An Evaluation of the LFR-260 Against a Traditional Phoropter in Visual Acuity Testing
Phase: NA
Conditions: Visual Acuity, Astigmatism, Anisometropia
Sponsor: Evolution Optiks Limited

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LFR-260 Investigational Plan_v1.0_18-Feb-2022 
 
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An evaluation of the LFR-260 against a traditional phoropter in visual acuity testing 
 
 
Version:   
 
 
1.0 
 
Version Date:  
 
18-Feb-2022 
 
Investigational Product: 
LFR-260 
 
Protocol Number: 
 
LFR-260-2021 
 
 
 
 
Sponsor: 
 
 
Evolution Optiks Limited  
 
 
 
 
Contact: 
 
 
Jennifer Mercuri, MS 
jennifermercuri@emergentclinical.com  
 
 
 
 
 
Confidentiality Statement 
 
The information provided in this document is strictly confidential and is available for review to 
investigators, potential investigators, FDA and appropriate Ethics Committees or Investigational 
Review Boards.  No disclosure should take place without written authorization from Sponsor, 
except to the extent necessary to obtain informed consent from potential subjects. 
 
This document has been developed in accordance with the guidelines for conducting industry 
sponsored the US Food and Drug Administration trials including the Declaration of Helsinki, the 
Code of Federal Regulations 21 CFR Part 50- Protection of Human Subjects, 21 CFR Part 54- 
Financial Disclosure, 21 CFR Part 56- Institutional Review Boards, 21 CFR 812 as well as 
international standards such as ICH E6 (R2) Good Clinical Practice: Consolidated Guidance. 
 

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LFR-260 Investigational Plan_v1.0_18-Feb-2022 
 
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Version History  
 
Version # 
Version Date 
Significant Changes from Previous Version 
Version 1 
18-Feb-2022 
• Original Protocol Version 

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LFR-260 Investigational Plan_v1.0_18-Feb-2022 
 
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Table 1: Abbreviations 
ADE 
Adverse device effect 
AE 
Adverse event 
BCVA 
Best Corrected Visual Acuity 
CFR 
Code of federal regulations 
CRF 
Case report form 
ECP 
Eye Care Professional 
EDC 
Electronic data capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IRB 
Institutional Review Board 
IWRS 
Interactive web response system 
LAR 
Legally Authorized Representative 
MRSE 
Manifest Refractive Spherical Equivalent 
PHI 
Protected health information 
SAP 
Statistical analysis plan 
SAE 
Serious adverse event 
SCA 
Sphere, Cylinder, Axis 
SOC 
Standard of care 
UADE 
Unanticipated adverse device effect 
VA 
Visual acuity 
 
Table 2 Definitions of conditions and materials 
Astigmatism 
a refractive problem with the eye related to the shape of the lens, which 
causes blurry vision 
Hyperopia 
farsightedness 
Myopia 
nearsightedness 
Presbyopia 
a condition related to aging that causes lens of the eye to have trouble 
focusing 
Phoropter 
Device to perform traditional refraction eye examination 
 
 

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TABLE OF CONTENTS  
 
 
1.0 
Introduction ..................................................................................................................... 13 
1.1 
Background and Significance ............................................................................... 13 
1.2 
Device Name and Intended Use ............................................................................ 13 
1.3 
Regulatory Status and Clinical Data ..................................................................... 13 
2.0 
Objectives and Study Endpoints ................................................................................... 13 
2.1 
Objective ............................................................................................................... 13 
2.2 
Rationale ............................................................................................................... 14 
2.3 
Primary Endpoints ................................................................................................ 14 
2.4 
Secondary outcomes ............................................................................................. 14 
2.4.1 Secondary Endpoints ................................................................................ 14 
2.5 
Hypotheses ............................................................................................................ 14 
2.5.1 Primary Effectiveness Hypothesis ............................................................ 14 
3.0 
Subject Selection ............................................................................................................. 15 
3.1 
Number of Sites / Investigators ............................................................................. 15 
3.2 
Number of Subjects ............................................................................................... 15 
3.3 
Study Arms ........................................................................................................... 15 
3.4 
Inclusion criteria ................................................................................................... 15 
3.5 
Exclusion criteria .................................................................................................. 16 
4.0 
Study Overview ............................................................................................................... 16 
4.1 
Study Design ......................................................................................................... 16 
4.2 
Investigational group ............................................................................................ 17 
4.3 
Control group ........................................................................................................ 18 
4.4 
Visual Acuity Testing Procedure .......................................................................... 18 
4.5 
Test sequence ........................................................................................................ 19 
4.6 
Letter scores calculation ....................................................................................... 19 
4.7 
Subject Screening and Recruitment ...................................................................... 19 
4.8 
Randomization ...................................................................................................... 20 
4.9 
Visit Summary ...................................................................................................... 20 
4.9.1 Screening/Initial Assessment .................................................................... 20 
4.9.2 Precision Tests .......................................................................................... 21 
4.9.3 Offsite Testing .......................................................................................... 22 
4.9.4 Remote Testing ......................................................................................... 22 
4.9.5 Subject Discontinuation or Withdrawal .................................................... 22 
4.10 
Study Duration ...................................................................................................... 23 
4.11 
Clinical and Functional Assessments .................................................................... 23 
4.12 
Prior, Concomitant, and Excluded Therapy .......................................................... 23 
5.0 
Safety Evaluation ............................................................................................................ 23 
5.1 
Serious Adverse Event Parameters ....................................................................... 24 
5.2 
AE / SAE Recording and Reporting ..................................................................... 24 
6.0 
Clinical Supplies .............................................................................................................. 25 
6.1 
Receiving, Storage, Dispensing and Return of Investigational Product ............... 25 
6.1.1 Receipt and Accountability ....................................................................... 25 
6.1.2 Storage and Return or Destruction of Investigational Product ................. 25 
6.1.3 Dispensing of Investigational Device ....................................................... 25 

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7.0 
Statistical Analysis .......................................................................................................... 26 
7.1 
Study Design and Randomization ......................................................................... 26 
7.2 
Analysis Sets ......................................................................................................... 26 
7.2.1 Intent-to-Treat (ITT) ................................................................................. 26 
7.2.2 Full Analysis Set (FAS) ............................................................................ 26 
7.2.3 Per Protocol ............................................................................................... 26 
7.3 
Primary Effectiveness Endpoint ........................................................................... 26 
7.4 
Primary Effectiveness Hypothesis ........................................................................ 26 
7.5 
Sample Size Determination ................................................................................... 27 
7.6 
Testing of Primary Effectiveness Hypothesis ....................................................... 27 
7.7 
Other Planned Analyses ........................................................................................ 27 
7.7.1 Bland-Altman Agreement Analysis .......................................................... 27 
7.7.2 Poolability and Homogeneity of Treatment Effects ................................. 27 
7.7.3 Poolability and Homogeneity of Treatment Effects ................................. 28 
7.7.4 Reliability and Repeatability Analysis ...................................................... 28 
8.0 
Risk Analysis ................................................................................................................... 28 
9.0 
Investigator Selection and Regulatory Assessment ..................................................... 29 
9.1 
Investigator Responsibilities ................................................................................. 29 
9.2 
Institutional Review Board Approval ................................................................... 29 
9.3 
Investigator’s Agreement ...................................................................................... 29 
9.4 
Regulatory documentation and Assessment of Facilities ..................................... 29 
9.5 
Informed Consent .................................................................................................. 30 
9.6 
Subject Stipends .................................................................................................... 31 
9.7 
Confidentiality of Data ......................................................................................... 31 
9.8 
Amendments to Protocol ....................................................................................... 31 
9.9 
Protocol Adherence ............................................................................................... 32 
9.10 
Change in Investigator .......................................................................................... 32 
9.11 
Records Retention ................................................................................................. 32 

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PROTOCOL SIGNATURE PAGE 
 
The signature below constitutes the approval of this protocol entitled “An evaluation of the 
LFR-260 against a traditional phoropter in visual acuity testing”, and provides the necessary 
assurances that this trial will be conducted in compliance of all stipulations of the protocol, 
including all statements regarding confidentiality, and according to local legal and regulatory 
requirements, the Food and Drug Administration, International Conference on Harmonization 
Good Clinical Practice E6 R2 (ICH-GCP), and applicable US regulatory requirements. 
 
 
 
___________________________________________________ 
Investigator’s Printed Name 
 
 
___________________________________________________       _________________ 
Investigator’s Signature 
 
 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY SYNOPSIS 
 
Title 
An evaluation of the LFR-260 against a traditional phoropter in 
visual acuity testing 
Protocol Number 
LFR-260-101 
Study Design 
2x2 Crossover  
Number of Study Sites 
2 sites, 3 locations 
Number of Subjects 
Up to 108 subjects (216 eyes) 
Study Population 
Healthy volunteers 
Investigational Device 
LFR-260 in a standard visual acuity test 
Comparator Device 
Any 510(k) exempt phoropter legally marketed in the US 
(Refractor, Manual, Non-Powered, Including Phoropter) 
Study Objective 
To evaluate the agreement of LFR-260 (investigational device) to 
traditional phoropter (comparator device) when applied in visual 
acuity test in subjects undergoing a full routine eye examination. 
Study Endpoints 
The primary effectiveness endpoint is to demonstrate that the 
LFR-260 is within 0.5D (+/-) in measuring sphere and cylinder 
results and within 10 degrees for axis results among subjects with 
low astigmatism and within 5 degrees among subjects with moderate 
to high astigmatism from the traditional phoropter in a very large 
proportion of subjects. 
 
 
 

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Statistical 
Considerations 
The objective of the statistical analysis is to evaluate agreement in 
sphere, cylinder,  and axis measurements between LFR-260 and 
traditional refraction performed by a traditional phoropter.  
Specifically, the subjective manifest refraction measured by means 
of a traditional phoropter will serve as the reference control and is 
considered to be the gold standard for the purpose of this evaluation. 
 
The accuracy of the acuity measurement obtained by the LFR-260 
will be evaluated for both cases (uncorrected, corrected) measured 
with the conventional phoropter. It will be assessed comparing the 
LFR-260 acuity measurement to the conventional acuity 
measurement using a Snellen chart (scored to the letter), with similar 
analyses used for the refractive components. 
 
For each measurement, the paired difference will be computed.  
Good clinical agreement is defined a priori as ≤±0.5 D for sphere 
and cylinder measurements and ≤±10 degrees for axis measurements 
for subjects with low astigmatism and ≤±5 degrees for axis 
measurements for subjects with low astigmatism. 
  
The unit of analysis will be the individual eye.  Overall device 
performance will be summarized as the number of and percentage of 
eyes meeting three of the good clinical agreement criteria listed 
above.   
 
 
The relationship between bias and 
the mean of measurements will characterized.   
 
A supporting analysis will evaluate the vector difference between 
investigational device measurements and the gold standard in terms 
of sphere and cylinder measurements.  The vector differences is 
square root of (X1-Y1) + (X2-Y2) where the X1 and X2 are 
measurements of sphere and cylinder using the investigational 
devices and Y1 and Y2 are the same measurements using the gold 
standard.   

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Homogeneity of treatment effects across sites will be evaluated 
comparing site level differences between the investigational device and 
the gold standard separately for sphere, cylinder, and axis and also for 
the vector analysis of sphere and cylinder.  
 
Similarly, differences between measurements from the investigational 
device and the gold standard device will be summarized by gender, age 
category, race, and ethnicity to investigate consistency or heterogeneity 
of the treatment effect across those subgroups, separately for sphere, 
cylinder, and axis and also for the vector analysis of sphere and 
cylinder. 
 
The primary analysis will be based on the intent-to-treat (ITT) analysis 
set and will use multiple imputation to address missing values.  The 
multiple imputation (MI) model will include  sphere, cylinder, and 
axis measurements for both the investigational device and the gold 
standard device and baseline characteristics including age and 
gender. Analyses will be repeated in a per protocol analysis set that 
includes eyes with complete data.  
  
 
Reliability (repeatability and reproducibility) of LFR-260 will be 
conducted in a subset of subjects for which measurements will be 
obtained twice in an office context.   This analysis will be repeated 
in a remote context. Reliability will be evaluated using intraclass 
correlations for each of the continuous measurements, sphere, 
cylinder, and axis.  
. 
 
 
 

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Study Criteria 
Inclusion Criteria 
Participants must fulfill all of the following criteria in order to be 
eligible for the study: 
1. The participant or legal guardian is willing and able to 
understand, sign and date the Ethics committee approved 
study specific Informed Consent Form.  
2. The participant is a male or female between the ages of 12 
and 65 (inclusive). 
3. The participant has a history of the following: 
o No more than mild to moderate far-sightedness or 
near-sightedness (i.e. Spherical equivalent refraction 
(SER) between +10 to -15). 
o an astigmatism of 2.5D or less. 
o an anisometropia of 1.5D or less. 
4. The participant is free of ocular and systemic abnormalities 
that might affect visual functions. 
 
Exclusion Criteria 
Participants will be excluded from participation in the study if any of 
the following criteria are met at screening: 
1. The participant has diabetes mellitus (Type 1 or 2). 
2. The participant has an autoimmune condition. 
3. The participant is pregnant (self-reported). 
4. The participant has an active corneal or conjunctival 
infection. 
5. The participant has an active corneal, conjunctival, or 
intraocular inflammation (i.e. - uveitis). 
6. The participant has diabetic retinopathy. 
7. The participant has glaucoma or ocular hypertension. 
8. The participant has macular degeneration. 
9. The participant has had a previous ocular surgery. 
10. The participant has ocular and systemic diseases or 
abnormalities that might affect visual functions. 
11. The participant has a history of amblyopia, strabismus, or 
any other binocular vision abnormality. 
12. The participant has a history of AMD (age macular 
degeneration).  

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13. The participant is a prisoner, a transient or has been treated 
for alcohol and/or drug abuse in an inpatient substance abuse 
program within 6 months prior to proposed study enrolment. 
14. The participant will not be able to complete questionnaires. 
15. The participant is currently in an investigational study for a 
similar purpose. 
16. The participant, in the judgment of the Investigator, may be 
inappropriate for the intended study procedures. 

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STUDY FLOWCHART AND FOLLOW-UP ASSESSMENTS 
 
 
Study Procedure 
Screening and 
Initial 
Assessment  
Repeatability 
Testing  
+1 hour (+/- 30 mins) 
Reproducibility 
Testing 
Offsite Testing 
Remote Testing 
 
Subset of LFR-260 
(n=33) 
Subset of LFR-260 
(n=33) 
Subset of LFR-260 
(n=21) 
Subset of LFR-260 
(n=21) 
Informed Consent / Assent (where applicable) 
X 
 
 
 
 
Relevant Medical History 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Subject Eligibility Verification 
X 
 
 
 
 
Prior Medications  
X 
 
 
 
 
Randomization 
X 
 
 
 
 
Baseline Visual Acuity  - Device #1 
X 
 
 
 
 
Refraction (including retinoscopy) - Device #1 
X 
 
 
 
 
Best Corrected Visual Acuity - Device #1 
X 
 
 
 
 
Baseline Visual Acuity  - Device #2 
X 
 
 
 
 
Refraction (including retinoscopy) - Device #2 
X 
 
 
 
 
Best Corrected Visual Acuity - Device #2 
X 
 
 
 
 
Repeatability 
Refraction 
(including 
retinoscopy) – LFR-260 only with same ECP 
 
X 
 
 
 
 
 
Reproducibility 
Refraction 
(including 
retinoscopy) – LFR-260 only with 2nd ECP 
 
 
 
X 
 
 
Offsite Refraction (including retinoscopy) –  
LFR-260 only in offsite location 
 
 
 
 
X 
 
Remote Refraction (including retinoscopy) – 
LFR-260 only 
 
 
 
 
X 
Additional Best Corrected Visual Acuity – 
LFR-260 only 
 
X 
X 
X 
X 
End of Study  
X 
X 
X 
X 
X 

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1.0 
Introduction 
1.1 
Background and Significance 
The LFR-260 was designed by comparing its capabilities against an optical bench and physical 
lenses. Further, it has been tested for quality of image composition and correctness at all the points 
on the spectrum of settings that we intend to cover. 
 
1.2 
Device Name and Intended Use 
The LFR-260 is intended to be used for distance vision testing in any environment, may it be in 
optometric clinics or in the field outside of the clinic, because of its compact form factor and 
portability.  
 
The LFR-260 is an application-controlled instrument providing capabilities for distance vision 
testing including sphere, cylinder, and axis. The visual acuity and eye subjective manifest 
refraction determination will always be administered by an eye care professional (ECP) licensed 
and registered by the appropriated body in the region intended to be used. The instrument is 
designed in a way that it will only work with approved personnel and the use of secure credentials. 
 
The device is intended to be used in patients aged from 12-65 years old with healthy visual systems 
and a refractive error no bigger than (+10 to -15D) and astigmatism no bigger than 2.5D (if any). 
 
1.3 
Regulatory Status and Clinical Data 
The LFR-260 has not been cleared for use outside of this investigation.  
2.0 
Objectives and Study Endpoints 
2.1 
Objective 
The aim of this trial is to establish if LFR-260 (investigational device) is in agreement with a 
gold standard in effectiveness to a traditional phoropter (control device) when applied in visual 
acuity test in subjects undergoing a full routine eye examination.  This will be demonstrated by 
measuring that the LFR-260 is within 0.5D (+/-) in sphere and cylinder results and within 10 
degrees for axis results from the traditional phoropter measurements. 
 

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2.2 
Rationale 
The purpose of this test is to evaluate the agreement to a gold standard of the refraction results 
provided by LFR-260 compared to a traditional refraction assessment conducted using a traditional 
phoropter (commonly used at optometry offices as the standard device used for measuring 
refraction). 
 
Refraction test is part of a routine eye examination and from now on we will use the terms 
refraction test and vision test indistinctly. We propose the use of LFR-260 to provide information 
of the visual capabilities of the patient. The test will be provided and supervised by a qualified 
ECP appropriately registered and licensed in the region where the test. 
 
2.3 
Primary Endpoints 
The primary effectiveness endpoint is to demonstrate that the LFR-260 is within 0.5D (+/-) in 
measuring sphere and cylinder results and within 10 degrees for axis results from the traditional 
phoropter.  Precision testing will also be conducted to confirm repeatability and reproducibility of 
the LFR-260. 
 
2.4 
Secondary outcomes 
2.4.1 
Secondary Endpoints 
o Patient satisfaction with LFR-260 device Quad view 
o Eyecare provider satisfaction with LFR-260 related to usability, convenience 
 
 
2.5 
Hypotheses 
2.5.1 
Primary Effectiveness Hypothesis 
 
The primary hypothesis for this study is that the probability of simultaneously achieving 
good clinical agreement for sphere, cylinder, and axis exceeds a performance goal (PG) for 
measurements made by the LFR-260 compared to those obtained using traditional 
phoropter.  The a priori PG is 0.80.  Good clinical agreement is defined as a sphere and 
cylinder measurements that are within +/- 0.5 D and  within 10 degrees for axis among 
subjects with low astigmatism and within 5 degrees among subjects with moderate to high 
astigmatism. 

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3.0 
Subject Selection 
3.1 
Number of Sites / Investigators 
Investigators responsible for the conduct of this study in compliance with this protocol will be 
qualified ECPs (licensed optometrist or ophthalmologist) who are skilled in refraction testing via 
a traditional phoropter.  Two (2) sites at 3 locations (one site has multiple satellite locations) in the 
United States will be selected for participation in this study.  Each location will have 2 ECPs 
available for testing/evaluation for a total of 6 different ECPs for the study. 
 
3.2 
Number of Subjects 
Accounting for lost to follow-up, a total of up to 108 subjects (216 eyes) will be enrolled in the 
study. To control any effect of the instrument induced myopia, we expect to enroll an age tiered 
distribution of participants of the following approximate percentages: 
• Approximately 45% Pediatrics (age from 12 until ≤21 years) 
• Approximately 55% Adults/Geriatrics (age between 22-65) 
 
A large portion of the subjects belongs to pediatric population such distribution will address the 
presence or absence of induced instrument myopia.  
 
3.3 
Study Arms 
All subjects will be randomized by treatment order to the following refractor testing methods: 
• Group I: LFR-260 
• Group II: Traditional Phoropter 
 
3.4 
Inclusion criteria 
Participants must fulfill all of the following criteria in order to be eligible for the study: 
1. The participant or legal guardian is willing and able to understand, sign and date the Ethics 
committee approved study specific Informed Consent Form.  
2. The participant is a male or female between the ages of 12 and 65 (inclusive). 
3. The participant has a history of the following: 
o No more than mild to moderate far-sightedness or near-sightedness (i.e. Spherical 
equivalent refraction (SER) between +10 to -15). 
o an astigmatism of 2.5D or less. 
o an anisometropia of 1.5D or less. 
4. The participant is free of ocular and systemic abnormalities that might affect visual 
functions. 
 

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3.5 
Exclusion criteria 
Participants will be excluded from participation in the study if any of the following criteria are met 
at screening: 
1. The participant has diabetes mellitus (Type 1 or 2). 
2. The participant has an autoimmune condition. 
3. The participant is pregnant (self-reported). 
4. The participant has an active corneal or conjunctival infection. 
5. The participant has an active corneal, conjunctival, or intraocular inflammation (i.e. - 
uveitis). 
6. The participant has diabetic retinopathy. 
7. The participant has glaucoma or ocular hypertension. 
8. The participant has macular degeneration. 
9. The participant has had a previous ocular surgery. 
10. The participant has ocular and systemic diseases or abnormalities that might affect visual 
functions. 
11. The participant has a history of amblyopia, strabismus, or any other binocular vision 
abnormality. 
12. The participant has a history of AMD (age macular degeneration).  
13. The participant is a prisoner, a transient or has been treated for alcohol and/or drug abuse 
in an inpatient substance abuse program within 6 months prior to proposed study 
enrolment. 
14. The participant will not be able to complete questionnaires. 
15. The participant is currently in an investigational study for a similar purpose. 
16. The participant, in the judgment of the Investigator, may be inappropriate for the intended 
study procedures. 
 
4.0 
Study Overview 
4.1 
Study Design 
This study is organized as multicenter, randomized cross-over study trial.  There are two groups 
involved in the trial, the investigational group and the active control group.  The comparison with 
a placebo group is not part of the trial for ethical reasons.  
 

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4.2 
Investigational group 
The LFR-260 is a portable digital refractor which allows for determination of refractive error as 
well as for fully remote refractions while social distancing. The device offers a solution that 
embodies all the aspects that are typically associated with a refraction evaluation in a mobile 
approach while giving the practitioner full control, ease of use and patient comfort. 
 
 
Figure 1: Image of the LFR-260 
A standard phoropter on the market is comprised of a set of lenses which can be adjusted by an 
ECP to guide a patient through different settings as in "do you see better now?" format. In contrast, 
the objective device, LFR-260, achieves the same functionality but relies on a digital approach 
based on a micro lens array, a high-density embedded display, and a tunable lens. The device was 
developed taking a different approach that allows a significant reduction in the number of lenses, 
allowing higher portability and smaller footprint. The lower number of lenses does not 
compromise functionality compared to other traditional solutions. With these components, the 
LFR-260 provides the same capabilities as traditional lens systems, however in a portable, 
lightweight format.  
The instrument will be able to perform traditional refractive tests with the standard optotypes 
(Snellen, ETDRS, Landolt C, LEA symbols) such as: 
• Determining the required spherical correction 

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• Determining the required astigmatic correction measuring with JCC (Jackson 
cross-cylinder) – magnitude and direction. 
 
4.3 
Control group 
The control group is a traditional refraction performed by a phoropter. The results for both 
refractions will be recorded separating the components Sphere (S), Cylinder (C) and Axis (A). A 
calculation of the spherical equivalent will be performed at the end of the visit and both values will 
be recorded in the study documentation. The best corrected visual acuity for each measurement 
will be recorded. 
 
4.4 
Visual Acuity Testing Procedure 
All the subjects will undergo the standard visual acuity testing using both the LFR-260 and the 
traditional phoropter. Both eyes will be tested, always starting with the right eye. Both eyes will 
be tested with a traditional phoropter and the LFR-260. The subject will be seated on a height 
adjustable chair to ensure comfort during the test. Once the subject is seating comfortably the 
examiner will measure the distance between the outer canthus of the eye and the visual acuity to 
be used. The left eye will be patched while testing the right eye and vice versa. They could be 
covered with the occlude or using the masking capabilities of the LFR-260. 
 
The following outcomes will be measured (for both eyes):  
• Unaided VA 
• Aided VA 
• Distance for the test 
 
Evaluation of the refractive state should be performed by reading the Snellen chart (or equivalent 
depending on the patient) at 20 feet (or adjusted to the appropriate distance depending on the 
dimensions of the actual optometric office). The subject should be informed that the chart only 
includes letters (or equivalent for patient population). 
 
Outcomes will be recorded. If a line was incomplete, the scored letters should be added to the VA. 
The goal is to obtain best corrected visual acuity (20/20 Snellen) to ensure that the highest level of 
visual acuity possible for the patient. 
 
Visual acuity testing will be performed without the use of cycloplegic agents and or pupil dilation 
at all times. To control the potential effect of instrument myopia we will propose starting the 
examination using the fogging method to relax any potential accommodation.  
 

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4.5 
Test sequence 
In the traditional refractor procedure of Snellen charts (or equivalent), if the patient cannot see a 
letter, the practitioner moves the patient closer to the chart 1m at the time. In the case of LFR-260, 
the letter sizes will adjust to simulate such movement and change of perceived size and recorded 
accordingly. Such adjustment should take place until the subject can see the top letters. The 
smallest letter the subject can see clearly would be considered the VA for distance. 
 
Actual test sequence: 
a) Screening phase: In which the examiner will initially determine by single letter 
presentations what would be the smallest Snellen chart (or equivalent) level at which the 
subject will correctly identify letters. 
b) Testing phase: the examiner will start presenting letters of the size determined at the 
screening phase and smaller ones. 
c) Test continuation: if a letter is missed at a level, one level larger will be added to the testing. 
If a letter is correct at a level, one level smaller will be added to the mix. 
d) Acuity determination: Tests of 5 letters at each level until smallest level with 5/5 letters 
correct and the smallest level with 0/5 correct are determined. 
e) Quad view: at any time during a refraction, the ECP may provide a patient with a “quad 
view”.  This mode shows four different prescriptions simultaneously and allows the patient 
to switch from a memory-based decision to a solely vision-based decision. 
 
4.6 
Letter scores calculation 
With the lens correction obtained and present either on the phoropter or the LFR-260, the subject 
will be asked to read the Snellen chart (or equivalent) emphasizing that each letter will be scored 
and will ask the subject to take their time in answering in order to achieve best identification. The 
examiner will record each letter identified correctly on a score sheet. If a letter is not correctly 
recognized it will not be recorded, each correct letter is a point. The score of each line, even if 
zero, and the total score for the eye will be recorded right after the examination and recorded in 
the patient chart and the case report form.  
 
4.7 
Subject Screening and Recruitment 
A study coordinator (e.g. research nurse or staff member) designated specifically for this study, 
investigator, or sub-investigator at each investigative site will approach each potential subject and 
inquire about their interest and eligibility in participating in this study. If the patient wishes to 
participate, a member of the research team will go through the informed consent / assent (where 
applicable) process, which will explain the purpose of the study, the procedures, the risk/benefits, 
alternatives to participation, and their confidentiality.  After the consent process, the subject will 
be screened to confirm eligibility. 

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At the baseline visit, each subject choosing to participate will sign and date an informed consent 
and HIPAA authorization / assent (where applicable).  A copy of the consent and authorization 
will be placed into the subject’s medical record.   
Study guidelines, aimed at helping guide the subject in their follow-up responsibilities, will include 
a subject information worksheet and site contact information for advice in case of complications 
or questions regarding follow-up visits.  
 
4.8 
Randomization 
The randomization will be performed between the LFR-260 and the traditional phoropter within 
site to account for the first system used. Randomization will be carried out according to the blocks 
procedure to avoid order imbalance of first device used in the trial.   
4.9 
Visit Summary  
4.9.1 
Screening/Initial Assessment  
The procedures to be completed at Visit 1 are as follows: 
• Screening: Talk to the patient to determine if he/she would fit study requirements, and 
assess likelihood of meeting enrollment criteria. 
• Informed Consent / Assent: Obtain subject informed consent or assent for minors.  Allow 
subject or their legally authorized representative (LAR) sufficient time to thoroughly read 
and understand the consent form and answer any questions he/she may have about the 
study.  If subject provides informed consent, complete the subject enrollment log. 
• Inclusion Criteria: Ensure subject meets all inclusion criteria. 
• Exclusion Criteria: Ensure subject does not meet any of the exclusion criteria. 
• Pre-study assessments: Obtain medical history and demographics from subject. 
• Prior medications/therapy: Note any medications or therapy that the subject is currently 
taking. Medications of note include: 
 
 
 
 
 
• Randomization: determine the order of system utilized for testing 
• Device #1 testing including: 
o Baseline Visual Acuity 

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o Refraction (including retinoscopy) 
o Measure Best Corrected Visual Acuity 
• Device #2 testing including: 
o Baseline Visual Acuity 
o Refraction (including retinoscopy) 
o Measure Best Corrected Visual Acuity 
• Patient satisfaction with LFR-260 device Quad view 
• Eyecare provider satisfaction with LFR-260 related to usability, convenience 
*Conclusion of Study: Study coordinator will complete the Study Exit Form, which will indicate 
the conclusion of subject participation in this study. 
*For subjects included in the Precision Tests or Remote Testing (4.9.2 and 4.9.3), Study Exit Form 
to be completed after all testing is completed. 
4.9.2 
Precision Tests 
 
1. Repeatability Testing (+1 hour post initial testing) 
 
In a subset of 33 patients (11 per location), LFR-260 testing will be repeated by the same ECP to 
confirm the initial findings.  One ECP per location will perform Repeatability Testing for a total 
of 3 ECPs included for this testing method. 
 
• ECP will complete Refraction with LFR-260 one hour post initial testing 
• Measure Best Corrected Visual Acuity 
• Conclusion of Study: Study coordinator will complete the Study Exit Form, which will 
indicate the conclusion of subject participation in this study. 
2. Reproducibility Testing  
 
In a separate subset of 33 patients (11 per location), LFR-260 testing will be reproduced by two 
separate ECP operators at each location for a total of 6 ECPs.   
 
If the patient is randomized to Group I, the steps listed below will be completed at the beginning 
of the patient visit.  If the patient is randomized to Group II, the steps listed below will be 
completed after the eye exam with use of the traditional phoropter.   
 
1. ECP #1 will complete Refraction with LFR-260. 
a.  Best Corrected Visual Acuity will be measured. 
2. ECP #1 will leave the room, and ECP #2 will complete Refraction with LFR-260. 
a. Best Corrected Visual Acuity will be measured. 

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3. Conclusion of Study: Study coordinator will complete the Study Exit Form, which will 
indicate the conclusion of subject participation in this study. 
4.9.3 
Offsite Testing 
In a separate subset of 21 patients (7 per location), LFR-260 testing will be completed by the ECP 
operators offsite at each location.   
 
After the initial LFR-260 and traditional phoropter is complete within the clinic, participants in 
the offsite testing cohort will be taken to a non-clinical setting for the following procedure: 
 
1. An additional LFR-260 will be set up in a remote location (room separate from clinic). 
2. The patient will be taken to the remote room, and the ECP will perform the refraction.  
3. Best Corrected Visual Acuity will be measured and collected. 
a. Results will be captured to compare against the initial LFR-260 refraction results. 
 
4.9.4 
Remote Testing 
In a separate subset of 21 patients (7 per location), LFR-260 testing will be completed by the ECP 
operators remotely at each location.   
 
After the initial LFR-260 and traditional phoropter is complete, participants in the remote testing 
cohort will remain in the clinical setting for the following procedure, while the ECP relocates to 
an area outside of the exam room: 
 
1. The patient will be shown the LFR-260 and site staff will oversee the telehealth refraction 
remotely on the LFR-260 by the ECP. 
2. Results for the Best Corrected Visual Acuity will be collected. 
a. Results will be captured to compare against the initial LFR-260 refraction results. 
 
4.9.5 
Subject Discontinuation or Withdrawal 
Subjects may withdraw their consent to participate in the clinical study at any time, for any reason. 
In addition, it may be necessary to terminate a subject from the clinical study due to medical safety 
consideration, non-compliance, or administrative concerns. If for any reason a subject is 
withdrawn or terminated before completing the study, the reasons for withdrawal or termination 
must be documented. If a subject is withdrawn or terminated due to medical safety considerations 
because of an adverse event, the adverse event must be followed by medical attention to 
satisfactory resolution and all study data related to the subject will be reported.  
Subjects who withdraw or are withdrawn prior to completion of the study periods will be scheduled 
a termination visit. At this visit, all study procedures will be completed according to the next 

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scheduled visit per protocol. All pertinent data will be documented in the source documents and 
the CRFs including a Study Exit form  
If the site is notified that a subject plans to withdraw during a study visit, the site will treat the 
current visit like the termination visit by completing the current visit (if able), all applicable source 
documents and the CRFs including the Study Exit CRF.  
4.10 Study Duration 
All subjects will be followed only for the initial visit as no follow-up assessments are expected 
after the initial visual acuity testing is complete.  
  
4.11 Clinical and Functional Assessments 
Subjects will be clinically evaluated by the Investigator or a qualified individual noted on the 
Delegation of Authority (DOA) log.  Clinical and functional assessments will be measured as 
follows: 
• Patient satisfaction with LFR-260 device Quad view 
• Head injury / concussion sub-group assessment (if applicable) 
o Measure any cognitive issues or nauseous experience to refraction. 
 
4.12 Prior, Concomitant, and Excluded Therapy 
All concomitant medications/therapies should be collected starting at Visit 1.  
 
5.0 
Safety Evaluation 
Adverse events are defined as any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other 
persons, whether or not related to the investigational medical device. See section 8.0 for anticipated 
risks during the trial. 
 
All adverse events will be collected and recorded, regardless of whether or not they are believed 
to be related to the device or anticipated. This includes the following:  
• Adverse Device Effect (ADE) – adverse event related to the use of an investigational 
medical device. 
• Serious Adverse Events (SAE) – an adverse event that led to death; led to serious 
deterioration in the health of the subject, that either resulted in: a life-threatening illness or 
injury; a permanent impairment of a body structure or a body function; in-patient or 
prolonged hospitalization; medical or surgical intervention to prevent life-threatening 

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illness or injury or permanent impairment to a body structure or a body function; led to 
fetal distress, fetal death or congenital abnormality/birth defect. 
• Unanticipated Adverse Device Effect (UADE) – any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if 
that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
• 
Device deficiency – inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
 
5.1 
Serious Adverse Event Parameters 
At any point during the clinical investigation, study termination or unblinding may be 
considered based on the frequency or severity of serious adverse device effects or serious 
adverse events. If this occurs, subjects will be notified of the study termination and 
follow-up requirements, as applicable. Every effort will be made to collect data 
regarding the subject disposition following such an event.  
 
5.2 
AE / SAE Recording and Reporting 
Any and all adverse events will be recorded on the Adverse Event Case Report Form.  
Investigators are required by federal regulations, to report all adverse events that occur 
during the course of a study to Evolution Optiks or their designee. All adverse events 
reported on the Case Report Form will be source data verified against the subject record. 
The site is also responsible for reporting adverse events to the governing IRB in 
accordance with the requirements of that IRB.  
 
Serious Adverse Events are to be reported to Evolution Optiks or their designee within 
24 hours of the investigator’s awareness of their occurrence. The Investigator is also 
required to report any UADEs to Evolution Optiks or their designee within 24 hours.  
The Investigator is also responsible for reporting these events to the governing IRB in 
accordance with the requirements of that IRB.  
 
The names and telephone numbers of the contact persons from Evolution Optiks or its 
designated representative are given in the table below: 
 
 
 
 

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SERIOUS ADVERSE EVENT SPONSOR CONTACT INFORMATION 
 
Name/Title 
 
Email 
Office  
Telephone 
Number 
Mobile 
Telephone 
Number 
 
Jennifer Mercuri, MS 
Project Manager 
jennifermercuri@emergentclinical.com 
 
 
 
 
 
 
 
 
 
6.0 
Clinical Supplies 
6.1 
Receiving, Storage, Dispensing and Return of Investigational Product 
6.1.1 
Receipt and Accountability 
It is the responsibility of the Investigator to ensure that all product received at the site are 
inventoried and accounted for throughout the study and recorded in the Product Accountability 
(inventory) log kept in the site study documents.   
 
6.1.2 
Storage and Return or Destruction of Investigational Product 
The Investigator will store the investigational product and dispose of remnants per the Sponsor’s 
instructions.  Unopened product will be returned to the Sponsor.  Product Accountability will be 
recorded in the source documentation and in the Product Accountability log for monitor review 
and reconciliation. 
 
6.1.3 
Dispensing of Investigational Device 
The Investigator will not supply study material to any person except designated staff participating 
in this study. Study material will only be dispensed from the designated investigational site to 
eligible study subjects.  

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7.0 Statistical Analysis  
7.1 
Study Design and Randomization 
The LFR-260-101 study is a multi-center, open-label, 2x2 cross-over design with the aim of 
investigating the effectiveness of the LFR-260 phoropter device compared to the traditional 
phoropter. 
 
7.2 
Analysis Sets 
7.2.1 
Intent-to-Treat (ITT) 
All randomized patients will be included in the intent-to-treat (ITT) analysis set according to the 
group to which they were randomized.  
7.2.2 
Full Analysis Set (FAS) 
The Full Analysis Set (FAS) analysis set will be defined similarly to the ITT analysis set except 
that patients will be analyzed according to the order of devices actually administered. Primary 
safety analyses will be conducted in the FAS analysis set.  If all ITT patients receive their intended 
device order, the FAS and ITT analysis sets will coincide and will be referred to as the ITT analysis 
set.   
7.2.3 
Per Protocol 
Primary effectiveness analyses may be repeated in a Per Protocol (PP) analysis set.  The PP 
analysis set will exclude from the ITT analysis set patients that had clinically significant violations 
of inclusion or exclusion criteria or post randomization protocol violations that may reasonably be 
predicted to impact on effectiveness endpoints and those that have missing data. 
 
7.3 
Primary Effectiveness Endpoint  
The primary effectiveness endpoint is to demonstrate that the LFR-260 is within 0.5D (+/-) in 
measuring sphere and cylinder results and within 10 degrees for axis results among subjects with 
low astigmatism and within 5 degrees among subjects with moderate to high astigmatism from 
the traditional phoropter in a very large proportion of subjects. 
 
7.4 
Primary Effectiveness Hypothesis  
The primary hypothesis for this study is that the probability of simultaneously achieving good 
clinical agreement for sphere, cylinder, and axis exceeds a performance goal for measurements 
made by the LFR-260 compared to those obtained using the control device, traditional phoropter.  
 
Symbolically, the null and alternative effectiveness hypotheses are: : 
 

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Ho: π ≤ PG 
Ha: π  > PG 
 
Where π is the true probability that the LFR 260 is within 0.5D (+/-) in measuring sphere and 
cylinder results and within 10 degrees for axis results among subjects with low astigmatism and 
within 5 degrees among subjects with moderate to high astigmatism from the traditional 
phoropter. 
 
For this study, PG is set to 0.80.  
 
7.5 
Sample Size Determination 
If the true π is equal to 0.90, then, a 1-sided exact binomial test at alpha=0.05 with 216 eyes (108 
subjects) has 99% power. 
 
7.6 
Testing of Primary Effectiveness Hypothesis 
The lower bound (LB) of a 1-sided exact binomial confidence interval will be determined and 
compared to 0.80.  If LB exceeds 0.80, the device will have met the a priori defined performance 
goal.  
 
7.7 
Other Planned Analyses  
7.7.1 
Bland-Altman Agreement Analysis 
Supporting analyses will evaluate the distribution of paired differences between LFR-260 
and reference for the three dimensions (sphere, cylinder, and axis) using Bland-Altman 
agreement analysis. This will include determination of the standard deviation of paired 
differences, the 95% limits of agreement, and an evaluation of systematic bias.  The 
Bland-Altman plot of paired differences versus the mean of measurements will be 
provided.  The relationship between bias and the mean of measurements will 
characterized.  The same analysis will be applied to the vector difference between LFR-
260 measurements and the gold standard in terms of sphere and cylinder measurements.  
The vector differences is square root of (X1-Y1) + (X2-Y2) where the X1 and X2 are 
measurements of sphere and cylinder using the investigational devices and Y1 and Y2 
are the same measurements using the gold standard.   
7.7.2 
Poolability and Homogeneity of Treatment Effects 
Homogeneity of treatment effects across sites will be evaluated by comparing differences 
between the LFR-260 and the gold standard separately for sphere, cylinder, and axis and 
also for the vector analysis of sphere and cylinder.  
 

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Similarly, differences between measurements from the investigational device and the 
gold standard device will be summarized by gender, age category, race, and ethnicity to 
investigate consistency or heterogeneity of the treatment effect across those subgroups, 
separately for sphere, cylinder, and axis and also for the vector analysis of sphere and 
cylinder. 
7.7.3 
Poolability and Homogeneity of Treatment Effects 
The primary analysis will be based on the ITT analysis set and will use multiple imputation 
to address missing values.  The MI model will include  sphere, cylinder, and axis 
measurements for both the investigational device and the gold standard device and 
baseline characteristics including age and gender. Analyses will be repeated in a per 
protocol analysis set that includes eyes will complete data.  A tipping point analysis will 
be performed to evaluate the robustness of results with regard to the missing-at-random 
(MAR) assumption necessary for the validity of the MI analyses.   
7.7.4 
Reliability and Repeatability Analysis 
Reliability of LFR-260 will be conducted in a subset of subjects for which measurements 
will be obtained twice in an office context.   This analysis will be repeated in a remote 
context. Reliability will be evaluated using intraclass correlations for each of the 
continuous measurements, sphere, cylinder, and axis and for the vector measurement of 
sphere and cylinder.  
 
For a subset of 33 subjects (66 eyes), the LFR-260 device will be measured again 
approximately 60 minutes after the initial assessment in order to measure the 
repeatability/accuracy of the device.   
 
8.0 
Risk Analysis 
The subjects in this study will be exposed to minimal increased potential risk.  The majority of 
procedures in this study correspond to the standard of care procedures.  
 
Trial-specific risks include the risks associated with investigational device (LFR-260) and the risks 
associated with trial-related investigations and data collection. 
 
Clinical investigations performed in this trial include non-invasive diagnostic methods and 
interview questionnaires.  These non-invasive diagnostics represent a minimal risk to the subject.  
 
All adverse events regardless of whether they were investigational device- related will be reported 
and recorded according to current regulations.  See Section 5 for more details. 
 

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9.0 
Investigator Selection and Regulatory Assessment 
9.1 
 Investigator Responsibilities 
Investigators will be identified based on their qualifications to conduct the investigation. Evolution 
Optiks will further assess the qualifications of each Investigator and their staff by conducting a 
review of their CV, checking the status of the Investigator within the FDA Debarment List, 
discussing the availability of the correct subject population at the institution and through a review 
of the clinical space to ensure that the facility has adequate amenities to conduct the study 
according to the protocol. The final determination on an Investigator’s participation will be made 
following review of the above criterion and completion of the Site Qualification/Pre-Study Visit. 
 
9.2 
Institutional Review Board Approval 
Investigators will be responsible for obtaining the initial and continuing review approvals from the 
governing IRB for the institution at which the proposed clinical investigation is to be conducted. 
Written certification of approval, and any conditions of approval imposed by the IRB, will be 
submitted to Evolution Optiks prior to the site’s participation in this investigation.  Investigational 
supplies will not be shipped to participating sites until documentation of IRB approval has been 
provided to Evolution Optiks. 
 
The Investigator and/or his staff is responsible for knowing and complying with any reporting 
requirements stipulated by their governing IRB. 
 
9.3 
Investigator’s Agreement 
Investigators will be advised of their responsibilities as Investigators in a clinical study. 
Investigators will also be advised regarding FDA regulations governing clinical studies under IDE 
regulations, and must abide by record keeping and reporting requirements. This information will 
be provided to the Investigators via the Investigator Agreement, which must be signed by the 
Investigator and returned to Evolution Optiks prior to study participation. 
 
9.4 
Regulatory documentation and Assessment of Facilities 
As part of the study start-up process, the Investigator and their staff will be required to supply 
documentation of their qualifications to participate in the study as well as a Financial Disclosure 
Form. Prior to participation in the study, each Investigator is required to submit the following 
documentation to Evolution Optiks: 
§ A signed Investigator’s Agreement  
§ A current signed and dated curriculum vitae (current within 2 years) 
§ A completed Financial Disclosure questionnaire  

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§ Written approval of the study protocol and associated Informed Consent Form / Assent 
from their governing IRB (This must be provided prior to Investigational product being 
sent to the site or any subjects being enrolled). The Investigator/site is also required to 
submit any information required as part of the approval/renewal process for their 
governing IRB. Reports of any protocol deviations, AEs and Lost-to-Follow-Up 
subjects should also be provided to the IRB according to their stated requirements. 
 
The Site Qualification Visit or Pre-Study Visit enables the Monitor to review the following with 
the Investigator and his staff: clinical protocol, the Investigator’s Brochure, the Investigational 
product(s) provided for the clinical study, Investigator responsibilities, data collection and 
reporting requirements.  
 
Another purpose of this visit is for the monitor to assure that the Investigator: 
§ Has appropriate training, facilities, patient load, staff, time and willingness to comply 
with study requirements; 
§ Understands the requirement to submit the clinical protocol and Investigator’s Brochure 
to the IRB for review and approval; 
§ Understands the requirement to maintain all study correspondence, study binders, case 
report forms and subject records on file; and 
§ Assumes responsibility for oversight of the investigation at his / her center  
 
The monitor will complete a Pre-Study Visit Report to document all activities and topics reviewed 
during the visit as well as the site personnel present for the meeting. The report will also document 
any open action items identified as a result of the visit.   
 
9.5 
Informed Consent 
Subjects expressing an interest in participating in the study will be provided a copy of the IRB 
approved Informed Consent Form /Assent (where applicable) for review. Any study-related 
questions posed by the potential subject will be answered by the Investigator or a qualified member 
of his/her study staff. Potential subjects willing to participate in the study will be required to sign 
and date the Informed Consent Form. Only those who meet all inclusion and exclusion criteria for 
the study may be enrolled. Execution of the Informed Consent Form must be obtained prior to 
initiating any study specific procedures. The signed original informed consent is to be maintained 
in the site records and the subject should be provided with a copy for their records. The entire 
Informed Consent process will be documented in the subject’s medical record.   
 

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9.6 
Subject Stipends 
Subject stipend or reimbursement will be determined on an Investigator site basis. If subject 
payments are allowed and warranted, monetary amounts will be reviewed and approved by the 
governing IRB and documented within each site ICF.  
 
9.7 
Confidentiality of Data 
Access to subject’s records is restricted to the Clinical Investigators, clinical site support staff, and 
to Evolution Optiks or their designee. Investigators are to instruct their staff in the methods and 
importance of maintaining subject confidentiality. Case Report Forms will be stored in secure, 
access-controlled locations at both the clinical sites and Sponsor’s locations.  Traceability of all 
forms will be maintained. Subjects will be assigned a subject number by the EDC system at the 
time of screening. On all CRFs or other reporting forms, study subjects should be identified only 
by their assigned subject number and initials. 
 
Study results reported by Evolution Optiks will be in aggregate form and individual identities will 
not be publicly disclosed. It is possible that regulatory authorities (i.e., FDA) may request detailed 
clinical information regarding specific subjects. In these situations, information will be provided 
to regulatory authorities by the assigned subject number and subject initials.  
 
The investigator agrees that complete source documents for this study will need to be available to 
appropriately qualified personnel from Evolution Optiks (or their designated representative) or to 
country specific health authority inspectors after appropriate notification. The verification of Case 
Report Form data will be done by direct inspection of source documents (where permitted by law). 
Record review will be done in compliance with HIPAA and in a manner that protects subject 
confidentiality.   
 
During the conduct of the study, Investigators must agree not to publicly disclose any study related 
information including the study design, results or conclusions of the investigation without prior 
consent of Evolution Optiks. 
 
9.8 
Amendments to Protocol 
While not expected, it is possible that Evolution Optiks may need to amend the clinical protocol 
(for example, at the request of the FDA, due to emergence of new information, etc.). In the event 
that this is needed, the protocol amendment will be reviewed and approved internally by the 
appropriate Evolution Optiks staff and the FDA. Once finalized, the amendment will be distributed 
to the participating Investigator sites. Protocol amendments must undergo IRB review and 
approval at each clinical site, but may undergo expedited review if minor changes are made in the 
protocol that does not alter subject risk. The written approval from the IRB for the amendment 

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should specifically refer to the Investigator, the protocol number and title, and reference any 
amendment numbers that are applicable.  
 
9.9 
Protocol Adherence 
It is the responsibility of each Investigator and Evolution Optiks to conduct this study in 
accordance with all aspects of the protocol, Institutional Review Board requirements, the 
Declaration of Helsinki, the Code of Federal Regulations 21 CFR Part 50- Protection of Human 
Subjects, 21 CFR Part 54- Financial Disclosure, 21 CFR Part 56- Institutional Review Boards, and 
21 CFR 812- Subparts C, Responsibilities of Sponsors, Subpart D, IRB Review and Approval, 
Subpart E, Responsibilities of Investigators and International Organization for Standardization 
(ISO) 14155:2020 and general Good Clinical Practice (GCP).  
 
In the event of protocol deviations, both Evolution Optiks and the IRB should be notified of the 
event via the Protocol Deviation Log as soon as possible. If necessary, corrective actions will be 
taken to ensure the subject’s safety and the integrity of the clinical investigation including, but not 
limited to site or study termination. 
 
9.10 Change in Investigator 
Should the Investigator, during the conduct of the study, resign, relocate or retire, he/she must 
immediately inform Evolution Optiks and provide an orderly process for study continuation. 
Should the Investigator, after completion of the study, resign, relocate or retire, he/she must 
immediately inform Evolution Optiks and provide an orderly process for record retention.   
 
9.11 Records Retention 
The types of records to be created and maintained for the clinical trial are dictated by the study 
protocol, Institutional Review Boards, and Federal regulations. U.S. Federal law requires 
maintenance of records of device disposition, signed consent forms, study data forms (CRFs), 
adverse event reports, all correspondence, dates of monitoring visits, and supporting information 
for a period of two years following the date of marketing clearance or until two years following 
notification by Evolution Optiks that the study has been discontinued. The Investigator has the 
responsibility to retain all study records, including the protocol, case report forms, IRB 
correspondence, letters to and from Evolution Optiks and any other applicable study 
documentation for the applicable period. 
 
At the completion of the required retention period, it is requested that the Investigator contact 
Evolution Optiks and allow Evolution Optiks the option of permanently retaining the Investigator's 
study records.  If the Investigator retires or relocates, he/she must identify an individual at their 
site who will hold responsibility for maintaining the study records. The name and title of this 

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individual should be provided to the Clinical Affairs Department at Evolution Optiks. Under no 
circumstances will anyone remove study records from the original study site without prior 
notification of, and approval by Evolution Optiks. 
 
Investigators may release responsibility to maintain records and transfer custody to any other 
person who accepts such responsibility. A notice of transfer must be given to FDA no later than 
ten working days after the transfer occurs.