Single Center Exploratory Study To Evaluate The Use Of The RxSight Light Adjustable Lens (LAL) And The Light Delivery Device (LDD) To Improve Visual Outcomes
Conditions: Aphakia, Cataract
Sponsor: RxSight, Inc.

 
 
 
 
 
PROTOCOL CSP-036-MX 
 
A SINGLE CENTER EXPLORATORY STUDY TO EVALUATE THE 
USE OF THE RXSIGHT LIGHT ADJUSTABLE LENS (LAL) AND THE 
LIGHT DELIVERY DEVICE (LDD) TO IMPROVE VISUAL 
OUTCOMES 
 
Rxsight, Inc. 
100 Columbia, Suite 120 
Aliso Viejo, CA 92656 
 
November 20, 2020 
Version 06 
 
 
 
 
 
 
 
 
I have read and agree to follow the procedures as outlined in this protocol. 
 
This protocol contains confidential proprietary information with respect to Rxsight products 
and clinical trials.  I agree to hold this information in confidence and not to disclose it to any 
third parties for a period of five years from the date of this agreement, or until this 
information becomes a matter of public knowledge through no action or failure on my part to 
maintain its confidentiality. 
 
 
_________________________________ 
  Site Name 
 
 
_________________________________ 
__________________ 
  Principal Investigator’s Signature 
  Date 
 

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TABLE OF CONTENTS 
 
 
PAGE 
1 
STUDY SYNOPSIS .....................................................................................................3 
2 
INTRODUCTION AND RATIONALE ...................................................................13 
3 
STUDY OBJECTIVE ................................................................................................15 
4 
STUDY DESIGN ........................................................................................................15 
5 
OUTCOME PARAMETERS ...................................................................................16 
6 
STUDY POPULATION ............................................................................................16 
6.1 
INCLUSION CRITERIA FOR SUBJECTS WHO DID NOT PREVIOUSLY 
PARTICIPATE IN CSP-037-MX .......................................................................16 
6.2 
EXCLUSION CRITERIA FOR SUBJECTS WHO DID NOT PREVIOUSLY 
PARTICIPATE IN CSP-037-MX .......................................................................17 
7 
STUDY MATERIALS AND METHODS ................................................................19 
7.1 
DEVICE DESCRIPTION ........................................................................................19 
 RxSight Light Adjustable Intraocular Lens ......................................19 
 Light Delivery Device (ldd) ..................................................................19 
 Device Manufacturer ...........................................................................19 
 Rxsight Insertion Device ......................................................................20 
 Indications for Use ...............................................................................20 
7.2 
SUBJECT ENTRY .................................................................................................20 
7.3 
LAL IMPLANTATION AND REFRACTIVE ADJUSTMENT ....................................22 
 Surgical Procedure ...............................................................................22 
 Light Treatment Procedure .................................................................23 
7.4 
EXAMINATION SCHEDULE .................................................................................27 
7.5 
CLINICAL PARAMETERS ....................................................................................28 
7.6 
DATA REPORTING ..............................................................................................34 
7.7 
STUDY COMPLETION PROCEDURES ..................................................................34 
 Subject Completion ..............................................................................34 
 Subject Withdrawal Prior to Implantation .......................................34 
 Subject Withdrawel Due to Intraoperative complications 
prior to implantation ............................................................................35 
 Subject Discontinuation After Implantation .....................................35 
 Lost to Follow-Up .................................................................................35 
 Study Termination ...............................................................................35 
8 
STATISTICAL METHODS .....................................................................................36 
8.1 
POPULATIONS FOR ANALYSIS .............................................................................36 

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 Exploratory Effectiveness Parameters ...............................................36 
8.2 
SAFETY PARAMETERS ........................................................................................37 
 Additional Safety Analyses ..................................................................37 
9 
SEQUENCE OF PLANNED ANALYSES ..............................................................38 
9.1 
INTERIM ANALYSES ...........................................................................................38 
9.2 
FINAL REPORT ...................................................................................................38 
10 
ADVERSE EVENTS .................................................................................................38 
10.1 ADVERSE EVENT (AE) DEFINITIONS .................................................................38 
10.2 ADVERSE DEVICE EFFECT (ADE) DEFINITION ..................................................38 
10.3 DEVICE DEFICIENCY (DD) DEFINITION ............................................................39 
10.4 SERIOUS ADVERSE EVENT (SAE) DEFINITION .................................................39 
 Identification and Collection ...............................................................39 
 Evaluations ............................................................................................40 
 SAE/Unanticipated Adverse Device Effect 
(UADE)/Unanticipated Serious Adverse Device Effect 
(USADE) Reporting .............................................................................41 
 Device Deficiency (DD) Reporting ......................................................41 
10.5 PREGNANCY .......................................................................................................41 
10.6 POTENTIAL ADVERSE EVENTS ..........................................................................42 
10.7 POTENTIAL BENEFITS ........................................................................................43 
11 
STUDY MONITORING ...........................................................................................43 
12 
ETHICAL AND REGULATORY CONSIDERATIONS ......................................44 
12.1 SUBJECT INFORMATION AND CONSENT ............................................................44 
12.2 DECLARATION OF HELSINKI .............................................................................44 
12.3 ISO 14155:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR 
HUMAN SUBJECTS- GOOD CLINICAL PRACTICE ............................................44 
12.4 ADDITIONAL REGULATORY CONSIDERATIONS ................................................44 
12.5 STUDY INITATION/CONDUCT .............................................................................44 
12.6 COMPLIANCE WITH THE CLINCIAL STUDY PROTOCOL ....................................44 
12.7 PROTOCOL DEVIATIONS (PDS) .........................................................................45 
12.8 PROTOCOL AMENDMENTS .................................................................................45 
12.9 PUBLICATION POLICY .......................................................................................45 
12.10 INSURANCE AND INDEMNITY .............................................................................45 
13 
REFERENCES ...........................................................................................................46 
 
  
 
 
 

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RXSIGHT, INC. 
 
PROTOCOL NO. CSP-036-MX 
 
A SINGLE CENTER EXPLORATORY STUDY TO EVALUATE THE USE OF THE 
RXSIGHT LIGHT ADJUSTABLE LENS (LAL) AND THE LIGHT DELIVERY 
DEVICE (LDD) TO IMPROVE VISUAL OUTCOMES 
 
1 
STUDY SYNOPSIS 
STUDY OBJECTIVE 
 
The objective of this study is to evaluate, for the visual correction of aphakia, whether the 
RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to 
improve visual outcomes after performing adjustments of the LAL with the LDD. This is an 
exploratory study. No primary effectiveness endpoints will be defined. 
 
STUDY POPULATION   
The study population will consist of up to 200 eyes in up to 100 subjects implanted with the 
LAL. A subset of the population may include study subjects who were already implanted 
with the LAL under RxSight’s CSP-037-MX protocol “A Single Center Exploratory Study to 
Evaluate the Effects of Ambient Sunlight Exposure on the RxSight Light Adjustable Lens 
(LAL)” but who have not received light treatments with the LDD. Subject’s eyes must meet 
all applicable inclusion criteria and none of the exclusion criteria as described. 
 
STUDY DESIGN 
 
A prospective, single center, exploratory study will be conducted. Subjects will be followed 
until completion of the Postop Month 6 or later follow-up visit. 
 
Patients who require cataract extraction and intraocular lens implantation will be pre-
screened for eligibility as part of pre-entry activity. If one or both eyes meet 
inclusion/exclusion criteria, delegated and trained study staff will explain the study purpose, 
procedures, risks/benefits and subject responsibilities to the potential participant. Written 
informed consent must be obtained prior to initiation of any clinical procedures that are 
performed solely for the purpose of determining eligibility for research. The patient is 
enrolled upon signing the informed consent. Both eyes of all subjects may be screened for 
eligibility at the same preoperative visit. If at any time during the preoperative visit, an eye 
does not meet inclusion or exclusion criteria, screening for that eye can be discontinued 
immediately. If only one eye is being screened, then the subject will be exited from the study. 
If both eyes of the subject are enrolled for study participation, each eye will be scheduled for 
surgery within a timeframe of the investigator’s choice but on separate days.  
 
Patients from RxSight’s CSP-037-MX study may have both eyes screened for study 
eligibility. The former CSP-037-MX study eye must meet all inclusion/exclusion criteria as 
specified below for subjects who previously participated in CSP-037-MX. If applicable, the 

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fellow eye (non-CSP-037-MX study eye) must meet all inclusion/exclusion criteria as 
specified below for subjects who did not previously participate in CSP-037-MX. If only the 
prior CSP-037-MX study eye is being considered for this study, the subject will need to 
review and sign only a CSP-036-MX written informed consent for former CSP-037-MX 
subjects. If both eyes are being considered for this study, the subject will also have to review 
and sign a CSP-036-MX written informed consent for subjects who had no affiliation with 
CSP-037-MX. 
  
At the discretion of the Principal Investigator, a subgroup of eyes will receive an 
 
 7-14 days postop. Commencing 17 to 30 days postop, all eyes will receive up to 
three adjustments and one to two lock-in treatments. Each light treatment will be separated 
by 2 to 7 days. The type of adjustment (spherocylindrical and/or presbyopia) the study eye 
receives is dependent on specific criteria at each light adjustment visit. Postoperatively, all 
subjects will undergo ophthalmic examinations until completion of the Postop Month 6 or 
later follow-up visit. 
 
For subjects that receive only non-presbyopic adjustments, uncorrected distance visual 
acuities will be presented and summarized. For subjects that receive a presbyopia adjustment, 
uncorrected distance, uncorrected intermediate and uncorrected near acuities will presented 
and summarized. Additional analyses may be performed. Safety for all study eyes will be 
evaluated per ISO 11979-7. 
 
DURATION OF STUDY 
Each subject will participate in the study for approximately 6-12 months. The recruitment 
phase is expected to last approximately 10 months. The complete study period is expected to 
be approximately 24 months.  
 
STUDY SITE 
The study will be performed in an ophthalmology clinic. The investigator will be an 
ophthalmic surgeon, specializing in cataract surgery with implantation of intraocular lenses. 
Study responsibilities will be registered in a delegation log that will be kept at the 
investigational site. The overall responsibility at the study clinic remains with the 
investigator. 
 
INCLUSION CRITERIA FOR SUBJECTS WHO DID NOT PREVIOUSLY PARTICIPATE IN CSP-
037-MX  
• Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for the implantation of the LAL. 
• 
Age 30 or older on the day cataract surgery is performed. 
• 
Preoperative keratometric cylinder ≤3.50 D. 
• 
Study eye must have a cataract causing reduction in best corrected distance visual 
acuity (BCDVA) to a level of 20/32 or worse with or without a glare source. 
• 
In subjects with only one eye enrolled in the study: Potential for BCDVA of 20/40 or 
better in the non-study eye after cataract removal and IOL implantation. 

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• 
Study eye has BCDVA projected to be 20/20 or better after cataract removal and IOL 
implantation as estimated by potential acuity meter (PAM) or surgeon estimation.   
• 
Study eye has clear intraocular media other than cataract. 
• 
Willing and able to comply with the requirements for study specific procedures and 
visits.  
• 
Study eye has average dilated pupil diameter of ≥7.0 mm.  
• 
Study eye requires an IOL power within the range available for the LAL. 
 
INCLUSION CRITERIA FOR SUBJECTS WHO PREVIOUSLY PARTICIPATED IN CSP-037-MX 
• Subject was previously enrolled within clinical study CSP-037-MX sponsored by 
RxSight, Inc. and meets the following inclusion criteria: 
o Potential for BCDVA of 20/40 or better in the non-study eye 
o Willing and able to comply with the requirements for study specific 
procedures and visits. 
o Former CSP-037-MX study eye can adequately dilate (enough of the 
edge of the LAL optic can be visualized to allow for centration during 
LDD light treatment). 
 
EXCLUSION CRITERIA FOR SUBJECTS WHO DID NOT PREVIOUSLY PARTICIPATE IN CSP-
037-MX  
• 
Study eye with zonular laxity or dehiscence. 
• 
Study eye with pre-existing macular disease that in the opinion of the investigator 
performing LDD light treatments would not be in the best interest of the patient. 
• 
Study eye with retinal degenerative disorder (other than macular degeneration) that is 
expected to cause future vision loss.   
• 
Subjects with diabetes with any evidence of retinopathy.   
• 
Study eye with a history of uveitis.    
• 
Study eye with significant anterior segment pathology, such as rubeosis iridis, 
aniridia, or iris coloboma. 
• 
Study eye with corneal pathology that is either progressive or sufficient to reduce 
BCDVA to worse than 20/20.  
• 
Study eye with any corneal dystrophy including basement membrane dystrophy that 
in the opinion of the investigator may confound the outcome. 
• 
Study eye with keratoconus or suspected of having keratoconus. 
• 
Study eye that has undergone previous intraocular surgery.  
• 
Study eye with previous trauma or developmental defects in which appropriate 
support of the intraocular lens (IOL) is not possible.  
• 
Subjects with serious co-morbid conditions that in the judgment of the investigator 
makes inclusion in the study not in the best interest of the subject. 

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• 
Subjects taking systemic medication that may increase sensitivity to UV light such as 
tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, 
hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and 
methoxsalen. LDD treatment in patients taking such medications may lead to 
irreversible phototoxic damage to the eye. This is only a partial list of 
photosensitizing medications. Please evaluate all medications that the patient is taking 
for this effect prior to consideration for implantation.  
• 
Subjects taking a systemic medication that is considered toxic to the retina such as 
tamoxifen. 
• 
Subjects who the doctor believes will be unable to maintain steady fixation that is 
necessary for centration of the LDD light treatment in the study eye. 
• 
Study eye with irregular astigmatism. 
• Study eye with history of ocular herpes simplex virus.  
• Current vitreoretinal disease or a high risk of future vitreoretinal disease that may 
require silicone oil as part of therapy in the study eye. 
 
 
EXCLUSION CRITERIA FOR SUBJECTS WHO PREVIOUSLY PARTICIPATED IN CSP-037-MX  
• 
Subjects taking systemic medication that may increase sensitivity to UV light such as 
tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, 
hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and 
methoxsalen. LDD treatment in patients taking such medications may lead to 
irreversible phototoxic damage to the eye. This is only a partial list of 
photosensitizing medications. Please evaluate all medications that the patient is taking 
for this effect prior to light treatments.  
• 
Subjects taking a systemic medication that is considered toxic to the retina such as 
tamoxifen. 
• 
Subjects who the doctor believes will be unable to maintain steady fixation that is 
necessary for centration of the LDD light treatment in the study eye. 
• 
Former CSP-037-MX study eye with history of ocular herpes simplex virus. 

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Unscheduled visits falling outside the designated ranges for scheduled visits will be considered “interim” visits 
for data recording purposes and a report form will be completed. 
 
 

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Clinical Parameters:  
 
 
 
 
 
 
4. 
Demographics 
5. 
Ocular History 
6. 
History of Medications 
7. 
Subjective symptoms/complaints (subject reported) 
8. 
Ocular Biometry: Axial length + Anterior Chamber Depth 
9. 
Corneal Topography 
10. Autorefraction 
11. Undilated photopic pupil diameter 
12. Corneal Keratometry 
13. Vision Quality Measurement 
14. Anterior Segment OCT 
15. Posterior Segment SD-OCT 
16. Monocular uncorrected distance visual acuity (UCDVA) 
17. Binocular uncorrected distance visual acuity 
18. Manifest Refraction 
19. Monocular best corrected distance visual acuity (BCDVA) 
20. Ocular Dominance Test 
21. Depth of focus testing 
22. Monocular distance corrected intermediate visual acuity (DCIVA) 
23. Monocular distance corrected near visual acuity (DCNVA) 
24. Monocular uncorrected near visual acuity (UCNVA) 
25. Binocular uncorrected near visual acuity 
26. Binocular uncorrected intermediate visual acuity 
27. Monocular uncorrected intermediate visual acuity (UCIVA) 
28. In-office Eyrthropsia assessment 
29. City University Color Test 
30. Monocular Distance corrected contrast sensitivity: Mesopic/Photopic with and w/o 
glare 
31. Intraocular pressure 
32. Slit lamp exam  
33. Fundus Exam 
34. Aberrometry 
35. Dilated pupil diameter  

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36. Adverse Event 
 

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ABBREVIATIONS AND DEFINITION OF TERMS 
ACD 
Anterior Chamber Depth 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
ANSI 
American National Standards Institute 
BCDVA 
Best Corrected Distance Visual Acuity 
CCC 
Continuous Circular Capsulorhexis 
CDRH 
Center for Devices and Radiological Health 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
CSP 
Clinical Study Protocol 
D 
Diopter 
DCIVA 
Distance Corrected Intermediate Visual Acuity 
DCNVA 
Distance Corrected Near Visual Acuity 
DD 
Device Deficiency 
DOF 
Depth of Focus 
EC 
Ethics Committee 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
IDE 
Investigational Device Exemption 
IOL 
Intraocular Lens 
IOP 
Intraocular Pressure 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
LDD 
Light Delivery Device 
M 
Month 
MR 
Manifest Refraction 
MRCYL 
Manifest Refraction Cylinder 
MRSE 
Manifest Refraction Spherical Equivalent 
OD 
Right eye 
OS 
Left eye 
PCO 
Posterior Capsular Opacity 
PI 
Principal Investigator 
PPC 
Precision Pulse Capsulotomy 
 
 

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LAL 
RxSight Light Adjustable Lens 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SE 
Spherical Equivalent 
SSI 
Secondary Surgical Intervention 
UADE 
Unanticipated Adverse Device Effect 
UCDVA 
Uncorrected Distance Visual Acuity 
UCIVA 
Uncorrected Intermediate Visual Acuity 
UCNVA 
Uncorrected Near Visual Acuity 
UP 
Unanticipated Problem 
UV 
Ultraviolet 
 

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2 
INTRODUCTION AND RATIONALE 
Cataract surgery is the most commonly performed procedure by the ophthalmic surgeon. It is 
estimated that more than 26 million cataract operations with intraocular lens (IOL) 
implantation were to be performed worldwide in 2017.1 The average age of cataract patients 
is reported to be 65 to 70 years old, with a small percentage of cataract surgeries being 
performed on patients as young as in their early 40’s.2,3 While key cataract technology 
advancements have resulted in important reductions in residual refractive error and improved 
uncorrected visual acuity, significant postoperative residual refractive error remains the most 
frequent cataract surgery complication. RxSight’s Light Adjustable Lens (LAL) addresses 
the problems of residual refractive error by allowing adjustment of the spherical and 
cylindrical power postoperatively. The Center for Devices and Radiological Health (CDRH) 
of the Food and Drug Administration (FDA) approved RxSight’s premarket approval (PMA)  
application for the LAL and Light Delivery Device (LDD) system on November 22, 2017. 
The system is indicated for the reduction of residual astigmatism to improve uncorrected 
visual acuity after removal of the cataractous natural lens by phacoemulsification and 
implantation of the intraocular lens in the capsular bag; in adult patients: 
• With pre-existing corneal astigmatism of ≥ 0.75 diopters 
• Without pre-existing macular disease 
 
The system also reduces the likelihood of clinically significant residual spherical refractive 
errors. 
 
Presbyopia, which will affect approximately 2.1 billion people by 2020, is the irreversible 
loss of the accommodative ability of the eye that occurs due to aging.4 Accommodation 
refers to the ability of the eye to increase the refractive power of its crystalline lens in order 
to focus near objects on the retina.5 Presbyopia typically occurs in people over 40 years of 
age and can cause a considerable decrease in the quality of life for many of those affected.6 
Without correction, presbyopia results in difficulty performing tasks at a customary working 
distance. Because most patients have daily activities that require them to read and work at 
near and with the increasing importance of intermediate vision to clearly see cell phones and 
computer monitors, patients are seeking treatment options to mitigate the effects of their 
presbyopia. 
 
The vast majority of cataract surgery patients are presbyopic preoperatively and all patients 
will experience presbyopia after cataract surgery. Cataract surgery presents patients with an 
 
1 Eyewiretoday. Steady Growth in Cataract Surgical Procedures is Expected Over the Next 5 Years, July 27, 2017. 
2 Cummings A. The Influence of Age on Refractive Cataract Surgery. CRSTEurope. Feb 2011. 
3 Gollogly H, Hodge D, St. Sauver J, Erie J. Increasing incidence of cataract surgery: Population –based study. J Cataract 
Refract Surg 2013; 39:1383-1389. 
4 Arlt EM, Krall EM, Moussa S, Grabner G, Dexl A. Implantable inlay devices for presbyopia: the evidence to date. Clin 
Ophthalmol. 2015 Jan 14;9:129-137. 
5 American Optometric Association. Care of the patient with presbyopia. St. Louis (MO): American Optometric 
Association; 2010. 
6 McDonnell PJ, Lee P, Spritzer K, Lindblad AS, Hays RD. Association of presbyopia with vision-targeted health-related 
quality of life. Arch Ophthalmol. 2003;121(11):1577-1581. 

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opportunity to not only remove the cataractous lens, but also to have presbyopia mitigated 
through the implantation of specific IOLs. Current techniques include the use of 
pseudophakic monovision and multifocal IOLs. 
 
Pseudophakic monovision is a concept in which 1 eye (usually dominant) is targeted for 
distance vision and the other eye is targeted for near vision after IOL implantation. 
Depending on the technique, target refraction of the non-dominant eye ranges from 1.00 to 
2.50 diopters (D) of myopia.7 Obtaining a pre-determined magnitude of anisometropia (i.e. 
refractive accuracy of the IOL implantation) between eyes is critical to achieving patient 
satisfaction as any inaccuracy could lead to inadequate distance or near vision or patient non-
adaptation to the amount of anisometropia. 
 
Multifocal IOLs can be refractive, diffractive, or hybrid diffractive-refractive. Diffractive 
multifocal IOLs use light diffraction to produce 2 focal points, one for distance vision and 
one for near vision. In refractive multifocal IOLs, refractive power changes from the center 
to the periphery of the IOL, thus producing many focal points. Recent studies of multifocal 
IOLs report good results for both near and distance vision in terms of spectacle 
independence, but these IOLs are frequently associated with a number of visual adverse 
effects, such as dysphotopsia, visual disturbances at night, halos, and glare.7        
 
This study aims to explore the treatment of the LAL postoperatively either with light 
treatment patterns intended to mitigate the effects of postoperative residual error only and/or 
combined with light treatment patterns that are intended to mitigate the effects of presbyopia 
by enhancing the patient’s intermediate and near vision. This latter mitigation is 
accomplished by designing the light treatment pattern to create a distribution of optical 
powers within the LAL. Light treatment patterns mitigating the effects of postoperative 
residual error will be evaluated by looking at postoperative uncorrected distance visual acuity 
while light treatment patterns intended to mitigate the effects of presbyopia will be evaluated 
by looking at postoperative uncorrected distance, intermediate and near visual acuity.
 
7 Labiris G, Giarmoukakis A, Patsiamanidi M, et al. Mini-monovision versus multifocal intraocular lens implantation. J 
Cataract Refract Surg 2015; 41:53-57. 
 
 

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3 
STUDY OBJECTIVE 
The objective of this study is to evaluate, for the visual correction of aphakia, whether the 
RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to 
improve visual outcomes after performing adjustments of the LAL with the LDD. This is an 
exploratory study. No primary effectiveness endpoints will be defined. 
4 
STUDY DESIGN 
A prospective, single center, exploratory study will be conducted. Subjects will be followed 
until completion of the Postop Month 6 or later follow-up visit. 
Patients who require cataract extraction and intraocular lens implantation will be pre-
screened for eligibility as part of pre-entry activity. If one or both eyes meet 
inclusion/exclusion criteria, delegated and trained study staff will explain the study purpose, 
procedures, risks/benefits and subject responsibilities to the potential participant. Written 
informed consent must be obtained prior to initiation of any clinical procedures that are 
performed solely for the purpose of determining eligibility for research. The patient is 
enrolled upon signing the informed consent. Both eyes of all subjects may be screened for 
eligibility at the same preoperative visit. If at any time during the preoperative visit, an eye 
does not meet inclusion or exclusion criteria, screening for that eye can be discontinued 
immediately. If only one eye is being screened, then the subject will be exited from the study. 
If both eyes of the subject are enrolled for study participation, each eye will be scheduled for 
surgery within a timeframe of the investigator’s choice but on separate days.  
 
Patients from RxSight’s CSP-037-MX study may have both eyes screened for study 
eligibility. The former CSP-037-MX study eye must meet all inclusion/exclusion criteria as 
specified below for subjects who previously participated in CSP-037-MX. If applicable, the 
fellow eye (CSP-037-MX non-study eye) must meet all inclusion/exclusion criteria as 
specified below for subjects who did not previously participate in CSP-037-MX. If only the 
prior CSP-037-MX study eye is being considered for this study, the subject will need to 
review and sign only a CSP-036-MX written informed consent for former CSP-037-MX 
subjects. If both eyes are being considered for this study, the subject will also have to review 
and sign a CSP-036-MX written informed consent for subjects who had no affiliation with 
CSP-037-MX. 
 
At the discretion of the Principal Investigator, a subgroup of eyes will receive an 
 
 7-14 days postop. Commencing 17 to 30 days postop, all eyes will receive up to 
three adjustments and one to two lock-in treatments. Each light treatment will be separated 
by 2 to 7 days. The type of adjustment (spherocylindrical and/or presbyopia) the study eye 
receives is dependent on specific criteria at each light adjustment visit. Postoperatively, all 
subjects will undergo ophthalmic examinations until completion of the Postop Month 6 or 
later follow-up visit. 
 

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For subjects that receive only non-presbyopic adjustments, uncorrected distance visual 
acuities will be presented and summarized. For subjects that receive a presbyopia adjustment, 
uncorrected distance, uncorrected intermediate and uncorrected near acuities will presented 
and summarized. Additional analyses may be performed. Safety for all study eyes will be 
evaluated per ISO 11979-7. 
 
5 
OUTCOME PARAMETERS 
The following visual performance parameters will be collected and summarized for eyes that 
received only non-presbyopic adjustments. 
• % of eyes with UCDVA of 20/20 or better at Postop Month 6 or later. 
 
The following visual performance parameters will be collected and summarized for eyes that 
received a presbyopia adjustment. 
• Proportion of eyes simultaneously with  (1) Monocular UCDVA of 20/25 or better 
and (2) Monocular UCIVA of 20/32 or better and  (3) Monocular UCNVA of 20/40 
or better at Postop Month 6 or later.  
 
Additional analyses may be performed. Clinical data for eyes receiving only non-presbyopic 
adjustments and eyes receiving a presbyopia adjustment may be summarized and analyzed 
separately. In addition, clinical data for former CSP-037-MX study eyes may be analyzed 
separately. 
 
Safety Parameters: 
• Incidence of persistent sight-threatening complications and adverse events and 
cumulative events defined per ISO 11979-7. 
The incidence of all other adverse events will also be presented. 
6 
STUDY POPULATION 
The study population will consist of up to 200 eyes in up to 100 subjects implanted with the 
LAL. A subset of the population may include study subjects who were already implanted 
with the LAL under RxSight’s CSP-037-MX protocol “A Single Center Exploratory Study to 
Evaluate the Effects of Ambient Sunlight Exposure on the RxSight Light Adjustable Lens 
(LAL)” but who have not received light treatments with the LDD. Subject’s eyes must meet 
all applicable inclusion criteria and none of the exclusion criteria as described. 
 
6.1 
INCLUSION CRITERIA FOR SUBJECTS WHO DID NOT PREVIOUSLY PARTICIPATE IN 
CSP-037-MX  
• Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for the implantation of the LAL. 
• 
Ages 30 or older on the day the cataract surgery is performed. 
• 
Preoperative keratometric cylinder ≤3.50 D. 

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• 
Study eye must have a cataract causing reduction in best corrected distance visual 
acuity (BCDVA) to a level of 20/32 or worse with or without a glare source. 
• 
In subjects with only one eye enrolled in the study: Potential for BCDVA of 20/40 or 
better in the non-study eye after cataract removal and IOL implantation. 
• 
Study eye has BCDVA projected to be 20/20 or better after cataract removal and IOL 
implantation as estimated by potential acuity meter (PAM) or surgeon estimation.   
• 
Study eye has clear intraocular media other than cataract. 
• 
Willing and able to comply with the requirements for study specific procedures and 
visits.  
• 
Study eye has average dilated pupil diameter of ≥7.0 mm.  
• 
Study eye requires an IOL power within the range available for the LAL. 
 
INCLUSION CRITERIA FOR SUBJECTS WHO PREVIOUSLY PARTICIPATED IN CSP-037-MX 
• Subject was previously enrolled within clinical study CSP-037-MX sponsored by 
RxSight, Inc. and meets the following inclusion criteria: 
o Must sign a CSP-036-MX written informed consent specific for 
former CSP-037-MX subjects 
o Potential for BCDVA of 20/40 or better in the non-study eye currently 
o Willing and able to comply with the requirements for study specific 
procedures and visits. 
o Former CSP-037-MX study eye can adequately dilate (enough of the 
edge of the LAL optic can be visualized to allow for centration during 
LDD light treatment). 
 
6.2 
EXCLUSION CRITERIA FOR SUBJECTS WHO DID NOT PREVIOUSLY PARTICIPATE IN 
CSP-037-MX 
• 
Study eye with zonular laxity or dehiscence. 
• 
Study eye with pre-existing macular disease that in the opinion of the investigator 
performing LDD light treatments would not be in the best interest of the patient. 
• 
Study eye with retinal degenerative disorder (other than macular degeneration) that is 
expected to cause future vision loss.   
• 
Subjects with diabetes with any evidence of retinopathy.   
• 
Study eye with a history of uveitis.    
• 
Study eye with significant anterior segment pathology, such as rubeosis iridis, 
aniridia, or iris coloboma. 
• 
Study eye with corneal pathology that is either progressive or sufficient to reduce 
BCDVA to worse than 20/20.  
• 
Any corneal dystrophy including basement membrane dystrophy in either eye that in 
the opinion of the investigator may confound the outcome. 
• 
Study eye with keratoconus or suspected of having keratoconus. 

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• 
Study eye that has undergone previous intraocular surgery.  
• 
Study eye with previous trauma or developmental defects in which appropriate 
support of the intraocular lens (IOL) is not possible.  
• 
Subjects with serious co-morbid conditions that in the judgment of the investigator 
makes inclusion in the study not in the best interest of the subject. 
• 
Subjects taking systemic medication that may increase sensitivity to UV light such as 
tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, 
hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and 
methoxsalen. LDD treatment in patients taking such medications may lead to 
irreversible phototoxic damage to the eye. This is only a partial list of 
photosensitizing medications. Please evaluate all medications that the patient is taking 
for this effect prior to consideration for implantation.  
• 
Subjects taking a systemic medication that is considered toxic to the retina such as 
tamoxifen. 
• 
Subjects who the doctor believes will be unable to maintain steady fixation that is 
necessary for centration of the LDD light treatment in the study eye. 
• 
Study eye with irregular astigmatism. 
• Study eye with history of ocular herpes simplex virus.  
• Current vitreoretinal disease or a high risk of future vitreoretinal disease that may 
require silicone oil as part of therapy in the study eye. 
 
EXCLUSION CRITERIA FOR SUBJECTS WHO PREVIOUSLY PARTICIPATED IN CSP-037-MX  
• 
Subjects taking systemic medication that may increase sensitivity to UV light such as 
tetracycline, doxycycline, psoralens, amiodarone, phenothiazines, chloroquine, 
hydrochlorothiazide, hypericin, ketoprofen, piroxicam, lomefloxacin, and 
methoxsalen. LDD treatment in patients taking such medications may lead to 
irreversible phototoxic damage to the eye. This is only a partial list of 
photosensitizing medications. Please evaluate all medications that the patient is taking 
for this effect prior to light treatments.  
• 
Subjects taking a systemic medication that is considered toxic to the retina such as 
tamoxifen. 
• 
Subjects who the doctor believes will be unable to maintain steady fixation that is 
necessary for centration of the LDD light treatment in the study eye. 
 

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7 
STUDY MATERIALS AND METHODS  
7.1 
DEVICE DESCRIPTION 
RxSight’s Light Adjustable Lens (LAL) is a silicone intraocular lens whose shape and 
focusing characteristics can be modified after implantation using an office-based UV light 
source, the RxSight Light Delivery Device (LDD), to improve uncorrected visual acuity. 
 
 RXSIGHT LIGHT ADJUSTABLE INTRAOCULAR LENS  
The RxSight Light Adjustable Lens (LAL) is a foldable posterior chamber, UV filtering, 
three-piece photoreactive silicone lens with blue PMMA (polymethylmethacrylate) modified-
C haptics, a 6.0 mm optic with squared posterior edge, and an overall diameter of 13.0 mm. 
 
The LAL silicone material is designed to respond to a narrowband UV light by incorporating 
photoreactive components in the cross-linked silicone lens matrix.  Post implantation, the 
LAL shape may be altered non-invasively by photoinitiation using a select spatial intensity 
profile. The silicone material contains photoreactive additive, which is selectively photo-
polymerized in targeted areas upon exposure to the near UV light to alter the lens shape thus 
modifying spherical and spherocylindrical power of the LAL or extending depth of focus or 
creating multifocality. A subsequent lock-in exposure is delivered to the implanted LAL to 
prevent further refractive changes due to exposure to sources of UV light such as sunlight or 
black light. 
 
 LIGHT DELIVERY DEVICE (LDD) 
RxSight’s Light Delivery Device (LDD) is a UV light projection system used to induce a 
predictable change in the LAL after implantation. RxSight’s LDD consists of an anterior 
segment biomicroscope with the addition of an optical projection system, electronic control 
circuitry, and a UV source. The LDD delivers light profiles with adequate intensity and 
duration to induce polymerization of photoreactive additive leading to a change of the 
implanted LAL. Because this procedure is performed after implantation, residual refractive 
errors can be minimized and/or a patient’s depth of focus can be extended, reducing the need 
for spectacles, corneal refractive procedures, or additional IOL procedures to optimize a 
patient’s vision. 
 
 DEVICE MANUFACTURER 
The LAL and LDD are manufactured by RxSight, Inc. located in Aliso Viejo, California. 
RxSight, Inc. has an established Quality Management System that is in conformance with the 
following standards: 
• 21 C.F.R. Part 820 (Quality System Regulation) 
• EN ISO 13485:2016 (Quality Management System with scope: design, manufacture, 
distribution and service of therapeutic, surgical and diagnostic devices and 
instruments especially for ophthalmology), and the Medical Device Directive 
93/42/EEC.  
 

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 RXSIGHT INSERTION DEVICE 
The LAL can be inserted into the eye using the RxSight Insertion Device, which is comprised 
of a re-usable titanium injector and a single-use, non-preloaded polypropylene cartridge with 
lubricating coating. 
 
 INDICATIONS FOR USE 
The RxSight Light Adjustable Lens (LAL) is an intraocular lens intended for primary 
implantation in the capsular bag for the visual correction of aphakia in adult patients with or 
without presbyopia in whom a cataractous lens has been removed. The Light Delivery 
Device (LDD) is used to improve uncorrected visual acuity by adjusting the LAL power to 
correct residual postoperative refractive error including -2.0 to +2.0 diopters of sphere and 
0.50 to 3 diopters of cylinder and by changing lens curvature to introduce controlled amounts 
of spherical aberration (± 1 micron) and center near add (up to 2 diopters). 
 
7.2 
SUBJECT ENTRY 
Patients who require cataract extraction and intraocular lens implantation will be pre-
screened for eligibility as part of pre-entry activity. If one or both eyes meet 
inclusion/exclusion criteria, delegated and trained study staff will explain the study purpose, 
procedures, risks/benefits and subject responsibilities to the potential participant. Written 
informed consent must be obtained prior to initiation of any clinical procedures that are 
performed solely for the purpose of determining eligibility for research. The patient is 
enrolled upon signing the informed consent. The subject will sign and date the informed 
consent form in the presence of the person conducting the consent process. The investigator 
and/or the person conducting the consent process will also sign and date the consent form. 
During the study, the subject will be provided with any new information that is received that 
could affect their health status or change their willingness to continue to participate in the 
study. Both eyes of all subjects may be screened for eligibility at the same preoperative visit. 
If at any time during the preoperative visit, an eye does not meet inclusion or exclusion 
criteria, screening for that eye can be discontinued immediately. If only one eye is being 
screened, then the subject will be exited from the study. The preoperative examination will 
be performed no more than 60 days prior to surgery. If the 60-day time period elapses, it is 
acceptable for patients to be re-screened by undergoing a complete preoperative examination. 
Ocular dominance testing will be performed as part of the preoperative evaluation to 
determine eye dominance. If both eyes of the subject are enrolled for study participation, 
each eye will be scheduled for surgery within a timeframe of the investigator’s choice but on 
separate days.  
 
Only subjects meeting all inclusion/exclusion criteria will be implanted. Those subjects who 
do not meet the inclusion/exclusion requirements will be considered screen failures. Unique 
identification numbers will be assigned to each subject. 
 
 

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Patients from RxSight’s CSP-037-MX study may have both eyes screened for study 
eligibility. The former CSP-037-MX study eye must meet all inclusion/exclusion criteria as 
specified below for subjects who previously participated in CSP-037-MX. If applicable, the 
fellow eye (CSP-037-MX non-study eye) must meet all inclusion/exclusion criteria as 
specified below for subjects who did not previously participate in CSP-037-MX. If only the 
prior CSP-037-MX study eye is being considered for this study, the subject will need to 
review and sign only a CSP-036-MX written informed consent for former CSP-037-MX 
subjects. If both eyes are being considered for this study, the subject will also have to review 
and sign a CSP-036-MX written informed consent for subjects who had no affiliation with 
CSP-037-MX.

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7.3 
LAL IMPLANTATION AND REFRACTIVE ADJUSTMENT 
 SURGICAL PROCEDURE 
The LAL will be implanted on Day 0 of the study using standard microsurgical techniques.  
 
No additional refractive procedures are allowed until after the Postop Month 6 or later visit.   
 
The surgical procedure will be performed as follows: 
1. Prepare and drape the eye for surgery in accordance with standard surgical procedures. 
2. A temporal clear corneal incision will be made using the surgeon’s standard 
instrumentation and techniques.  
3. Use viscoelastic to fill the anterior chamber through the incision opening.   
4. Perform an anterior circular capsulorhexis of a maximum of 5.2 mm in diameter using 
standard technique. The capsulorhexis should be well-centered with a 360° overlapping 
capsular edge to minimize IOL tilt and decentration and longitudinal IOL shift. The 
capsulorhexis and/or nuclear fragmentation can be performed with a femtosecond laser. 
Precision pulse capsulotomy (PPC) can also be used to perform the capsulorhexis.  
5. The surgeon will extract the cataract by phacoemulsification. 
6. In the event of an intraoperative complication prior to implantation of the LAL, 
including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous 
loss, iris trauma, corneal complications or any intraoperative abnormality that may affect 
the postoperative pupillary dilation, or the centration or tilt of the intraocular lens, do not 
implant the LAL.  
7. The LAL can be introduced into the eye using any of the following systems: 
a. The RxSight Insertion Device through a clear temporal corneal incision up to 
3.2 mm 
b. An insertion system of the investigator’s choice through a clear temporal 
corneal incision 
The LAL is placed into the capsular bag. If utilizing additional surgical instruments 
near the incision upon insertion, precaution should be taken not to contact the LAL 
optic with this additional instrument.  
8. Verify proper orientation of the LAL 
9. Aspirate any residual viscoelastic from the eye using a preferred technique. 
10. The wound may close without suturing. If the unsutured wound is not watertight, close it 
with a either a suture using standard technique or an ocular sealant (ReSure Sealant). 
11. After completion of the surgery, ocular anti-inflammatory and/or antibiotic drops may 
be applied in accordance with standard clinical practice. 
If a patch was used at the conclusion of surgery, the subject will wait for the surgeon to 
remove the patch.  

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 LIGHT TREATMENT PROCEDURE 
At the discretion of the Principal Investigator, a subgroup of eyes will receive an 
 
 7-14 days postop. Commencing 17 to 30 days postop, all eyes will receive up to 
three adjustments and one to two lock-in treatments. Each light treatment will be separated 
by 2 to 7 days. The type of adjustment (spherocylindrical and/or presbyopia) the study eye 
receives is dependent on specific criteria at each light adjustment visit. 
 
7.3.2.1 Postponement of Light Treatment Procedure(s) 
LDD treatment should be delayed if any of the following new symptoms or changes in 
performance are noted; 
• Color Vision Testing: Treatment should be delayed if the subject scores worse on Part 2 
for Tritan evaluation when compared to the initial pre-light treatment test. 
• Erythropsia Evaluation: With any score of 2 (red), the treatment should be delayed. 
• Best Corrected Distance Visual Acuity: With any loss of BCDVA (unless the cause is 
known to be non-retinal) of 10 letters or more on an ETDRS (logMAR) chart when 
compared to the initial pre-light treatment BCDVA, treatment should be delayed. 
 
The subject should return for follow-up visits until the subject’s visual assessment  
of erythropsia is a score of 0 or 1 (indicates the paper looks white or pink), the BCDVA is 
within 10 letters of the initial pre-light treatment BCDVA and an equivalent or better score 
than the initial pre-light treatment test is measured in the Tritan section of the City 
University Color Test, at which time the next LDD treatment may be delivered.  
 
• If sutures were utilized at the time of surgery to close the incision wound, light 
treatments should not commence on the study eye until a minimum time after suture 
removal that has been agreed upon by the Sponsor and the Principal Investigator. 
• A study eye with an ocular adverse event that could be negatively impacted by light 
treatment or negatively impact the effectiveness or safety of a light treatment should 
have light treatments delayed until after the adverse event has subsided.  This includes 
corneal edema and superficial punctate keratitis (SPK) (Grade 3 (moderate) or more 
severe)), retinal conditions including diabetic retinopathy and cystoid macular edema, 
epithelial defect, endophthalmitis or any other safety concern that the investigator 
believes may be negatively impacted by light treatment.   
• If a study eye is discovered with evidence of premature photopolymerization as 
evidenced as a zone on the lens surface, the investigator should contact the Sponsor for 
further instructions. (see Appendix 1 for additional details regarding premature 
photopolymerization).   
• Any study eye possessing clinically significant posterior capsular (PC) haze should 
undergo a YAG capsulotomy procedure prior to the adjustment. A minimum of 48 hours 

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should separate the YAG treatment from the corresponding refraction and LDD 
adjustment. 
 
7.3.2.2 Additional Clinical Testing 
Additional clinical testing may be performed on a subgroup of study subjects. The Principal 
Investigator may determine whether a subject will be included into a clinical test subgroup 
based on the adjustment light treatments to be performed. Clinical measurement subgroups 
will include: 
• Undilated photopic pupil diameter (Week 3, Post Lock-In, Month 3, Month 6 or later) 
• Binocular UCDVA, UCIVA, UCNVA (Week 3, Post Lock-In, Month 3, Month 6 or 
later) 
• Depth of Focus (Week 3, Lock-In #1, Post Lock-In, Month 3, Month 6 or later) 
• Monocular DCIVA, DCNVA, UCIVA, UCNVA (Week 3, Lock-In #1, Post Lock-In, 
Month 3, Month 6 or later) 
• Monocular Distance Corrected Contrast Sensitivity (Photopic/Mesopic) (Week 3, 
Post Lock-In, Month 3, Month 6 or later) 
• 
 
• Posterior Segment SD-OCT 
 
7.3.2.3 Procedure Preparation 
All eyes will be prepared for non-presbyopic adjustments with pupil dilation. All eyes will be 
prepared for presbyopic adjustments without pupil dilation. All lock-in light treatments will 
be administered through a dilated pupil. 
 
If dilation is required: 
The study eye will be dilated using any of the following pupil dilation drops (1.0% 
Tropicamide, 2.5% or 10% Phenylephrine, 0.5%, 1%, 2% Cyclopentolate) or pupil dilation 
gel (0.4% Ketorolac Tromethamine, 10% Phenylephrine, 2.5% Tropicamide). After waiting 
an appropriate amount of time for dilation to occur, the study eye will be examined to ensure 
that adequate dilation (enough of the edge of the LAL optic can be visualized to allow for 
centration during LDD light treatment) has been obtained. If adequate dilation has not been 
obtained, additional dilating drops with manual punctal occlusion or a sponge soaked in 
mydriatic medication and applied to the ocular surface can be utilized to try and gain further 
dilation. If adequate pupil dilation is still not achieved with the methods described above, the 
treatment will be rescheduled and the dilation attempted at another visit or another dilation 
method is used.  
Once adequate pupil dilation is achieved, patch the subject’s opposite eye and position the 
subject comfortably in front of the LDD with chin in the chinrest and forehead against the 
support bar. Ask the subject to grasp the handles on the LDD table for support. Inform the 
subject to concentrate on the green fixation light presented in front of them and to try and 
minimize eye movement. 

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If no dilation is required: 
The subject’s fellow eye will be patched and the subject will be comfortably positioned in 
front of the LDD with chin in the chinrest and forehead against the support bar. The subject 
is asked to grasp the handles on the LDD for support and is asked to look straight ahead and 
concentrate on the green fixation light presented in front of them and to try and minimize eye 
movement. 
 
7.3.2.4 Adjustment Procedure(s) 
Refer to the LDD Operator’s manual for instructions on LDD start up and instructions for the 
daily alignment test to be performed prior to the first treatment of the day to ensure the UV 
beam is aligned to the reticle. If the UV beam is not aligned to the reticle within the 
specifications detailed in the LDD Operator’s manual, do not perform treatments and call 
RxSight customer service immediately. 
1. Within the Patient ID and Patient Data screens, follow the touchscreen prompts to enter  
requested information. Press the “Proceed” button once information has been entered 
respectively for each screen. 
2. Within the Confirmation screen, review all information and press the “Confirm” button. 
3. Verify that the LDD ring lights and reticle target are activated. 
4. Apply topical anesthetic.   
5. Position the RxSight supplied contact lens (M = 0.766x, black contact lens) on the 
cornea using a Sponsor approved coupling medium.   
Note: The RxSight contact lens is similar to those used in other ophthalmic procedures 
in which customized magnification is required. To ensure correct magnification for 
treatment, use only the RxSight designated contact lens. 
6. Instruct the subject to focus straight ahead on the LDD fixation light with the study eye. 
7. Using the microscope, focus on the cornea and verify that there are no trapped bubbles 
present. Confirm alignment of the contact lens by approximately aligning the Purkinje 
images to the inner circle of the reticle target. 
8. For dilated pupil light treatments, using the microscope, focus on the LAL haptics and 
align the reticle target with the periphery of the LAL. Press the “Ready” button. Initiate 
the UV exposure as prompted by the LDD display using the trigger. Use the joystick to 
keep the LAL centered in the alignment reticle. Perform micro adjustments to keep the 
reticle target centered to the LAL and to keep the LAL in focus. In the case of subject 
movement, loss of alignment, or loss of focus, pause the treatment, quickly refocus, 
realign the lens with respect to the reticle beam, and immediately resume treatment to 
limit the duration of any pauses once the light treatment has been initiated.  
Note: Always maintain the LAL in focus by focusing at the haptics. Never focus onto 
the CCC (capsulotomy) or Purkinje images. 

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9. For undilated pupil light treatments, using the microscope, focus on the iris and align the 
reticle target with the pupil/iris edge landmark. Initiate the UV exposure as prompted by 
the LDD display using the joystick or foot pedal.  
10. If the event of an aborted Adjustment Treatment, do not initiate a new treatment 
sequence; instead; instruct the subject to return within the window of their next study 
visit for refractive evaluation to assess whether an adjustment treatment is required or to 
proceed directly to a lock-in treatment.    
11. The subject will return within the window of their next study visit for another light 
treatment. 
 
7.3.2.5 Lock-In Procedure(s) 
Refer to the LDD Operator’s manual for instructions on LDD start up and instructions for the 
daily alignment test to be performed prior to the first treatment of the day to ensure the UV 
beam is aligned to the reticle. If the UV beam is not aligned to the reticle within the 
specifications detailed in the LDD Operator’s manual, do not perform treatments and call 
RxSight customer service immediately. 
1. Within the Patient ID screen, utilize the pop-out menu within the Patient ID field to 
select the appropriate subject identification with eye to be treated. Reconfirm 
information displayed on screen and follow the touch screen prompts to enter in newly 
requested information. Press the “Proceed” button. 
2. Within the Confirmation screen, review all information and press the “Confirm” button. 
3. Verify that the LDD ring lights and reticle target are activated. 
4. Apply topical anesthetic.   
5. Position the RxSight supplied contact lens (M = 0.766x, black contact lens) on the 
cornea using a Sponsor approved coupling medium.   
Note: The RxSight contact lens is similar to those used in other ophthalmic procedures 
in which customized magnification is required. To ensure correct magnification for 
treatment, use only the RxSight designated contact lens. 
6. Instruct the subject to focus straight ahead on the LDD fixation light with the study eye. 
7. Using the microscope, focus on the cornea and verify that there are no trapped bubbles 
present. Confirm alignment of the contact lens by approximately aligning the Purkinje 
images to the inner circle of the reticle target. 
8. Using the microscope, focus on the LAL haptics and align the reticle target with the 
periphery of the LAL. 
9. Press the “Ready” button 
10. Initiate the irradiation delivery as prompted by the LDD display using the joystick or 
foot pedal to keep the LAL centered in the alignment reticle. 

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7.5 
CLINICAL PARAMETERS  
 
 
 
 
 
4. 
Demographics 
5. 
Ocular History 
6. 
History of Medications 
7. 
Subjective symptoms/complaints (subject reported) 
8. 
Ocular Biometry: Axial length + Anterior Chamber Depth 
9. 
Corneal Topography 
10. Autorefraction 
11. Undilated photopic pupil diameter 
12. Corneal Keratometry 
13. Vision Quality Measurement 
14. Anterior Segment OCT 
15. Posterior Segment SD-OCT 
16. Monocular uncorrected distance visual acuity (UCDVA) 
17. Binocular uncorrected distance visual acuity 
18. Manifest Refraction 
19. Monocular best corrected distance visual acuity (BCDVA) 
20. Ocular Dominance Test 
21. Depth of focus testing 
22. Monocular distance corrected intermediate visual acuity (DCIVA) 
23. Monocular distance corrected near visual acuity (DCNVA) 
24. Monocular uncorrected near visual acuity (UCNVA) 
25. Binocular uncorrected near visual acuity 
26. Binocular uncorrected intermediate visual acuity 
27. Monocular uncorrected intermediate visual acuity (UCIVA) 
28. In-office Eyrthropsia assessment 
29. City University Color Test 
30. Monocular Distance corrected contrast sensitivity: Mesopic/Photopic with+ w/o glare 
31. Intraocular pressure 
32. Slit lamp exam  
33. Fundus Exam 
34. Aberrometry 
35. Dilated pupil diameter 

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36. Adverse Event 

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7.6 
DATA REPORTING 
All study data will be recorded onto case report forms (electronic or paper) designed for the 
study. CRFs can be signed by the investigator either by paper signature or by electronic 
signature. The CRF may be the source document for some data and each site will document 
this with a note to file describing in which cases source data will be recorded directly onto 
the CRF. If paper CRFs are used, all CRFs will be completed in a legible manner in 
black/blue ink.  
Any corrections to the CRFs will be made by drawing a single line through the incorrect 
entry, recording the correct information, and initialing and dating the change.  The CRFs 
and/or data entered in the EDC system will be reviewed by the Study Monitor.  
All clinical data generated in the study will be submitted to RxSight or designated CRO for 
quality assurance review and statistical analysis.  All CRFs and/or data entered into the EDC 
system will be reviewed for completeness and evident recording errors will be rectified by 
contact with the appropriate clinical site.  Computerized data checks if applicable will be 
used to identify unusual data entries for verification prior to statistical analysis. 
To minimize the amount of missing data, investigators will be trained on the deleterious 
effect that missing data have on trial integrity and credibility and that missing data could 
diminish the scientific value of all subjects' altruistic contributions. 
 
7.7 
STUDY COMPLETION PROCEDURES 
A study Exit Form must be completed for all subjects enrolled in the study upon subject 
completion, withdrawal or discontinuation. 
 
 SUBJECT COMPLETION 
Subjects are considered to have completed the study if they have completed the Postop 
Month 6 or later visit.   
 
Subjects with ocular serious adverse events or adverse device effects that are unresolved at 
study exit should continue to be followed until resolution of the event or until they are stable 
per the investigator’s evaluation. 
 
 SUBJECT WITHDRAWAL PRIOR TO IMPLANTATION 
Subjects may be withdrawn from the study prior to implantation if they do not meet all 
inclusion/exclusion criteria (screen failures) or decide not to participate in the study.    
 
 

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 SUBJECT WITHDRAWEL DUE TO INTRAOPERATIVE COMPLICATIONS PRIOR TO 
IMPLANTATION 
Subjects that meet all inclusion/exclusion criteria but do not undergo implantation of a LAL 
IOL due to intraoperative complications prior to introduction of the LAL will be followed to 
resolution of any adverse events and then exited from the study. 
 
 SUBJECT DISCONTINUATION AFTER IMPLANTATION 
After LAL implantation, subjects may not be withdrawn from the study unless the LAL or 
LALs (in the case of bilaterally implanted subjects) have been explanted. In the case of an 
explant, the investigator should continue follow-up for a period that ensures no adverse 
consequences have resulted.  When possible, all necessary clinical assessments will be 
performed prior to the Subject exiting the study even if the assessment was not scheduled at 
that particular visit. 
 
Subjects may be discontinued from the study only if the LAL or LALs (in the case of 
bilaterally implanted subjects) have been explanted or subject has deceased.  The reason for 
discontinuation will be recorded on the appropriate study worksheet.  Subjects who are 
discontinued from the study will still be a part of the study analyses up until the point they 
are exited.   
  
 
 LOST TO FOLLOW-UP 
Subjects for which the final post-operative case report form is overdue and who refuse to be 
followed, or have difficulty being followed, or cannot be contacted despite extensive written 
and telephone follow-ups to determine the final clinical outcome, will be considered lost to 
follow-up. Sites must make a minimum of three documented attempts via telephone, email, 
or regular mail to contact the subject.  If the subject does not reply to any of these attempts, 
the site must send a letter by certified mail (with a request for notification of receipt of 
delivery) to the subject.  If a subject is non-responsive to these follow-up attempts, the 
subject will be considered to be lost to follow-up. 
 
 STUDY TERMINATION 
The study may be stopped at any time by the Sponsor(s) for reasonable cause with 
appropriate notification. Conditions that may warrant study termination include, but are not 
limited to the following: 
• Safety concerns. Clinical data from the study will be monitored to assure the safety of 
enrolled subjects. 
 
If the clinical study is prematurely terminated, the Sponsor will inform the Investigator, 
Ethics Committee, and other appropriate regulatory bodies. If the Sponsor terminates the 
study for safety reasons, it will immediately notify the Investigator, Ethics Committee, and 
other appropriate regulatory bodies and provide an explanation of the reasons for 
termination. The Investigator will be provided with instructions for study termination and 

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applicable subject follow-up. The Sponsor will continue to provide resources to fulfill the 
Clinical Study Plan obligations for follow-up of the subjects enrolled in the study. 
8 
STATISTICAL METHODS 
8.1 
POPULATIONS FOR ANALYSIS 
Exploratory effectiveness analyses will be performed on all eyes as specified. Clinical data 
for former CSP-037-MX study eyes may be analyzed separately. 
 
Safety analyses will be performed on observed data for all eyes of subjects who sign the 
informed consent and the procedure was attempted which is defined as the point at which the 
LAL makes contact with the eye. No imputation will be performed.  
 
 EXPLORATORY EFFECTIVENESS PARAMETERS 
Primary Exploratory Parameters 
Eyes that received only non-presbyopic adjustments. 
• % of eyes with UCDVA of 20/20 or better at Postop Month 6 or later 
 
Eyes that received a presbyopia adjustment. 
• Proportion of eyes simultaneously with  (1) Monocular UCDVA of 20/25 or better 
and (2) Monocular UCIVA of 20/32 or better and  (3) Monocular UCNVA of 20/40 
or better at Postop Month 6 or later.  
 
Clinical data for former CSP-037-MX study eyes may be analyzed separately. 
 
Additional Exploratory Parameters 
UCDVA 
Monocular and/or binocular UCDVA will be presented with the number and percent of eyes 
that fall into each category of visual acuity performance (e.g. 20/20 or better, 20/25 or better, 
20/32 or better, etc.) at each visit tested. Number and percent for eyes that only received non-
presbyopic adjustments and for eyes that received a presbyopia adjustment may be presented 
separately. In addition, clinical data for former CSP-037-MX study eyes may be analyzed 
separately. 
 
 
UCIVA, UCNVA, DCIVA, and DCNVA 
Monocular and/or binocular UCIVA, UCNVA, DCIVA, and DCNVA for eyes that received 
a presbyopia adjustment will be presented with the number and percent of eyes that fall into 
each category of visual acuity performance (e.g. 20/20 or better, 20/25 or better, 20/32 or 
better, etc.) at each visit tested. In addition, clinical data for former CSP-037-MX study eyes 
may be analyzed separately. 
 
Depth of Focus 

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9 
SEQUENCE OF PLANNED ANALYSES 
9.1 
INTERIM ANALYSES 
An interim analysis may be performed. Since there are no statistically based hypothesis 
driven endpoints or associated sample size, no multiplicity adjustment is needed. 
 
9.2 
FINAL REPORT 
When all enrolled study eyes have completed the Postop Month 6 or later visit or have been 
discontinued from the study, the data will be analyzed for a final study report.  
10 
ADVERSE EVENTS 
Throughout the study, adverse events are to be documented and reported on Adverse Event 
Forms (AE Forms) that are included in the study documentation. If an adverse event (AE) 
occurs, the first concern will be the safety and welfare of the subject; treatment should be 
provided as appropriate for the event. During the study, the Investigator should appropriately 
treat and follow each AE until it resolves, stabilizes, or it is determined that further 
improvement is not expected. Per Section 7.7.1, subjects with ocular serious adverse events 
or adverse device effects that are unresolved at study exit (Postop Month 6 or later) should 
continue to be followed until resolution of the event or until they are stable per the 
investigator’s evaluation. 
 
10.1 
ADVERSE EVENT (AE) DEFINITIONS  
 
An adverse event is 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. 
 
Note 1 to entry: This definition includes events related to the investigational medical device 
or the comparator. 
Note 2 to entry: This definition includes events related to the procedures involved. 
Note 3 to entry: For users or other persons, this definition is restricted to events related to 
investigational medical devices. 
The specific event should be reported as an AE: 
• An erythropsia score of 2 (red) at any time after the initial light treatment. 
 
10.2 
ADVERSE DEVICE EFFECT (ADE) DEFINITION 
Adverse event related to the use of an investigational medical device. 
 
Note 1: This definition includes adverse events resulting from insufficient or inadequate 
instructions for use, deployment, implantation, installation, or operation, or any malfunction 
of the investigational medical device. 

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Note 2: This definition includes any event resulting from use error or from intentional misuse 
of the investigational medical device. 
 
10.3 
DEVICE DEFICIENCY (DD) DEFINITION 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, 
safety or performance. Note: Device deficiencies include malfunctions, use errors, and 
inadequate labeling. 
 
10.4 
SERIOUS ADVERSE EVENT (SAE) DEFINITION 
Serious Adverse Events are AEs that lead to:  
• death  
• a serious deterioration in the health of the subject that:  
- results in a life-threatening illness or injury  
- results in a permanent impairment of a body structure or function (e.g., blindness)  
- requires in-subject hospitalization or prolongation of existing hospitalization  
- results in medical or surgical intervention to prevent permanent impairment to a 
body structure or a body function  
• fetal distress, fetal death, or a congenital abnormality or birth defect  
• a potentially sight-threatening condition 
• or is another important medical event.   
 
 IDENTIFICATION AND COLLECTION 
All AEs that occur during the study must be recorded in English on the adverse event Case 
Report Form. Each event must be on a separate form, regardless of whether one event may be 
secondary to another or from a single cause. Identification and collection of an AE begins 
after informed consent has been obtained and documented. Standard sources of identifying 
AEs include:  
• direct observation by the Investigator or study team member 
• asking the study participant a specific question (e.g., “Since your last visit, have you 
experienced any problems with your eyes or vision?”)  
• unsolicited volunteering of information by the study participant (e.g., “Doctor, I have 
had numerous headaches since I started using this lens.”)  
 
Ocular AEs and SAEs and systemic SAEs observed or elicited by the Investigator, reported 
by the subject, or resulting from a test result, etc., occurring during the clinical investigation 
must be documented. AE Forms are to be completed at the time of the event regardless of all 
data being available.   
 

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During the study, the Investigator should treat the study subject as appropriate to ensure 
his/her safety and welfare. Refer to Section 7.7.1 for additional information pertaining to 
ongoing AEs at subject exit.  
 
Pre-existing conditions will not be considered AE/SAEs but will be collected at the 
Preoperative Visit as medical history. A worsening of a pre-existing condition during the 
study should be documented as an AE and evaluated accordingly.  
 
Hospitalization is a criterion for assessment of seriousness. Hospitalization in the absence of 
a medical AE is not in itself an AE. For example, the following reports of hospitalization 
without a medical AE should not be considered either an SAE or an AE: 
• Planned hospitalization for a pre-existing condition without serious deterioration in 
health (e.g., planned knee replacement surgery)  
• Social admission (e.g., subject has no place to sleep)  
• Administrative admission (e.g., for yearly physical exam or elective procedures not 
related to the study)  
• Optional admission not associated with a precipitation medical AE (e.g., for elective 
cosmetic surgery)  
 
 EVALUATIONS 
When evaluating AEs, the Investigator must determine if the event is serious, assess the 
severity of symptoms, the relationship of the event to the device or study protocol, using the 
following guidelines:  
1. Severity  
Mild: subject awareness of a sign or symptom that is easily tolerated, requires no 
treatment, and does not interfere with subject’s daily activities  
Moderate: subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities, but can be relieved by 
simple therapeutic care  
Severe: a sign or symptom that interrupts the subject’s daily activity and requires 
systemic therapy or other treatment  
 
2. Relationship (Causality) to Study Device or Study Protocol  
Related:  There is at least a reasonable possibility that the AE/SAE is related to the 
study device or study protocol.  Reasonable possibility means that there is evidence to 
suggest a causal relationship between the study device or study protocol and the AE. 
Unrelated:  There is little or no reasonable possibility that the AE/SAE is related to 
the study device or study protocol.  This assessment implies that the AE/SAE has 
little or no temporal relationship to the study device and/or a more likely or certain 
alternative etiology exists. 
 

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 SAE/UNANTICIPATED ADVERSE DEVICE EFFECT (UADE)/UNANTICIPATED 
SERIOUS ADVERSE DEVICE EFFECT (USADE) REPORTING 
The site should report any event to the Sponsor and its representative in an expedited manner 
if it meets the criteria for an SAE and/or is an IOL explant from a study eye. Expedited 
reporting is calling or e-mailing the Sponsor and its representative within 48 hours of 
becoming aware of the event. Contact details are as follows: 
 
Email: jha@rxsight.com 
Tele: +1 949 521-7870 
 
When reporting an SAE to the Sponsor and/or its representative, the site should forward any 
supporting documents along with the SAE Report Form to the Sponsor and its designee 
within 5 days of the initial communication. Sites must also report the SAE to the reviewing 
Ethics Committee per its reporting procedures. 
 
An investigator shall submit to the Sponsor and to the reviewing IRB/EC a report of any 
Unanticipated Adverse Device Effect (UADE) occurring during an investigation as soon as 
possible, but in no event later than 10 working days after the investigator first learns of the 
effect or in accordance with National Regulations. As soon as notification of a potential 
UADE is received by the Sponsor, an investigation will be initiated to determine if the event 
is a UADE. If the event is confirmed to be a UADE, the regulatory authorities, all other 
participating Investigators and each reviewing IRB/EC must be notified within 10 working 
days of the initial report from the site, as applicable or in accordance with National 
Regulations. If it is determined that the UADE represents an unreasonable risk to study 
subjects, the study must be terminated within 5 working days following the decision, and no 
later than 15 working days after first learning of the UADE or in accordance with National 
Regulations. 
 
 DEVICE DEFICIENCY (DD) REPORTING 
All device deficiencies (DDs) should be reported to the Sponsor without unjustified delay. 
The Investigator is responsible for notifying the regulatory authorities and IRB/EC of DDs 
that could have led to a Serious Adverse Device Effect (SADE), if required by the national 
regulations or by the IRB/EC per each body’s reporting procedures. In the case of DDs that 
could have led to a SADE, the Sponsor will determine whether the risk analysis needs to be 
updated and assess whether corrective or preventative action is required.  
 
10.5 
PREGNANCY 
During the study, all female subjects of childbearing potential should be instructed to contact 
the investigator immediately if they suspect they might be pregnant (e.g., missed or late 
menstrual period).  Female subjects who become pregnant during the study will be followed 
until completion of pregnancy. Every effort will be made to obtain the health status of the 
mother and infant or fetus (in cases of miscarriage or therapeutic abortion) at term.  
Pregnancy itself is not considered an AE. 

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All confirmed pregnancies must be immediately reported to the Sponsor within 48 hours of 
the investigator’s awareness of the pregnancy.  
 
10.6 
POTENTIAL ADVERSE EVENTS 
The following have been identified as potential adverse events for all cataract surgeries 
including the LAL. Please notify the Sponsor regarding any events that may be occurring 
more frequently than your customary rates, or more frequently than expected at your site.  
 
Infection, inflammation, hypopyon, endophthalmitis, infectious keratitis, hyphema, retinal 
detachment or other retinal problems including cystoid macular edema and epiretinal 
membranes, toxic anterior segment syndrome, glaucoma, corneal endothelial damage, vitritis, 
corneal edema which may require correction with a corneal transplant, lens dislocation out of 
the posterior chamber, pupillary block, striation on the lens with or without visual sequelae, 
iritis, synechiae, ptosis, wound leak, flat anterior chamber, increased astigmatism, rupture of 
the capsule, iris prolapse, vitreous in the anterior chamber, and retained pieces of the lens in 
the eye. These adverse events may result in total loss of vision or the loss of an eye. 
Secondary surgery may be required after the cataract surgery to treat surgical complications. 
Additionally, a posterior capsulotomy may be required to treat posterior capsular haze after 
the cataract surgery. Visual problems after cataract surgery may include halos, glare, ghost 
images, and/or double vision.  These and other complications may result in permanent poor 
vision.    
 
Additional specific risks of the LAL include: 
The LAL must be implanted following specific surgical procedures. If these procedures are 
not followed by the surgeon, the lens may become scratched or improperly placed in the eye 
and may need to be explanted prior to light treatments. In order to perform the lens 
adjustment or the lens lock-in procedures, the subject’s pupil needs to be adequately dilated. 
If this cannot be accomplished for any reason, additional eye drops, injections into the eye, or 
surgery may need to be utilized to adequately dilate the pupil. If the pupil cannot be 
adequately dilated after these types of treatments, the LAL may need to be explanted. An 
unpredicted change in vision can occur resulting from ocular exposure to daylight or any 
other UV source before the LAL is locked-in. The light treatments may not improve vision 
and/or manifest refraction, and the adjustment/lock-in procedure may make vision worse, 
such that it may be necessary to remove and replace the LAL. Vision loss may be permanent 
and may not be improved by replacing the LAL. There is a potential risk for UV-induced 
damage to the eye, including the cornea and retina, which may be permanent. UV light can 
sometimes cause a reactivation of previous herpes virus infection in the eye. A reactivation 
of herpes virus can cause scarring of the cornea, blurred vision, eye pain, extreme light 
sensitivity, permanent loss of vision, and possible need for corneal transplant. Temporary or 
persistent erythropsia and/or temporary or persistent color vision deficiency may occur. 
Corneal dryness and corneal abrasions from the lens used for adjustment and lock-in can 
occur. After the lens adjustment(s) or after the lens lock-in procedures, discomfort, itching 
and light sensitivity may occur. In cases where a spherocylinder adjustment is performed, it 

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is possible that visual disturbances may occur if the IOL rotates or if the correction is not 
performed on the correct axis of astigmatism. 
 
 
10.7 
POTENTIAL BENEFITS 
The subject’s benefit from taking part in this study is the correction of the loss of vision from 
the natural cataract lens potentially without the need of glasses, contact lenses, or secondary 
surgical procedures for optimal distance or optimal distance, intermediate, and near vision.
 
 
11 
STUDY MONITORING 
RxSight clinical personnel or designated CRO will monitor all clinical studies in a manner 
consistent with any applicable health authority regulations and the clinical research standards 
adopted by RxSight. Study monitoring will involve the following elements:  
• Member(s) of RxSight’s Clinical Affairs Department or designated CRO may meet 
with investigators prior to the initiation of the study in order to review the adequacy 
of the subject population, facilities, and equipment with respect to the needs of the 
study, and to familiarize the investigator with the study protocol. This evaluation 
may be performed remotely.  
• A member of RxSight’s Clinical Affairs Department or designated CRO may meet 
with the investigator(s) at the time study subjects begin to be enrolled in order to 
ensure that subjects are being properly selected and that study data are being 
correctly recorded. These meetings and assessments may be performed remotely. 
• A member of RxSight or designated CRO may visit the clinical site at any time 
during the study to review study CRFs and/or data entered in the EDC system. 
Remote review of study worksheets, case histories and other data (including data 
with PHI) may be reviewed remotely. 
• Interim monitoring visits and telephone consultations will occur as necessary during 
the course of the study to ensure the proper progress and documentation of the study 
findings. Interim monitoring visits may be performed remotely; this includes remote 
review of study worksheets, case histories and other data which may contain PHI.  
• RxSight clinical personnel may visit the site at any time during the course of the 
study to observe implantation of the LAL and the adjustment and lock-in treatments 
to ensure that the procedures described in the protocol are being followed. Visits by 
RxSight clinical personnel may occur via video conferencing.  
• RxSight clinical personnel may also observe examination techniques used by study 
personnel to ensure that the procedures being utilized are the procedures described in 
Appendix 1 of the protocol. RxSight clinical personnel may also observe 
examination techniques via video conferencing. 
 
 

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12 
ETHICAL AND REGULATORY CONSIDERATIONS 
12.1 
SUBJECT INFORMATION AND CONSENT 
It is the responsibility of the Principal Investigator or authorized designee to give each 
subject prior to inclusion in the study full and adequate verbal and written information 
regarding the objective and procedures of the study and the possible risks involved.  The 
subjects will be informed about their right to refuse to participate in the study.  The written 
consent form will be given to each subject before enrollment.  It is the responsibility of the 
Principal Investigator to obtain a signed informed consent form and to ensure the subject is 
given a copy. 
 
The Principal Investigator or authorized designee needs to file the informed consent forms 
for review by RxSight study monitors.  The Investigator or authorized designee will 
acknowledge the receipt of the informed consent form from each subject by signing the 
appropriate pages of these documents. 
 
12.2 
DECLARATION OF HELSINKI 
The study will be performed in accordance with the relevant recommendations guiding 
physicians in biomedical research involving human subjects adopted by the 18th World 
Medical Assembly, Helsinki, Finland, 1964 and later revisions, as well as applicable U.S. 
Food and Drug Administration regulations (21 CFR Parts 50, 56, and 812).  
 
It is the responsibility of the Principal Investigator to obtain Institutional Review Board 
approval of the Study Protocol and to keep the IRB informed of serious side effects or 
adverse events and any amendments to the protocol. 
 
12.3 
ISO 14155:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN 
SUBJECTS- GOOD CLINICAL PRACTICE 
This study will be performed in compliance with ISO 14155:2011. 
 
12.4 
ADDITIONAL REGULATORY CONSIDERATIONS 
The proposed study is subject to all applicable governmental rules and regulations 
concerning the conduct of clinical trials on human subjects.  This includes, but is not 
necessarily limited to, the approval of an Ethics Committee; obtaining prospective informed 
consent; monitoring of the conduct of the study, the completeness of the study CRFs, and/or 
accuracy of data entered into the EDC system, as may be employed, by the Sponsor or its 
designee(s); and record retention by the Sponsor in accordance with Good Clinical Practice.  
 
12.5 
STUDY INITATION/CONDUCT 
The study will not commence until approval is obtained from the Ethics Committee. Any 
additional requirements imposed by the Ethics Committee shall be followed. 
 
12.6 
COMPLIANCE WITH THE CLINCIAL STUDY PROTOCOL 

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The Investigator shall conduct this clinical investigation in accordance with the signed 
agreement with the Sponsor, the investigational plan, and the applicable regulations. The 
Investigator shall avoid improper influence on or inducement of the subject, Sponsor, 
Monitor, other Investigator(s) or other parties participating in or contributing to the clinical 
investigation.  
 
12.7 
PROTOCOL DEVIATIONS (PDS) 
Protocol deviations should be avoided.  Any deviation from the protocol will be recorded on 
a Case Report Form together with an explanation for the deviation.  Deviations should be 
reported to the Sponsor, who is responsible for analyzing them and assessing their 
significance. 
 
Deviations should be reviewed to determine the need to amend the protocol or to terminate 
the investigation. 
 
NOTE:  When relevant, Ethics Committees and Competent Authorities or the appropriate 
regulatory bodies will be informed of protocol deviations. 
 
 
12.8 
PROTOCOL AMENDMENTS 
Modification of the protocol is prohibited without prior written agreement in the form of a 
protocol amendment. All amendments will be created by the Sponsor and must be approved 
by the Ethics Committee or other regulatory bodies as needed prior to implementation except 
when required to mitigate immediate safety risks or when the changes involve only logistical 
or administrative revisions. All protocol amendments must be clearly summarized to outline 
the changes that were made. 
 
12.9 
PUBLICATION POLICY 
The final report of the study will be available to the ethics committee and the investigator as 
requested. The study results may be submitted for publication in peer-reviewed journals as 
well as presented at scientific meetings and congresses where all identifiable data will be 
anonymized. 
 
12.10 INSURANCE AND INDEMNITY 
The Sponsor shall ensure that acceptable insurance and indemnification is in place prior to 
enrollment of the first study subject.

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13 
REFERENCES 
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2. Cummings A. The Influence of Age on Refractive Cataract Surgery. CRSTEurope. 
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3. Gollogly H, Hodge D, St. Sauver J, Erie J. Increasing incidence of cataract surgery: 
Population –based study. J Cataract Refract Surg 2013; 39:1383-1389. 
4. Arlt EM, Krall EM, Moussa S, Grabner G, Dexl A. Implantable inlay devices for 
presbyopia: the evidence to date. Clin Ophthalmol. 2015 Jan 14;9:129-137. 
5. American Optometric Association. Care of the patient with presbyopia. St. Louis 
(MO): American Optometric Association; 2010. 
6. McDonnell PJ, Lee P, Spritzer K, Lindblad AS, Hays RD. Association of presbyopia 
with vision-targeted health-related quality of life. Arch Ophthalmol. 
2003;121(11):1577-1581. 
7. Labiris G, Giarmoukakis A, Patsiamanidi M, et al. Mini-monovision versus 
multifocal intraocular lens implantation. J Cataract Refract Surg 2015; 41:53-57. 
8. McAlinden C, Pesudovs K, Moore JE. The Development of an Instrument to Measure 
Quality of Vision: The Quality of Vision (QoV) Questionnaire. Invest Ophthalmol 
Vis Sci. 2010;51:5537-5545.