A Prospective, Randomized, Controlled, Multi-center Clinical Study to Evaluate the Safety and Effectiveness of the RxSight Light Adjustable Lens (LAL) in Subjects With Prior Corneal Refractive Surgery
Phase: NA
Conditions: Aphakia, Cataract
Sponsor: RxSight, Inc.

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PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL   
PAGE 1 
 
 
RXSIGHT, INC. 
 
PROTOCOL NO. CSP-027 
 
A PROSPECTIVE RANDOMIZED CONTROLLED MULTI-CENTER CLINICAL 
STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE RXSIGHT 
LIGHT ADJUSTABLE LENS (LAL) IN SUBJECTS WITH PRIOR CORNEAL 
REFRACTIVE SURGERY 
 
1 
STUDY SYNOPSIS 
STUDY OBJECTIVE 
 
The primary objective of this study is to evaluate, for the visual correction of aphakia, the 
safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery 
Device (LDD) to reduce postoperative refractive error and improve uncorrected distance 
visual acuity in eyes with prior corneal refractive surgery. A control group consisting of 
fellow eyes implanted with a commercially available monofocal IOL will be used to compare 
the safety and effectiveness of the LAL. 
 
STUDY POPULATION   
The study population will consist of up to 120 subjects with implantation of the LAL 
attempted in the primary eye. Eyes successfully implanted with the LAL will have a 
commercially available monofocal control, the Sensar AR40e (Abbott Medical Optics), 
implanted in the fellow eye following cataract removal. All study eyes must have undergone 
prior corneal refractive surgery, have preoperative keratometric astigmatism of ≤ 2.00 D, and 
meet all the applicable inclusion criteria and none of the exclusion criteria.  
 
STUDY DESIGN 
 
A prospective, randomized, controlled, multi-center, clinical study will be conducted at a 
maximum of 8 sites located in the United States. Subjects will be followed for a 6-month 
period. A minimum of 12 bilateral subjects will undergo study implantation at each 
participating site, with less than 25% of the total study population implanted at one clinical 
site. 
 
Patients who require bilateral cataract extraction and intraocular lens implantation will be 
screened for eligibility. If it is determined that the patient may be eligible to participate, 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. Both eyes of all 
subjects will be screened for eligibility at the same preoperative visit. A pre-determined 
randomization scheme will be utilized to designate each of the patient’s eyes as the primary 
eye (LAL) or the fellow eye (Control). The subject’s fellow eye will be scheduled for surgery 
a minimum of 7 days after the primary eye. If surgical complications occur with the primary 
eye and no LAL is implanted, the subject is exited from the study. 
 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL   
PAGE 2 
 
 
 
Commencing at the Postop Week 3 visit, all primary eyes will be refracted, undergo visual 
testing, and receive a power adjustment based on the manifest refraction as determined from 
testing at 4 meters.
 
 Subjects will return 3 to 7 days after their adjustment and the same 
measurements performed again. Depending on the adjustment(s) performed, primary eyes 
will receive one to three adjustments and one to two lock-in treatments. All light treatments 
are separated by 3 to 7 days. 
 
Postoperatively, all subjects will undergo complete ophthalmic examinations starting with 
the Postop Week 1 visit. Bilateral ophthalmic examinations can occur if the postoperative 
visit windows allow. Examinations will occur at regular intervals over a 6-month period to 
evaluate the safety and effectiveness of the LAL compared to the control. 
 
 
 Masked 
examiners will be utilized at Postop Week 3, Postop Month 3, and Postop Month 6. 
 
Effectiveness data will be compared between the LAL and Control groups. Safety for all 
study eyes will be evaluated per ISO 11979-7. 
 
Both eyes of all subjects will be screened for eligibility at the same preoperative visit. If at 
any time during the screening, either eye does not meet inclusion or exclusion criteria, 
screening for that subject should be discontinued.  
 
INCLUSION CRITERIA 
• Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for the bilateral implantation of an intraocular lens (IOL). 
• 
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. 
• 
Preoperative keratometric cylinder ≤ 2.00 in both eyes. 
• 
History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive 
Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-
LASIK, or Epi-LASEK   more than 1 year prior in both eyes. 
• 
Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a 
level of 20/40 or worse with or without a glare source in both eyes. 
• 
Best corrected distance visual acuity projected (by clinical estimate based upon past 
ocular history and retinal exam) to be 20/20 or better after cataract removal and 
intraocular lens (IOL) implantation in both eyes.   
• 
Clear intraocular media other than cataract in both eyes. 
• 
Willing and able to comply with the requirements for study specific procedures and 
visits.  
• 
Average dilated pupil diameter of ³7.0 mm in both eyes.  
• 
Able to complete a written questionnaire in English. 

PROTOCOL # CSP-027 
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• 
Requires an IOL power within the range available for both the LAL and the Sensar 
AR40e. 
 
 
EXCLUSION CRITERIA 
• 
Prior history of Intacs, Radial keratotomy (RK), Conductive keratoplasty (CK), 
Astigmatic keratotomy (AK), Phakic IOL (ICL), Refractive Lens Exchange (RLE), or 
Corneal Inlay in either eye. 
• 
Clinically significant dry eye syndrome (DES) in either eye. 
• 
Clinically significant corneal haze in either eye.  
• 
Pseudoexfoliation in either eye. 
• 
Pre-existing macular disease in either eye. 
• 
Patients with sufficiently dense cataracts that preclude examination of the macula in 
either eye. 
• 
Diabetes with any evidence of retinopathy in either eye.   
• 
Evidence of glaucomatous optic neuropathy in either eye.    
• 
History of uveitis in either eye.    
• 
Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris 
coloboma in either eye. 
• 
Corneal pathology or corneal dystrophy that is either progressive or sufficient to 
reduce BCDVA to worse than 20/20 in either eye.  
• 
Evidence of ectasia in either eye. 
• 
Previous intraocular surgery in either eye. Eyes with previous pterygium excision are 
permitted as long as the pterygium did not extend more than 2mm onto the cornea 
from the limbus.  
• 
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 either eye. 
• 
Irregular astigmatism in either eye. 
• History of ocular herpes simplex virus in either eye.  
• Eye that has been compromised due to previous trauma or developmental defects in 
which appropriate support of the intraocular lens (IOL) is not possible. 

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• Current vitreoretinal disease or a high risk for future vitreoretinal disease that may 
require silicone oil as part of therapy in either eye.        
 
OUTCOME PARAMETERS 
 
Effectiveness Parameters: 
Primary Endpoints 
• Magnitude of manifest cylinder (MRCYL) at Postop Month 6 
• Absolute Manifest Refraction Spherical Equivalent (MRSE) at Postop Month 6 
• Best corrected distance visual acuity (BCDVA) of 20/40 or better at Postop Month 
6 
 
The MRCYL and MRSE outcomes will be compared between the two study groups, LAL 
and Control. 
 
Per ISO 11979-7:2014 (E), one-sided upper 95% confidence limit of the percentage of 
LAL-implanted eyes with BCDVA of 20/40 or better at Postop Month 6 is higher than 
the performance rate of 92.5%.  It should be noted that all three effectiveness endpoints 
must be statistically significant in order to conclude the effectiveness of the LAL.  
Therefore, no additional significance level adjustment will be performed for these three 
primary endpoints. 
 
Secondary Endpoints 
• Uncorrected distance visual acuity (UCDVA) at Postop Month 6 
• UCDVA at Postop Month 6 for subjects measured with keratometric cylinder 
(Kcyl) <0.75 D in both eyes at the preoperative examination. 
The UCDVA outcomes will be compared between the two study groups, LAL and 
Control. 
The secondary effectiveness endpoints will not be tested unless all three primary 
effectiveness endpoints are statistically significant.  Due to this step-down approach, no 
additional adjustment will be made for the significance levels. 
 
Safety Parameters: 
• Incidence of ocular serious adverse events including persistent and cumulative events 
defined per ISO 11979-7.  
 
The incidence of all other adverse events will also be presented. 
 
Examination Schedule: 
Subjects who agree to participate in the study will return for the listed follow-up 
examinations: 
 
 

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Primary Study Eye (LAL) 
Evaluation 
 
Preoperative OU 
Maximum of 60 days prior to 
Operative LAL Visit 
Operative LAL 
Day 0, day of LAL surgery 
Postop Day 1 LAL 
Days 1 to 2 post-Operative 
LAL Visit 
Postop Week 1 LAL 
Days 7 to 14 post-Operative 
LAL Visit 
Postop Week 3 LAL (Adjustment 
#1) 
Days 17 to 24 post-Operative 
LAL Visit  
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 Months 1-2 
7 to 14 days post final lock-In  
Postop Month 3 LAL 
Days 60 to 90 post-Operative 
LAL Visit 
Postop Month 6 LAL 
Days 120 to 180 post-
Operative LAL Visit 
Postop Month 12, if needed 
Days 330 to 420 post-
Operative LAL Visit 
 
 
 
 
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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Fellow Study Eye (Control) 
Evaluation 
 
Operative Control 
Minimum of 7 days post- 
Operative LAL Visit 
Postop Day 1 Control 
Days 1 to 2 post-Operative 
Control Visit 
Postop Week 1 Control  
Days 7 to 14 post-Operative 
Control Visit 
Postop Week 3 Control 
Days 17 to 24 post-Operative 
Control Visit  
Postop Month 3 Control 
Days 60 to 90 post-Operative 
Control Visit 
Postop Month 6 Control 
Days 120 to 180 post-
Operative Control Visit 
 
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:  
Clinical assessments when indicated will be performed in the following order: 
1. Demographics 
2. 
 
3. 
 
4. Ocular history including medications 
5. Ocular Biometry: Anterior chamber depth (ACD) and axial length (Optical or 
immersion A-scan biometry) 
6. Subjective symptoms/complaints (subject reported) 
7. 
 
8. Corneal Topography 
9. Autorefraction 
10. Corneal Keratometry 
11. Specular Microscopy 
12. Uncorrected distance visual acuity (UCDVA) 
13. Manifest Refraction 
14. Best corrected distance visual acuity (BCDVA) 
15. 
 
16. 
 
17. Distance corrected contrast sensitivity: Mesopic/Photopic with and w/o glare 
18. 
 
 

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19. Intraocular pressure 
20. Slit Lamp Examination  
21. Dilated pupil diameter 
22. Fundus Exam 
23. Fundus Photos 
24. 
 
25. Adverse Events 
 
 

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ABBREVIATIONS AND DEFINITION OF TERMS 
ACD 
Anterior Chamber Depth 
AE 
Adverse Event 
AK 
Astigmatic Keratotomy 
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 
CI 
Confidence Interval 
CK 
Conductive Keratoplasty 
CRF 
Case Report Form 
CRO 
Contract Research Organization 
D 
Diopter 
DES 
Dry Eye Syndrome 
DEQ 
Defocus Equivalent 
 
 
ECC 
Endothelial Cell Count 
ECD 
Endothelial Cell Density 
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 
ITT 
Intent To Treat 
LASEK 
Laser Assisted Subepithelial Keratomileusis 
LASIK 
Laser Assisted In Situ Keratomileusis 
LDD 
Light Delivery Device 
MR 
Manifest Refraction 
MRCYL 
Manifest Refraction Cylinder 
MRSE 
Manifest Refraction Spherical Equivalent 
OCT 
Optical Coherence Tomography 
PCO 
Posterior Capsular Opacity 

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PMA 
Premarket Application 
PPC 
Precision Pulse Capsulotomy 
PRK 
Photorefractive Keratectomy 
 
 
RK 
Radial Keratotomy 
RLE 
Refractive Lens Exchange 
LAL 
RxSight Light Adjustable Lens 
SAE 
Serious Adverse Event 
SE 
Spherical Equivalent 
SPK 
Superficial Punctate Keratitis 
SSI 
Secondary Surgical Intervention 
 
 
UADE 
Unanticipated Adverse Device Effect 
UCDVA 
Uncorrected Distance Visual Acuity 
UV 
Ultraviolet 
 
 
 

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approximately 80% of these patients within ± 1.0 D.8  In addition, these patients can also 
have unanticipated post-operative astigmatism, since the original LASIK may have included 
lenticular astigmatism correction, with removal of the lens unmasking laser-induced corneal 
astigmatism.9  
 
These more variable results contrast with non-LASIK patients undergoing cataract surgery 
with traditional monofocal IOLs, where the percentage within ± 0.5 D of the predicted 
refraction can reach 80% or more depending on surgeon techniques and the patient 
population.  In the Phase III study conducted under IDE G100240 in patients with low pre-
operative keratometric cylinder, 84% of control eyes implanted with a monofocal IOL were 
within ± 0.5 D of the predicted MRSE.  While the LAL group performed even better, with 
91% within ± 0.5 D, the main clinical benefit of this improvement in MRSE was a reduction 
in the number of outliers with significantly higher residual refractive errors.  Because the 
number of such outliers is potentially much higher in post-LASIK eyes undergoing cataract 
surgery, these patients would likely see a larger clinical benefit by reducing the range of 
residual MRSE errors due to the inherent difficulties in predicting IOL power in this group.  
In addition, by producing the desired change in spherocylindrical power of the implanted 
Light Adjustable Lens (LAL), unanticipated post-operative astigmatism can also be 
addressed, potentially reducing the need for secondary surgical procedures for the vast 
majority of post-LASIK patients with residual refractive error. 
 
To evaluate this potential, we propose to compare 6 months postoperative refractive and 
visual acuity data for LAL eyes compared to a control group of fellow eyes implanted with a 
commercially available monofocal IOL. Based on the anticipated range of post-operative 
residual MRSE being within the LAL adjustment range, similar final outcomes are 
anticipated when compared with the LAL group studied under IDE G100240.    
 
2.1 
CLINICAL STUDIES PERFORMED WITH PRIOR VERSION OF THE LIGHT ADJUSTABLE 
LENS AND LIGHT DELIVERY DEVICE 
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. 
 
                                               
8 Hamill E, Wang L, Chopra H, Hill W, Koch D. Intraocular lens power calculations in eyes with previous hyperopic laser 
in situ keratomileusis or photorefractive keratectomy. J Cataract Refract Surg 2017; 43:189-194. 
9 https://www.reviewofophthalmology.com/article/post-refractive-cataract-choosing-lens-and-target 

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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 
 
The system also reduces the likelihood of clinically significant residual spherical refractive 
errors. 
 
 
 
 
 
 
 
 
  
 
 

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3 
STUDY OBJECTIVE 
The primary objective of this study is to evaluate, for the visual correction of aphakia, the 
safety and effectiveness of the RxSight Light Adjustable Lens (LAL) and Light Delivery 
Device (LDD) to reduce postoperative refractive error and improve uncorrected distance 
visual acuity in eyes with prior corneal refractive surgery. A control group consisting of 
fellow eyes implanted with a commercially available monofocal IOL will be used to compare 
the safety and effectiveness of the LAL. 
4 
STUDY DESIGN 
A prospective, randomized, controlled, multi-center, clinical study will be conducted at a 
maximum of 8 sites located in the United States. Subjects will be followed for a 6-month 
period. A minimum of 12 subjects will undergo study implantation at each participating site, 
with less than 25% of the total study population implanted at one clinical site. 
 
Patients who require bilateral cataract extraction and intraocular lens implantation will be 
screened for eligibility. If it is determined that the patient may be eligible to participate, 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. Both eyes of all 
subjects will be screened for eligibility at the same preoperative visit. A pre-determined 
randomization scheme will be utilized to designate each of the patient’s eyes as the primary 
eye (LAL) or the fellow eye (Control). The subject’s fellow eye will be scheduled for surgery 
a minimum of 7 days after the primary eye. If surgical complications occur with the primary 
eye and no LAL is implanted, the subject is exited from the study.  
 
Commencing at the Postop Week 3 visit, all primary eyes will be refracted, undergo visual 
testing, and receive a power adjustment based on the manifest refraction as determined from 
testing at 4 meters.
 
 Subjects will return 3 to 7 days after their adjustment and the same 
measurements performed again. Depending on the adjustment(s) performed, primary eyes 
will receive one to three adjustments and one to two lock-in treatments. All light treatments 
are separated by 3 to 7 days. 
 
Postoperatively, all subjects will undergo complete ophthalmic examinations starting with 
the Postop Week 1 visit. Bilateral ophthalmic examinations can occur if the postoperative 
visit windows allow. Examinations will occur at regular intervals over a 6-month period to 
evaluate the safety and effectiveness of the LAL compared to the control. Masked examiners 
will be utilized at Postop Week 3, Postop Month 3, and Postop Month 6. 
 
For subject complaints related to refractive anisometropia of greater than 1.5 diopters  
secondary to a refractive surprise with the fellow eye (Control), a secondary surgical 
intervention (SSI) may be performed on the fellow eye if both the investigator and subject 
agree it is in the best interest of the subject. 
 

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Effectiveness data will be compared between the LAL and Control groups. Safety for all 
study eyes will be evaluated per ISO 11979-7. 
 
 

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5 
OUTCOME PARAMETERS 
5.1 
EFFECTIVENESS PARAMETER 
Primary Endpoints 
• Magnitude of manifest cylinder (MRCYL) at Postop Month 6 
• Absolute Manifest Refraction Spherical Equivalent (MRSE) at Postop Month 6 
• Outcome of best corrected distance visual acuity (BCDVA) of 20/40 or better at 
Postop Month 6 
 
The MRCYL and MRSE outcomes will be compared between the two study groups, LAL 
and Control. 
 
Per ISO 11979-7:2014 (E), one-sided upper 95% confidence limit of the percentage of 
LAL implanted eyes with BCDVA of 20/40 or better at Postop Month 6 is higher than the 
performance rate of 92.5%. It should be noted that all three effectiveness endpoints must 
be statistically significant in order to conclude the effectiveness of the LAL. Therefore, 
no additional significance level adjustment will be performed for these three primary 
endpoints. 
 
Secondary Endpoints 
• Uncorrected distance visual acuity (UCDVA) at Postop Month 6 
• UCDVA at Postop Month 6 for subjects measured with keratometric cylinder 
(Kcyl) <0.75 D in both eyes at the preoperative examination. 
The UCDVA outcomes will be compared between the two study groups, LAL and 
Control. 
The secondary effectiveness endpoints will not be tested unless all three primary 
effectiveness endpoints are statistically significant.  Due to this step-down approach, no 
additional adjustment will be made for the significance levels. 
 
5.2 
SAFETY PARAMETERS  
• Incidence of ocular serious adverse events including persistent and cumulative 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 120 subjects with implantation of the LAL 
attempted in the primary eye. Eyes successfully implanted with the LAL will have a 
commercially available monofocal control IOL, the Sensar AR40e (Abbott Medical Optics), 
implanted in the fellow eye following cataract removal. All study eyes must have undergone 
prior corneal refractive surgery, have preoperative keratometric astigmatism of ≤2.00 D, and 
meet all the applicable inclusion criteria and none of the exclusion criteria.  
 
Both eyes of all subjects will be screened for eligibility at the same preoperative visit. If at 
any time during the screening, either eye does not meet inclusion or exclusion criteria, 
screening for that subject should be discontinued.  
 
6.1 
INCLUSION CRITERIA 
• Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for the bilateral implantation of an intraocular lens (IOL). 
• 
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. 
• 
Preoperative keratometric cylinder ≤ 2.00 in both eyes. 
• 
History of Laser-Assisted In Situ Keratomileusis (LASIK), Photorefractive 
Keratectomy (PRK), Laser-Assisted Subepithelial Keratomileusis (LASEK), Epi-
LASIK, or Epi-LASEK more than 1 year prior in both eyes. 
• 
Cataract causing reduction in best corrected distance visual acuity (BCDVA) to a 
level of 20/40 or worse with or without a glare source in both eyes. 
• 
Best corrected distance visual acuity projected (by clinical estimate based upon past 
ocular history and retinal exam) to be 20/20 or better after cataract removal and IOL 
implantation in both eyes.   
• 
Clear intraocular media other than cataract in both eyes. 
• 
Willing and able to comply with the requirements for study specific procedures and 
visits.  
• 
Average dilated pupil diameter of ³7.0 mm in both eyes.  
• 
Able to complete a written questionnaire in English. 
• 
Requires an IOL power within the range available for both the LAL and the Sensar 
AR40e. 
 
6.2 
EXCLUSION CRITERIA 
• 
Prior history of Intacs, RK, CK, AK, Phakic IOL (ICL), Refractive Lens Exchange 
(RLE), or Corneal Inlay in either eye. 
• 
Clinically significant dry eye syndrome (DES) in either eye. 
• 
Clinically significant corneal haze in either eye.  
• 
Pseudoexfoliation in either eye. 
• 
Pre-existing macular disease in either eye. 

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• 
Patients with sufficiently dense cataracts that preclude examination of the macula in 
either eye. 
• 
Diabetes with any evidence of retinopathy in either eye.   
• 
Evidence of glaucomatous optic neuropathy in either eye.    
• 
History of uveitis in either eye.    
• 
Significant anterior segment pathology, such as rubeosis iridis, aniridia, or iris 
coloboma in either eye. 
• 
Corneal pathology or corneal dystrophy that is either progressive or sufficient to 
reduce BCDVA to worse than 20/20 in either eye.  
• 
Evidence of ectasia in either eye. 
• 
Previous intraocular surgery in either eye. Eyes with previous pterygium excision are 
permitted as long as the pterygium did not extend more than 2mm onto the cornea 
from the limbus.  
• 
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 either eye. 
• 
Irregular astigmatism in either eye. 
• History of ocular herpes simplex virus in either eye.  
• Eye that has been compromised due to previous trauma or developmental defects in 
which appropriate support of the intraocular lens (IOL) is not possible. 
• Current vitreoretinal disease or a high risk for future vitreoretinal disease that may 
require silicone oil as part of therapy in either eye. 
 
 

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PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 22 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.2 
SUBJECT ENTRY 
Patients who require bilateral cataract extraction and intraocular lens implantation will be 
screened for eligibility. If it is determined that the patient may be eligible to participate, 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. Both eyes of all subjects will be screened for eligibility at the same 
preoperative visit. A pre-determined randomization scheme will be utilized to designate each 
of the patient’s eyes as the primary eye (LAL) or the fellow eye (Control). The preoperative 
examination will be performed no more than 60 days prior to surgery for either the primary 
eye (LAL) or the fellow eye (Control). If the 60-day time period elapses for either eye, it is 
acceptable for patients to be re-screened by undergoing a complete preoperative examination. 
The subject’s fellow eye will be scheduled for surgery a minimum of 7 days after the primary 
eye. If surgical complications occur with the primary eye and no LAL is implanted, the 
subject is exited from the study. 
 
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. Subjects 
will continue to be enrolled until up to 120 subjects have had LAL implantation attempted in 
the primary eye.  Unique identification numbers will be assigned to each subject. 
 
The implant lens power for the LAL and the Control IOL will be calculated based upon the 
ocular biometry data and the ASCRS calculator (http://iolcalc.ascrs.org). The investigator 
should select the IOL formula to be used in a particular subject. The same formula must be 
used on both eyes of a subject and must be determined prior to randomization. A 
postoperative spherical equivalent (SE) outcome closest to emmetropia will be targeted in 
both eyes. The lens power in either eye will not be altered based on intraoperative 
diagnostics. 
 
 

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PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 25 
 
 
• 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
• 
 
                                               
12 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.  
 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 26 
 
 
 
  
 
OR 
• 
 
 
OR 
• 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
7.3.2.3 Procedure Preparation 
Protocol-required measurements should be completed prior to adjustment or lock-in 
treatments. 
 
The subject should be prepared for light treatments as follows: 
1. The study eye will be dilated using any of the following pupil dilation drops 
 
 or pupil 
dilation gel 
 
After waiting an appropriate amount of time for dilation to occur, the study eye will be 
examined to ensure that adequate dilation 
 
has been obtained. If 
adequate dilation has not been obtained, additional dilating drops with manual punctal 
                                               
 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 27 
 
 
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.  
2. 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. 
 
7.3.2.4 Adjustment Procedure(s) 
Refer to the LDD Operator’s manual for instructions on LDD start up 
 
 
 
1. All adjustment procedure(s) will be recorded. 
2. 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. 
3. Within the Confirmation screen, review all information and press the “Confirm” button. 
4. Verify that the LDD ring lights and reticle target are activated. 
5. Apply topical anesthetic.   
6. Position the RxSight supplied contact lens 
 on the 
cornea using 
 as the 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. 
7. Instruct 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. Confirm 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 
periphery of the LAL. 
10. Press the “Ready” button 
11. 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. 
12. 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 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 28 
 
 
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. 
13. If the event of an aborted Adjustment Treatment, do not initiate a new treatment 
sequence; instead; instruct 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.    
14. Following the light adjustment, the subject will continue to wear their UV protective 
eyewear as instructed until exactly 24 hours after the final lock-in treatment has been 
completed. 
15. 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. A second adjustment treatment will be performed if guided by 
the LDD. 
 
 
 
 
 
 
 
7.3.2.5 Lock-In Procedure(s) 
Refer to the LDD Operator’s manual for instructions on LDD start up 
 
 
 
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. Reconfirm 
information displayed on screen and follow the touch screen prompts to enter in newly 
requested information. Press the “Proceed” button. 
3. Within the Confirmation screen, review all information and press the “Confirm” button. 
4. Verify that the LDD ring lights and reticle target are activated. 
5. Apply topical anesthetic.   
6. Position the RxSight supplied contact lens 
 on the 
cornea using 
 as the coupling medium.   

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 29 
 
 
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. 
7. Instruct 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. Confirm 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 
periphery of the LAL. 
10. Press the “Ready” button 
11. 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. 
12. 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. 
13. If the lock-in treatment is aborted before completion, contact the Sponsor for technical 
assistance.   
14. Upon completion of the lock-in #1 treatment, a notification may appear that informs 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 hours after the final lock-in treatment has been completed. 
 
7.4 
CONTROL LENS IMPLANTATION 
 will be implanted in the 
subject’s fellow eye a minimum of 7 days after the LAL has been successfully implanted in 
the primary eye. Standard microsurgical techniques will be employed. A clear corneal 
incision of temporal orientation will be made. Limbal relaxing incisions (LRI) are not to be 
used during surgery to implant the Control lens.  
 
For subject complaints related to refractive anisometropia of greater than 1.5 diopters  
secondary to a refractive surprise with the fellow eye (Control), a secondary surgical 
intervention (SSI) may be performed on the fellow eye if both the investigator and subject 
agree it is in the best interest of the subject.   

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7.5 
EXAMINATION SCHEDULE  
Subjects who agree to participate in the study will return for the listed follow-up 
examinations: 
 
 

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PAGE 31 
 
 
Primary Study Eye (LAL) 
Evaluation 
 
Preoperative OU 
Maximum of 60 days prior to 
Operative LAL Visit 
Operative LAL 
Day 0, day of LAL surgery 
Postop Day 1 LAL 
Days 1 to 2 post-Operative 
LAL Visit 
Postop Week 1 LAL 
Days 7 to 14 post-Operative 
LAL Visit 
Postop Week 3 LAL (Adjustment 
#1) 
Days 17 to 24 post-Operative 
LAL Visit  
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 Months 1-2 
7 to 14 days post final lock-In  
Postop Month 3 LAL 
Days 60 to 90 post-Operative 
LAL Visit 
Postop Month 6 LAL 
Days 120 to 180 post-
Operative LAL Visit 
Postop Month 12, if needed 
Days 330 to 420 post-
Operative LAL Visit 
 
 
 
 
 
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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Fellow Study Eye (Control) 
Evaluation 
 
Operative Control 
Minimum of 7 days post- 
Operative LAL Visit 
Postop Day 1 Control 
Days 1 to 2 post-Operative 
Control Visit 
Postop Week 1 Control  
Days 7 to 14 post-Operative 
Control Visit 
Postop Week 3 Control 
Days 17 to 24 post-Operative 
Control Visit  
Postop Month 3 Control 
Days 60 to 90 post-Operative 
Control Visit 
Postop Month 6 Control 
Days 120 to 180 post-
Operative Control Visit 
 
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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PAGE 33 
 
 
 
7.6 
CLINICAL PARAMETERS  
The following study parameters will be assessed as specified here and in Table 2 and 3. 
Assessments will be performed using the techniques described in 
 
1. Demographics 
2. 
 
3. 
 
4. Ocular history including medications 
5. Ocular Biometry: ACD and axial length (Optical or immersion A-scan biometry) 
6. Subjective symptoms/complaints (subject reported) 
7. 
 
8. Corneal Topography 
9. Autorefraction 
10. Corneal Keratometry 
11. Specular Microscopy 
12. Uncorrected distance visual acuity (UCDVA) 
13. Manifest Refraction 
14. Best corrected distance visual acuity (BCDVA) 
15. 
 
16. 
 
17. Distance corrected contrast sensitivity: Mesopic/Photopic with and w/o glare 
18. 
 
19. Intraocular pressure  
20. Slit Lamp Examination 
21. Dilated pupil diameter  
22. Fundus Exam 
23. Fundus Photos 
24. 
 
25. Adverse Events 

PROTOCOL # CSP-027 
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PAGE 34 
 
 
Table 2.  Schedule of Visits and Clinical Parameters for Primary Study Eyes (LAL) 
Visits 
Preop OU 
Operative LAL 
Postop Day 1 LAL 
Postop Week 1 LAL 
Postop Week 3 LAL 
Adjustment #2 
(if needed) 
Adjustment #3 
(if needed) 
Lock-in #1 
Lock-in #2 
(if needed) 
Post Months 1-2 
Postop Month 3 LAL 
Postop Month 6 LAL 
Postop Month 12 
(if needed) 
Unscheduled Visit3 
  
Demographics  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
 
 
 
 
X 
X 
X 
 
 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Ocular History Including Medications 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Ocular Biometry (ACD + Axial length)  
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Subjective Symptoms/Complaints (Subject 
reported) 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
Corneal Topography 
X 
 
 
 
M 
 
 
 
 
 
 
 
 
 
Autorefraction 
 
 
 
X 
M 
X 
X 
X 
X 
X 
M 
M 
X 
 
Corneal Keratometry 
X 
 
 
 
M 
 
 
 
 
 
 
M 
 
 
Specular Microscopy 
X 
 
 
 
M 
 
 
 
 
 
 
M 
 
 
Uncorrected distance visual acuity (UCDVA) 
X 
 
X 
X 
M 
X 
X 
X 
X 
X 
M 
M 
X 
X 
Manifest Refraction  
X 
 
 
X 
M 
X 
X 
X 
X 
X 
M 
M 
X 
X 
Best corrected Visual Acuity Distance 
(BCDVA) 
X 
 
 
X 
M 
X 
X 
X 
X 
X 
M 
M 
X 
X 
 
 
 
 
 
M 
X 
X 
X 
X 
X 
M 
M 
X 
 
 
 
 
 
 
M 
X 
X 
X 
X 
X 
M 
M 
X 
 
Distance Corrected Contrast Sensitivity 
(Mesopic/Photopic w and w/o glare) 
 
 
 
 
M 
 
 
 
 
 
 
M 
 
 
 
 
 
 
 
X 
 
 
 
 
X2 
X2 
X2 
X2 
 

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PAGE 35 
 
 
Visits 
Preop OU 
Operative LAL 
Postop Day 1 LAL 
Postop Week 1 LAL 
Postop Week 3 LAL 
Adjustment #2 
(if needed) 
Adjustment #3 
(if needed) 
Lock-in #1 
Lock-in #2 
(if needed) 
Post Months 1-2 
Postop Month 3 LAL 
Postop Month 6 LAL 
Postop Month 12 
(if needed) 
Unscheduled Visit3 
  
Intraocular Pressure 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Slit Lamp Exam 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Dilated Pupil Diameter  
X 
 
 
 
X 
X 
X 
X 
X 
 
 
 
 
 
Fundus Exam 
X 
 
 
 
X 
 
 
 
 
 
 
X 
X 
 
Fundus Photos 
X 
 
 
 
X 
 
 
 
 
 
 
X 
X 
 
 
 
 
 
 
X 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
X1 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 36 
 
 
 
Table 3.  Schedule of Visits and Clinical Parameters for Fellow Study Eyes (Control) 
Visits 
Preop OU 
Operative Control 
Postop Day 1 Control 
Postop Week 1 
Control 
Postop Week 3 
Control 
Postop Month 3 
Control 
Postop Month 6 
Control 
Unscheduled Visit1 
  
Demographics  
X 
 
 
 
 
 
 
 
 
X 
 
 
 
X 
X 
X 
 
 
 
 
 
 
X 
X 
X 
 
Ocular History Including Medications 
X 
X 
X 
X 
X 
X 
X 
 
Ocular Biometry (ACD + Axial length)  
X 
 
 
 
 
 
 
 
Subjective Symptoms/Complaints (Subject 
reported) 
 
 
X 
X 
X 
X 
X 
X 
Corneal Topography 
X 
 
 
 
M 
 
 
 
Autorefraction 
 
 
 
X 
M 
M 
M 
 
Corneal Keratometry 
X 
 
 
 
M 
 
M 
 
Specular Microscopy 
X 
 
 
 
M 
 
M 
 
Uncorrected distance visual acuity (UCDVA) 
X 
 
X 
X 
M 
M 
M 
X 
Manifest Refraction  
X 
 
 
X 
M 
M 
M 
X 
Best corrected Visual Acuity Distance 
(BCDVA) 
X 
 
 
X 
M 
M 
M 
X 
 
 
 
 
 
M 
M 
M 
 
 
 
 
 
 
M 
M 
M 
 
Distance Corrected Contrast Sensitivity 
(Mesopic/Photopic w and w/o glare) 
 
 
 
 
M 
 
M 
 
Intraocular Pressure 
X 
 
X 
X 
X 
X 
X 
 
Slit Lamp Exam 
X 
 
X 
X 
X 
X 
X 
X 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 37 
 
 
Visits 
Preop OU 
Operative Control 
Postop Day 1 Control 
Postop Week 1 
Control 
Postop Week 3 
Control 
Postop Month 3 
Control 
Postop Month 6 
Control 
Unscheduled Visit1 
  
Dilated Pupil Diameter  
X 
 
 
 
X 
 
 
 
Fundus Exam 
X 
 
 
 
X 
 
X 
 
Fundus Photos 
X 
 
 
 
X 
 
X 
 
Spectral Domain Optical Coherence 
Tomography (SD-OCT) 
 
 
 
 
X 
 
 
 
Adverse Events 
 
X 
X 
X 
X 
X 
X 
X 
 
1Tests indicated with an “X” must be performed at each unscheduled visit. Other tests may be conducted based on the investigator’s assessment of the 
subject. 
 
 
 
 
 
 
 

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CONFIDENTIAL    
PAGE 40 
 
 
 
8 
STATISTICAL METHODS 
8.1 
SAMPLE SIZE CALCULATION 
The sample size of up to 120 subjects with implantation of the LAL attempted in the primary 
eye for this study is based on the statistical tests on effectiveness endpoints described below. 
Safety of the LAL was studied under RxSight’s premarket approval application (PMA) 
P160055 which was approved by the Center for Devices and Radiological Health (CDRH) of 
the Food and Drug Administration (FDA) on November 22, 2017.  
 
Primary Effectiveness Endpoints 
1. Magnitude of Manifest Cylinder (MRCYL) at Postop Month 6 
H0: µDMRCYL  = 0 versus Ha: µDMRCYL < 0 with a one-side significance level of 0.025, 
where µDMRCYL is the mean of difference in MRCYL (DMRCYL) at Postop Month 6 
between the LAL eye and Control eye of bilateral subjects.  The DMRCYL for each 
subject equals MRCYL of the LAL eye minus MRCYL of the Control eye.  Since the 
magnitude of MRCYL will be used in the calculation, a negative DMRCYL represents a 
better outcome in the LAL eye than that in the Control eye. 
Per the previous PMA clinical study, the standard deviation of the MRCYL at Postop 
Month 6 is 0.37 D for the LAL group and 0.62D for the Control group.  Assuming that 
the MRCYL measurement of the two eyes of a subject are independent, the estimated 
standard deviation of DMRCYL is 0.73 (= square-root of the sum of 0.372 and 0.622).  It 
is expected that the postoperative MRCYL of the post-LASIK or other corneal refractive 
surgery eyes may have more variation, the standard deviation of DMRCYL is estimated 
as 1.00 D (about 1.5 times of the estimation based on the PMA observations) for sample 
size calculation.  Based on the one-sided one-sample t-test (i.e. paired t-test) with a 
significance level of 0.025, a sample size of 77 subjects can provide a statistical power of 
90% if the true µDMRCYL at Postop Month 6 is -0.375 D.  
  
2. Absolute Manifest Refraction Spherical Equivalent (MRSE) at  Postop Month 6 
H0: µD|MRSE| = 0 versus Ha: µD|MRSE| < 0 with a one-side significance level of 0.025, where 
µD|MRSE| is the mean difference in absolute MRSE (D|MRSE|) at Postop Month 6 between 
two eyes of bilateral subjects.   The D|MRSE| equals |MRSE| of LAL eye minuses 
|MRSE| of Control eye.  A negative D|MRSE| represents a better outcome in the LAL eye 
than that in the Control eye. 
Per the previous PMA clinical study, the standard deviation of |MRSE| at Postop Month 6 
is 0.23 D for the LAL group and 0.33 for the control group.  Assuming that the MRSE 
measurement at Postop Month 6 of the two eyes of the same subject are independent, the 
estimated standard deviation of D|MRSE| is 0.41 (= square-root of the sum of 0.232 and 
0.332).  As mentioned in the section above, a larger standard deviation, 0.62 (~ 1.5 ´ 
0.41), is used for the sample size calculation.  Based on the one-sided one-sample t-test 
(i.e. paired t-test) with a significance level of 0.025, a sample size of 67 subjects can 
provide a statistical power of 90% if the true µD|MRSE| is -0.25 D.  

PROTOCOL # CSP-027 
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PAGE 41 
 
 
 
 
3. Outcome of BCDVA of 20/40 or better at Postop Month 6. 
The statistical hypotheses for this endpoint are based on ISO 11979-7: 2014 (E) 
H0: p ³ 0.925  versus Ha: p < 0.925 with a one-side significance level of 0.05, where p is 
the proportion of LAL eyes with BCDVA of 20/40 or better at Postop Month 6.  If the Ha 
is rejected, then the BCDVA outcome supports the LAL effect on improving BCDVA 
from pre-operative. 
Based on a one-sided Binomial distribution with a significance level of 0.025, a sample 
size of 99 subjects is needed for a statistical power of 90% at a true rate of 0.825 (i.e. 0.1 
lower than the ISO grid of 0.925). 
 
Secondary Effectiveness Endpoints 
It should be noted that the LAL effect on the two secondary effectiveness endpoints will 
not be considered unless all of the three primary effectiveness endpoints demonstrate the 
LAL effect.  Additionally, the statistical objectives here are to demonstrate effectiveness 
of the LAL on either of these two secondary effectiveness endpoints, so the significance 
level for each of these two effectiveness endpoints is one-sided 0.0125 (= 0.025 ÷ 2). 
1. UCDVA at  Postop Month 6. 
H0: µDUCDVA = 0 versus Ha: µDUCDVA < 0 with a one-side significance level of 0.0125, 
where µDUCDVA is the mean difference in logMAR UCDVA (DUCDVA) at Postop Month 
6 between two eyes of bilateral subjects.   The DUCDVA equals logMAR UCDVA of 
LAL eye minus logMAR UCDVA of Control eye.  The lower the logMAR value is, the 
better the UCDVA is. A negative DUCDVA represents a better outcome in the LAL eye 
than that in the Control eye. 
Per the previous PMA clinical study, the standard deviation of logMAR UCDVA at 
Postop Month 6 is 0.11 D for the LAL group and 0.17 for the control group.  Assuming 
the UCDVA at Postop Month 6 of the two eyes of the same subject are independent, the 
estimated standard deviation of DUCDVA is 0.21 (= square-root of the sum of 0.112 and 
0.172).  Again, a larger standard deviation, 0.32 (~ 1.5 ´ 0.21) is used for the sample size 
calculation.  Based on the one-sided one-sample t-test (i.e. paired t-test) with a 
significance level of 0.0125, a sample size of 60 subjects can provide a statistical power 
of 90% if the true µDUCDVA is -0.15 (i.e. 1.5 lines). 
 
2. UCDVA at Postop Month 6 for subjects with keratometric cylinder (Kcyl) < 0.75 D 
at the preoperative examination in both eyes 
H0: µDUCDVA_L = 0 versus Ha: µDUCDVA_L < 0 with a one-side significance level of 0.0125, 
where µDUCDVA_L is the mean DUCDVA at Postop Month 6 for subjects with Kcyl < 0.75 
D (low cylinder) at the preoperative examination in both eyes.   
Based on the same assumptions discussed in the Section above, the required sample size 
for the analysis is 60 subjects.  It is estimated that about 60% of the subjects at Postop 

PROTOCOL # CSP-027 
VERSION 06 07-03-2019 
RXSIGHT, INC. 
CONFIDENTIAL    
PAGE 42 
 
 
 
Month 6 will have a preoperative KCyl of < 0.75 D.  Therefore, 100 (= 60 ÷ 60%) 
bilateral subjects at Postop Month 6 are needed for this endpoint 
 
Study Sample Size 
Based on the sample size calculation for the primary and secondary primary effectiveness 
endpoints above, a sample size of 100 bilateral subjects at Postop Month 6 will be sufficient 
for the study. With a drop-out rate of at most 10% within the 6-month follow-up period and 
possible postponed LDD treatment after postoperative 6 months, up to 110 bilateral subjects 
should be implanted with LAL in one eye and Control lens in the other eye.  Considering 
possible intraoperative complications that prevent the LAL implantation, it is determined that 
the study should attempt implantation in up to 120 eligible bilateral subjects in order to have 
at least 100 bilateral subjects at Postop Month 6. 
 
 
8.2 
GENERAL CONSIDERATION 
The statistical analysis of the data will be performed using SAS version 9.3 or higher or 
another industry standard statistical software package.  Continuous variables will be 
summarized using descriptive statistics, specifically the mean, median, standard deviation, 
minimum and maximum. Categorical variables will be summarized by frequencies and 
percentages. The summaries will be provided for the LAL eyes and Control eyes separately.  
For continuous outcomes, the difference between the two eyes of the same subject will be 
calculated and summarized by using descriptive statistics for continuous outcomes.  
Unless otherwise specified, all p-values will be two-sided for a two-sided significance level 
of 0.05 (or one-sided for a one-sided significance level of 0.025) and all confidence intervals 
will be two-sided at 95% confidence level. Safety analyses will be performed on eyes in 
which IOL implants are attempted. 
 
A detailed statistical analysis plan (SAP) will be developed and finalized prior to the 
locking of the database for this study. 
 
8.3 
BASELINE CHARACTERISTICS 
Baseline characteristics (such as age, gender, race, and pre-operative pathology) will be 
summarized descriptively for subjects with the LAL implantation attempted and for subjects 
implanted with LAL in one eye and Control lens in the other eye by means and standard 
deviations or by counts and percentages, as appropriate.  They will also be stratified by the 
study site in order to assess the similarity of these baseline characteristics among the study 
sites. 
 
Baseline characteristics will be listed for subjects with a successful LAL implantation but a 
failed Control lens implantation, if they exist. 
 
 

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function of intended cylinder change and as a function of intended MRSE change. In order to 
evaluate the MRSE treatment effect on the cylindrical outcome, a regression analysis on the 
vector length with the intended cylinder correction and intended MRSE correction as 
independent factors will be performed.  The regression residual will be checked for the 
model fitting. 
 
Refractive Cylinder Stability  
Refractive cylinder stability will be presented for consistent cohort and eyes with two 
consecutive visits.  The following statistics will be calculated. 
• 
Percentage of eyes that achieve change of ≤1.00 D of refractive cylinder; 
• 
Percentage of eyes that achieve change of ≤0.50 D of refractive cylinder; 
• 
Mean MRCYL change between two visits and the corresponding 95% confidence 
interval, mean change per month, and mean change per year 
 
MRSE 
MRSE and change in MRSE from Postop Week 3 will be summarized by the descriptive 
statistics for continuous outcomes (such as mean and standard deviation) for each visit. The 
number and percent of eyes with an MRSE of £ ±0.25 D, ±0.50, ±0.75 D, ±1.0 D, and ±2.0 D 
will be reported for each visit.  For each subject, the difference in the MRSE between two 
eyes (= LAL-eye – Control-eye) at Postop Week 3 and beyond will be calculated and the 
difference will be summarized by using descriptive statistics for continuous variables. 
In addition, for the LAL eyes, the MRSE at Postop Month 6 will be summarized 
descriptively (mean, standard deviation, minimum/maximum, quartiles, number and percent 
of eyes in the outcome categories described above) by the Postop Week 3 MRSE (using 1.00 
D bins), by the Postop Week 3 MRSE (using 1.00 D bins), and by the pre-operative Kcyl 
(using 0.25 D bins). The same analyses will be performed for the control eyes. The observed 
outcomes will be clinically compared.  It should be noted that two eyes of the same subjects 
can be in different Postop Week-3 MRCYL groups, different Postop Week-3 MRSE groups, 
or different preoperative Kcyl groups.  
Additionally, for the LAL eyes, a scatter plot will be presented showing the change in MRSE 
between the Postop Week 3 and 6 month visit as a function of intended MRSE change and 
intended cylinder change. For evaluating the cylindrical treatment effect on the MRSE 
outcome, a regression analysis on MRSE change with the intended MRSE change and 
intended cylinder change as independent factors will be performed.  The regression residuals 
will be used to validate the fitted model. 
 
Accuracy of MRSE 
The number and percent of eyes with a MRSE correction compared to the intended target 
within 0.25 D, 0.50 D, 0.75 D, 1.0 D, 1.25 D, 1.5 D, 1.75 D, and ≥2.0 D will be reported at 
each visit beginning at Postop Months 1-2. For eyes without MRSE correction, 0.00 D will 
be used for the intended target.  Additionally, the deviation of the achieved adjustment from 
the attempted adjustment will be summarized by the descriptive statistics for continuous 
outcomes.  
 

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The analyses for the LAL eyes described above will also be stratified by the Postop Week 3 
MRCYL (using 1.00 D bins) and the Postop Week 3 MRSE (using 1.00 D bins).  
 
Absolute MRSE 
Absolute MRSE and change in absolute MRSE from Postop Week 3 will be summarized by 
the descriptive statistics for continuous outcomes (such as mean and standard deviation) for 
each visit.  The D|MRSE| at Postop Week 3 and beyond will also be summarized by using 
descriptive statistics for continuous variables. 
Additionally, for the LAL eyes, the absolute MRSE outcomes at Postop Month 6 will be 
stratified by signed MRSE at Postop Week 3 (using 0.25 D bins) and summarized 
descriptively (mean, standard deviation, minimum/maximum, quartiles). The mean percent 
reduction and the number in each bin will also be provided. 
 
Refractive MRSE stability 
The refractive stable point will be determined based on the five criteria described in Section 
F.3 of ANSI Z80.11-2012 document as follows: 
• At least 95% of the treated eyes have a change ≤1.00 D of MRSE between the two 
refractions; 
• The mean rate of change in MRSE, as determined by a paired analysis, is ≤0.5 D per 
year (0.04 D/month) over the same time period; 
• The mean rate of change of MRSE decreases monotonically over time, with a 
projected asymptote of zero or a rate of change attributable to normal aging; 
• The 95% confidence interval for mean rate of change includes zero or a rate of 
change attributable to normal aging. 
 
The MRSE change between the following post-adjustment visit intervals will be presented. 
• From Postop Months 1-2 to Postop Month 3 
• From Postop Month 3 to Postop Month 6 
 
Defocus Equivalent (DEQ) 
The DEQ will be summarized descriptively at Postop Week 3 and beginning at Postop 
Months 1-2.  The number and percent of eyes with DEQ ≤0.5 D and 1.0 D will also be 
summarized at the corresponding visit.  
 
Autorefraction 
Autorefraction sphere, cylinder, and spherical equivalent will be summarized descriptively at 
each visit.   
Since, for the LAL eyes, the light adjustment will be based on the manifest refraction, the 
following change in auto-refraction cylinder (Cyl) and reduction in auto-refraction spherical 
equivalent (SE) will be calculated for each LAL eye:   
Change in Cyl = (Postop Month 6 autorefraction Cyl – Postop Week 3 MRCYL), 
 
Change in SE = (Postop Month 6 autorefraction SE – Postop Week 3 MRSE) 

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The change in cylinder and the change in the spherical equivalent will be summarized 
descriptively by mean, standard deviation, median, minimum, and maximum. 
 
UCDVA 
UCDVA will be presented with the number and percent of eyes who fall into each category 
of UCDVA at each visit (e.g. 20/20 or better, 20/25 or better, 20/32 or better, etc.).  The 
logMAR UCDVA will be summarized by descriptive statistics for continuous outcomes for 
each visit.  Change in UCDVA from Postop Week 3 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”.  The change in logMAR UCDVA from Postop Week 3 
will also be presented. 
The outcome of within-subject DUCDVA will be presented at each visit as categorical 
outcomes of “LAL 15 letters or more better”, “LAL 10-14 letters better”, “LAL 5-9 letters 
better”, “LAL 1-4 letters better”, “LAL = Control”, “Control 1-4 letters better”, “Control 5-9 
letters better”, “Control 10-14 letters better”, and “Control 15 letters or more better”.  The 
descriptive statistics for continuous outcomes will also be calculated for the within-subject 
DUCDVA. 
 
BCDVA 
BCDVA will be presented with the number and percent of eyes that fall into each category of 
BCDVA at each visit (e.g. 20/20 or better, 20/25 or better, 20/32 or better, etc.). The 
logMAR BCDVA at each visit will also be presented by using descriptive statistics for 
continuous variables.  The analyses will be repeated for the Best Case Cohort.  
 
Per ISO 11979-7 2014 (E), the BCDVA categorical summaries described above will also be 
stratified by the following covariates and clinical outcomes for the LAL eyes. 
• Age group (based on observed quartiles) 
• With versus without ISO cumulative AEs 
• With versus without ISO persistent AEs 
• With versus without preoperative ocular pathology 
• Study site 
 
The analyses above may be reconsidered due to the observed stratification.  For example, if 
no subjects are reported with any ISO persistent AEs, then the BCDVA by ISO persistent 
AEs will not be performed. 
 
For the LAL and Control eyes that cannot achieve BCDVA of 20/40 or better at the last 
available visit, the BCDVA data listing along with the reported possible reasons of failing to 
achieve 20/40 or better will be provided. 
 
 

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8.6 
SAFETY PARAMETERS  
The following safety outcomes will be summarized descriptively based on the observed data 
of the Safety population for the LAL eyes and Control eyes separately, except for 
 
, 
, and 
 
 which will be summarized based on the observed data of the 
Safety population subjects. The 95% confidence intervals for means or percentage may be 
presented, as appropriate. 
Adverse Events 
Number and percent of eyes will be summarized for each reported ocular AE at the operative 
visit and each postoperative visit.  Serious ocular AEs and the non-ocular serious AEs will be 
summarized in the same manner.  Additionally, for each of the device related AE reported 
during the study, the number and percent of study eyes reported with the event will be 
presented.  For each reported AE, a two-sided 95% confidence interval will be provided for 
the percent of eyes reported with the AE during the study (i.e. at £ 6 months.)  
 
Each ISO defined cumulative and persistent adverse events at Postop Month 6 will be 
summarized per ISO 11979-7:2014 (E) using count and percent of subjects reported with 
such event.  The maximum number of cases allowed before the ISO-defined SPE rate of each 
adverse event will be calculated.  For each ISO adverse event, if the observed incidence for 
the LAL eye group is at most the maximum number of cases, it can be concluded that the 
LAL does not have a rate higher than the corresponding ISO-defined SPE rate. 
 
The cumulative and persistent adverse events during the 6-month follow-up period will also 
be stratified by age (per quartiles) and study sites. 
 
Change in BCDVA 
Change in BCDVA 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”.  The 90% confidence interval (corresponding to the 
one-sided test recommended by the ISO 11979-7 for cumulative and persistent adverse 
events) for the percent of eyes with a BSCVA loss of ³ 10 letters will be calculated per 
binomial distribution.  The mean change in logMAR BCDVA from Postop Week 3 or 
Preoperative with the 95% confidence interval for the mean will also be presented. Similarly, 
the mean change from the prior visit to the next visit will also be summarized in the same 
manner.   
 
The listing of BCDVA and the possible reason for BCDVA loss of 10 letters or more will be 
provided for the eyes reported with a 10-letter or more loss in BCDVA during the study (i.e. 
from preoperative visit or previous visit). 
 
 
 

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Distance Corrected Contrast Sensitivity 
For the contrast sensitivity (in log units) at each spatial frequency level under each of the four 
test conditions (photopic with and without glare and mesopic with and without glare) at 
Postop Week 3 and Postop Month 6 will be summarized by mean, standard deviation, 
median, minimum and maximum for the eyes participated in the contrast sensitivity sub-
study.  The number and percent of eyes that cannot see any plate will be presented. 
 
The mean of “within-eye” loss of contrast sensitivity from Postop Week 3 to Postop Month 6 
will be provided with the 1-sided 95% confidence interval for each spatial frequency.  The 
percentage of eyes showing > 0.3 log unit loss at two or more spatial frequencies will be 
calculated. 
 
 
 
 
Increased Astigmatism 
Number and percent of eyes with increased astigmatism from Postop Week 3 will be reported 
at each postoperative visit  
 
Subjective Symptoms and Complaints 
Number and percent of eyes will be summarized for each reported subjective symptom.  
 
Other Ocular Examinations 
Slit lamp and fundus exam findings and IOP including changes will be summarized 
descriptively. Number of subjects with fundus exam changes from the pre-op and Postop 
Week 3 evaluation will be summarized.   
 
 
 

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Endothelial Cell Density (ECD) and Morphology Data 
Specular Microscopy data includes endothelial cell density, hexagonality and coefficient of 
variation. These endpoints will be summarized by mean, standard deviation, 95% CI of the 
mean, minimum and maximum.  The change in ECD and percent change in ECD from 
preoperative will be summarized in the same manner.  Additionally, ECD change and ECD 
percent change for each eye will be calculated between Preoperative and Postop Week 3 and 
between Postop Week 3 and Postop Month 6.  These changes will be summarized by mean, 
standard deviation, 95% CI for mean, minimum, and maximum.  Additionally, at Postop 
Week 3 and Postop Month 6, the number and percent of eyes with an ECD of < 1500 
cells/mm2 and number and percent of eyes with an ECD change from baseline £ -25% (i.e. 
and an ECD loss of ³ 25%) along with the 95% confidence interval of the percentage derived 
per binomial distribution will be calculated for the LAL eyes and Control eyes separately.  
The percent ECD loss (%ECL) at Postop Month 6 for each eye and the difference between 
%ECL (D%ECL) at Postop Month 6 for each subject are derived as follows: 
 
 
%ECL = (ECD at Preop – ECD at Postop Month 6) ÷ ECD at Preop ´ 100% 
 
D%ECL = %ECL of LAL eye - %ECL for Control eye 
 
The descriptive statistics for continuous variables will be used to summarize D%ECL.  A 
one-sided 95% upper confidence limit for mean D%ECL will be derived based on t-
distribution. If the Nichamin III foldable lens inserter is used during the study, the analyses 
may be stratified by the subjects with versus without the use of Nichamin III foldable lens 
inserter. 
It should be noted that, per the previous PMA clinical study, the standard deviation of 
D%ECL is estimated as 4%.  For a statistical hypotheses test of H0: Mean of D%ECL ³ 5% 
versus Ha: Mean of D%ECL < 5% (i.e. the mean of %ECL in the LAL eyes is at most 5% 
higher than that in the control eyes) with a one-sided significance level of 0.05, a sample size 
of 100 bilateral subjects at 6 months can provide the following statistical power at different 
true values of Mean of D%ECL.  The derived one-sided 95% upper confidence limit of mean 
D%ECL described above can be used to compare against the 5% used in the statistical 
hypotheses described above. 
 
True  
µD%ECL 
Statistical  
Power 
0.0% 
>0.99 
0.5% 
>0.99 
1.0% 
>0.99 
1.5% 
>0.99 
2.0% 
>0.99 

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9 
ADVERSE EVENTS 
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. 
 
9.1 
ADVERSE EVENT DEFINITIONS 
 
 
An adverse event (AE) 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. 
 
Unanticipated Adverse Device Effects (UADE) are any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with a device, if that 
effect, problem, or death was not previously identified in nature, severity or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects. 
 
An investigator will submit to the Sponsor and to the reviewing IRB a report of any 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. The Sponsor will immediately conduct an 
evaluation of any unanticipated adverse device effect. The results of the evaluation will be 
reported to FDA and to all reviewing IRB’s and participating investigators within 10 working 
days of the Sponsor becoming aware of the event. Thereafter the Sponsor shall submit 
additional reports concerning the effect as FDA requests. If a UADE is determined by the 
Sponsor to present an unreasonable risk to study subjects, all investigations or parts of the 
investigation presenting that risk will be terminated as soon as possible. Termination will 
occur not later than 5 working days after this determination is made, and not later than 15 
working days after first receiving notice of the event. The investigation will not be resumed 
without IRB and FDA approval.  
 
The following need to be reported as AEs as specified: 
1. Anterior Chamber Inflammation 
• Iritis/cells/flare (if present after Postop Week 1 and greater than grade 1 (trace)) 
or (any iritis/cells/flare present at Postop Month 6 of any grade) OR 

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• Chronic anterior uveitis (Persistent anterior segment inflammation characterized 
by grade 1+ cell or greater using Standardization of Uveitis Nomenclature 
criteria; persistent for greater than 3 months after surgery, or relapses in less than 
3 months after discontinuation of therapy, or the subject is maintained on therapy 
for more than 3 months to control inflammation). 
2. Corneal edema: 
• If present after Postop Week 1 and greater than grade 1 (trace)) or (if present at 
Postop Month 6 of any grade) OR 
• Corneal swelling (stromal or epithelial) resulting in BCDVA ≤20/40 after Postop 
Week 3) 
3. Raised intraocular pressure (IOP) >10 mmHg above preoperative and greater than 25 
mmHg (if present after Postop Week 1) AND unrelated to mechanical pupillary block 
 
 
 
 
 
Per the Special Report: The American Academy of Ophthalmology Task Force Consensus 
Statement on Adverse Events with Intraocular Lenses, the following types of adverse events 
will be reviewed by the Sponsor to determine if they meet the following definitions for 
reporting purposes: 
Adverse Event 
Definition 
Clinically significant 
cystoid macular edema 
Macular edema diagnosed by clinical examination and adjunct testing (e.g., 
OCT, FA, or other method) resulting in reduced BCDVA to20/40 or worse 
after Postop Week 3 
Endophthalmitis 
Postoperative intraocular inflammation requiring vitreous tap and use of 
intraocular antibiotics 
Mechanical pupillary 
block 
A shallowing of the peripheral and/or central anterior chamber with or without 
elevation of IOP by obstruction of the flow of aqueous humor from the 
posterior chamber through the pupil to the anterior chamber. This may be 
induced by the crystalline lens, vitreous face, or implanted devices 
Rhegmatogenous Retinal 
Detachment 
Partial or complete retinal detachment associated with retinal tear 
 
Toxic anterior segment 
syndrome 
An acute, noninfectious inflammation of the anterior segment of the eye that 
develops within 24 to 48 hours after surgery and is characterized by corneal 
edema and accumulation of white cells in the anterior chamber of the eye 
Secondary IOL 
intervention 
Exchange: The investigational device is replaced with the same lens model. 
Removal: The investigational device is removed and replaced with a 
noninvestigational lens or no lens is implanted. 
Reposition: The existing IOL is surgically moved to another location or 
rotated. 

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images, and/or double vision.  These and other complications may result in permanent poor 
vision.    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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10 
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's Clinical Affairs Department. 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 worksheets and 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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11 
ETHICAL AND REGULATORY CONSIDERATIONS 
11.1 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 a HIPAA consent form 
and to ensure the subject is given a copy of each. 
 
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. 
 
11.2 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. 
 
11.3 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 Institutional Review Board (where applicable); 
obtaining prospective informed consent; monitoring of the conduct of the study, the 
completeness of the study worksheets, and 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 21 CFR Subpart G-Records and Reports.  
 
 
 
 

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12 
REFERENCES 
1. 
https://www.statista.com/statistics/271478/number-of-lasik-surgeries-in-the-us/ 
2. 
https://www.lasik.com/articles/lasik-increasing-among-younger-adults/ 
3. 
https://www.reviewofoptometry.com/article/when-cataract-develops-long-after-
lasik 
4. 
https://crstoday.com/articles/2014-jul/choosing-an-iol-after-lasik/ 
5. 
https://www.reviewofophthalmology.com/article/cataract-patients-younger-
every-year 
6. 
http://www.nj.com/healthfit/index.ssf/2014/09/advances in cataract surgery allow 
patients to see their way to a clearer future.html 
7. 
Vrijman V. Willem van der Linden J et al. Multifocal intraocular lens 
implantation after previous corneal refractive laser surgery for myopia. J Cataract 
Refract Surg Volume 43, Issue 7, July 2017, 909-914. 
8. 
Hamill E, Wang L, Chopra H, Hill W, Koch D. Intraocular lens power 
calculations in eyes with previous hyperopic laser in situ keratomileusis or 
photorefractive keratectomy. J Cataract Refract Surg 2017; 43:189-194. 
9. 
https://www.reviewofophthalmology.com/article/post-refractive-cataract-
choosing-lens-and-target 
10. Brierley L. Refractive Results after Implantation of a Light-Adjustable 
Intraocular Lens in Postrefractive Surgery Cataract Patients. Ophthalmology 
2013 Oct; 120(10):1968-72. 
11. Rocha G. Mednick Z. Light Adjustable Intraocular Lens in post-LASIK and 
post-traumatic cataract patient. J Cataract Refract Surg 2012; 38:1101-1104. 
12. 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.  
13.
 
14.