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.
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
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.
Parallel
LACRIFILL® Canalicular Gel administration
DeviceLACRIFILL® 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
Procedure/SurgeryLacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.
Inter-eye difference in Schirmer Test 1 at month 1
Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.
Inter-eye difference in Schirmers Test 1 at month 3
Difference in Schirmer Test I tear production between the Lacrifill-treated eye and the contralateral standard-of-care eye at 3 month after cataract surgery. Schirmer Test I measures tear production as the length of wetting of a standardized filter paper strip over 5 minutes, expressed in millimeters (mm). Values for each eye range from 0 to 35 mm, with higher values indicating greater tear production. The inter-eye difference is calculated as the Schirmer Test I value in the Lacrifill-treated eye minus the value in the standard-of-care eye, resulting in a possible range of -35 to +35 mm. Positive values indicate greater tear production in the Lacrifill-treated eye.
Inter-eye difference in Oxford grading at month 1 and months 3
Difference in ocular surface staining between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 and 3 months after cataract surgery, assessed using the Oxford Scheme for Ocular Surface Staining. The Oxford score ranges from 0 to 5 for each eye, with higher scores indicating greater ocular surface staining and therefore a worse outcome. The inter-eye difference is calculated as the Oxford score in the Lacrifill-treated eye minus the score in the standard-of-care eye, resulting in a possible range of -5 to +5. Negative values indicate less ocular surface staining, and therefore a better outcome, in the Lacrifill-treated eye.
Inter-eye difference in tear break up time (TBUT) at month 1 and 3
Difference in Tear Film Break-Up Time (TBUT) between the Lacrifill-treated eye and the contralateral standard-of-care eye at 1 and 3 months after cataract surgery. TBUT is measured in seconds and represents the time between a complete blink and the first appearance of a break in the tear film. Higher TBUT values indicate greater tear film stability and therefore a better outcome. The inter-eye difference is calculated as the TBUT in the Lacrifill-treated eye minus the TBUT in the standard-of-care eye; positive values indicate greater tear film stability in the Lacrifill-treated eye.
Non-invasive tear break-up time measured with the MS-39 at Months 1 and 3
Tear film stability will be assessed using the first non-invasive tear break-up time (NIBUT) measured with the MS-39 anterior segment analyzer (CSO, Florence, Italy). The integrated Placido disk-based tear film analysis detects the time from the last blink to the first detected disruption of the tear film. NIBUT is recorded in seconds. Higher values indicate greater tear film stability and therefore a better outcome. Measurements will be performed separately in the Lacrifill-treated eye and the contralateral sham-treated eye.
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