A Prospective, Single-Arm Study Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of Dry Eye Disease in Patients Undergoing Refractive Cataract Surgery
Vance Thompson Vision
Summary
To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery
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.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Yes
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…
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
Location
- Vance Thompson Vision Clinic, Prof. LLCSioux Falls, South Dakota