Visual Performance and Patient Satisfaction With A New Monofocal Intraocular Lens
Phase: NA
Conditions: Cataract, Presbyopia
Sponsor: Carolina Eyecare Physicians, LLC

 
Solomon KD, Sandoval HP 
 
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VISUAL PERFORMANCE AND PATIENT SATISFACTION WITH A NEW MONOFOCAL INTRAOCULAR LENS 
 
 
 
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:  
JJV – Tecnis Eyhance Intraocular lens Toric (DIUxxx) and non-toric 
(DIB00) 
 
Protocol Number: 
 
CEP-21-001 
 
 
 
 
Initial version date: 06Apr2021 
 
 
 
 
Version 2.0 17May2021 
 
 
 
 
Version 2.1 06Jul2021 
 
 
 
 
Version 2.2 10Jan2022 Amendment #1 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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 
 
 

 
Solomon KD, Sandoval HP 
 
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Version   2.2 10Jan20222.1 06Jul2021 
 
VISUAL PERFORMANCE AND PATIENT SATISFACTION WITH A NEW MONOFOCAL INTRAOCULAR LENS 
 
 
INTRODUCTION 
Current visual outcomes expectations of cataract in some patients are similar to those of refractive 
surgery patients. Their desire is to be spectacle independent for far, intermediate and near vision 
activities. Some may have already enjoyed freedom from glasses and would like to continue after the 
cataracts are removed. Different options are available. These options include: mono-vision and 
presbyopia correcting intraocular lenses (IOL).  
Mono-vision can be achieved using monofocal IOLs by setting the non-dominant eye to -1.75 (range may 
vary according to patient’s preference -1.25 to -2.50 D) and the dominant eye to plano at time of 
cataract surgery, or postoperatively using contact lenses, or undergoing LASIK.  
Presbyopia correcting IOLs (PCIOLs) include accommodative, multifocal (MIOLs, bi and trifocals) and 
extended depth of focus (EDOF) IOLs.   Patients’ complaints of glare and halos are common with all 
MIOLs and EDOF. The severity of these symptoms varies according to the actual IOL design. These 
optical phenomena may prevent a large percentage of patients from choosing a PCIOL even though they 
still want to achieve spectacle independence postoperatively at all distances. 
Monofocal lenses correct only at the target distance chosen (i.e., distance without intermediate or near 
vision improvement or near without distance improvement). Intermediate vision has become important 
for many daily activities such as reading a mobile phone or tablet. Tecnis Eyhance IOL, recently approved 
by the FDA,A is a new generation of monofocal lenses designed to improve and/or enhance intermediate 
vision without compromising the distance vision with low incidence of halo, glare or starburst. Auffarth 
et al1 in a study that included 67 patients implanted bilaterally with the Eyhance IOL showed an 
improvement of 1 line of intermediate visual acuity compared to a standard monofocal IOL (ZCB00). 
Additionally, they reported no differences between the 2 groups in contrast sensitivity and visual 
disturbances complains.  
The purpose of this study is to evaluate the visual outcomes of a monofocal IOL with an enhanced 
intermediate function, in patients with or without astigmatism, when both eyes are targeted for 
emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients 
undergoing routine cataract surgery. 
 
1. OBJECTIVE: 
 
The main objective of this study is to evaluate the visual outcomes of a monofocal IOL with an enhanced 
intermediate function, in patients with or without astigmatism, when both eyes are targeted for 
emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients 
undergoing routine cataract surgery. 

 
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2. STUDY DESIGN AND METHODS: 
 
A. 
Test article: Tecnis Eyhance Intraocular lens Toric (DIUxxx) and non-toric (DIB00) 
 
B. 
Study Design:  Prospective, multicenter (up to 2 sites in USA), randomized, patient-masked 
bilateral eye study. 
 
C. 
Subjects: A total of 74 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 cataract extraction with intraocular lens implantation.  
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 within 6 - 30 days between 
surgeries. 
7. Subjects who require an IOL power in the range of +5.0 D to +34.0 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 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. Irregular astigmatism. 
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 refractive surgery. 
13. Previous keratoplasty 
14. Severe dry eye 
15. Pupil abnormalities 

 
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16. 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) 
17. Anesthesia other than topical anesthesia (i.e. retrobulbar, general, etc). 
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. 
 
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 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 

 
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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: 
Patients will be randomized to one of two groups: 
• 
Group A, plano OU. The target refraction for both eyes will be emmetropia (± 0.25 D). 
• 
Group B, mini monovision. The target refraction for the dominant eye will be plano (± 
0.25 D) and for the non-dominant eye between -0.75D ±0.15. 
 
C. 
Study Visit Schedule and Assessments (Table 1). 
 
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 
3. Visit 3: Day 1: (12 to 48 hours) after surgery  
4. Visit 4: Month 1: 30 ±7 days postoperative after second eye surgery 
4. Visit 5: Month 3: 90 ±15 days postoperative after second eye surgery 
 
 

 
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D. Measurements and evaluations 
 
1. 
Visit 1:  Informed consent process will be conducted at this visit. Assessments include  best-
corrected distance  visual acuity (BCDVA, Snellen chart), manifest refraction, intraocular 
pressure (IOP), corneal topography (if astigmatism correction),  eye dominance, slit lamp 
examination including dilated fundus exam, cataract density and type. 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 
 
Each subject will be randomized to Group A (emmetropia OU) or B (mini monovision). 
Randomization will ensure that an equal number of subjects are enrolled in each group. 
 
2. Visit 2: The surgeon may use his preferred small incision cataract extraction technique 
(manual phacoemulsification or laser assisted). The assigned 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 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 patients.  IOL power changes 
based on intraoperative aberrometry (i.e., ORA) are not allowed. 
 
3. Visit 3: monocular UCVA (Snellen), slit lamp examination, IOP, and lens orientation (if toric 
lens and deem necessary by the investigator) and any device deficiencies.  
 
4. Visit 4: Slit lamp examination, manifest refraction, monocular and binocular UCDVA, BCDVA, 
UCIVA (at 66 cm), DCIVA (at 66 cm), UCNVA (at 40 cm), and DCNVA (at 40), IOP, IOL 
orientation (if toric lens) and dilated fundus exam as deemed necessary by the investigator, 
patient satisfaction, visual symptoms and spectacle independence questionnaires, and any 
device deficiencies. 
 
5. Visit 5: Slit lamp examination, manifest refraction, binocular UCDVA, BCDVA, UCIVA (at 66 
cm), DCIVA (at 66 cm), UCNVA (at 40 cm), DCNVA (at 40), and DCNVA at best distance, 
binocular low contrast (10%) photopic and mesopic BCDVA, DC binocular defocus curve, IOL 
orientation (if toric lens) and dilated fundus exam as deemed necessary by the investigator, 
patient satisfaction, visual symptoms and spectacle independence questionnaires, and any 
device deficiencies. 
 
DC: distance corrected. DC, for the purpose of this study, is defined as corrected for the target 
refraction (i.e. emmetropia OU corrected for plano. Mini monovison dominant eye corrected for 
plano and the non-dominant eye for -0.75). 
 
All adverse events and complaints will be monitored and recorded at all study visits. 
 

 
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Table 1.  Visits and Study Assessments 
 
  
Visit 1 
Screening 
Visit 
2/2A 
DOS 
Visit 
3/3A 
POD #1 
Visit 4 
1-Month 
Visit 5 
3-Month 
Informed Consent  
 X  
  
  
  
 
Inclusion/Exclusion 
 X  
  
  
  
 
Demographics/PMH/Ocular history 
 X  
  
  
  
 
Eye dominance 
X 
 
 
 
 
BCVA (Standard of care, Snellen) 
X 
 
 
 
 
UCVA (Standard of care, Snellen) 
 
 
X 
 
 
UCVA ETDRS (4m) 
 
  
 
 X*  
 X**  
Manifest refraction – Max Plus 
 
  
 
 X  
 X  
BCVA ETDRS (4m) 
  
  
 
 X*  
 X**  
UCIVA ETDRS (66 cm) 
  
  
 
 X*  
 X**  
DCIVA ETDRS (66 cm) 
  
  
 
 X*  
 X** 
UCNVA ETDRS (40 cm) 
  
  
 
 X*  
 X**  
DCNVA ETDRS (40 cm) 
  
  
 
 X*  
 X**  
DCNVA at best distance 
 
 
 
 
X** 
DCVA Photopic low contrast (10%)  
 
 
 
 
X** 
DCVA Mesopic low contrast (10%)  
 
 
 
 
X** 
Defocus curve 
  
  
 
 
X** 
Intraocular Pressure (Standard of care) 
X 
  
 X  
 X  
 
SLE 
 X  
  
 X  
 X  
 X  
Dilated fundus exam 
 X  
  
 
 X‡  
 X‡  
Cataract density / type 
 X  
  
  
  
 
Corneal topography¥ 
X 
 
  
  
 
Intraoperative data 
 
X 
 
 
 
Toric IOL position 
 
X† 
X†‡ 
X†‡ 
X‡ 
Questionnaires  
X  
  
 
 X  
 X  
AE/Device deficiencies 
  
X  
 X  
 X  
 X  
 
X To be performed as scheduled 
* Monocular and binocular testing 
** Binocular testing only 
‡ To be performed as deem necessary by the investigator. 
† If toric lens 
¥ If astigmatism correction (toric or corneal arcuates) 

 
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DC: distance corrected. DC, for the purpose of this study, is defined as corrected for the target refraction 
(i.e. emmetropia OU corrected for plano. Mini monovison dominant eye corrected for plano and the 
non-dominant eye for -0.75). 
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. 
 
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 
The sample size estimates depend in large part on the standard deviation (SD) for logMAR 
UCIVA. Assuming a SD of 0.12 (from a previous Eyhance study), for the two-sided t-test (alpha 
=0.05) for the intermediate visual acuity endpoint, we will need 31 subjects in each group 
(emmetropia / mini monovision) to detect differences of 0.1 logMAR (1 line difference) with 
90% power.  Total sample size = 62.  Allowing 10 % for the potential confounding factor of 
having 2 sites, and 10% assumed dropout rate, 74 subjects will be enrolled (37 in each group). 
Table 2 summarizes the sample size estimate. 
Table 2. Sample size estimate. 
 
 
TOTAL 
Mini monovision 
Emmetropia 
Sample size 
62 
31 
31 
10% multiple sites 
6 
3 
3 

 
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10% dropout rate 
6 
3 
3 
Total sample size 
74 
37 
37 
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:  
Comparisons between the groups: 
 
1. 
Primary Endpoints:  
Binocular distance-corrected intermediate (66 cm) visual acuity at 3 months. Distance 
corrected. DC, for the purpose of this study, is defined as corrected for the target 
refraction (i.e. emmetropia OU corrected for plano. Mini monovison dominant eye 
corrected for plano and the non-dominant eye for -0.75). 
 
2. 
Secondary Endpoints: 
1. Binocular defocus curve at 3 months 
2. Binocular low contrast distance visual acuity at 3 months 
3. Uncorrected and distance-corrected near (40 cm) visual acuity at 1 and 3 months 
4. Uncorrected and distance-corrected intermediate (66 cm) visual acuity at 1 and 3 
months 
5. Uncorrected and best-corrected distance (4 m) visual acuity at 1 and 3  months 
6. Distance-corrected near visual acuity at best distance at 3 months 
7. To evaluate patient’s overall satisfaction of their vision 
8. To evaluate patient’s spectacle independence 
9. To evaluate visual symptoms using a questionnaire. 
10. Residual mean spherical equivalent refraction at 3 months  
11. Residual refractive sphere at 3 months 
12. Residual refractive cylinder at 3 months 
13. Percentage of eyes with postoperative MRSE accuracy to target ≤ 0.5D at 3 months  
 
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 

 
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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 and research staff involved in the study.  Study records will be kept on file at 
each site.  Any statistical analysis and publication will not include any subject identifiers.  Medical 
records will be made available only for review by the investigators, study Monitor or Auditor, 
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. 
 
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 3 year after the date on which the investigation is terminated or completed. 
 
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.  
 
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 provided to each site, site will email the password 
protected file to the study manager with the CRFs for remote monitoring. Additionally, monitoring 
site visits will be made by the study manager 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 

 
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necessary, queries will be generated and forwarded to the investigative site. 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 nor will it be used for future research. 
Electronic data will be stored and accessed on a portable device. The laptop is password protected 
and only the study manager has access to it. Additionally, database will be password protected. 
 
8. INVESTIGATIONAL PRODUCT  
 
A. 
Description  
The Eyhance IOLs (DIB00 and DIUxxx) are monofocal refractive IOLs designed to enhance 
intermediate distance vision without compromising distance vision.    The lens power continuously 
increases from its edge to the center extending the range of vision when compared to a standard 
monofocal IOL. 
 
B. 
Treatment/Dosing Regimen 
The Tecnis Eyhance IOL is intended for primary implantation for the visual correction of aphakia 
secondary to removal of a cataractous lens in adult patients. 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 
Each site will be provided with randomization envelopes. The envelopes will be sequentially 
numbered. 
 
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 
An account will be set up with the manufacturer of the lens (Johnson and Johnson Vision) that will 
provide the lens at no cost to the participants. IOLs will be ordered once the subject’s qualification 
for the study has been confirmed. IOLs will be shipped to the site and will be stored and dispensed 
following the routine standard of care for cataract surgery. Unused IOLs will be returned to Johnson 
and Johnson Vision following their instructions. 
 
Or, Johnson and Johnson Vision will provide a consignment of lenses that will be stored at the site 
and unused IOLs will be returned to Johnson and Johnson Vision following their instructions at the 

 
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end of the study. 
 
In both instances, an implantation log will be kept. 
 
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 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 monofocal 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 persons 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. 
 

 
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13. REFERENCES 
1. Auffarth GU, Gerl M, Tsai L et l. Clinical evaluation of a new monofocal intraocular lens with 
enhanced intermediate function in cataract patients. J Cataract Refract Surg. 2021; 47:184 – 191 
A. 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P980040S117