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

Vance Thompson Vision

Status

Enrolling

Conditions

Dry Eye Disease (DED)

Treatments

Device: Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML

Study type

Interventional

Funder types

Other

Identifiers

NCT07155057

Lacrifill IIT

Details and patient eligibility

About

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

Full description

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.

Enrollment

60 estimated patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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