm), binocular BCDVA low contrast (10% and 25%), DC binocular defocus 
curve, pupil size at 66 and 40 cm will be performed under mesopic conditions 
(3-5 cd/m2). Additionally, bilateral BCDVA as well as DCIVA and DCNVA will be 
performed under photopic conditions. Other assessments will include the 
manifest refraction, I-Trace (at one site only), halo and glare simulator, IOL 

 
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orientation (if a toric lens) and dilated fundus exam as deemed necessary by 
the investigator, patient satisfaction, visual symptoms and spectacle 
independence questionnaires, and any device deficiencies. A routine slit lamp 
examination will also be conducted. 
 
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 
3-Month 
90 ±15 days 
Informed Consent  
X  
 
 
Inclusion/Exclusion 
X  
X 
  
Demographics/Ocular history 
X  
 
  
BCVA Snellen 
X 
 
 
UCVA ETDRS (4m) under mesopic 
conditions 
 
 
X* 
UCIVA ETDRS (66 cm) under mesopic 
conditions 
 
 
X** 
UCNVA ETDRS (40 cm) under mesopic 
conditions 
 
 
X** 
Manifest refraction – Max Plus 
 
 
X 
BCVA ETDRS (4m) under photopic 
conditions 
 
 
X** 
DCIVA ETDRS (66 cm) under photopic 
conditions 
 
 
X** 
DCNVA ETDRS (40 cm) under photopic 
conditions 
 
 
X** 
BCVA ETDRS (4m) under mesopic 
conditions 
 
 
X* 
BCVA Mesopic low contrast (10%) at 4 
m under mesopic conditions 
 
 
X** 
BCVA Mesopic low contrast (25%) at 4 
m under mesopic conditions 
 
 
X** 
DCIVA ETDRS (66 cm) under mesopic 
conditions 
 
 
X** 
DCNVA ETDRS (40 cm) under mesopic 
conditions 
 
 
X** 
Defocus curve under mesopic 
conditions 
 
 
X** 

 
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Pupil size at 66 cm under mesopic 
conditions 
 
 
X 
Pupil size at 40 cm under mesopic 
conditions 
 
 
X 
SLE 
X 
 
X 
i-Trace‡ 
X 
 
X 
Halo and glare simulator 
X‡‡ 
 
X‡‡ 
Dilated fundus exam 
X 
 
X† 
Cataract density / type 
X 
 
 
Intraoperative data 
 
X 
 
Toric IOL position 
 
X 
X† 
Questionnaires  
X  
 
X 
AE/Device deficiencies 
 
X 
X 
 
X To be performed as scheduled 
* Monocular and binocular testing  
** Binocular testing only 
‡ To be performed at one site only (CEP) 
‡‡ With and without correction 
†To be performed as deem necessary by the investigator. 
DC: distance corrected.  
 
D. Study endpoint criteria 
 
1. 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. 
 
2. 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. 
 
3. 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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4. 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. 
 
5. Study Completion: The study will be complete when all enrolled patients have 
completed Visit 5 or have been terminated from the study. 
 
3. STATISTICAL CONSIDERATIONS 
 
A. Sample size 
The sample size estimates depend in large part on the standard deviation (SD) for 
logMAR UCIVA. Assuming a SD of 0.122 for the two-sided t-test (alpha =0.05) for 
the intermediate visual acuity endpoint, we will need 32 subjects in each group 
(Symfony with Optiblue/ Vivity) to detect differences of 0.1 logMAR (1 line 
difference) with 90% power. Total sample size = 64.  
 
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 Endpoint: 
Binocular distance corrected intermediate visual acuity at 66 cm under 
mesopic conditions. 
2. Secondary Endpoints: 
a. Defocus curve under mesopic conditions 
b. Binocular low contrast distance visual acuity under mesopic conditions 
c. Uncorrected and distance-corrected near (40 cm) visual acuity under 
mesopic conditions. 
D. Uncorrected intermediate (66 cm) visual acuity under mesopic conditions 

 
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E. Uncorrected and best-corrected distance (4 m) visual acuity  
F. Non-directed complaints 
G. To evaluate patient’s overall satisfaction of their vision 
H. To evaluate patient’s spectacle independence 
I. To evaluate visual symptoms using a questionnaire 
J. To evaluate the functional vision questionnaire 
K. Residual mean spherical equivalent refraction  
L. Residual refractive sphere  
M. Residual refractive cylinder  
N. Percentage of eyes with postoperative MRSE accuracy to target ≤ 0.5D  
 
3. 
Exploratory endpoints: 
a. Effect of pupil size at 66 cm 
b. Effect of pupil size at 40 cm 
c. Angle alpha effect on visual disturbances 
d. i-Trace evaluation of depth of focus, modulation transfer function (MTF), 
visual function analysis, and point spread function (PST) among others. 
 
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. 
 
4. 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 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, Sponsor Company or Research Institution, the IRB, and other State or 
Federal Regulatory Agencies, if necessary. All information in these records will be 
kept confidential. 
 

 
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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 
study. The investigator must maintain the required records during the 
investigation and for a period of 2 years after the date on which the investigation 
is terminated, completed, or published then records will be scanned and kept 
electronically on a secured server. 
 
5. STUDY MONITORING, AUDITING, AND INSPECTING 
A. 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. If electronic source records are maintained, these 
records must be 21 CFR Part 11 compliant and will be printed and certified for 
verification as needed.  
 
B. The required examination must be recorded on the CRFs. CRFs will 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. 
 
C. Data from CRFs will be entered into a database. Upon completion of the CRFs, the 
data will be reviewed by study designated personnel and statistician for accuracy 
and completeness. If corrections and/or any additions to the data are deemed 
necessary, queries will be generated. Designated research staff 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. 
 
D. Data will not be sold to third parties but collected data may be used for additional 
analysis in the future. 
 
6. INVESTIGATIONAL PRODUCT  

 
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A. Description  
The Symfony InteliLight IOL (DXR00V or DXW150 – 375 – Toric II IOL) combines an 
echelette design (to create an extended depth of focus) with an achromatic 
technology (to correct chromatic aberrations) and a violet-light filter that 
diminishes the perception of visual disturbances such as halo, glare, and 
starburst. The lens has been designed to provide high quality vision up to 26 
inches so patients may still need to wear glasses for some activities mainly at 
near. 
 
Acrysof® IQ Vivity Intraocular Lens is a non-diffractive aspheric IOL that provides 
an extended range of vision maintaining low incidence of visual disturbances 
when compared to a monofocal IOL. The extended vision ranging from distance to 
near is obtained by a Wavefront-shaping technology on the anterior surface of 
the lens. 
 
B. Treatment/Dosing Regimen 
The IOL will be implanted at time of uncomplicated routine cataract surgery. 
Intraocular lenses are implantable medical devices and are intended for long term 
use over the lifetime of the patient. 
 
C. Method for Assigning Subjects to Treatment/Dosing Groups 
N/A 
 
D. Subject Compliance Monitoring  
Since the IOL is implanted at time of cataract surgery, subject compliance will not 
be an issue in this particular study. 
 
E. Packaging, Receiving, Storage, Dispensing and Return 
N/A 
 
7. ETHICAL CONSIDERATIONS 
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 involved in the conduct of the clinical trial are qualified to perform their 

 
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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 
follow the applicable regulatory laws and conditions of approval imposed by the IRB. 
 
8. 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. 
 
9. 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. 
 
REFERENCES: 
1. Calladine D, Evans JR, Shah S, Leyland M. Multifocal versus monofocal intraocular lenses after 
cataract extraction. Cochrane Database Syst Rev. 2012;(9):CD003169.  
 
2. Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual 
outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal 
clinical trial. J Cataract Refract Surg. 2022; 48:288-297 
 
3. McCabe C, Berdahl J, Reiser H, Newsom TH, Cibik L, Koch D, Lemp-Hull J, Jasti S. Clinical 
outcomes in a U.S. registration study of a new EDOF intraocular lens with a nondiffractive 
design. J Cataract Refract Surg. 2022; 48:1297-1304. 
 

 
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4. Tahmaz V, Siebelmann S, Koch KR, Cursiefen C, Langenbucher A, Hoerster R. Evaluation of a 
Novel Non-Diffractive Extended Depth of Focus Intraocular Lens - First Results from a 
Prospective Study. Curr Eye Res. 2022; 47:1149-1155. 
 
4. Nowik KE, Nowik K, Kanclerz P, Szaflik JP. Clinical Performance of Extended Depth of Focus 
(EDOF) Intraocular Lenses - A Retrospective Comparative Study of Mini Well Ready and 
Symfony. Clin Ophthalmol. 2022; 16:1613-1621. 
 
5. Schojai M, Schultz T, Jerke C, Böcker J, Dick HB Visual performance comparison of 2 extended 
depth-of-focus intraocular lenses. J Cataract Refract Surg. 2020; 46:388-393 
 
6. Guarro M, Sararols L, Londoño GJ, Goñi I, Vázquez M, Ruiz S, López S. Visual disturbances 
produced after the implantation of 3 EDOF intraocular lenses vs 1 monofocal intraocular 
lens. J Cataract Refract Surg. 2022; 48:1354-1359. 
 
7. Sandoval HP, Lane S, Slade S, Potvin R, Donnenfeld ED, Solomon KD. Extended depth-of-focus 
toric intraocular lens targeted for binocular emmetropia or slight myopia in the nondominant 
eye: Visual and refractive clinical outcomes. J Cataract Refract Surg. 2019; 45:1398-1403.