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...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.展开更多
基金Project supported by the Key Research&Development Projects of Zhejiang Province(No.2018C03082)the Health Commission of Zhejiang Province(Nos.WKJ-ZJ-1905 and 2018ZD007),China
文摘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.
