Ambispective Analysis of Patient Reported Outcomes and Visual Acuity in Patients With Bilateral Implantation of Odyssey Intraocular Lenses
Conditions: Cataract
Sponsor: Mann Eye Institute

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Ambispective Analysis of Patient Reported Outcomes and Visual Acuity
in Patients with Bilateral Implantation of Odyssey Intraocular Lenses
An investigator-initiated clinical trial
1.  TITLE PAGE
Protocol Number:
PB-24-01
Amendment Number
Version 1.0
IRB / ERC
Advarra IRB
6940 Columbia Gateway Drive, Suite 110
Columbia, MD 21046
Sponsor Name & Address:
Phillip Brunson, OD
Mann Eye Institute
5115 Fannin St Suite 1000, Houston, TX 77004
(funding only, this is an investigator-sponsored study)
Johnson & Johnson
1700 E Saint Andrew Pl
Santa Ana, CA 92705
Test Articles:
The TECNIS Odyssey Intraocular Lens (toric and non-toric)
  Investigators:
  
   Phillip Brunson, OD
  Sub-Investigators:
  Alex Hacopian, MD
  Mylan Nguyen, OD

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2 . INVESTIGATOR AGREEMENT
I confirm that I have read and that I understand this protocol and understand the 
use of the study products. I agree to conduct this study in accordance with the 
requirements of this protocol and also protect the rights, safety, privacy, and well-
being of study subjects in accordance with the following:
•
The ethical principles that have their origin in the Declaration of Helsinki.
•
All applicable laws and regulations, including, without limitation, data privacy 
laws and regulations.
•
Regulatory requirements for reporting serious adverse events defined in Section 
13 of this protocol.
Signature of Investigator  (Date)
Investigator Name (print or type)
Investigator’s Title
Name of Facility
Location of Facility (City)

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3.  GENERAL INFORMATION
Objective
To evaluate 3-month postoperative outcomes for bilateral 
implantation of the Odyssey intraocular lens (IOL).
The hypothesis is that the Odyssey IOL will provide good visual 
outcomes at distance, intermediate, and near.
Test Article(s)
The TECNIS Odyssey Intraocular Lens (toric and non-toric)
Sample size
40 subjects total (80 eyes)
Study Population
Patients aged 50 years and older who underwent bilateral cataract
surgery with Odyssey IOL implantation.
Number of sites
One
Study Design
Single center, ambispective study.
Masking
None.
Variables
Primary:  Photopic and mesopic visual acuity at distance (6m), 
intermediate at 66cm, and near visual acuity at 40cm and 
33cm.
Secondary:
•
Assessment of Intraocular Lens Implant Symptoms 
Questionnaire (AIOLIS)
Exploratory:
•
Correlation of postoperative quality of vision concerns 
compared to corneal performance index.
•
Correlation of pupil size compared to patient satisfaction.
Duration / Follow-up
3+ months postoperative
The study will be registered with clinicaltrials.gov.
The study will be conducted in compliance with the protocol, GCP and applicable 
regulatory requirements

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4.  TABLE OF CONTENTS
1.  TITLE PAGE...............................................................................................................................1
2 . INVESTIGATOR AGREEMENT....................................................................................................2
3.  GENERAL INFORMATION.........................................................................................................3
4.  TABLE OF CONTENTS................................................................................................................4
5.  INTRODUCTION........................................................................................................................6
6.  OBJECTIVE(S)............................................................................................................................6
7.  SUBJECTS..................................................................................................................................6
7.1. Subject PopulaIon........................................................................................................6
7.2. Inclusion Criteria...........................................................................................................6
7.3. Exclusion Criteria..........................................................................................................6
8.  STUDY DESIGN..........................................................................................................................7
8.1. Study Design.................................................................................................................7
8.2. Methods Used to Minimize Bias...................................................................................7
9.  STUDY PROCEDURE..................................................................................................................7
9.1. Informed Consent / Subject enrollment.......................................................................7
9.2. Visits and ExaminaIons................................................................................................8
9.3. Study Methods and Measurements.............................................................................8
9.4.  Unscheduled Visits.......................................................................................................9
9.5.  DisconInued Subjects..................................................................................................9
10.  ANALYSIS PLAN.....................................................................................................................10
10.1. Analysis Data Sets.....................................................................................................10
10.2. StaIsIcal Methodology............................................................................................10
10.3. General StaIsIcal ConsideraIons............................................................................10
11.  SAMPLE SIZE JUSTIFICATION................................................................................................10
12. CONFIDENTIALITY/PUBLICATION OF THE STUDY.................................................................10
13.  QUALITY COMPLAINTS AND ADVERSE EVENTS...................................................................11
13.1. General InformaIon.................................................................................................11
13.2. Monitoring for Adverse Events.................................................................................11
13.3. Procedures for Recording and ReporIng AEs and SAEs...........................................11
13.4. Follow-Up of Adverse Events and Quality Complaints.............................................14

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13.5. Safety Analyses.........................................................................................................14
14. GCP, ICH and ETHICAL CONSIDERATIONS.............................................................................14
14.1 ConﬁdenIality............................................................................................................15
15.  STANDARD EVALUATION PROCEDURES..............................................................................15
Table 15.1. Proposed Visits and Study Assessments.........................................................15
16. DATA CONFIDENTIALITY........................................................................................................15
17. FINANCIAL AND INSURANCE INFORMATION/STUDY RELATED INJURIES.............................16
18. STUDY ENDPOINT CRITERIA..................................................................................................16
18.1. PaIent CompleIon of Study.....................................................................................16
18.2. PaIent DisconInuaIon............................................................................................16
18.3. PaIent TerminaIon..................................................................................................16
18.4. Study TerminaIon....................................................................................................16
18.5. Study CompleIon.....................................................................................................17
19. SUMMARY OF RISKS AND BENEFITS.....................................................................................17
19.1. Summary of risks.......................................................................................................17
19.2. Summary of beneﬁts.................................................................................................17
REFERENCES................................................................................................................................17

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5.  INTRODUCTION
Previous multifocal intraocular lenses (IOLs) have dramatically increased spectacle 
independence compared to a monofocal, however, there have been several reports of 
compromised quality of vision including halos, glare, and loss of contrast sensitivity. The
TECNIS Odyssey IOL aims to consistently deliver a high level of spectacle 
independence, providing a broader range of vision, without sacrificing quality of vision. 
However, there is limited data on the visual outcomes for patients with the Odyssey IOL. 
The purpose of this study is to evaluate 3-month postoperative outcomes for bilateral 
implantation of the Odyssey IOL.
6.  OBJECTIVE(S)
To evaluate 3-month postoperative outcomes for bilateral implantation of the Odyssey 
IOL.
7.  SUBJECTS
7.1. Subject Population
Eligible test subjects will be aged 50 years and older who underwent bilateral cataract 
surgery with Odyssey IOL implantation.
A total of 40 subjects at one site will be enrolled. Both eyes of a subject must be enrolled.
Subjects must meet the inclusion criteria. Prior to enrollment, subjects will be provided 
information on the study and asked to sign a patient information and consent form to 
participate. The patient information and consent form will be approved by an appropriate 
ethics committee.
7.2. Inclusion Criteria
Subjects are eligible for the study if they meet the following criteria:
Note: Ocular criteria must be met in both eyes.
•
Patients aged 50 years and older who underwent bilateral cataract surgery with 
Odyssey IOL implantation.
7.3. Exclusion Criteria
If any of the following exclusion criteria are applicable to the subject or either eye, the 
subject should not be enrolled in the study.
•
Significant ocular comorbidities (e.g., macular degeneration, glaucoma).
•
< 2 weeks post YAG capsulotomy.
•
Best corrected distance visual acuity worse than 20/25.
The principal investigator reserves the right to declare a patient ineligible or non-
evaluable based on medical evidence that indicates they are unsuitable for the trial.

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8.  STUDY DESIGN
8.1. Study Design
This study is a single center, ambispective study of visual outcomes after successful 
bilateral cataract surgery. Subjects will be assessed at least 3 months postoperatively at a 
single visit. Clinical evaluations will include administration of the AIOLIS and OSDI 
questionnaires, as well as measurement of visual acuities at distance, intermediate, and 
near.
Primary:  Photopic and mesopic visual acuity at distance (6m), intermediate at 66cm 
utilizing near point card, and near visual acuity at 40cm and 33cm.
Secondary:
•
Assessment of Intraocular Lens Implant Symptoms Questionnaire (AIOLIS) 
Exploratory:
•
Correlation of postoperative quality of vision concerns compared to corneal 
performance index.
8.2. Methods Used to Minimize Bias
Patient selection will be based on the patient’s interest and the surgeon’s opinion as to 
whether they are a suitable candidate for inclusion.
The measurement of visual acuity will be conducted in a systematic fashion to minimize 
bias. Individuals conducting visual acuity measures will be instructed to perform the 
same testing in the same fashion for all subjects, with the same level of encouragement to
subjects. Questionnaire instructions will be provided to all patients in a similar manner.
All data collection will be completed through provided Case Report Forms (CRFs) or 
computer files generated by automated test equipment. All site personnel involved in the 
study will be trained in regard to conducting study-specific procedures.
9.  STUDY PROCEDURE
9.1. Informed Consent / Subject enrollment
No subject will be enrolled into the study who 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 
medical records. A signed copy will be provided to the subject.

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9.2. Visits and Examinations
Subjects will participate in one study visit, including the screening visit. The visit 
schedule, complete with window and associated CRF forms, are displayed in Table 9.2-1.
Details of each study visit, including testing to be conducted, are provided below.
Table 9.2-1.  Visit Schedule
Visit
Number
Visit Window
CRF
Number
1
Day 0
1
9.2.1. Visit 1
At Visit 1, subjects will be consented, qualified for the study (compared with 
inclusion/exclusion criteria), and assigned a study ID/subject number.  Subject 
numbers will be assigned sequentially at each site in the order of enrollment.
A medical history will be taken and exams will include the tests described below:
§
Photopic and mesopic visual acuity at distance (6m), intermediate (66cm), 
and near (40cm and 33cm).
§
Assessment of Intraocular Lens Implant Symptoms Questionnaire 
(AIOLIS).
§
Ocular Surface Disease Index Questionnaire (OSDI)
§
iTrace.
§
Pupil size.
In addition, all site-specific, routine, usual standard of care measures should be 
undertaken.
Measurements should be made as described in section 9.3 below.
9.3. Study Methods and Measurements
All routine testing and basic eye examinations should be carried out at each study visit.  
Abnormalities should be recorded in the CRF “Comment” section.  Specific study 
examination procedures are outlined below.
9.3.1. Manifest Refraction
Perform a manifest refraction with a high contrast chart under photopic lighting 
conditions (85 cd/m2).  Document refraction results with sphere, cylinder and axis 
readings.  If uncorrected visual acuity is not improved by manifest refraction, use 
zero for sphere and cylinder and draw a line through the blank for the axis.

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Note:  Each subject should be manually refracted to his/her best correction by an 
ophthalmologist, optometrist, or a skilled technician using a phoropter or trial 
lenses.
9.3.2. Visual Acuity (VA)
To obtain VA, ask subjects to begin reading the chart at the smallest row where 
all letters are easily distinguishable.  Have subjects continue to read rows with 
smaller letters and encourage subjects to guess at all letters in a line if at least one 
correct response was given on the previous row.  Request subjects read rows until 
no letters on a row are read correctly or until all letters on a row are too 
indistinguishable to even be guessed.
While the subject is reading the chart, record the number of letters on each line 
read incorrectly by the subject. The last line from which the subject read at least 
one letter correctly is recorded as the baseline VA.  The actual VA is calculated 
using the baseline VA line and the number of letters read incorrectly.
Distance VA
Measure distance visual acuity using a high contrast chart under photopic and 
mesopic lighting at a distance of 6m.
Intermediate VA
Have the subject view an appropriately-scaled high-contrast high contrast chart 
under photopic and mesopic lighting at a distance of 66cm.
Near VA
Have the subject view an appropriately-scaled high-contrast high contrast chart 
under photopic and mesopic lighting at distances of 40cm and 33cm.
9.3.3 Questionnaire
The AIOLIS and ODSI will be administered to subjects. The administrator should
ensure the subjects understand the nature of the questions but should not interpret 
them for the subject.
9.3.4 iTrace
Perform diagnostic scans with the iTrace (Tracey Technologies).
9.4.  Unscheduled Visits
Unscheduled exams may be conducted at the discretion of the Investigator with all 
relevant information from the exam recorded in the source documents and on the 
Unscheduled Visit pages within the CRF booklet.

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9.5.  Discontinued Subjects
Discontinued subjects are those who do not have an exit visit or who come into the office
to be exited prior to the scheduled final study visit. Subjects may be discontinued from 
the study at any time if, in the opinion of the investigator, their continued participation in 
the study poses a risk to their health. The reasons for discontinuation include:
a.
Adverse event;
b. Lost to follow-up;
c.
Subject decision unrelated to an adverse event;
d. Protocol violation;
e.
Treatment failure;
f.
Other.
To ensure the safety of all subjects who discontinue prior to the final visit, investigators 
should assess each subject and, if necessary, advise them of any therapies and/or medical 
procedures that might be needed to maintain their health. Any changes in medical health 
and/or use of concomitant medications should also be captured.
10.  ANALYSIS PLAN
10.1. Analysis Data Sets
All subjects who are enrolled in the study will be evaluated for safety.  Efficacy analyses 
will be performed based on data from those eyes where uncomplicated cataract surgery 
with IOL implantation was completed.
10.2. Statistical Methodology
A summary of the data will be prepared for all measurement time points.
10.2.1. Within-treatment Changes
For variables measured on a continuous scale, these summaries will include the 
sample size, as well as the mean, standard deviation, median, minimum, and 
maximum. For variables measured on a categorical scale, summaries will provide 
the number and percentage of eyes in each category. These summaries will be 
provided for all eyes completing the study.
10.3. General Statistical Considerations
The statistical analyses will be performed using R, version 4.4.0 or higher.  Any 
statistical tests of hypotheses will employ a level of significance of alpha=0.05.
11.  SAMPLE SIZE JUSTIFICATION
It is worth noting that prior studies with between 30 and 40 subjects have allowed 
successful determinations to be made in the performance of different IOLs.1-3 It is 
expected that 35 subjects (70 eyes) will provide sufficient data to characterize the clinical
performance of the lens. To allow for dropout, 40 subjects (80 eyes) will be enrolled.

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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.
All study data will be collected on appropriate Case Report Forms (CRFs). No protected 
health information will be included on the forms. CRFs will be retained in the patient’s 
file for a minimum period of 3 years. Collected information will only be used for 
purposes of this study and no information will be sold to third parties. The following 
people will have access to your study records:
•    Study Doctor and staff involved with the study
•    Study Monitor or Auditor
•    Sponsor Company or Research Institution
•    Review boards or accrediting agencies
•    Other State or Federal Regulatory Agencies
The de-identified data may be shared with other researchers for future analysis.
13.  QUALITY COMPLAINTS AND ADVERSE EVENTS
All subjects will be monitored for adverse events over the course of the study. A place to 
record any adverse event is included on each case report form.
13.1. General Information
An Adverse Event (AE) is any untoward medical occurrence in a subject who is 
administered. a study treatment regardless of whether or not the event has a causal 
relationship with the treatment. An AE, therefore, can be any unfavorable or unintended 
sign (including an abnormal laboratory finding), symptom, or disease temporally 
associated with the study treatment, whether or not related to the treatment. In clinical 
studies, an AE can include an untoward medical occurrence occurring at any time, 
including run-in or washout periods, even if no study treatment has been administered.
13.2. Monitoring for Adverse Events
At each visit, after the subject has had the opportunity to spontaneously mention any 
problems, the Investigator should inquire about AEs by asking if the patient has any 
problems.
13.3. Procedures for Recording and Reporting AEs and SAEs
Subsequent to signing an informed consent form, all untoward medical occurrences that 
occur during the course of the study must be documented on an Adverse Event Form 

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(AEF). A separate AEF must be filled out for each event. When possible, signs and 
symptoms indicating a common underlying pathology should be documented as one 
comprehensive event. For each recorded event, the AE documentation must include the 
onset date, outcome, resolution date (if event is resolved), intensity (i.e., severity), any 
action with study treatment taken as a result of the event, and an assessment of the 
adverse event’s relationship to the study treatment.
Nonserious Adverse Events
A nonserious AE is defined as any untoward change in a subject's medical health that 
does not meet serious criteria noted below (e.g., is not life-threatening, does not require 
hospitalization, does not prolong a current hospitalization, is not disabling, etc.). All 
adverse events must be reported regardless of whether or not they are related to the study 
treatment.
For nonserious adverse events, an AEF containing all available information will be 
collected on a routine basis and submitted to the Medical Monitor at the close of the 
study.
Serious Adverse Events
A serious adverse event (SAE) is defined as any adverse experience that meets any of the
following criteria:
•
Results in death.
•
Is life-threatening.
NOTE: Life-threatening means that the subject was at immediate risk of death 
from the reaction as it occurred; i.e., it does not include a reaction which 
hypothetically might have caused death had it occurred in a more severe form.
•
Requires inpatient hospitalization or prolongation of existing hospitalization.
NOTE: In general, hospitalization signifies that the individual remained at the 
hospital or emergency ward for observation and/or treatment (usually involving 
an overnight stay) that would not have been appropriate in the physician's office 
or an out-patient setting. Complications that occur during hospitalization are AEs.
If a complication prolongs hospitalization or fulfills any other serious criteria, the 
event is serious. When in doubt as to whether “hospitalization” occurred, the 
event should be considered serious.
•
Results in persistent or significant disability/incapacity. Disability is defined as a 
substantial disruption of a person’s ability to conduct normal life functions.
NOTE: The term disability means a substantial disruption of a person’s ability to 
conduct normal life functions. This definition is not intended to include 
experiences of relatively minor medical significance such as uncomplicated 
headache, nausea, vomiting, diarrhea, influenza, or accidental trauma (e.g., 
sprained ankle) which may interfere or prevent everyday life functions but do not 
constitute a substantial disruption.
•
Is an important medical event. An important medical event is an event that may not 
result in death, be life-threatening, or require hospitalization but may be considered 
an SAE when, based upon appropriate medical judgment, it may jeopardize the 
subject and may require medical or surgical intervention to prevent one of the 

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outcomes listed in the definitions for SAEs. Examples of such medical events include 
allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in subject hospitalization, or 
the development of drug dependency or drug abuse.
All available information on a serious adverse event(s) and any other associated AE, 
if applicable, must be forwarded to the study coordinator for forwarding to the 
Medical Monitor immediately (i.e., within one working day of the Investigator’s or 
site’s knowledge of the event) as follows:
o
In studies utilizing EDC (electronic data capture), all available information for
the SAE and any associated AE(s) must be entered immediately into the EDC 
system.
o
Additional information for any applicable event is to be reported as soon as it 
becomes available.
In addition to the reporting of serious adverse events to the study Medical Monitor, the 
SAE must be reported to the IRB / IEC according to their requirements.
The investigator must document all adverse device events (serious and nonserious but 
related) and all serious adverse events (related and unrelated) on the Adverse Device 
Effect and Serious Adverse Event Form. Any device quality complaints will also be 
documented.
•
Both the Quality Complaint Form and the Adverse Device Effect and Serious
Adverse Event Form must be e-mailed immediately to the study coordinator.
•
Additional relevant information is to be reported as soon as it becomes 
available.
Study coordinator contact information is provided below.
Table 13.3.-1:
Contact Information for the Study
Study Staff
Business
Phone
e-mail
24-hour
Office Phone
Melissa Hamann
Wright
713-580-2500
ext. 2389
Melissa.Wright@manneye.com
832-368-0117
Further, depending upon the nature of the adverse event (serious or nonserious) or quality
complaint being reported, the study sponsor may request copies of applicable portions of 
the subject’s medical records.  The investigator must also report all adverse events and 
quality complaints according to the relevant IRB requirements.

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12.3.1 Intensity and Causality Assessments
For every adverse event and quality complaint, the investigator must assess the 
causality as Related or Not Related to the medical device under investigation. An 
assessment of causality will also be performed by the Medical Monitor utilizing 
the same definitions, as shown below:
Causality
Related
An adverse event or quality complaint classified as related may be 
either definitely related or possibly related where a direct cause 
and effect relationship with the medical device has not been 
demonstrated, but there is a reasonable possibility that the adverse 
event or quality complaint was caused by the medical device.
Not Related
An adverse event or quality complaint classified as not related may
either be definitely unrelated or simply unlikely to be related (i.e., 
there are other more likely causes for the adverse event or quality 
complaint).
Where appropriate, the investigator must assess the intensity (severity) of the 
adverse event as mild, moderate, or severe based on medical judgment with 
consideration of any subjective symptom(s), as defined below:
Intensity (Severity)
Mild
An adverse event is mild if the subject is aware of but can easily 
tolerate the sign or symptom.
Moderate
An adverse event is moderate if the sign or symptom results in 
discomfort significant enough to cause interference with the 
subject’s usual activities.
Severe
An adverse event is severe if the sign or symptom is incapacitating 
and results in the subject’s inability to work or engage in their 
usual activities.
The investigator must document any action taken (i.e., medication, intervention, 
or treatment plan) and outcome of the adverse event or quality complaint when 
applicable.
13.4. Follow-Up of Adverse Events and Quality Complaints
The investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures 
are maintained after the study.  Any additional data from these follow-up procedures 
must be documented and available to the study coordinator who, with the Medical 
Monitor, will determine when the data need to be documented on the CRFs.

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13.5. Safety Analyses
The type, severity, duration and frequency of reported ocular adverse events will be 
tabulated.  Adverse events will also be summarized for events that were considered 
treatment-related.
14. GCP, ICH and ETHICAL CONSIDERATIONS
This study will be conducted in compliance with Good Clinical Practices (GCPs), 
including International Harmonization (ICH) Guidelines, and in general, consistent with 
the 1996 version of the Declaration of Helsinki.  In addition, all applicable local, state 
and federal requirements will be adhered to.
This study is to be conducted in accordance with Institutional Review Board regulations.
The investigator will obtain appropriate IRB/ethics committee approval prior to initiating 
the study.
The study will be registered with clinicaltrials.gov.
14.1 Confidentiality
The data collected will be data typical for the procedure(s) when performed on eyes 
outside the study. Any data collected will become part of the patient’s clinical record. 
The data will be subject to the same privacy and confidentiality as other data in the 
clinical record.
Only the principal investigator, research consultant and clinic staff will have access to the
data collected. All data shared outside the practice will be de-identified; patients’ 
protected health information will not be available and will not be reported in any analyses
or publications. No data will be sold to third parties. De-identified data may be used for 
future research.
15.  STANDARD EVALUATION PROCEDURES
Table 15.1. Proposed Visits and Study Assessments
Activity
Visit 1
Informed Consent
X
Demographics
X
General Information: Medical History
X
Uncorrected photopic and mesopic distance VA (6m, monocular and binocular)
X
Uncorrected photopic and mesopic intermediate VA (66cm, monocular and binocular)
X
Uncorrected photopic and mesopic near VA (40cm, monocular and binocular)
X
Uncorrected photopic and mesopic near VA (33cm, monocular and binocular)
X
Distance corrected photopic and mesopic distance VA (6m, monocular and binocular)
X
Distance corrected photopic and mesopic intermediate VA (66cm, monocular and binocular)
X
Distance corrected photopic and mesopic near VA (40cm, monocular and binocular)
X
Distance corrected photopic and mesopic near VA (33cm, monocular and binocular)
X
AIOLIS
X
OSDI
X

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iTrace
X
Monitor for Adverse Events and Device Deficiencies
X
Complete Exit Form1
X
1 Complete Exit Form upon termination of subject participation, or at the final visit, whichever occurs first.
16. DATA CONFIDENTIALITY
No protected health information (PHI), including the patient’s name and date of birth, 
will be collected; to ensure this, no PHI information is permitted to be entered on any of 
the Case Report Forms (CRFs). Subjects will only be identified by subject IDs and 
identities will be removed at the initial visit so that there is no further need to protect or 
destroy the information. Collected information will only be used for purposes of this 
study and no information will be sold to third parties. The non-PHI information collected 
may be used for future research, though there is currently no plan to do so.
17. FINANCIAL AND INSURANCE INFORMATION/STUDY RELATED 
INJURIES
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 
Doctor’s instructions and the study requirements, the patient will be instructed to contact 
his or her doctor immediately. The Study Doctor is to treat the injured subject as needed 
for those injuries caused directly by this research study. In the event of injury or illness 
caused by or occurring during a subject’s participation in this research study, all charges 
for medical care provided to the subject will be billed to his or her insurance company. 
The Study Doctor or Sponsor does not offer to cover the medical care costs for injuries or
illnesses that are not caused directly by the research study. The Sponsor does not offer to 
provide any other compensation, unless specifically agreed to elsewhere in this 
document. This information will be provided to each study subject before the start of the 
study in the consent form.
18. STUDY ENDPOINT CRITERIA
18.1. Patient Completion of Study
If a study patient has completed the final visit of the study, he/she is considered to have 
completed the study.
 18.2. 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.
 18.3. 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 

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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.
18.4. 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.
18.5. Study Completion
The study will be complete when all enrolled patients have completed their visit or have 
been terminated from the study.
19. SUMMARY OF RISKS AND BENEFITS
19.1. Summary of risks
The risks with this study are similar to those for any patient receiving care following 
cataract surgery and IOL implantation. There is no increased risk associated with the 
proposed study.
19.2. Summary of benefits
Subjects may be compensated up to $200 for completing the study.
REFERENCES
1.
Daya S, Espinosa Lagana M. Visual and Refractive Outcomes of a New 
Hydrophobic Trifocal Toric Intraocular Lens. Clin Ophthalmol. 2024;18:997-
1007.
2.
Gundersen KG. Rotational stability and visual performance 3 months after 
bilateral implantation of a new toric extended range of vision intraocular lens. 
Clin Ophthalmol. 2018;12:1269-1278.
3.
Newsom TH, Potvin R. Evaluation of quality of vision and visual outcomes with 
bilateral implantation of a non-diffractive extended vision intraocular lens with a 
target of slight myopia in the non-dominant eye. Clinical Ophthalmology. 
2022;Volume 16:183-190.