RecruitingNot ApplicableNCT07155057

Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery

A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery

Sponsor

Vance Thompson Vision

Enrollment

60 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Dry Eye Disease (DED)

Summary

To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery

Eligibility

Min Age: 22 Years

Inclusion Criteria7

Be willing and able to understand and sign the informed consent form (ICF)
Men or non-pregnant women age 22 or older
Clear intraocular media other than cataract
Diagnosis of dry eye disease (OSDI score ≥ 13)
Non-invasive Tear break up time ≤ 10 seconds in at least one eye
Willing and able to comply with all study related visits and procedures
In the opinion of the investigator, patients who are appropriate for advanced technology lens implants

Exclusion Criteria2

History of punctal cautery
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

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Interventions

DEVICECross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML

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