Temporary Tear Duct Filling With Hyaluronic Acid Gel and Assessment of Dry Eye Disease (DED) After Bilateral Cataract Surgery

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

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.

Inclusion Criteria:

• Uncomplicated bilateral cataract surgery for age-related cataract within the last 2-7 days
• Implantation of the same type of lens in both eyes (diopters may differ).
• Age 45-99 years
• Willingness to complete the study
• Signed informed consent form

Exclusion Criteria:

• Bilateral cataract due to a different cause
• Retinal findings affecting quality of life or visual acuity in any eye
• History of uncontrolled glaucoma in any eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma mediation)
• Active or suspected ocular or periocular infection in the study eye.
• Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye.