Dry Eye, Dry Eye Disease (DED), Dry Eye Sensation After Cataract Surgery
Conditions
Keywords
dry eye disease, hyaluronic acid, lacrimal plug
Brief 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.
Interventions
DEVICELACRIFILL® 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.
PROCEDURESham lacrimal canalicular procedure
Lacrimal irrigation performed as a sham procedure in the control eye without administration of LACRIFILL® Canalicular Gel or temporary canalicular occlusion.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized, contralateral-eye controlled study. Within each participant, one eye is randomly assigned to temporary lacrimal occlusion with LACRIFILL® Canalicular Gel and the fellow eye to a sham lacrimal irrigation procedure. Each participant therefore receives both interventions, with treatment allocation randomized at the eye level.
Eligibility
Sex/Gender
ALL
Age
45 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-eye difference in Schirmer Test 1 at month 1 | 1 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-eye difference in Schirmers Test 1 at month 3 | 3 Months | 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 | 1 month, 3 months | 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 | 1 month; 3 months | 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 | 1 month; 3 months | 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. |
| Halo/glare size measured with the Real Artificial Lens Vision (RALV) system | 1 month and 3 months | Halo/glare size will be quantitatively assessed using the Real Artificial Lens Vision (RALV) halo/glare test. Participants view a central white light source while optotypes are presented at decreasing radial distances from the light source. Halo/glare size is recorded as angular extent in milliradians (mrad). Higher values indicate a larger halo/glare phenomenon and therefore greater visual disturbance. Measurements will be performed separately for the Lacrifill-treated eye and the contralateral sham-treated eye. |
| Outcomes of questionnaires | 1 month; 3 months | Report of the dry eye disease questionnaires (OSDI and SPEED) and the National Eye Institute Visual function questionnaire 25 at month 1 and 3 |
| Number of applied artifical tear drops | 3 months | Self-reported number of average applications of artificial tear drops per eye per day. |
| Incidence of adverse events and device- or procedure-related adverse events | 3 months | Incidence, nature, severity, and relationship to the investigational device and/or procedure of adverse events, including serious adverse events and serious adverse device effects. |
| Inter-eye difference in visual quality assessment | 1 month; 3 months | Difference in Visual quality assessment measured by Refractive Artificial Lens Vision (RALV) at month 1 and 3 |
Countries
Austria
Outcome results
None listed