Effect Of Intraoperative Lacrifill® Placement On Postoperative Tear Film Stability In Patients With Pre-Existing Mild Dry Eye Disease Undergoing Cataract Surgery

To evaluate the efficacy of intraoperative lacrimal drainage occlusion using Lacrifill®, a cross-linked hyaluronic acid canalicular gel, in postoperative tear film stability and symptoms in patients with pre-existing mild dry eye disease (DED) undergoing cataract surgery. To date, no studies have specifically investigated the intraoperative use of canalicular gel occlusion as a preventive strategy for post-cataract surgery dry eye exacerbation.

Prospective, single-center exploratory study conducted at the Department of Ophthalmology, AOU Careggi, University of Florence, Italy.

20 patients with mild DED (Schirmer I test <10 mm and stable use of lubricants ≥3 times/day for at least 1 month) undergoing unilateral cataract surgery were enrolled. Patients were assigned to either cataract surgery with intraoperative Lacrifill® placement (intervention group) or standard cataract surgery (control group). The fellow eye served as an additional intra-subject comparator. The primary outcome was Tear Break-Up Time (TBUT); secondary outcomes included tear meniscus height (TMH), Schirmer test I, Ocular Surface Disease Index (OSDI) and corneal staining. Assessments were performed at baseline, 4 weeks and 8 weeks post-operatively.

At 1 month, eyes treated with intraoperative Lacrifill® exhibited significantly better TBUT and OSDI scores compared to controls (p<0.05). Schirmer test and TMH also tended to be more favorable in the Lacrifill® group, though these differences did not reach statistical significance. Corneal staining showed no intergroup variation. At 2 months, no statistically significant differences were observed between groups for TBUT, Schirmer test, TMH, or corneal staining; however, all parameters continued to trend in favor of the Lacrifill® group, and OSDI scores remained significantly lower (p<0.05). While both groups showed higher tear film instability at 1 month, Lacrifill® TBUT values were similar to fellow non-operated eyes at 2 months (p=0.27).

Intraoperative placement of Lacrifill® may represent a promising strategy for perioperative ocular surface management in patients with pre-existing mild dry eye undergoing cataract surgery. It seems to provide a significant clinical advantage in the early postoperative phase and it leads to a sustained improvement in patient-reported symptoms up to 2 months. Although intergroup differences were attenuated by 2 months, the early benefits observed at 1 month support further investigation in larger, adequately powered studies to better define the potential role of intraoperative canalicular occlusion as a preventive approach in patients at higher risk of postoperative dry eye exacerbation.