Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched With the Symfony With Intelilight
Conditions: Bilateral Cataract, Presbyopia
Sponsor: Center For Sight

 
Soscia W, Sandoval HP 
 
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Evaluating A Novel Strategy: The Synergy IOL Mixed and Matched with the Symfony with 
Intelilight 
 
Sponsor:  
 
 
Center for Sight 
 
 
 
 
2601 S Tamiami Trail 
Sarasota, FL 34239  
(941) 925 2020 / (843) 881 3937 
 
Principal Investigator:  
William Soscia, MD 
Project Manager: 
 
Helga P. Sandoval, MD, MSCR, Director of Clinical Research 
Study Product:  
JJV – Synergy IOL and Symfony with InteliLight 
Protocol Number: 
 
CFS-22-001 
 
 
 
 
Initial version date: 03May2022 
 
 
 
 
Final version date: 18 Aug2022 
 
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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EVALUATING A NOVEL STRATEGY: THE SYNERGY IOL MIXED AND MATCHED WITH THE SYMFONY 
WITH INTELILIGHT 
 
Presbyopia-correcting intraocular lenses (IOLs) have evolved rapidly in recent years. Such IOLs 
include extended depth of focus (EDOF) and multifocal (MF) IOLs. The goal of these lenses and 
their various iterations over time has been to provide an excellent range of focus at distance, 
intermediate, and near distances, good quality of vision and contrast sensitivity under different 
lighting conditions, good reading ability, and the minimization of photic phenomena. The TECNIS 
Synergy IOL is a one-piece presbyopia correcting IOL available in non-toric and toric versions that 
was introduced to the US market in June 2021. 
 
At our center, we were the first site in the US to implant the Synergy (June 7, 2021) and have 
been using the IOL ever since. This Synergy IOL is part of the TECNIS platform, which is composed 
of time-tested hydrophobic acrylic material with ultraviolet and violet light absorber, 6-mm 
aspheric optic, refractive index of 1.47, and continuous 360 ° posterior square edge design. The 
company boasts that the new Synergy IOL combines the benefits from the TECNIS Multifocal and 
TECNIS Symfony (EDOF) diffractive designs, and that it delivers a wider range of continuous 
vision and better near vision in day and night than a leading trifocal IOL.1  
 
Early reports from many centers across the country and other countries appear to indicate that 
the Synergy IOL implanted bilaterally is yielding very good results at all ranges, particularly at 
near.2-4 Anecdotally, some surgeons have reported excellent near vision with good but not great 
distance vision.  
 
Prior to utilizing the Synergy IOL, our center along with many high-volume centers across the 
country, employed a mix and match strategy utilizing the TECNIS Symfony in the dominant eye 
and the TECNIS Multifocal in the non-dominant eye with good results and high patient 
satisfaction.5  
 
We propose conducting a prospective evaluation of a mix and match strategy incorporating 
Symfony with InteliLight in the dominant eye and Synergy IOL in the non-dominant eye. The 
Symfony lens, an Extended Depth of Focus (EDOF) lens, known for its superior distance and 
intermediate vision, has been upgraded to the OptiBlue version (InteliLight). The Symfony with 
InteliLight has an enhanced echelette design and a violet light filter. The upgraded echelette 
design utilizes a high-resolution lathing process that helps reduce light scatter and halo intensity. 
The violet light filter is designed to mitigate halo, glare, and starbursts.  
 
1. OBJECTIVE: 
The purpose of this study is to evaluate the visual outcomes, visual disturbances, patient 
satisfaction and spectacle independence of the Symfony with InteliLight when implanted in 

 
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the dominant eye and a Synergy is implanted in the non-dominant eye in patients with or 
without astigmatism after routine cataract surgery. 
 
2. STUDY ENDPOINTS:  
1. Primary Endpoints:  
Binocular defocus curve at 3 months 
 
2. Secondary Endpoints: 
a. Monocular and binocular uncorrected and distance-corrected near at 40 cm 
visual acuity at 3 months. 
b. Monocular and binocular uncorrected and distance-corrected near at 33 cm 
visual acuity at 3 months 
c. Monocular and binocular uncorrected and distance-corrected intermediate (66 
cm) visual acuity at 3 months 
d. Monocular and binocular uncorrected and best-corrected distance (4 m) visual 
acuity at 3 months 
e. To evaluate patient’s vision satisfaction at 3 months 
f. To evaluate patient’s spectacle independence at 3 months 
g. To evaluate visual symptoms using a questionnaire at 3 months 
h. To evaluate functional vision using a questionnaire at 3 months 
 
3. STUDY DESIGN: 
Prospective, multicenter (up to 2 site in US), non-randomized, bilateral eye study. 
 
4. INCLUSION/EXCLUSION CRITERIA 
 
4.1. Inclusion Criteria: 
Subjects MUST fulfill the following conditions to qualify for enrollment into the trial 
1. Subject is undergoing bilateral lens extraction with intraocular lens implantation of the 
Symfony with InteliLight in the dominant eye and a Synergy in the non-dominant eye.  
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 with topical anesthesia in both eyes 
within 2 to 30 days between surgeries 
7. Subjects who require an IOL power in the range of +5.00 D to +34.0 D only. 
8. Subjects who require a toric IOL up to +3.75 D at the IOL plane (2.57 D corneal plane). 
9. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both 
eyes. 
 

 
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4.2. Exclusion Criteria: 
Subjects with ANY of the following conditions on the eligibility exam 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. History of chronic intraocular inflammation. 
8. History of retinal detachment. 
9. Pseudoexfoliation syndrome or any other condition that has the potential to weaken 
the zonules. 
10. Previous intraocular surgery. 
11. Previous corneal refractive surgery (i.e. LASIK, PRK, RK). 
12. Previous keratoplasty 
13. Severe dry eye 
14. Pupil abnormalities 
15. Anesthesia other than topical or peribulbar anesthesia (i.e. retrobulbar, general, etc). 
16. 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. 
17. 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. 
 
4.3. Exclusion Criteria at time of surgery: 
If any of the following exclusion criteria are applicable to the study eye, the subject 
should not continue in the study. 
1. Other ocular surgery procedures, i.e. iStent, anterior vitrectomy 
2. Significant vitreous loss 
3. Significant anterior chamber hyphema 
4. Uncontrollable intraocular pressure 
5. Zonular or capsular rupture 

 
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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 procedure, such as pupil stretch, expanders, 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 
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 
 
5. STUDY PROCEDURES 
 
5.1. 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/or the in-house TV’s of the 
different locations, on the practices website and social media as deem necessary. Once 
identified as a study candidate, the patient will be asked if he/she would like to 
participate. The sub-investigator(s), study coordinator or an appropriately trained staff 
member will answer any and all questions and will obtain informed consent. A copy of 
the informed consent document will be given to the subject. The principal investigator 

 
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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 patient given consent, 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 consent to be enrolled in the study. Informed consent will be 
obtained prior to collecting any data for the study. The original documents will be 
maintained by the investigator as a permanent part of the subject's research records and 
a copy will be provided to the patient.  
 
5.2. Informed consent: 
Subjects will be consented either in person in the office or verbally over the phone. 
• In person consent process: Patients being considered for enrollment who are 
consented in the office will be required to sign the ICF agreeing to participate in 
the study. A copy of the signed consent form will be given to the subject. 
• Over the phone consent process: Site staff delegated to perform the informed 
consent process along with a witness will sign the ICF. Subject will be asked to 
sign the consent during visit 2. A copy of the signed consent form will be given to 
the subject. 
 
5.3. Surgery Procedures: 
Subjects will be implanted with the Symfony with IntelliLight in the dominant eye and a 
Synergy lens in the non-dominant eye. Patients will receive either a non-toric or toric IOL 
based on the amount of astigmatism. The target refraction for both eyes will be closest 
to plano. 
 
5.4. Study Visit Schedule and Assessments (Table 1). 
 
5.4.1. Visit Schedule: Subjects will be examined at the following intervals: 
1. Visit 1: Screening and enrollment: Preoperative evaluation completed not more 
than eight weeks before surgery 
2. Visit 2: Day of Surgery for each eye 
3. Visit 3: Month 3: 90 ±15 days postoperative after second eye surgery 
 
5.4.2. Measurements and evaluations 
1. 
Visit 1:  Informed consent process will be conducted at this visit. Assessments 
include best-corrected Snellen visual acuity, intraocular pressure (IOP), slit lamp 
examination including dilated fundus exam, cataract density and type, and visual 
symptoms, patient satisfaction, spectacle independence and visual function 

 
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questionnaires.  Any testing that is part of the site’s preoperative cataract 
surgery standard of care evaluation may be performed prior to signing the 
informed consent 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 patients 
 
2. Visit 2: The surgeon may use his preferred cataract extraction technique (manual 
or laser). The lens will be implanted in the bag.  The following information will be 
captured the day of surgery: phaco technique (manual or laser), lens implanted 
and power, target refraction, residual astigmatism and axis for Toric Calculator (if 
applicable), additional surgical procedures, intraoperative complications, and any 
device deficiencies.  The surgeon’s standard post cataract surgery treatment will 
be used in all patients.   
 
Visit 3: Slit lamp examination, manifest refraction, monocular and binocular 
uncorrected as well as distance corrected visual acuities will be evaluated at 4 m, 
66 cm, 40 cm, 33 cm and best distance, and defocus curve. Additionally, dilated 
fundus exam (as deem necessary by the investigator), visual symptoms, patient 
satisfaction, spectacle independence and visual function questionnaires, adverse 
events and any device deficiencies will be evaluated. 
 
Table 1. Study Visit Schedule and Assessments  
 
  
Visit 1 
Screening 
Visit 2 and 2A 
DOS 
Visit 3 
3-Month 
90 ±15 days 
Informed Consent  
X  
 
 
Inclusion/Exclusion 
X  
X 
  
Demographics/Ocular history 
X  
 
  
BCVA Snellen 
X 
 
 
Eye dominance 
X 
 
 
UCVA ETDRS (4m) 
 
 
X* 
UCIVA ETDRS (66 cm) 
 
 
X* 
UCNVA ETDRS (40 cm)  
 
 
X* 
UCNVA ETDRS (33 cm) 
 
 
X* 
UCNVA ETDRS (at best distance)  
 
 
X* 
Manifest refraction – Max Plus 
 
 
X  
BCVA ETDRS (4m)  
 
 
X* 
DCIVA ETDRS (66 cm)  
 
 
X* 

 
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DCNVA ETDRS (40 cm)  
 
 
X* 
DCNVA ETDRS (33 cm) 
 
 
X* 
DCNVA ETDRS (at best distance) 
 
 
X* 
Defocus curve  
 
 
X** 
SLE 
X 
 
X  
Intraocular pressure 
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 as deem necessary by the investigator. 
DC: distance corrected.  
 
5.5. Study endpoint criteria 
 
5.5.1. Patient Completion of Study: If a study patient has completed the final visit (Visit 
3) of the study, he/she is considered to have completed the study. 
 
5.5.2. 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. Subjects who are 
discontinued after first eye surgery before second eye surgery will also be replaced. 
 
5.5.3. 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. 
 
5.5.4. 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. 

 
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5.5.5. Study Completion: The study will be complete when all enrolled patients have 
completed Visit 3 or have been terminated from the study. 
 
6. STATISTICAL CONSIDERATIONS 
 
6.1. 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’. 
 
6.2. 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. Vision 
satisfaction, spectacle independence and visual symptoms will be compared to a 
historical control of patients implanted bilaterally with Synergy OU. Data analysis will be 
conducted by a third-party consultant. 
 
6.3. 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. 
 
7. DATA HANDLING AND RECORD KEEPING 
 
7.1. 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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7.2. 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 or completed then 
records will be scanned and kept electronically in a secured server. 
 
8. 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.  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.  
 
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. 
 
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. 
 
Data will not be sold to third parties. 
 
9. INVESTIGATIONAL PRODUCT  
 
9.1. 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. 
 
The Synergy IOL (DR00V or DFW150-375 – Synergy Toric II IOL) using TECNIS Simplicity 
Delivery System is a presbyopia correcting IOL designed to improve intermediate and 

 
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near vision, while maintaining distance visual acuity.  This continuous range of focus lens 
provides a full range of vision and increased spectacle independence. 
 
9.2. 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. 
 
9.3. Method for Assigning Subjects to Treatment/Dosing Groups 
N/A 
 
9.4. Subject Compliance Monitoring  
Since the IOL is implanted at time of cataract surgery, subject compliance will not be an issue 
in this particular study. 
 
9.5. Packaging, Receiving, Storage, Dispensing and Return 
N/A 
 
10. 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 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. 
 
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 persons outside 
of the Study.  Results will be submitted for publication and presentation at national and/or 

 
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international meetings. A manuscript will be submitted to peer-review journals for 
publication but there is no guarantee of acceptance. 
 
REFERENCES: 
1. TECNIS Synergy Value Brief, Johnson & Johnson Surgical Vision. 2021. 
2. Ferreira TB, Ribeiro FJ, Silva D, Matos AC, Gaspar S, Almeida S. Comparison of refractive 
and visual outcomes of 3 presbyopia-correcting intraocular lenses. J Cataract Refract 
Surg. 2022 Mar 1;48(3):280-287. 
3. Gabrić N, Gabrić I, Gabrić K, Biščević A, Piñero DP, Bohač M. Clinical Outcomes with a 
New Continuous Range of Vision Presbyopia-Correcting Intraocular Lens. J Refract Surg. 
2021 Apr;37(4):256-262. 
4. Ribeiro FJ, Ferreira TB, Silva D, Matos AC, Gaspar S. Visual outcomes and patient 
satisfaction after implantation of a presbyopia-correcting intraocular lens that combines 
extended depth-of-focus and multifocal profiles. J Cataract Refract Surg. 2021 Nov 
1;47(11):1448-1453. 
5. Sandoval HP, Potvin R, Solomon KD. Visual Acuity, Defocus Curve, Reading Speed and 
Patient Satisfaction with a Combined Extended Depth of Focus Intraocular Lens and 
Multifocal Intraocular Lens Modality. Clin Ophthalmol. 2020 Sep 15;14:2667-2677.