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

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

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.

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