NCT07155057

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Vance Thompson Vision · Academic / Other
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DEVICE	Cross-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

Timeline

• Start date: 2025-09-03
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2025-09-04
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study