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
Conditions: Aphakia, Cataract
Sponsor: RxSight, Inc.

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PROTOCOL CSP-032 
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 
Sponsor: RxSight, Inc. 
100 Columbia, Suite 120 
Aliso Viejo, CA 92656 
April 09, 2019 
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 
NCT03895034

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TABLE OF CONTENTS 
PAGE 
1 
STUDY SYNOPSIS .....................................................................................................0 
2 
INTRODUCTION AND RATIONALE .....................................................................8 
2.1 
CLINICAL STUDIES PERFORMED WITH THE LIGHT ADJUSTABLE LENS AND
LIGHT DELIVERY DEVICE .................................................................................10 
3 
STUDY OBJECTIVE ................................................................................................12 
4 
STUDY DESIGN ........................................................................................................12 
5 
OUTCOME PARAMETERS ...................................................................................13 
SAFETY PARAMETERS .................................................................................................13 
6 
STUDY POPULATION ............................................................................................14 
6.1 
REQUIRED INCLUSION CRITERIA ......................................................................14 
6.2 
OPTIONAL INCLUSION CRITERIA ......................................................................14 
6.3 
REQUIRED EXCLUSION CRITERIA .....................................................................14 
7 
STUDY MATERIALS AND METHODS ................................................................15 
7.1 
DEVICE DESCRIPTION ........................................................................................15 
RxSight Light Adjustable Intraocular Lens ......................................15 
Light Delivery Device (LDD) ...............................................................16 
Device Manufacturer ...........................................................................17 
RxSight Insertion Device .....................................................................17 
Indications for Use ...............................................................................17 
7.2 
SUBJECT ENTRY .................................................................................................17 
7.3 
LAL IMPLANTATION AND REFRACTIVE ADJUSTMENT ....................................18 
Surgical Procedure ...............................................................................18 
Light Treatment Procedure .................................................................19 
7.4 
EXAMINATION SCHEDULE .................................................................................24 
7.5 
CLINICAL PARAMETERS ....................................................................................25 
7.6 
DATA REPORTING ..............................................................................................28 
7.7 
STUDY COMPLETION PROCEDURES ..................................................................29 
Subject Completion ..............................................................................29 
Subject Withdrawal Prior to Implantation .......................................29 
Subject Withdrawal due to intraoperative complications 
prior to  Implantation ..........................................................................29 
Subject Discontinuation After Implantation .....................................29 
Lost to Follow-Up .................................................................................30 
Study Termination ...............................................................................30 

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8 
STATISTICAL METHODS .....................................................................................31 
8.1 
POPULATIONS FOR ANALYSIS .............................................................................31 
Exploratory Effectiveness Parameters ...............................................31 
8.2 
SAFETY PARAMETERS ........................................................................................31 
Additional Safety Analyses ..................................................................32 
9 
SEQUENCE OF PLANNED ANALYSES ..............................................................32 
9.1 
INTERIM ANALYSES ...........................................................................................32 
9.2 
FINAL REPORT ...................................................................................................32 
10 
ADVERSE EVENTS .................................................................................................33 
10.1 ADVERSE EVENT (AE) DEFINITIONS .................................................................33 
10.2 ADVERSE DEVICE EFFECT (ADE) DEFINITION ..................................................33 
10.3 DEVICE DEFICIENCY (DD) DEFINITION ............................................................33 
10.4 SERIOUS ADVERSE EVENT (SAE) DEFINITION .................................................33 
Identification and Collection ...............................................................34 
Evaluations ............................................................................................35 
SAE/Unanticipated Adverse Device Effect 
(UADE)/Unanticipated Serious Adverse Device Effect 
(USADE) Reporting .............................................................................35 
Device Deficiency (DD) Reporting ......................................................36 
10.5 PREGNANCY .......................................................................................................36 
10.6 POTENTIAL ADVERSE EVENTS ..........................................................................36 
10.7 POTENTIAL BENEFITS ........................................................................................37 
11 
STUDY MONITORING ...........................................................................................38 
12 
ETHICAL AND REGULATORY CONSIDERATIONS ......................................39 
12.1 SUBJECT INFORMATION AND CONSENT ............................................................39 
12.2 DECLARATION OF HELSINKI .............................................................................39 
12.3 ISO 14155:2011 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR
HUMAN SUBJECTS- GOOD CLINICAL PRACTICE ..............................................39 
12.4 ADDITIONAL REGULATORY CONSIDERATIONS ................................................39 
12.5 STUDY INITATION/CONDUCT .............................................................................39 
12.6 COMPLIANCE WITH THE CLINCIAL STUDY PROTOCOL ....................................39 
12.7 PROTOCOL DEVIATIONS (PDS) .........................................................................40 
12.8 PROTOCOL AMENDMENTS .................................................................................40 
12.9 PUBLICATION POLICY .......................................................................................40 
12.10 INSURANCE AND INDEMNITY .............................................................................40 
13 
REFERENCES ...........................................................................................................41 

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PROTOCOL # CSP-032 
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RXSIGHT, INC. 
PROTOCOL NO. CSP-032 
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 identified. 
STUDY POPULATION  
The study population will consist of up to 200 eyes in up to 200 subjects (one or two eyes per 
subject).  
STUDY DESIGN 
A prospective, controlled, single center, exploratory clinical study will be conducted. 
Subjects will be followed until the completion of a Postop Month 3 or later visit. Subjects 
who were enrolled under protocol version 05 will be reconsented prior to undergoing a 
Postop Month 3 or later visit. Subjects who were enrolled under protocol version 05 and 
exited from the study after their Postop Months 1-2 visit will be reconsented prior to 
undergoing the Postop Month 3 or later visit. 
Patients who require cataract extraction and intraocular lens implantation will be screened for 
eligibility. If one or both eyes meet inclusion/exclusion criteria, study staff will explain the 
study purpose, procedures, risks/benefits and subject responsibilities to the potential 
participant. Written informed consent will be obtained prior to any study specific testing. The 
patient is enrolled upon signing the informed consent. 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. 
Commencing at the Postop Week 3 visit, all eyes will receive two to three adjustments and 
one to two lock-in treatments. Each light treatment will be separated by 3 to 7 days. 
 
ostoperatively, all subjects will undergo 
complete ophthalmic examinations at regular intervals. 
For subjects that receive only spherical/sphero-cylindrical adjustments, distance visual 
acuities will be presented and summarized. For subjects that receive a presbyopia adjustment, 
distance, intermediate, and near visual acuities and depth of focus (DOF) curves will be 

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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 3-9 months. Time of participation is dependent 
on the date of the Postop Month 3 or later visit. The recruitment phase is expected to last 
approximately 12 months. The complete study period is expected to be 14 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. 
Both eyes of all subjects should be screened for eligibility. If at any time during the 
screening, an eye does not meet inclusion or exclusion criteria, screening for that eye will be 
discontinued.  
REQUIRED INCLUSION CRITERIA 
•
Must sign a written Informed Consent form and be willing to undergo cataract
surgery for unilateral or bilateral implantation of the LAL.
•
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed.
•
Study eye must have 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.
•
Study eye must have BCDVA projected (by clinical estimate based upon past ocular
history or retinal exam) to be 20/20 or better after cataract removal and IOL
implantation.
•
If only one eye of a subject is enrolled, the non-study eye must have the potential for
BCDVA of 20/40 or better.
•
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 a dilated pupil diameter of ≥7.0 mm.
•
Study eye has an undilated distance viewing pupil diameter >2.5 mm.
•
Study eye requires an IOL power within the range available for the LAL.
OPTIONAL INCLUSION CRITERIA 
•
Study eye was previously enrolled within clinical study CSP-026 sponsored by
RxSight, Inc.

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REQUIRED EXCLUSION CRITERIA 
•
Serious co-morbid conditions that in the judgment of the investigator makes inclusion
in the study not in the best interest of the subject.
•
Study eye with pseudoexfoliation.
•
Study eye with diabetes with any evidence of retinopathy.
•
Study eye with evidence of glaucomatous optic neuropathy.
•
Study eye with history of uveitis.
•
Study eye with significant anterior segment pathology, such as rubeosis iridis,
aniridia, or iris coloboma.
•
Study eye with corneal pathology or corneal dystrophy that is either progressive or
sufficient to reduce BCDVA to worse than 20/20.
•
Study eye with clinically significant dry eye syndrome (DES).
•
Study eye with keratoconus or suspected of having keratoconus.
•
Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive
keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens
(ICL), Corneal Inlay, intraocular surgery, or with previous pterygium excision unless
the pterygium did not extend more than 2mm onto the cornea from the limbus.
•
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.
•
Study eye with irregular astigmatism.
•
Study eye with a history of ocular herpes simplex virus.
•
Subjects who the doctor believes will be unable to maintain steady fixation that is
necessary for centration of the LDD light treatment.
•
Study eye with previous trauma or developmental defects in which appropriate
support of the intraocular lens (IOL) is not possible.
•
Study eye with current vitreoretinal disease or are at a high risk for future
vitreoretinal disease that may require silicone oil as part of therapy.

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OUTCOME PARAMETERS 
RxSIGHT, INC. 
The following visual perfo1mance parameters will be collected and summarized for subjects 
that received only spherical/sphere-cylindrical adjustments. 
•
% of eyes with UCDV A of 20/20 or better at Postop Month 1-2 and the Postop
Month 3 or later visit
The following visual performance parameters will be collected and summarized for subjects 
that were bilaterally implanted with the LAL and received a presbyopia adjustment. 
•
Proportion of subjects simultaneously with (I) Binocular UCDV A of 20/20 or
better and (2) Binocular UCIV A of 20/25 or better and (3) Binocular UCNV A of
20/40 or better at Postop Month 1-2 and the Postop Month 3 or later visit
•
Change in pseudoaccommodation (D) at Postop Month 1-2 and the Po stop Month 3
or later visit from pre-light adjustment at Postop Week 3
Additional analyses may be perfo1med. Clinical data for subjects receiving only 
spherical/sphere-cylindrical adjustments and subjects receiving a presbyopia adjustment will 
be summarized and analyzed separately. 
Safety Parameters: 
•
fucidence of cumulative ocular serious adverse events defined per ISO 11979-7.
The incidence of all other adverse events will also be presented. 
Subjects who agree to paiticipate in the study will return for the listed follow-up 
examinations for each study eye: 
Examination Schedule: 
Evaluation 
Preoperative 
Day -60 to Day -1 
Operative 
Day 0, day of surge1y 
Postop Day 1 
Days 1 to 2 postop 
Postop Week 3 
Days 17 to 24 postop: Adjustment #1 
Adjustment #2, if needed 
3 to 7 days post Adjustment #1 
Adjustment #3, if needed 
3 to 7 days post Adjustment #2 
Lock-in #1 
3 to 7 days post final adjustment 
Lock-in #2, if needed 
3 to 7 days post lock-in #1 
Postop Month 1-2 
7 to 14 days post final lock-In 
Postop Month 3 or later 
2:90 days postop 
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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.  
  
Clinical Parameters:  
 
2. Demographics 
3. Ocular history including medications 
4. Subjective symptoms/complaints (subject reported) 
5. Compliance with UV spectacles 
6. Ocular Biometry: ACD and axial length (Optical biometry) 
7. Corneal Topography 
8. Autorefraction 
9. Corneal Keratometry 
10. Vision Quality Measurement 
11. Undilated Distance Viewing Pupil Diameter 
12. Binocular UCDVA 
13. Monocular uncorrected distance visual acuity (UCDVA) 
14. Manifest Refraction 
15. Monocular best corrected distance visual acuity (BCDVA) 
16. Ocular Dominance Test 
17. Pseudo accommodation testing 
18. Mesopic binocular distance corrected contrast sensitivity testing 
19. Mesopic monocular distance corrected contrast sensitivity testing 
20. Photopic binocular distance corrected contrast sensitivity testing 
21. Photopic monocular distance corrected contrast sensitivity testing 
22. Monocular distance corrected 10% low contrast intermediate visual acuity (photopic 
only) 
23. Monocular distance corrected intermediate visual acuity (DCIVA) 
24. Monocular distance corrected intermediate visual acuity (DCIVA) with +1.50 D add 
25. Monocular uncorrected intermediate visual acuity (UCIVA) 
26. Binocular UCIVA 
27. Undilated Intermediate Viewing Pupil Diameter 
28. Monocular distance corrected 10% low contrast near visual acuity (photopic only)  
29. Monocular distance corrected near visual acuity (DCNVA) 
30. Monocular distance corrected near visual acuity (DCNVA) with a +2.50 D add 
31. Monocular uncorrected near visual acuity (UCNVA) 
32. Binocular UCNVA 
33. Undilated Near Viewing Pupil Diameter 

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35. Intraocular pressure 
36. Slit Lamp Examination 
37. Fundus Exam 
38. Aberrometry  
39. Dilated pupil diameter 
40. Adverse Events 
 

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ABBREVIATIONS AND DEFINITION OF TERMS 
ACD 
Anterior Chamber Depth 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
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 
DES 
Dry Eye Syndrome 
DOF 
Depth of Focus 
EC 
Ethics Committee 
EDC 
Electronic Data Capture 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
IDE 
Investigational Device Exemption 
IOL 
Intraocular Lens 
IOP 
Intraocular Pressure 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
LAL 
RxSight Light Adjustable Lens 
LDD 
Light Delivery Device 
MR 
Manifest Refraction 
MRSE 
Manifest Refraction Spherical Equivalent 
PCO 
Posterior Capsular Opacity 
PMA 
Premarket Application 
PMMA 
Polymethylmethacrylate 
PPC 
Precision Pulse Capsulotomy 
 
 
SAE 
Serious Adverse Event 
SE 
Spherical Equivalent 

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SPK 
Superficial Punctate Keratitis 
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. 
 
                                                 
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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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 
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        
 
 
 
  
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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2.1 
CLINICAL STUDIES PERFORMED WITH THE LIGHT ADJUSTABLE LENS AND LIGHT
DELIVERY DEVICE 
US Phase III Study Conducted Under IDE G100240 
A 600 eye prospective, randomized, controlled, multi-center clinical trial of the LAL and 
LDD designed to evaluate safety and effectiveness over a 12-month period was conducted at 
17 sites. In addition to the visual correction of aphakia, reduction in residual 
spherocylindrical refractive error and improvement in uncorrected visual acuity were 
evaluated following LAL implantation and subsequent refractive adjustment of the LAL by 
the LDD.  
Eyes with ≥0.75 and ≤2.5 diopters (D) of keratometric cylinder were randomly assigned to 
receive either the LAL or a commercially available, posterior chamber, non-accommodating, 
control monofocal IOL. Six hundred eyes were implanted with 403 eyes randomized to the 
LAL group and 197 eyes to the Control group. 
Co-primary effectiveness endpoints included percent reduction in manifest cylinder, percent 
mean absolute reduction in manifest refraction spherical equivalent (MRSE), and rotation of 
the LAL. All primary effectiveness endpoints compared pre-adjustment (LAL) or 17-21 days 
(Control) to 6 months postoperatively and the first two endpoints compared results between 
the LAL and Control groups. All three co-primary effectiveness endpoints were met with a p-
value <0.0001. The difference in means for percent reduction in manifest cylinder was 
54.7%, with a p-value <0.0001. The difference in means for percent reduction in absolute 
MRSE was 41.1% with a p-value <0.0001. Rotation of the LAL of ≤5 degrees was observed 
in 96.1% of LAL implanted eyes with both the upper and lower bound of the 95% confidence 
interval exceeding the requirement of 90%.  
100% of eyes in both the LAL and Control groups had BSCVA of 20/40 or better, exceeding 
the historic grid rate of 92.5% (ISO 11979-7). The incidence of sight-threatening 
complications and adverse events for the LAL and Control groups were also below the 
threshold rates calculated from the 1-year historical grid for intraocular lenses (ISO 11979-7, 
Ophthalmic implants- Intraocular lenses- Part 7: Clinical investigations) except for the 
category of Secondary Surgical Interventions (SSI), which was significantly higher than the 
historical rate (p<.05). 
On November 22, 2017, the Center for Devices and Radiological Health (CDRH) of the Food 
and Drug Administration (FDA) approved RxSight’s premarket approval application (PMA) 
for the Light Adjustable Lens (LAL) and Light Delivery Device (LDD) system. This 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

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The system also reduces the likelihood of clinically significant residual spherical refractive 
errors. 
 
 
 
 
 
 
 
 
 
 
8 Hengerer FH, Bocker J, Dick BH, Conrad-Hengerer I. Light adjustable lens. New options for customized correction of 
presbyopia. Ophthalmologe. 2012 Jul; 109(7): 676-82. 

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3 
STUDY OBJECTIVE 
RxSIGHT, INC. 
The objective of this study is to evaluate, for the visual co1Tection of aphakia, whether the 
RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) can be used to 
improve visual outcomes after perfo1ming adjustments of the LAL with the LDD. This is an 
explorato1y study. No primaiy effectiveness endpoints will be identified. 
4 
STUDY DESIGN 
A prospective, controlled, single center, explorat01y clinical study will be conducted. 
Subjects will be followed until the completion of a Postop Month 3 or later visit. Subjects 
who were enrolled under protocol version 05 will be reconsented prior to undergoing a 
Postop Month 3 or later visit. Subjects who were enrolled under protocol version 05 and 
exited from the study after their Postop Months 1-2 visit will be reconsented prior to 
undergoing the Postop Month 3 or later visit. 
Patients who require cataract extraction and intraocular lens implantation will be screened for 
eligibility. If one or both eyes meet inclusion/exclusion criteria, study staff will explain the 
study pmpose, procedmes, risks/benefits and subject responsibilities to the potential 
paiticipant. Written infonned consent will be obtained prior to any study specific testing. The 
patient is enrolled upon signing the info1med consent. If both eyes of the subject are enrolled 
for study pruticipation, each eye will be scheduled for smgery within a timeframe of the 
investigator's choice but on sepru·ate days. 
Commencing at the Po stop Week 3 visit, all eyes will receive two to three adjustments ai1d 
one to two lock-in treatments. Each light treatment will be sepru·ated by 3 to 7 days. 
 
 
 
Postoperatively, all subjects will undergo complete ophthalmic exruninations at regulai· 
intervals. 
For subjects that receive only spherical/sphero-cylindrical adjustments, distance visual 
acuities will be presented and summarized. For subjects that receive a presbyopia adjustment, 
distance, inte1mediate, and neru· visual acuities and depth of focus (DOF) cmves will be 
presented and smnmai·ized. Additional analyses may be perfo1med. Safety for all study eyes 
will be evaluated per ISO 11979-7. 
DURATION OF STUDY 
Each subject will paiticipate in the study for 3-9 months. Time of 
on the date of the Posto Month 3 or later visit. 
STUDY SITE 
The study will be perfo1med in an ophthalmology clinic. The investigator will be an 
ophthalmic surgeon, specializing in cataract surge1y with implantation of intraocular lenses. 
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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. 
5 
OUTCOME PARAMETERS 
The following visual performance parameters will be collected and summarized for subjects 
that received only spherical/sphero-cylindrical adjustments. 
•
% of eyes with UCDVA of 20/20 or better at Postop Month 1-2 and the Postop
Month 3 or later visit.
The following visual performance parameters will be collected and summarized for subjects 
that were bilaterally implanted with the LAL and received a presbyopia adjustment. 
•
Proportion of subjects simultaneously with (1) Binocular UCDVA of 20/20 or
better and (2) Binocular UCIVA of 20/25 or better and (3) Binocular UCNVA of
20/40 or better at Postop Month 1-2 and the Postop Month 3 or later visit.
•
Change in pseudoaccommodation (D) at Postop Month 1-2 and the Postop Month 3
or later visit from pre-light adjustment at Postop Week 3
Additional analyses may be performed. Clinical data for subjects receiving only 
spherical/sphero-cylindrical adjustments  and subjects receiving a presbyopia adjustment will 
be summarized and analyzed separately. 
SAFETY PARAMETERS
•
Incidence of cumulative ocular serious adverse events defined per ISO 11979-7.
The incidence of all other adverse events will also be presented. 

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6 
STUDY POPULATION 
The study population will consist of up to 200 eyes in up to 200 subjects (one or two eyes per 
subject).  
 
Both eyes of all subjects should be screened for eligibility. If at any time during the 
screening, an eye does not meet inclusion or exclusion criteria, screening for that eye will be 
discontinued.  
 
6.1 
REQUIRED INCLUSION CRITERIA 
• Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for unilateral or bilateral implantation of the LAL. 
• 
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. 
• 
Study eye must have 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. 
• 
Study eye must have BCDVA projected (by clinical estimate based upon past ocular 
history or retinal exam) to be 20/20 or better after cataract removal and IOL 
implantation. 
• 
If only one eye of a subject is enrolled, the non-study eye must have the potential for 
BCVDA of 20/40 or better. 
• 
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 a dilated pupil diameter of ≥7.0 mm.  
• 
Study eye has an undilated distance viewing pupil diameter >2.5 mm. 
• 
Study eye requires an IOL power within the range available for the LAL. 
 
6.2 
OPTIONAL INCLUSION CRITERIA 
• 
Study eye was previously enrolled within clinical study CSP-026 sponsored by 
RxSight, Inc. 
 
6.3 
REQUIRED EXCLUSION CRITERIA 
• 
Serious co-morbid conditions that in the judgment of the investigator makes inclusion 
in the study not in the best interest of the subject. 
• 
Study eye with pseudoexfoliation. 
• 
Study eye with diabetes with any evidence of retinopathy.   
• 
Study eye with evidence of glaucomatous optic neuropathy.    
• 
Study eye with history of uveitis.    
• 
Study eye with significant anterior segment pathology, such as rubeosis iridis, 
aniridia, or iris coloboma. 

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•
Study eye with corneal pathology or corneal dystrophy that is either progressive or
sufficient to reduce BCDVA to worse than 20/20.
•
Study eye with clinically significant dry eye syndrome (DES).
•
Study eye with keratoconus or suspected of having keratoconus.
•
Study eye with prior history of Intacs, Radial keratotomy (RK), Conductive
keratoplasty (CK), Astigmatic keratotomy (AK), Phakic Implantable Collamer Lens
(ICL), Corneal Inlay, intraocular surgery, or with previous pterygium excision unless
the pterygium did not extend more than 2mm onto the cornea from the limbus.
•
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.
•
Study eye with irregular astigmatism.
•
Study eye with a history of ocular herpes simplex virus.
•
Subjects who the doctor believes will be unable to maintain steady fixation that is
necessary for centration of the LDD light treatment.
•
Study eye with previous trauma or developmental defects in which appropriate
support of the intraocular lens (IOL) is not possible.
•
Study eye with current vitreoretinal disease or are at a high risk for future
vitreoretinal disease that may require silicone oil as part of therapy.
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 optic design also features a UV filtering posterior surface layer, to further enhance 
the UV absorbing properties of the LAL lens and limit retinal exposure.  
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 

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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. The change in the shape becomes permanent when the remaining 
photoreactive additive is consumed following application of a non-profiled beam of the same 
ultraviolet light. 
LIGHT DELIVERY DEVICE (LDD) 
RxSight’s Light Delivery Device (LDD) is a UV light projection system (Figure 1) 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. 
FIGURE 1:  RXSIGHT LIGHT DELIVERY DEVICE (LDD) 

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DEVICE MANUFACTURER 
The LAL and LDD are manufactured by RxSight, Inc. located in Aliso Viejo, California 
(FDA Establishment Registration No. 3012712027). 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.
The Sponsor will keep records to document the physical location of all investigational 
devices from shipment to the investigational sites until use, return or disposal. Traceability 
for both the LAL and LDD will be achieved by use of device serial numbers.  
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return, and disposal of the investigational devices, which shall include: 
•
The date of receipt
•
Identification of each investigational device (batch number/serial number or unique
code),
•
The expiry date, if applicable,
•
The date or dates of use,
•
Subject identification
•
Date on which the investigational device was returned/explanted from subject, if
applicable, and
•
The date of return of unused, expired or malfunctioning investigational devices, if
applicable.
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 

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Patients who require cataract extraction and intraocular lens implantation will have both eyes 
screened for eligibility. If one or both eyes meet inclusion/exclusion criteria, study staff will 
explain the study purpose, procedures, risk/benefits and subject responsibilities to the 
potential participant. Written informed consent will be obtained prior to any study specific 
testing. 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. 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. 
The implant lens power for the LAL will be calculated based upon the ocular biometry data 
and a lens power formula of the surgeon’s choice. A postoperative spherical equivalent (SE) 
outcome of the physician’s choice will be targeted. 
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 3 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

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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. Nichamin III Foldable Lens Inserter (Rhein Medical 05-2349) with the
Nichamin II Foldable Lens Insertion Forceps (Rhein Medical 05-2348)
through a temporal clear corneal incision of 3.5-3.8 mm
c.
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.
12. The subject will be provided with two pairs of RxSight approved UV protective
spectacles (one clear and one tinted) to protect the implanted LAL from extraneous
sources of UV light. It is important to direct the subject to follow all instructions that are
provided with the UV protective spectacles.
If a patch was used at the conclusion of surgery, the subject will wait for the surgeon to
remove the patch. Once removed, the subject will begin wear of the UV protective
eyewear as instructed.
LIGHT TREATMENT PROCEDURE 
Seventeen (17) to 24 days after surgery, the subject will return for the Postop Week 3 
evaluation and a 1st adjustment treatment of the LAL. Subsequent second and third 
adjustment treatments, if necessary, will all be separated by 3-7 days. The subject will 
receive the 1st lock-in treatment 3-7 days after the final adjustment treatment. If necessary, 
lock-in #2 may be performed 3-7 days after lock-in #1. Depending on the adjustment(s) 
performed, all eyes will receive two to three adjustments and one or two lock-in treatments. 
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; 

PROTOCOL# CSP-032 
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RxSIGHT, INC. 
•
Best Conected Distance Visual Acuity: With any loss ofBCDVA (unless the cause is
known to be non-retinal) of 10 letters or more on an ETD RS (logMAR) chart compared
to the Postop Week 3 BCDVA, treatment should be delayed.
•
If sutures were utilized at the time of surge1y to close the incision wound, light
treatments should not commence on the study eye until a minimum of 4 weeks after
suture removal. 9
•
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, and endophthalmitis.
•
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 instmctions. (see-for additional details regarding premature
photopolymerization).
•
Any study eye possessing clinically significant posterior capsular (PC) haze should
undergo a Y AG capsulotomy procedure prior to the adjustment. A minimum of 48 homs
should separate the Y AG treatment from the conesponding refraction and LDD
adjustment.
7.3.2.2 Additional Clinical Testing 
 
 
•
Monocular and/or binocular contrast sensitivity (photopic/mesopic) at the Postop
Month 1-2 visit and Postop Month 3 or later visit.
•
Monocular and binocular inte1mediate and near visual acuity measurements at the
Adjustment #2 and Adjustment #3 visits
7.3.2.3 Procedure Preparation 
 
9 Azar D, Stark W, Dodick J, et al. Prospective, randomized vector analysis of astigmatism after three-, one-, and no-suture
phacoemulsification. J Cataract Refract Surg 1997; 23:1164-1173. 
Page 20 of 60

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If dilation is required: 
u il dilation dro s-
or pupil dilation 
. After waiting 
an appropnate amount o tune or 1 ation to occur, t e stu y eye w1 
e 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 tiy and gain finther 
dilation. If adequate pupil dilation is still not achieved with the methods described above, the 
ti·eatment 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 comfo1tably in front of the LDD with chin in the chinrest and forehead against the 
suppo1t bar. Ask the subject to grasp the handles on the LDD table for support. Info1m the 
subject to concentrate on the green fixation light presented in front of them and to tiy and 
minimize eye movement. 
If no dilation is required: 
The subject's fellow eye will be patched and the subject will be comfo1tably positioned in 
front of the LDD with chin in the chimest and forehead against the support bar. The subject 
is asked to grasp the handles on the LDD for suppo1t and is asked to look straight ahead and 
concentrate on the green fixation light presented in front of them and to t1y and minimize eye 
movement. 
7.3.2.4 Adjustment Procedure(s) 
Refer to the LDD Operator's manual for instructions on LDD strut up and instiuctions for the 
daily alignment test to be perfo1med prior to the first ti·eatment 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 perfo1m treatments and call 
RxSight customer service immediately. 
1. All adjustment procedure(s) will be recorded.
Page 21 of 60

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2. Within the Patient ID and Patient Data screens, follow the touchscreen prompts to enter
requested info1mation. Press the "Proceed" button once info1mation has been entered
respectively for each screen.
3. Within the Confnmation screen, review all info1mation and press the "Confnm" button.
4. Verify that the LDD ring lights and reticle target are activated.
5. Apply topical anesthetic.
6. 
on the 
cornea usmg 
Note: The RxSight contact lens is similar to those used in other ophthalmic procedures 
in which customized magnification is required. To ensure conect magnification for 
treatment, use only the RxSight designated contact lens. 
7. Instmct the subject to focus straight ahead on the LDD fixation light with the study eye.
8. Using the microscope, focus on the cornea and verify that there are no trapped bubbles
present. Confnm alignment of the contact lens by approximately aligning the Purkinje
images to the inner circle of the reticle target.
9. For dilated pupil light treatments, using the microscope, focus on the LAL haptics and
align the reticle target with the periphe1y 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. Perfo1m 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.
10.
11. If the event of an aborted Adjustment Treatment, do not initiate a new treatment
sequence; instead; instmct the subject to return 3-7 days later for refractive evaluation to
assess whether an adjustment treatment is required or to proceed directly to a lock-in
treatment.
12. Following the light adjustment, the subject will continue to wear their UV protective
eyewear as instrncted until exactly 24 hours after the fmal lock-in treatment has been
completed.
13. The subject will return 3 to 7 days following the power adjustment treatment for another
light treatment. The subject may receive up to 3 adjustment treatments before receiving
the 1st lock-in treatment.
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7.3.2.5 Lock-In Procedure(s) 
RxSIGHT, INC. 
Refer to the LDD Operator's manual for instructions on LDD start up and instructions for the 
daily alignment test to be perfo1med prior to the first 1:J.·eatment 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 perfo1m 1:J.·eatments and call 
RxSight customer service immediately. 
1. All lock-in procedure(s) will be recorded.
2. 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. Reconfnm
information displayed on screen and follow the touch screen prompts to enter in newly
requested info1mation. Press the "Proceed" button.
3. Within the Confnmation screen, review all info1mation and press the "Confnm" button.
4. Verify that the LDD ring lights and reticle target are activated.
5. Apply topical anesthetic.
6. 
on the 
cornea usmg 
Note: The RxSight contact lens is similar to those used in other ophthalmic procedures 
in which customized magnification is required. To ensure co1Tect magnification for 
treatment, use only the RxSight designated contact lens. 
7.
Instrnct the subject to focus straight ahead on the LDD fixation light with the study eye.
8. Using the microscope, focus on the cornea and verify that there are no trapped bubbles
present. Confnm alignment of the contact lens by approximately aligning the Purkinje
images to the inner circle of the reticle target.
9. Using the microscope, focus on the LAL haptics and align the reticle target with the
periphe1y of the LAL.
10. Press the "Ready" button
11. Initiate the i1rndiation delive1y as prompted by the LDD display using the joystick or
foot pedal to keep the LAL centered in the alignment reticle.
12. Perfo1m 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 1:J.'eatment, quickly refocus, realign the lens with respect to the reticle beam, and
immediately resume 1:J.·eatment 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.
13. If the lock-in treatment is abolied before completion, contact the Sponsor for technical
assistance.
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14. Upon completion of the lock-in #1 treatment, a notification may appear that infonns the
user that a lock-in #2 treatment is not required for the subject. If this notification
appears, proceed to step #16. If no notification appears, then the subject will require a
lock-in #2 treatment and proceed to step #15.
15. The subject will return for the second lock-in treatment 3 to 7 days after the first lock-in
treatment.
16. The subject will be permitted to discontinue wear of the UV protective eyewear exactly
24 homs after the final lock-in treatment has been completed.
7.4 
EXAMINATION SCHEDULE 
Subjects who agree to pru.ticipate in the study will return for the listed follow-up 
exru.ninations for each study eye: 
Evaluation 
Preoperative 
Day -60 to Day -1 
Operative 
Day 0, day of surge1y 
Postop Day 1 
Days 1 to 2 postop 
Postop Week 3 
Days 17 to 24 postop: Adjustment #1 
Adjustment #2, if needed 
3 to 7 days post Adjustment #1 
Adjustment #3, if needed 
3 to 7 days post Adjustment #2 
Lock-in #1 
3 to 7 days post final adjustment
Lock-in #2, if needed 
3 to 7 days post lock-in #1 
Postop Month 1-2 
7 to 14 days post final lock-in 
Postop Month 3 or later visit 
2:90 days postop
Unscheduled visits falling outside the designated ranges for scheduled visits will be 
considered "interim" visits for data recording pmposes and a repo1t fo1m will be completed. 
Page 24 of 60

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7.5 
CLINICAL PARAMETERS
42. Demographics
43. Ocular history including medications
44. Subjective symptoms/complaints (subject reported)
45. Compliance with UV spectacles
46. Ocular Biometry: ACD and axial length (Optical biometry)
47. Corneal Topography
48. Autorefraction
49. Corneal Keratometry
50. Vision Quality Measurement
51. Undilated Distance Viewing Pupil Diameter
52. Binocular UCDVA
53. Monocular uncorrected distance visual acuity (UCDVA)
54. Manifest Refraction
55. Monocular best corrected distance visual acuity (BCDVA)
56. Ocular Dominance Test
57. Pseudo accommodation testing
58. Mesopic binocular distance corrected contrast sensitivity testing
59. Mesopic monocular distance corrected contrast sensitivity testing
60. Photopic binocular distance corrected contrast sensitivity testing
61. Photopic monocular distance corrected contrast sensitivity testing
62. Monocular distance corrected 10% low contrast intermediate visual acuity (photopic
only)
63. Monocular distance corrected intermediate visual acuity (DCIVA)
64. Monocular distance corrected intermediate visual acuity (DCIVA) with +1.50 D add
65. Monocular uncorrected intermediate visual acuity (UCIVA)
66. Binocular UCIVA
67. Undilated Intermediate Viewing Pupil Diameter
68. Monocular distance corrected 10% low contrast near visual acuity (photopic only)
69. Monocular distance corrected near visual acuity (DCNVA)
70. Monocular distance corrected near visual acuity (DCNVA) with a +2.50 D add
71. Monocular uncorrected near visual acuity (UCNVA)
72. Binocular UCNVA
73. Undilated Near Viewing Pupil Diameter

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75. Intraocular pressure
76. Slit Lamp Examination
77. Fundus Exam
78. Aberrometry
79. Dilated pupil diameter
80. Adverse Events

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Table 1. Schedule of Visits and Clinical Parameters 
M 
N 
M 
-
:it: ,_, 
:it:-
 
>, 
.:ii: 
-
 
- "O 
- "O 
:it: 
Q. 
 
 = 	 = 	 
·..::
Q 
 
 "O 
 "O = 
Visits 
2 
 
s t e 
1 
,.. 
Q. 
...  
Q., 
 
,s 
Q. "' = ,.,, = 
u 
Q. 
0 
.:, !'t: -=- 
0 
"' -
0 
"' 

 
0 
"O --
"O --
Q., 
< 
< 
 
X 
X 
Demographics 
X 
Ocular History Including Medications 
X 
X 
X 
X 
X 
X 
X 
Subjective Symptoms/Complaints (Subject 
X 
X 
X 
X 
X 
repo1ted) 
Compliance with UV Spectacles 
X 
X 
X 
X 
X 
Ocular Biometry (ACD + Axial length) 
X 
Corneal Topography 
X 
X 
Autorefraction 
X 
X 
X 
X 
Corneal Keratometry 
X 
X 
Vision Quality Measurement (HD Analyzer) 
X 
X 
Undilated Distance Viewing Pupil Diameter 
X 
X 
Binocular UCDV A 
xi
Monocular tmcoITected distance visual acuity 
X 
X 
X 
X 
X 
X 
(UCDVA) 
Manifest Refraction 
X 
X 
X 
X 
X 
Monocular best c01Tected distance visual 
X 
X 
X 
X 
X 
acuity (BCDV A) 
Ocular Dominance Test 
X 
X 
Pseudo Accommodation Testing 
X 
x2
Mesopic binocular distance coITected contrast 
X 
sensitivity testing 
Mesopic monocular distance coITected 
X 
contrast sensitivity testing 
Photopic binocular distance coITected contrast 
X 
sensitivity testing 
Photopic monocular distance coITe.cted 
X 
contrast sensitivity testing 
Monocular distance coITected 10% low 
X 
contrast inte1mediate visual acuity (photopic) 
Monocular distance coITected intermediate 
X 
X2,4 
x2,4
X2
visual acuity (DCIV A) 
Monocular distance coITected i11te1mediate 
X 
x2,4 
x2,4 
x2
visual acuity (DCIV A) with+ 1.50 D add 
Page 27 of 60 
RxSIGHT, L"'lC. 
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PROTOCOL# CSP-032 
VERSION06 
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RxSIGHT, L"'lC. 
t") 
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acuity (UCIV A) 
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X 
x2,4 
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X 
contrast near visual acuity (photopic) 
Monocular distance con-ected near visual 
X 
x2,4 
x2,4 
x2 
acuity (DCNV A) 
Monocular distance con-ected near visual 
X 
X2,4 
x2,4 
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acuity (DCNV A) with +2.50 D add 
Monocular uncon-ected near visual acuity 
X 
x2,4 
x2,4 
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(UCNVA) 
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xi 
x1,2,4 
x1,2,4 
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X 
X2,4 
x2,4 
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Intraocular Pressure 
X 
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X 
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FundusExam 
X 
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Aben-ometiy 
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2 Only performed on subjects receiving a presbyopia treatment. 
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3 Tests indicated with an "X" must be perfonned at each unscheduled visit. Other tests may be conducted 
based on the investigator's assessment of the subject. 
4May be perfonned if the events described in section 7.3.2.2 of the protocol occur. 
7.6 
DATA REPORTING 
All study data will be recorded onto case repo1t fo1ms ( 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 somce document for some data and each site will document 
this with a note to file describing in which cases somce 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. 
Page 28 of 60
·;;; >
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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 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 3 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.   
SUBJECT WITHDRAWAL DUE TO INTRAOPERATIVE COMPLICATIONS PRIOR TO
IMPLANTATION 
Subjects that meet all inclusion/exclusion criteria but do not undergo implantation of the 
LAL 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 implantation, subjects may not be withdrawn from the study unless the study lens has 
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. 

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Subjects may be discontinued from the study only when the study lens has 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 
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. 

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8 
STATISTICAL METHODS 
8.1 
POPULATIONS FOR ANALYSIS
Exploratory effectiveness analyses will be performed on all eyes as specified. 
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 
UCDVA 
Monocular and 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 of eyes for subjects that only 
received spherical/sphero-cylindrical adjustments and for subjects that received a presbyopia 
adjustment will be presented separately. 
UCIVA, UCNVA, DCIVA, and DCNVA 
Monocular and/or binocular UCIVA, UCNVA, DCIVA, and DCNVA for subjects 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.  
Pseudo Accommodation 
The mean acuity across all subjects that received a presbyopia adjustment will be calculated 
and plotted separately. The mean, standard deviation, and confidence intervals for each point 
on the curve will be reported. 
 
 
8.2 
SAFETY PARAMETERS
•
Incidence of cumulative ocular serious adverse events defined per ISO 11979-7.
The incidence of all other adverse events will also be presented. 
 
 

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8.2.1 
ADDITIONAL SAFETY ANALYSES 
RxSIGHT, L"'lC. 
The safety outcomes will be sunnnarized descriptively for all eyes that have the procedure 
attempted. 
BCDVA 
Monocular BCDV A will be presented with the number and percent of eyes who fall into each 
category ofBCDVA at each visit (e.g. 20/20 or better, 20/25 or better, 20/32 or better, etc.). 
The mean BCVDA letter score will be calculated for each visit. Change in BCVDA from 
Postop Week 3 or from Preoperative will be presented at each visit as categorical outcomes 
of "Increase in 15 letters or more", "Increase in 10-14 letters", "Increase in 5-9 letters", "No 
change", "Decrease in 5-9 letters", "Decrease in 10-14 letters", and "Decrease in 15 letters or 
more". 
Intraocular Pressure (IOP) 
The IOP and change in IOP from preoperative will be sunnnarized by mean, standard 
deviation, median, minimum and maximum. The number and percent of eyes repoI1ed with 
IOP a 25 mmHg or an IOP increase ofb 10 mmHg from preop will be provided at each visit. 
Slit Lamp Examination and Fundus Examination Findings 
The outcomes will be summarized descriptively by coUI1t and percent of eyes with each 
possible finding category. 
9 
SEQUENCE OF PLANNED ANALYSES 
9.1 
INTERIM ANALYSES 
An interim analysis may be perfonned. 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 3 or later visit or have been 
discontinued from the study, the data will be analyzed for a fmal study repo1t. 
Page 32 of 60 

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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. 
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 
at any time after Postop Week 3. 
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. 
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:

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- 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.   
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)

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•
Optional admission not associated with a precipitation medical AE (e.g., for elective
cosmetic surge1y)
10.4.2 EVALUATIONS 
When evaluating AEs, the Investigator must detennine 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 intenupts 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 ce1tain
alternative etiology exists.
10.4.3 SAE/UNANTICIPATED ADVERSE DEVICE EFFECT (UADE)/UNANTICIPATED 
SERIOUS ADVERSE DEVICE EFFECT (USADE) REPORTING 
The site should repo1t 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: 
Tele: 
When repo1ting an SAE to the Sponsor and/or its representative, the site should fo1ward any 
suppo1ting documents along with the SAE Repo1t Fo1m to the Sponsor and its designee 
within 5 days of the initial communication. Sites must also repo1t the SAE to the reviewing 
Ethics Committee per its repo1ting procedures. 
An investigator shall submit to the Sponsor and to the reviewing IRB/EC a repo1t of any 
Unanticipated Adverse Device Effect (UADE) occmTing dming an investigation as soon as 
Page 35 of 60 

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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. 
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. 

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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 
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 optimatl distance, intermediate, and near vision.  

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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.
•
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.
•
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.
•
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.
•
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.
•
RxSight clinical personnel may also observe examination techniques used by study
personnel to ensure that the procedures being utilized are the procedures described in
of the protocol. 

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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.  

PROTOCOL # CSP-032 
VERSION 06 
RXSIGHT, INC. 
CONFIDENTIAL    
Page 41 of 60 
13 
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