Objective: To evaluate the safety and effectiveness of eyelid margin cleaning using Deep Cleaning Device for the treatment of meibomian gland dysfunction-associated dry eye.
Methods: This was a prospective, randomized, open-label, investigator-masked, and self-controlled study. We randomly assigned one eye of patients with meibomian gland dysfunction-associated dry eye to the treatment group, and the other eye to the control group. Both groups received artificial tears and lid warming; the treatment group received an additional one-time in-office eyelid margin cleaning using Deep Cleaning Device. Non-invasive tear break-up time (NITBUT) and tear meniscus height (TMH) of each eye, and Standard Patient Evaluation for Eye Dryness II (SPEED II) score of each patient were evaluated before and at one week after treatment.
Results: Thirty eyes of 15 patients were enrolled. No adverse effects occurred during the treatment. Compared with the baseline values, the SPEED score decreased significantly at one week after treatment (mean±95% confidence interval, 11.00±0.99 vs. 5.67±1.67, P<0.0001), the NITBUT-first in the treatment group increased significantly at one week after treatment ((4.74±1.27) s vs. (7.49±2.22) s, P=0.01). The NITBUT-first was significantly longer in the treatment group ((7.49±2.22) s) than in the control group ((5.17±0.91) s) at one week after treatment (P=0.042). No significant differences were found in other tear film parameters between the two groups.
Conclusions: Eyelid margin cleaning using the novel Deep Cleaning Device is a convenient, effective, and safe treatment for patients with meibomian gland dysfunction-associated dry eye.
Keywords: Eyelid margin cleaning; Deep Cleaning Device; Meibomian gland dysfunction; Dry eye.