NCT07155057NARecruitingAccepts Healthy Volunteers
Evaluating Crosslinked Hyaluronate Canalicular Gel for the Treatment of DED in Patients Undergoing Cataract Surgery
Vance Thompson Vision
Start Date
9/3/2025
Completion Date
12/1/2026
Summary
To review how patients report using a hyaluronate crosslinked canalicular gel placed before cataract surgery
Detailed 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 Criteria
Age Range: 22 years to No maximum
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
Interventions
DEVICE
Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML
Conditions
Dry Eye Disease (DED)
Locations
Vance Thompson Vision Clinic, Prof. LLC
Sioux Falls, South Dakota 57105
United States