A Single Center Exploratory Study to Evaluate Uncorrected Distance Vision and Quality of Vision After Light Treatments of an Implanted RxSight Light Adjustable Lens (RXLAL) With The Light Delivery Device (LDD) in Subjects With Preoperative Corneal Astigmatism
Phase: NA
Conditions: Aphakia, Cataract
Sponsor: RxSight, Inc.

PROTOCOL CSP-028 
A SINGLE CENTER EXPLORATORY STUDY TO EVALUATE 
UNCORRECTED DISTANCE VISION AND QUALITY OF VISION 
AFTER LIGHT TREATMENTS OF AN IMPLANTED RXSIGHT 
LIGHT ADJUSTABLE LENS (RXLAL) WITH THE LIGHT DELIVERY 
DEVICE (LDD) IN SUBJECTS WITH PREOPERATIVE CORNEAL 
ASTIGMATISM 
RxSight, Inc. 
100 Columbia, Suite 120 
Aliso Viejo, CA 92656 
Version 04 
April 27, 2018 
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 
NCT03729024

PROTOCOL # CSP-028 
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TABLE OF CONTENTS 
 
 
TABLE OF CONTENTS 
 
PAGE 
1 
STUDY SYNOPSIS ...............................................................................................1 
2 
INTRODUCTION AND RATIONALE ................................................................8 
2.1 
CLINICAL STUDIES PERFORMED WITH THE LIGHT ADJUSTABLE LENS AND 
LIGHT DELIVERY DEVICE ..............................................................................9 
3 
STUDY OBJECTIVE ..........................................................................................11 
4 
STUDY DESIGN .................................................................................................11 
5 
OUTCOME PARAMETERS ..............................................................................11 
5.1 
EXPLORATORY EFFECTIVENESS PARAMETERS .............................................11 
5.2 
SAFETY PARAMETERS ..................................................................................11 
6 
STUDY POPULATION ......................................................................................12 
6.1 
INCLUSION CRITERIA ...................................................................................12 
6.2 
EXCLUSION CRITERIA ..................................................................................12 
7 
STUDY MATERIALS AND METHODS............................................................13 
7.1 
DEVICE DESCRIPTION ..................................................................................13 
7.1.1 RxSight Light Adjustable Intraocular Lens....................................14 
7.1.2 Light Delivery Device (LDD)...........................................................15 
7.1.3 RxSight Insertion Device .................................................................16 
7.1.4 Indications for Use ..........................................................................16 
7.2 
SUBJECT ENTRY...........................................................................................16 
7.3 
RXLAL IMPLANTATION AND REFRACTIVE ADJUSTMENT .............................17 
7.3.1 Surgical Procedure ..........................................................................17 
7.3.2 Light Treatment Procedure.............................................................18 
7.4 
EXAMINATION SCHEDULE ............................................................................23 
7.5 
CLINICAL PARAMETERS...............................................................................23 
7.6 
DATA REPORTING ........................................................................................27 
7.7 
STUDY COMPLETION PROCEDURES ..............................................................27 
7.7.1 Subject Completion .........................................................................27 
7.7.2 Subject Withdrawal Prior to Implantation .....................................27 
7.7.3 Subject Withdrawal due to intraoperative complications 
prior to  Implantation......................................................................27 
7.7.4 Subject Discontinuation After Implantation ...................................28 
7.7.5 Lost to Follow-Up ............................................................................28 
8 
STATISTICAL METHODS ................................................................................29 
8.1 
POPULATIONS FOR ANALYSIS .......................................................................29 

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TABLE OF CONTENTS 
 
 
8.1.1 Exploratory Effectiveness Parameters ............................................29 
8.2 
SAFETY PARAMETERS ..................................................................................30 
8.2.1 Additional Safety Analyses..............................................................30 
9 
ADVERSE EVENTS ...........................................................................................31 
9.1 
ADVERSE EVENT DEFINITIONS .....................................................................31 
9.2 
SERIOUS ADVERSE EVENT DEFINITION ........................................................31 
9.2.1 Identification and Collection ...........................................................32 
9.2.2 Evaluations ......................................................................................32 
9.2.3 SAE Reporting ................................................................................33 
9.2.4 Pregnancy ........................................................................................33 
9.2.5 Potential Adverse Events.................................................................34 
10 
STUDY MONITORING......................................................................................35 
11 
ETHICAL AND REGULATORY CONSIDERATIONS ....................................36 
11.1 SUBJECT INFORMATION AND CONSENT ........................................................36 
11.2 DECLARATION OF HELSINKI ........................................................................36 
11.3 ADDITIONAL REGULATORY CONSIDERATIONS .............................................36 
12 
REFERENCES ....................................................................................................37 
 
  
 
  

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RXSIGHT, INC. 
 
PROTOCOL NO. CSP-028 
 
A SINGLE CENTER EXPLORATORY STUDY TO EVALUATE UNCORRECTED 
DISTANCE VISION AND QUALITY OF VISION AFTER LIGHT TREATMENTS 
OF AN IMPLANTED RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL) WITH THE 
LIGHT DELIVERY DEVICE (LDD) IN SUBJECTS WITH PREOPERATIVE 
CORNEAL ASTIGMATISM 
 
1 
STUDY SYNOPSIS 
STUDY OBJECTIVE 
 
The objective of this study is to evaluate uncorrected distance vision and quality of vision as 
measured by the McAlinden QoV questionnaire 3 months following the final lock-in 
treatment of an implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery 
Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory 
study. No primary effectiveness endpoints will be defined. 
 
STUDY POPULATION   
The study population will consist of up to 150 eyes in up to 75 subjects with 0.50 to 3.00 D 
of pre-operative keratometric astigmatism implanted with the RxLAL. Approximately 1/2 of 
the study population should have ≥0.50 D and ≤1.5 D of preoperative keratometric 
astigmatism and approximately 1/2 of the study population should have >1.5 D and ≤3.00 D 
of preoperative keratometric astigmatism. At least 10 eyes should have >2 D of preoperative 
keratometric astigmatism. 
 
STUDY DESIGN 
 
A prospective, single center, randomized, exploratory clinical study will be conducted. 
Subjects will be followed for a 6-month period.  
 
Patients who require 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. If both eyes of a patient 
meet study eligibility, a pre-determined randomization scheme will be utilized to designate 
each of the patient’s eyes as the primary eye or the fellow eye. If only one eye of a patient 
meets study eligibility, that eye will automatically be designated as the primary eye. 
 
At 3 weeks post-implantation, eyes will be refracted, undergo visual testing, and receive a 
power adjustment based on the manifest refraction. Subjects will return 3 to 7 days after their 
adjustment and the same measurements performed again. Depending on the adjustment(s) 
performed, subjects will receive one to three adjustments and one or two lock-in treatments.  

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Postoperatively, subjects will undergo complete ophthalmic examinations at regular intervals 
over a 6-month period.  
 
Uncorrected distance visual acuity (UCDVA) and responses from the Quality of Vision 
(QoV) questionnaire will be summarized. All ocular adverse events (device related and 
unrelated) during the conduct of the study will be reported. All Secondary Surgical 
Interventions (SSIs) in study eyes during the conduct of the study will also be reported. 
 
Both eyes of all subjects should be screened for eligibility.   
 
INCLUSION CRITERIA 
• Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for unilateral or bilateral implantation of the RxLAL. 
• 
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. 
• 
Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D . 
• 
Study eye must have 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 best corrected distance visual acuity 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 subject eye is enrolled in the study, the non-study eye must have potential 
for BCDVA of 20/40 or better after cataract removal and IOL implantation.  
• 
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 requires an IOL power within the range available for the RxLAL. 
 
 
EXCLUSION CRITERIA 
• 
Study eye with zonular laxity or dehiscence. 
• 
Study eye with pseudoexfoliation. 
• 
Study eye with age-related macular degeneration involving the presence of 
geographic atrophy or soft drusen. 
• 
Study eye with retinal degenerative disorder or macular disorder (other than mild 
macular degeneration) that is expected to cause future vision loss.   
• 
Study eye with diabetes with any evidence of retinopathy.   
• 
Study eye with evidence of glaucomatous optic neuropathy.    
• 
Study eye with history of uveitis.    

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• 
Study eye with significant anterior segment pathology, such as rubeosis iridis, 
aniridia, or iris coloboma. 
• 
Study eye with corneal pathology that is either progressive or sufficient to reduce 
BCDVA to worse than 20/20.  
• 
Study eye with 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, or with previous pterygium excision unless the pterygium did 
not extend more than 2mm onto the cornea from the limbus.  
• 
Study eye with clinically significant dry eye syndrome (DES). 
• 
Study eye with clinically significant corneal haze. 
• 
Study eye with clinically significant corneal opacity. 
• 
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. 
• 
Study eye with irregular astigmatism. 
• Study eye with history of ocular herpes simplex virus.  
• Study eye with history of a congenital color vision defect. 
 
 
OUTCOME PARAMETERS 
 
Exploratory Effectiveness Parameter: 
• Percent of eyes with UCDVA of 20/20 or better at 6 Months Postop (3 Months Post 
Lock-In)  
Exploratory effectiveness analyses will be based on the 6-month UCDVA of eyes 
successfully implanted with the RxLAL. 
 
Safety Parameters: 
The following safety parameters will be evaluated at 6 Months Postop (3 Months Post Lock-
In): 
• Ocular adverse events (device related and unrelated) of the study eyes that occur 
during the conduct of the study. 

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• Secondary Surgical Interventions (SSIs) of the study eyes that occur during the 
conduct of the study.  
 
 
 

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17. Fundus Exam 
18. Adverse Events 
 

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ABBREVIATIONS AND DEFINITION OF TERMS 
AE 
Adverse Event 
AK 
Astigmatic Keratotomy 
ANSI 
American National Standards Institute 
BCDVA 
Best Corrected Distance Visual Acuity 
CI 
Confidence Interval 
CK 
Conductive Keratoplasty 
CRF 
Case Report Form 
D 
Diopter 
DES 
Dry Eye Syndrome 
ETDRS 
Early Treatment Diabetic Retinopathy Study 
GCP 
Good Clinical Practice 
ICH 
International Conference on Harmonization 
ICL 
Phakic Implantable Collamer Lens 
IOL 
Intraocular Lens 
IOP 
Intraocular Pressure 
LASIK 
Laser Assisted In-Situ Keratomileusis 
LDD 
Light Delivery Device 
MR 
Manifest Refraction 
MRCYL 
Manifest Refraction Cylinder 
MRSE 
Manifest Refraction Spherical Equivalent 
OD 
Right eye 
OS 
Left eye 
PCO 
Posterior Capsular Opacity 
PI 
Principal Investigator 
RxLAL 
RxSight Light Adjustable Lens 
SAE 
Serious Adverse Event 
SD 
Standard Deviation 
SE 
Spherical Equivalent 
UCDVA 
Uncorrected Distance Visual Acuity 
 

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2 
INTRODUCTION AND RATIONALE 
In modern cataract surgery, spectacle freedom for the patient, either for distance vision, near 
vision, or both, is becoming more important. Globally, key cataract technology 
advancements (e.g.; monofocal, toric, and foldable IOLs; ultrasound, optical and 
intraoperative biometry; phacoemulsification and femtosecond laser assisted surgery), have 
resulted in important reductions in residual refractive error and improved uncorrected 
distance visual acuity (UCDVA), both of which are highly correlated with patient satisfaction 
following cataract surgery.1,2 
 
However, while the potential for significant post-operative residual refractive error has been 
reduced, it remains the most frequent cataract surgery complication. Approximately 30-60% 
of patients undergoing monofocal IOL implantation and 15-30% of patients undergoing toric 
IOL procedures require spectacle correction for distance correction as a result of a non-
emmetropic refraction.3,4,5,6   The large majority of these patients have residual refractive 
errors that are less than 2 D of magnitude. 4, 7,8  
 
The major causes for residual refractive error following cataract surgery include: 
• Estimation errors for postoperative IOL position, preoperative axial length measurement 
and limitations of IOL calculation formulas that affect both spherical and toric IOLs.9,10  
• Pre-existing corneal astigmatism (reported to exceed 1.00 D in approximately one-third 
of cataract patients) and imprecise preoperative measurement of corneal astigmatism.11,12 
 
 
 
1  
Nordan, LT. The Surgical Rehabilitation of Vision. Gower Medical, New York, 1991. 
2  
Kirwan C, Nolan JM, Stack J, et al.  Determinants of patient satisfaction and function related to vision following 
cataract surgery in eyes with no visually consequential ocular co-morbidity.  Graefes Arch Clin Exp Ophthal 
2015;253:1735-1744. 
3 
 Agresta B, Knorz MC, Donatti C, Jackson D.  Visual acuity improvements after implantiaton of toric intraocular lenses 
in cataract patients with astigmatism: a systematic review.  Graefes Arch Clin Exp Ophthal 2012;12:41. 
4 
 Brandser R, Haaskjold E, Drolsum L. Accuracy of IOL calculation in cataract surgery. Acta Ophthalmol  Scan 
1997;75:162-165. 
5 
 Steinert RF, Aker BL, Trentacost DJ, Smith PJ, Tarantino N.  A prospective comparative study of the AMO ARRAY 
zonal-progressive multifocal silicone intraocular lens and a monofocal intraocular lens.  Ophthalmology 
1999;106(7):1243-55. 
6 
 Connors R 3rd, Boseman P 3rd, Olson RJ.  Accuracy and reproducibility of biometry using partial coherence 
interferometry.  J Cataract Refract Surg 2002;28(2):235-238. 
7 
 Olsen T, Bargum R. Outcome monitoring in cataract surgery. Acta Ophthalmol Scand. 1995;73(5):433-7. 
8 
 Wegener M, Alsbirk PH, Hojgaard-Olsen K.  Outcome of 1000 consecutive clinic- and hospital-based cataract 
surgeries in a Danish county.  J Cataract Refract Surg 1998;24(8):1152-60. 
9 
Norrby S. Sources of error in intraocular lens power calculation. J Cataract Refract Surg 2008; 34:368–376.  
10 
Hirnschall N, Hoffmann PC, Draschl P, et al. Evaluation of factors influencing the remaining astigmatism after toric 
intraocular lens implantation. J Refract Surg 2014;6:1–7. 
11 
Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, et al. Prevalence of corneal astigmatism before cataract 
surgery. J Cataract Refract Surg 2009;35:70–75. 
12 
Lekhanont K, Wuthisiri W, Chatchaipun P, Vongthongsri A. Prevalence of corneal astigmatism in cataract surgery 
candidates in Bangkok, Thailand. J Cataract Refract Surg 2011;37:613–615. 

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• Surgical variations in the size and central position of the capsulorhexis which may 
influence the final position of the IOL inside the bag and are surgeon-dependent, and 
surgically induced astigmatism (SIA).13 
• Healing process, such as anterior movement of the IOL resulting from postoperative 
capsular bag fibrosis and contraction.13 
 
When spectacle or contact lens correction is not adequate or desired, secondary surgical 
procedures currently available to address residual refractive error include excimer laser 
corneal surgery, astigmatic keratotomy, piggyback (second) IOL placement and IOL 
exchange. Incorrect lens power remains one of the major causes cited for the removal of 
intraocular lenses.5,6,14 
 
RxSight addresses the problem of residual refractive error with an IOL for which spherical 
and cylindrical power can be adjusted post-implantation. Following surgical implantation and 
a period of post-operative stabilization, patients return for examination and refractive 
adjustment in the office using a profiled beam of light from the Light Delivery Device 
(LDD). By producing the desired change in lens curvature and spherocylindrical power of the 
implanted RxSight Light Adjustable Lens (RxLAL), this approach can obviate the need for 
secondary surgical procedures for the vast majority of patients with residual refractive error.  
 
 
2.1 
CLINICAL STUDIES PERFORMED WITH THE LIGHT ADJUSTABLE LENS AND LIGHT 
DELIVERY DEVICE 
U.S. Phase III Study 
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 the United States under an Investigational Device Exemption. In addition to the 
visual correction of aphakia, reduction in residual spherocylindrical refractive error and 
improvement in uncorrected distance 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 
 
13 McIntyre JS, Werner L, Fuller SR, et al. Assessment of a single-piece hydrophilic acrylic IOL for piggyback sulcus 
fixation in pseudophakic cadaver eyes. J Cataract Refract Surg 2012;38:155–162. 
14  Mamalis, N.; Spencer, T. S.; Complications of foldable intraocular lenses requiring explantation or secondary 
intervention – 2000 survey update. J Cataract Refract Surg 2001;27(8):1310-1317. 

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3 
STUDY OBJECTIVE 
The objective of this study is to evaluate uncorrected distance vision and quality of vision as 
measured by the McAlinden QoV questionnaire 3 months following the final lock-in 
treatment of the implanted RxSight Light Adjustable Lens (RxLAL) with the Light Delivery 
Device (LDD) in subjects with preoperative keratometric astigmatism. This is an exploratory 
study. No primary effectiveness endpoints will be defined. 
4 
STUDY DESIGN 
A prospective, single center, randomized, exploratory clinical study will be conducted. 
Subjects will be followed for a 6-month period.  
 
Patients who require 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. If both eyes of a patient 
meet study eligibility, a pre-determined randomization scheme will be utilized to designate 
each of the patient’s eyes as the primary eye or the fellow eye. If only one eye of a patient 
meets study eligibility, that eye will automatically be designated as the primary eye. 
 
At 3 weeks post-implantation, eyes will be refracted, undergo visual testing, and receive a 
power adjustment based on the manifest refraction. Subjects will return 3 to 7 days after their 
adjustment and the same measurements performed again. Depending on the adjustment(s) 
performed, subjects will receive one to three adjustments and one or two lock-in treatments.  
 
Postoperatively, subjects will undergo complete ophthalmic examinations at regular intervals 
over a 6-month period. 
 
Uncorrected distance visual acuity (UCDVA) and responses from the Quality of Vision  
(QoV) questionnaire will be summarized. All ocular adverse events (device related and 
unrelated) during the conduct of the study will be reported. All Secondary Surgical 
Interventions (SSIs) in study eyes during the conduct of the study will also be reported.  
5 
OUTCOME PARAMETERS 
5.1 
EXPLORATORY EFFECTIVENESS PARAMETERS 
• Percent of eyes with UCDVA of 20/20 or better at 6 Months Postop (3 Months 
Post Lock-In) 
Exploratory effectiveness analyses will be based on the 6-month UCDVA of eyes 
successfully implanted with the RxLAL. 
 
5.2 
SAFETY PARAMETERS  

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The following safety parameters will be evaluated at 6 Months Postop (3 Months Post Lock-
In): 
• Ocular adverse events (device related and unrelated) of the study eyes during the 
conduct of the study. 
• Secondary Surgical Interventions (SSIs) of the study eyes during the conduct of 
the study.  
6 
STUDY POPULATION 
The study population will consist of up to 150 eyes in up to 75 subjects with 0.50 to 3.00 D 
of pre-operative keratometric astigmatism implanted with the RxLAL. Approximately 1/2 of 
the study population should have ≥0.50 D and ≤1.5 D of preoperative keratometric 
astigmatism and approximately 1/2 of the study population should have >1.5 D and ≤3.00 D 
of preoperative keratometric astigmatism. At least 10 eyes should have >2 D of preoperative 
keratometric astigmatism.  
 
Both eyes of all subjects should be screened for eligibility. 
 
6.1 
INCLUSION CRITERIA 
• 
Must sign a written Informed Consent form and be willing to undergo cataract 
surgery for unilateral or bilateral implantation of the RxLAL. 
• 
Between the ages of 40 and 80 inclusive on the day the cataract surgery is performed. 
• 
Study eye must have preoperative keratometric cylinder of ≥0.50 D and ≤3.00 D. 
• 
Study eye must have 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 best corrected distance visual acuity 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 subject eye is enrolled in the study, the non-study eye must have potential 
for BCDVA of 20/40 or better after cataract removal and IOL implantation.   
• 
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 requires an IOL power within the range available for the RxLAL. 
 
 
6.2 
EXCLUSION CRITERIA 
• 
Study eye with zonular laxity or dehiscence. 
• 
Study eye with pseudoexfoliation. 
• 
Study eye with age-related macular degeneration involving the presence of 
geographic atrophy or soft drusen. 

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• 
Study eye with retinal degenerative disorder or macular disorder (other than mild 
macular degeneration) that is expected to cause future vision loss.   
• 
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 that is either progressive or sufficient to reduce 
BCDVA to worse than 20/20.  
• 
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 Collemer Lens 
(ICL), Corneal Inlay, or with previous pterygium excision unless the pterygium did 
not extend more than 2mm onto the cornea from the limbus. 
• 
Study eye with clinically significant dry eye syndrome (DES). 
• 
Study eye with clinically significant corneal haze.  
• 
Study eye with clinically significant corneal opacity. 
• 
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. 
• 
Study eye with irregular astigmatism. 
• Study eye with a history of ocular herpes simplex virus.  
• Study eye with a history of a congenital color vision defect. 
 
7 
STUDY MATERIALS AND METHODS  
7.1 
DEVICE DESCRIPTION 
RxSight’s Light Adjustable Lens (RxLAL) 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 distance visual 
acuity. 
 

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7.1.1 RXSIGHT LIGHT ADJUSTABLE INTRAOCULAR LENS 
The RxSight Light Adjustable Lens (RxLAL) is a foldable posterior chamber, UV filtering, 
three-piece photoreactive silicone lens with blue PMMA (polymethylmethacrylate) modified-
C haptics, a 6.0 mm biconvex optic with squared posterior edge, and an overall diameter of 
13.0 mm. The RxLAL optic design (Figure 1) features a posterior surface layer, 0.05 mm 
thick, to further enhance the UV absorbing properties of the RxLAL lens and limit retinal 
exposure.  
 
 
 
FIGURE 1:  RXSIGHT LIGHT ADJUSTABLE LENS (RXLAL)  
(A) TOP VIEW AND (B) CROSS-SECTION VIEW OF THE OPTIC SHOWING  
RXLAL WITH A POSTERIOR LAYER 
 
 
A summary of the RxLAL design characteristics is presented below: 
Lens Optic 
• Material:  Photo-reactive, UV absorbing Silicone 
• Light transmission:  UV cut-off at 10% T = 394 ± 2 nm 
• Index of refraction:  1.43 
• Diopter power:  +10 to +15.0 diopters and +25.0 to +30.0 D in 1.0 diopter 
increments; +16.0 to +24.0 diopters in 0.5 diopter increments 
• Optic type:  Biconvex  
• Optic edge:  Square on posterior surface and round on anterior surface 
• Overall diameter:  13.0 mm 
• Optic diameter:  6.0 mm 
 
Haptics 
 
o Configuration:  Modified C 
o Material:  Blue polymethylmethacrylate 
o Haptic angle:  10° 
 
The RxLAL silicone material is designed to respond to a narrowband UV light of a select 
spatial intensity profile. The silicone material contains photoreactive additive, which is 

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selectively photo-polymerized in targeted areas upon exposure to the near UV light to alter 
the lens shape thus modifying spherical and sphero-cylindrical power of the RxLAL. 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. 
 
7.1.2 LIGHT DELIVERY DEVICE (LDD) 
RxSight’s Light Delivery Device (LDD) is a UV light projection system (Figure 2) used to 
induce a predictable change in RxLAL power 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 spatially light profiles with 
adequate intensity and duration to induce polymerization of photoreactive additive leading to 
a refractive power change of the RxLAL. Because this procedure is performed after 
implantation, residual refractive errors can be corrected, reducing the need for spectacles, 
corneal refractive procedures, or additional IOL procedures to optimize a patient’s vision. 
 
 
FIGURE 2:  RXSIGHT LIGHT DELIVERY DEVICE (LDD) 
 

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7.1.3 RXSIGHT INSERTION DEVICE 
The RxLAL can be inserted in to 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.  
 
7.1.4 INDICATIONS FOR USE 
The RxSight Light Adjustable Lens (RxLAL) 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 RxLAL power to 
correct residual postoperative refractive error including -2.0 to +2.0 diopters of sphere and 
0.50 to 3 diopters of cylinder and by changing lens curvature to introduce controlled amounts 
of spherical aberration (+/- 1 micron) and center near add (up to 2 diopters). 
 
7.2 
SUBJECT ENTRY 
Patients who require cataract extraction and intraocular lens implantation will be 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. The preoperative examination will be performed no more than 90 days prior to 
surgery. If the 90-day time period elapses, it is acceptable for patients to be re-screened by 
undergoing a complete preoperative examination. If both eyes of a patient meet study 
eligibility, a pre-determined randomization scheme will be utilized to designate each of the 
patient’s eyes as the primary eye or the fellow eye. If only one eye of a patient meets study 
eligibility, that eye will automatically be designated as the primary eye. 
 
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 approximately 150 eyes in about 75 subjects have 
undergone implantation. Unique identification numbers will be assigned to each subject. 
 
Study enrollment will be tracked to ensure that approximately 1/2 of the study population 
will have ≥0.50 D to ≤1.5 D of preoperative keratometric astigmatism and approximately 
1/2 of the study population will have >1.5 D to ≤3.00 D of preoperative keratometric 
astigmatism. At least 10 eyes should have >2 D of preoperative keratometric astigmatism.  
Implantations in one bin may be suspended to ensure enrollment in all bins meets these 
requirements. 
 
The implant lens power for the RxLAL will be calculated based upon the ocular biometry 
data and a lens power formula of the surgeon’s choice with a postoperative spherical 

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equivalent (SE) outcome closest to emmetropia. If both eyes of a patient are enrolled, the 
primary eye will be scheduled for implantation prior to the fellow eye.  
 
7.3 
RXLAL IMPLANTATION AND REFRACTIVE ADJUSTMENT 
7.3.1 SURGICAL PROCEDURE 
The RxLAL will be implanted on Day 0 of the study using standard microsurgical 
techniques.  
 
No additional refractive procedures are allowed until after the 3 Month Post Lock-In/6 
months postop visit.   
 
In subjects with both eyes enrolled, if surgical complications occur with the primary eye and 
no RxLAL is implanted, the subject should be Exited from the study and no RxLAL should 
be implanted in the fellow eye. 
 
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 at a location of the surgeon’s discretion 
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 RxLAL, 
including posterior capsule rupture, zonular rupture, radial capsulorhexis tear, vitreous 
loss, iris trauma, corneal complications or any intraoperative abnormality that may affect 
the postoperative pupillary dilation, or the centration or tilt of the intraocular lens, do not 
implant the RxLAL.  
7. The RxLAL can be introduced into the eye using any of the following insertion 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. 
The RxLAL is placed into the capsular bag. If utilizing additional surgical instruments near 
the incision upon insertion, precaution should be taken not to contact the RxLAL optic with 
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• If sutures were utilized at the time of surgery to close the incision wound, light 
treatments should not commence on the study eye until a minimum of 4 weeks after 
suture removal.16 
• 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 instructions. (see 
 for additional details regarding premature 
photopolymerization).   
• Any study eye possessing clinically significant posterior capsular (PC) haze should 
undergo a YAG capsulotomy procedure prior to the adjustment. A minimum of 48 hours 
should separate the YAG treatment from the corresponding refraction and LDD 
adjustment. 
 
 
 
 
16  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.  

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10. Manifest Refraction 
11. Best corrected distance visual acuity (BCDVA) Monocular 
 
 
14. Intraocular pressure 
15. Dilated pupil diameter  
16. Slit Lamp Examination 
17. Fundus Exam 
18. Adverse Events 

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7.6 
DATA REPORTING 
All study data will be recorded onto case report forms (electronic or paper) designed for the 
study. CRFs can be signed by the investigator either by paper signature or by electronic 
signature. The CRF may be the source document for some data and each site will document 
this with a note to file describing in which cases source data will be recorded directly onto 
the CRF. If paper CRFs are used, all CRFs will be completed in a legible manner in 
black/blue ink.  
Any corrections to the CRFs will be made by drawing a single line through the incorrect 
entry, recording the correct information, and initialing and dating the change.  The CRFs 
and/or data entered in the EDC system will be reviewed by the Study Monitor.  
All clinical data generated in the study will be submitted to RxSight or designated CRO for 
quality assurance review and statistical analysis.  All CRFs and 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 
An End of Study Form must be completed for all subjects enrolled in the study upon subject 
completion, withdrawal or discontinuation. 
 
7.7.1 SUBJECT COMPLETION 
Subjects are considered to have completed the study if they have completed the 6 Months 
Postop (3 Months Post Lock-In) examination.   
 
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. 
  
7.7.2 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.   
 
7.7.3 SUBJECT WITHDRAWAL DUE TO INTRAOPERATIVE COMPLICATIONS PRIOR TO 
 
IMPLANTATION 
Subjects that meet all inclusion/exclusion criteria but do not undergo implantation of the 
RxLAL due to intraoperative complications prior to introduction of the RxLAL will be 
followed to resolution of any adverse events and then exited from the study.  
 

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7.7.4 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. 
 
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.   
 
7.7.5 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. 
 
 

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8 
STATISTICAL METHODS 
 
8.1 
POPULATIONS FOR ANALYSIS 
Exploratory effectiveness analyses will be performed on observed data for all primary eyes, 
fellow eyes, and all eyes successfully implanted with the RxLAL.  
 
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 
RxLAL makes contact with the eye. No imputation will be performed. 
 
8.1.1 EXPLORATORY EFFECTIVENESS PARAMETERS 
The following exploratory effectiveness outcomes will be summarized descriptively based on 
the observed data.  Except for the Quality of Vision Questionnaire (QoV), all the observed 
data will be summarized for the primary eyes and fellow eyes successfully implanted with 
RxLAL separately.  The summaries will also be performed for all eyes. 
 
UCDVA 
Number and percent of primary eyes, fellow eyes, and all eyes (i.e. primary and fellow eyes) 
successfully implanted with the RxLAL with a UCDVA of 20/20 or better at 6 Months 
Postop (3 Months Post Lock-In) will be presented and the corresponding 95% confidence 
interval for the percent based on the binomial distribution will be calculated. 
 
UCDVA will be presented with the number and percent of eyes that fall into each category of 
UCDVA (e.g. 20/20 or better, 20/25 or better, 20/32 or better, etc.) at each visit.  The mean 
UCDVA letter score will be calculated 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 mean change from 
Postop Week 3 will also be presented. 
 
UCDVA will also be presented with the number and percent of eyes that fall into each 
category of UCDVA (e.g. 20/20 or better, 20/25 or better, 20/32 or better, etc.) stratified into 
two bins based on preoperative keratometric cylinder (≥0.50 D and ≤1.50 D) and (>1.50 D 
and ≤3.00 D). The mean UCDVA letter score will be calculated for each of the two defined 
preoperative keratometric cylinder bins. 
 
Quality of Vision17 Questionnaire 
Results of the Quality of Vision Questionnaire will be summarized descriptively for subjects 
bilaterally implanted with the RxLAL and for subjects with the RxLAL implanted only in the 
 
17 McAlinden C, Pesudovs K, Moore JE. The Development of an Instrument to Measure Quality of Vision: The Quality of 
Vision (QoV) Questionnaire. Invest Ophthalmol Vis Sci. 2010;51:5537-5545. 
 

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- 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.   
 
9.2.1 IDENTIFICATION AND COLLECTION 
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. During the study, the Investigator should treat the study subject as 
appropriate to ensure his/her safety and welfare. Refer to Section 7.7.1 for additional 
information pertaining to ongoing AEs at subject exit.  
 
Pre-existing conditions will not be considered AE/SAEs but will be collected at the 
Preoperative Visit as medical history. A worsening of a pre-existing condition during the 
study should be documented as an AE and evaluated accordingly.  
 
Hospitalization is a criterion for assessment of seriousness. Hospitalization in the absence of 
a medical AE is not in itself an AE. For example, the following reports of hospitalization 
without a medical AE should not be considered either an SAE or an AE: 
• Planned hospitalization for a pre-existing condition without serious deterioration in 
health (e.g., planned knee replacement surgery)  
• Social admission (e.g., subject has no place to sleep)  
• Administrative admission (e.g., for yearly physical exam or elective procedures not 
related to the study)  
• Optional admission not associated with a precipitation medical AE (e.g., for elective 
cosmetic surgery)  
 
9.2.2 EVALUATIONS 
When evaluating AEs, the Investigator must determine if the event is serious, assess the 
severity of symptoms, the relationship of the event to the device or study protocol, using the 
following guidelines:  

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1. Severity  
Mild: subject awareness of a sign or symptom that is easily tolerated, requires no 
treatment, and does not interfere with subject’s daily activities  
Moderate: subject awareness of a sign or symptom which may be a low level of 
concern to the subject and may interfere with daily activities, but can be relieved by 
simple therapeutic care  
Severe: a sign or symptom that interrupts the subject’s daily activity and requires 
systemic therapy or other treatment  
 
2. Relationship (Causality) to Study Device or Study Protocol  
Related:  There is at least a reasonable possibility that the AE/SAE is related to the 
study device or study protocol.  Reasonable possibility means that there is evidence to 
suggest a causal relationship between the study device or study protocol and the AE. 
Unrelated:  There is little or no reasonable possibility that the AE/SAE is related to 
the study device or study protocol.  This assessment implies that the AE/SAE has 
little or no temporal relationship to the study device and/or a more likely or certain 
alternative etiology exists. 
 
9.2.3 SAE REPORTING 
The site should report any event to the Sponsor and its representative in an expedited manner 
if it meets the criteria for an SAE and/or is an IOL explant from a study eye. Expedited 
reporting is calling or e-mailing the Sponsor and its representative within 48 hours of 
becoming aware of the event. When reporting an SAE to the Sponsor and/or its 
representative, the site should forward any supporting documents along with the SAE Report 
Form to the Sponsor and its designee within 5 days of the initial communication. Sites must 
also report the SAE to the reviewing Ethics Committee per its reporting procedures. 
 
 
9.2.4 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.  
 

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9.2.5 POTENTIAL ADVERSE EVENTS 
The following have been identified as potential adverse events for all cataract surgeries 
including the RxLAL. 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, 
corneal edema which may require correction with a corneal transplant, lens dislocation out of 
the posterior chamber, pupillary block, striation on the lens with or without visual sequelae, 
iritis, synechiae, ptosis, wound leak, flat anterior chamber, increased astigmatism, rupture of 
the capsule, iris prolapse, vitreous in the anterior chamber, and retained pieces of the lens in 
the eye. These adverse events may result in total loss of vision or the loss of an eye. 
Secondary surgery may be required after the cataract surgery to treat surgical complications. 
Additionally, a posterior capsulotomy may be required to treat posterior capsular haze after 
the cataract surgery. Visual problems after cataract surgery may include halos, glare, ghost 
images, and/or double vision.  These and other complications may result in permanent poor 
vision.    
 
Additional specific risks of the RxLAL include: 
The RxLAL 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 RxLAL 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 RxLAL 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 RxLAL. Vision loss may be 
permanent and may not be improved by replacing the RxLAL. 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. 
 
 
 
 

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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. 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 RxLAL 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 
. 
  
 
 

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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 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.  
 
It is the responsibility of the Principal Investigator to obtain Ethics Committee approval of 
the Study Protocol and to keep the Ethics Committee 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 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.  
 
 
 
 

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12 
REFERENCES 
1. 
Nordan, LT. The Surgical Rehabilitation of Vision. Gower Medical, New York, 
1991. 
2. 
Kirwan C, Nolan JM, Stack J, et al.  Determinants of patient satisfaction and 
function related to vision following cataract surgery in eyes with no visually 
consequential ocular co-morbidity.  Graefes Arch Clin Exp Ophthal 
2015;253:1735-1744. 
3. 
Agresta B, Knorz MC, Donatti C, Jackson D.  Visual acuity improvements after 
implantation of toric intraocular lenses in cataract patients with astigmatism: a 
systematic review.  Graefes Arch Clin Exp Ophthal 2012;12:41. 
4. 
Brandser R, Haaskjold E, Drolsum L. Accuracy of IOL calculation in cataract 
surgery. Acta Ophthalmol  Scan 1997;75:162-165. 
5. 
Steinert RF, Aker BL, Trentacost DJ, Smith PJ, Tarantino N.  A prospective 
comparative study of the AMO ARRAY zonal-progressive multifocal silicone 
intraocular lens and a monofocal intraocular lens.  Ophthalmology 
1999;106(7):1243-55. 
6. 
Connors R 3rd, Boseman P 3rd, Olson RJ.  Accuracy and reproducibility of 
biometry using partial coherence interferometry.  J Cataract Refract Surg 
2002;28(2):235-238. 
7. 
Olsen T, Bargum R. Outcome monitoring in cataract surgery. Acta Ophthalmol 
Scand. 1995;73(5):433-7. 
8. 
Wegener M, Alsbirk PH, Hojgaard-Olsen K.  Outcome of 1000 consecutive 
clinic- and hospital-based cataract surgeries in a Danish county.  J Cataract 
Refract Surg 1998;24(8):1152-60. 
9. 
Norrby S. Sources of error in intraocular lens power calculation. J Cataract 
Refract Surg 2008; 34:368–376.  
10. Hirnschall N, Hoffmann PC, Draschl P, et al. Evaluation of factors influencing 
the remaining astigmatism after toric intraocular lens implantation. J Refract 
Surg 2014;6:1–7. 
11. Ferrer-Blasco T, Montes-Mico R, Peixoto-de-Matos SC, et al. Prevalence of 
corneal astigmatism before cataract surgery. J Cataract Refract Surg 2009;35:70–
75. 
12. Lekhanont K, Wuthisiri W, Chatchaipun P, Vongthongsri A. Prevalence of 
corneal astigmatism in cataract surgery candidates in Bangkok, Thailand. J 
Cataract Refract Surg 2011;37:613–615. 

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13. McIntyre JS, Werner L, Fuller SR, et al. Assessment of a single-piece 
hydrophilic acrylic IOL for piggyback sulcus fixation in pseudophakic cadaver 
eyes. J Cataract Refract Surg 2012;38:155–162. 
14. Mamalis, N.; Spencer, T. S.; Complications of foldable intraocular lenses 
requiring explantation or secondary intervention – 2000 survey update. J 
Cataract Refract Surg 2001;27(8):1310-1317. 
15. Hengerer F, Dick HB, Conrad-Hengerer I. Clinical Evaluation of an Ultraviolet 
Light Adjustable Intraocular Lens Implanted after Cataract Removal: Eighteen 
Months Follow-up. Ophthalmology 2011; 118:2382-2388. 
16. 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.  
17. McAlinden C, Pesudovs K, Moore JE. The Development of an Instrument to 
Measure Quality of Vision: The Quality of Vision (QoV) Questionnaire. Invest 
Ophthalmol Vis Sci. 2010;51:5537-5545.