A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery
Phase: NA
Conditions: Dry Eye Disease (DED)
Sponsor: Vance Thompson Vision

Crosslinked Hyaluronate Canalicular Gel: A Benefit Study 
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Clinical Study Protocol 
 
A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the 
Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery 
 
 
Date of Issue:   
 
05/14/2025 
 
Sponsor:      
 
 
Vance Thompson Vision 
 
 
 
 
 
 
Sponsor Location:   
 
Vance Thompson Vision  
 
 
 
 
 
3101 West 57th Street 
 
 
 
 
Sioux Falls, SD, 57108 
 
Study Name:  
 
The LaReCa Study 
 
 
 
 
 
 
 
Study Phase:  
 
Investigator-Sponsored Trial 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Clinical Study Protocol Synopsis 
 
Title:  A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for 
the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery  
 
Principal Investigator:  Kayla Karpuk, OD / Vance Thompson, MD 
 
Sponsor Location:     Vance Thompson Vision 
 
 
 
 3101 West 57th Street 
 
 
 
 Sioux Falls, SD, 57108 
 
Study Name: Crosslinked Hyaluronate Canalicular Gel: A Benefit Study 
 
 
Objective: To determine patient reported outcomes of hyaluronate crosslinked canalicular gel 
placed in patients undergoing refractive cataract surgery  
Background: Dry eye disease (DED) is a prevalent condition among patients presenting for 
cataract surgery, with nearly 50% exhibiting signs of DED, even if asymptomatic. 1 As a result, 
DED is often undiagnosed and underreported in patients undergoing cataract surgery.1 This pre-
existing condition can be exacerbated by the surgical procedure itself, leading to increased 
ocular surface irritation, fluctuating vision, and overall discomfort after surgery.2 Consequently, 
despite achieving an improvement in vision from the cataract removal, patients may report 
dissatisfaction due to these persistent DED symptoms, highlighting a critical gap in aligning 
surgical success with patient-reported outcomes.2,3 
The cataract surgery process, involving corneal incisions and abundant use of perioperative 
medications, can disrupt tear film stability and worsen DED.1 Therefore, perioperative 
identification and management of DED is essential to optimize the visual and refractive 
outcome of the surgery. Addressing ocular surface health prior to surgery contributes to 
improved  accuracy of biometric measurements, which are critical for intraocular lens (IOL) 
power calculations and achieving desired refractive targets.3,4 Proactive management helps 
stabilize and prepare the ocular surface, potentially reducing postoperative complications and 
ensuring that patient expectations are more closely met.4 
Fortunately, the dry eye treatment landscape continues to evolve which enables more 
individualized care for patients. Recently, a cross-linked hyaluronic acid canalicular gel 
(Lacrifill®) was introduced, which represents a novel, alternative solution for lacrimal occlusion. 
This treatment works by occluding the tear drainage system, thereby increasing the retention 
of natural tears, improving tear film stability, and reducing ocular surface irritation.5 Proactive 
use of the canalicular gel could  lead to more reliable pre-operative measurements, better 
visual outcomes, and increased post-operative comfort, which is particularly important for 

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patients receiving advanced technology IOLs.5 Improvements in both signs and symptoms of 
DED have been reported using lacrimal occlusion, suggesting it could play a valuable role in 
optimizing the cataract surgery experience.6 
Study Design:  Prospective, single-site, single-arm study enrolling 60 patients who have elected 
advanced IOL implantation at the time of cataract surgery and have a diagnosis of dry eye 
disease. The study will consist of 5 study visits, over a 3-5 month time period. Patients will 
receive bilateral lacrimal occlusion of crosslinked hyaluronate canalicular gel pre-operatively 
The primary endpoint will be the change from baseline to 3- month visit in non-invasive tear 
break up time (NITBUT) in primary eyes as measured by a non-invasive, automated ocular 
surface analyzer. Additional endpoints measured will be the change from baseline in the visual 
analog score and OSDI. The effect of pre-operative lacrimal occlusion on accuracy of 
preoperative biometry/keratometry measurements will be evaluated as well as residual 
refractive error at 30 and 90 days post-operative. 
Subject Population: 60 subjects, who have elected bilateral refractive cataract surgery will be 
enrolled.  
 
Materials and Methods 
 
● Informed consent will be obtained prior to collection of any study specific data.   
● Each subjects’ demographics, medical and ocular history will be reviewed. 
● Inclusion and exclusion criteria will be reviewed for each subject.   
● Subjects will be asked to report satisfaction using the visual Analog Score (VAS) and dry 
eye symptoms using the Ocular Surface Disease Index (OSDI) 
● Subjects’ monocular and binocular uncorrected distance visual acuity (UDVA) will be 
obtained on an ETDRS chart at a distance of 4 meters 
● A manifest refraction will be performed on each subject. 
● Monocular and binocular best corrected distance visual acuity (BCDVA) will be obtained 
on an ETDRS chart at a distance of 20 feet in photopic lighting conditions. 
● Biometry measurements will be obtained. 
● Objective tear meniscus height will be measured. 
● Objective non-invasive tear break up time will be measured. 
● The subjects’ eyes will be thoroughly examined at the slit lamp. 
● Bilateral canalicular occlusion with cross-linked hyaluronate will be performed prior to 
cataract surgery 
● Patients will undergo standard of care cataract post-operative visit testing and 
procedures 
 
 
 
 

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Inclusion criteria:   
 
1. Be willing and able to understand and sign the informed consent form (ICF) 
2. Men or non-pregnant women age 22 or older 
3. Clear intraocular media other than cataract 
4. Diagnosis of dry eye disease (OSDI score ≥ 13)    
5. Non-invasive Tear break up time ≤ 10 seconds in at least one eye 
6. Willing and able to comply with all study related visits and procedures 
7. In the opinion of the investigator, patients who are appropriate for advanced 
technology lens implants 
 
Exclusion criteria:   
 
1. History of punctal cautery 
2. Lacrimal anatomy (e.g., nasolacrimal duct obstruction) that per investigator suggests 
that the patient would not be a good candidate for lacrimal occlusion or patients for 
whom lacrimal occlusion would increase risk 
 
Procedures 
 
Subjects will be recruited from the site’s current patient population who have been scheduled 
for refractive cataract surgery and have a concomitant diagnosis of dry eye disease. Enrollment 
and informed consent will be administered by study coordinators. Data will be collected by 
investigators and study coordinators as follows.  
 
Visit 0 (7 to 45 days prior to surgery):  
o Informed consent will be obtained prior to collection of any study-specific data. 
o Potential subjects’ demographics, medical and ocular history, and concomitant 
medications will be reviewed. 
o Inclusion and exclusion criteria will be reviewed for each subject.  
o Ocular Surface Disease Index (OSDI) will be obtained 
o Visual Analog Score will be obtained 

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o Pre-operative biometry measurements will be obtained 
o Non-invasive tear break up time (NITBUT) will be obtained 
o Automated tear meniscus (TMH) will be obtained 
o Best-corrected distance visual acuity (BCDVA) will be obtained using the ETDRS  
o Slit Lamp Exam 
o NaFl staining will be measured (NEI grading scale) 
o If both eyes qualify for the study, the primary eye will be the eye with the 
smaller NITBUT.  If the NITBUT is the same in both eyes, the primary eye will be 
the right eye. 
o Lacrimal occlusion of the inferior canaliculi of both eyes will be performed 
Visit 1A/B (operative day[s]):  
o Repeated biometry measurements obtained on each eye 
o VAS 
o Patients may undergo sequential bilateral surgery per site standard of care 
o Adverse events will be collected 
Visit 2 (1-2 days post-op):  
o UCDVA as measured by ETDRS 
o Slit lamp exam  
o Corneal fluorescein staining  
o Intraocular pressure measured by standard of care 
o Adverse events will be collected 
Visit 3 (7 days post cataract surgery +/- 2 days) 
o OSDI  
o VAS 
o NITBUT 
o TMH 
o Manifest refraction 
o UCDVA/BCDVA measured by ETDRS 
o Slit lamp exam  
o Corneal fluorescein staining  
o Intraocular pressure measured by standard of care 
o Adverse events will be collected 
Visit 4 (30 days post cataract surgery +/- 7 days) 
o OSDI 
o VAS 
o NITBUT 
o TMH 
o Manifest refraction 
o UCDVA/BCDVA measured by ETDRS 
o Slit lamp exam  
o Corneal fluorescein staining 
o Intraocular pressure measured by standard of care 
o Dilated fundus exam  
o Adverse events will be collected 

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Visit 5 (90 days post cataract surgery +/- 14 days) 
o OSDI 
o VAS 
o NITBUT 
o TMH 
o Manifest refraction 
o UCDVA/BCDVA measured by ETDRS 
o Slit lamp exam  
o Corneal fluorescein staining 
o Intraocular pressure measured by standard of care 
o Adverse events will be collected 
 
 
Data Analysis and Data Monitoring 
 
Data will be captured by the principal investigators, sub-investigators and study 
coordinators.  Data will be documented on source documents and subjects will be identified by 
subject numbers. 
 
Data analysis will occur on an excel spreadsheet or in R statistical software with subjects 
identified by subject number. The Excel spreadsheet or R scripts will be on computer(s) that are 
password protected. 
Baseline demographic and ocular characteristics will be quantified using descriptive statistics. 
Statistical analysis will be completed on all primary and secondary endpoints. A primary analysis 
will be conducted upon completion of the 3-month study period with an interim analysis of the 
first 30 patients to complete all visits.  
The planned sample size is 60 eyes of 60 patients, with the primary eye selected as the eye with 
lower NITBUT at screening. Sample size was calculated to provide 80% power to detect a 
meaningful change of 0.8 seconds or greater from baseline to 3-months in NITBUT.   
Secondary analyses will include fellow eyes and all (primary + fellow) eyes.   
Data Storage and Confidentiality 
Private information and your medical record will be shared with individuals and organizations 
that conduct or watch over this research, including: 
● The research sponsor 
● People who work with the research sponsor 
● The Institutional Review Board (IRB) that reviewed this research 
We may publish the results of this research. However, we will keep all names and other 
identifying information confidential. 
 
We protect all information from disclosure to others to the extent required by law. We cannot 
promise complete secrecy. 

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Sources documents will be placed in a binder and stored in locked cabinets.   
This trial will be conducted in compliance with the protocol, GCP, and applicable regulatory 
requirement(s). 
 
The participation for this trial is voluntary and subjects may stop or withdraw during the one-
time examination at their discretion.   
 
The principal investigator will report to the IRB any changes in research activity, serious adverse 
events, and completion of the study. 
 
 
 
Sources 
1. Trattler WB, Majmudar PA, Donnenfeld ED, et al. The Prospective Health Assessment of 
Cataract Patients’ Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 
2017;11:1423-1430.  
2. De Gregorio C, Nunziata S, Spelta S, Lauretti P, Barone V, Surico PL, Mori T, Coassin M, Di 
Zazzo A. Unhappy 20/20: A New Challenge for Cataract Surgery. Journal of Clinical 
Medicine. 2025; 14(5):1408 
3. Epitropoulos, A. T., et al. Effect of tear osmolarity on repeatability of keratometry for 
cataract surgery planning. J Cataract Refract Surg. 2013;39(9):1352-1358. 
4. Lai, E. C., & STArr, C. E. (2014). Managing dry eye disease in cataract patients. Cataract & 
Refractive Surgery Today, 14(1), 53-55. 
5. Fezza, J. P. (2018). Cross-linked hyaluronic acid gel occlusive device for the treatment of 
dry eye syndrome. Clinical Ophthalmology, 2277-2283.  
6. Packer, M., Lindstrom, R., Thompson, V., Parekh, J. G., Gupta, P., Nijm, L. M., & 
Donnenfeld, E. (2022). The Effectiveness and Safety of a Novel Crosslinked Hyaluronate 
Canalicular Gel Occlusive Device for Dry Eye. Journal of Cataract & Refractive Surgery, 
10-1097.