Clinical Research Directory
Browse clinical research sites, groups, and studies.
Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery
Sponsor: Medical University of Vienna
Summary
Dry eye disease can occur or worsen after cataract surgery and may cause ocular discomfort and reduced visual quality. Standard treatment commonly includes artificial tear eye drops, which provide temporary lubrication. Temporary occlusion of the tear drainage system may offer an alternative approach by increasing tear retention and improving tear film stability. This prospective, randomized, double-blind, inter-eye study will evaluate the use of LACRIFILL® Canalicular Gel, a crosslinked hyaluronic acid gel placed in the tear drainage system, in patients who have undergone bilateral cataract surgery. Treatment allocation will be randomized at the eye level within each participant. One eye will be assigned to treatment with LACRIFILL®, while the fellow eye will serve as the control and receive standard care with artificial tear eye drops. The study will compare the development and severity of dry eye disease between the randomized treatment and control eyes. The main outcome will be tear production measured by the Schirmer Test 1 one month after treatment. Additional assessments will include tear film stability, ocular surface findings, anterior segment imaging, visual quality, dry eye symptoms, use of artificial tears, and treatment-related safety outcomes during a three-month follow-up period.
Official title: Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery in a Prospective Randomized Controlled Inter-eye Study
Key Details
Gender
All
Age Range
45 Years - 99 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-09-15
Completion Date
2027-12-31
Last Updated
2026-09-09
Healthy Volunteers
No
Interventions
LACRIFILL® Canalicular Gel administration
LACRIFILL® Canalicular Gel is a crosslinked hyaluronic acid hydrogel administered intracanalicularly into the lower canaliculus. Approximately 0.2 mL is administered as a single application to the randomized treatment eye to achieve temporary occlusion of the lacrimal drainage system.
Sham lacrimal canalicular procedure
Lacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.
Locations (1)
Medical University of Vienna, Department of Ophthalmology and Optometry
Vienna, State of Vienna, Austria