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A prospective study to evaluate the safety and efficacy of a novel mechanical eyelid device (NuLidsTM by NuSight Medical, LLC, Rancho Santa Fe, CA) used at home for the treatment of dry eye disease (DED), blepharitis (anterior and posterior) and meibomian gland disease (MGD).
Seventy-four (74) eyes of thirty-seven (37) patients were self-treated with the NuLidsTM device at home. Inclusion criteria included blepharitis, MGD and/or DED. After an initial training session, each eyelid was treated for 15 seconds (total of 1 minute per treatment session per day). The following tests were collected before the first treatment and after the final treatment: OSDI survey, BCVA, Tear Osmolarity Test (Tear Lab), Tear Break Up Time (TBUT), Meibomian Gland Score (MGS), Meibomian Glands Yielding Liquid Secre-tions (MGYLS), Sicca Ocular Staining Score. Satisfaction with treatment survey was taken after treatment.
All measured parameters had a statistically significant improvement. Symptoms improved based on an average decrease in OSDI score from 54.2 ± 19.5 (mean ± SD) to 26.7 ± 18.4 (P < 0.001). Tear osmolarity improved from 315 ± 15.7 to 306 ± 13.9 (P = 0.002). TBUT was noted to improve from pre-treatment of 4.8 ± 1.7 seconds to post-treatment of 7.9 ± 4.1 seconds (P < 0.001). MGS improved from 8.9 ± 5.1 to 7.0 ± 5.9 (P = 0.01). MGYLS improved from 8.7 ± 6.2 to 15.8 ± 6.9 (P = 0.002). Sicca Ocular Staining Score improved from 2.7 ± 2.1 to 1.4 ± 1.5 (P = 0.002).
There were no adverse events. No corneal or conjunctival trauma. No patients dropped out of the trial due to discomfort. 91% of participants agreed or strongly agreed that the device was easy and convenient to use. Of those previously using manual lid scrubs, 82% felt the NuLids device was easier and more comfortable to use. 89% described little or no discomfort. 95% were satisfied or very satisfied with the overall treatment.
A mechanical device was safely used by patients at home for 1 minute daily for 30 days to treat DED, blepharitis, and MGD. There was a statistically significant improvement in signs and symptoms of DED as shown by improved OSDI, tear osmolarity, TBUT, MGS, MGYLS, and Ocular Staining Score. High patient satisfaction along with the low risk of adverse events supports the use of this device as a valid tool to treat DED, blepharitis, and MGD.
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