Ophthalmology Department, Shamir Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Ophthalmology Department, Shamir Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Cont Lens Anterior Eye. 2022 Dec;45(6):101741. doi: 10.1016/j.clae.2022.101741. Epub 2022 Jul 18.
To examine the effects of treatment with a thermomechanical skin device to the eyelid area on the clinical signs and symptoms of patients who suffer from dry eye disease (DED) secondary to meibomian gland dysfunction (MGD).
Forty patients aged 45 years or older with DED due to MGD were recruited. Both eyes (n = 80) of each patient received three treatments with the Tixel device (Novoxel®, Israel), with each treatment separated by a 2-week period. Treatment was applied across the upper and lower eyelids, with the same intensity, tip protrusion distance, and contact duration. Two additional follow-up visits were performed at 2-week intervals after treatment cessation. DED status was evaluated during each visit via SPEED II questionnaire, tear break-up time (TBUT), corneal staining score (CSS), MGD score, and frequency of lubricant use. Visual acuity (VA) was recorded during first and last visits.
Mean age was 64.3 ± 12.4 years and 72.5 % (n = 29) were female. 45 % (n = 18) had a history of blepharitis, 12.5 % (n = 5) had chalazia, and 17.5 % (n = 7) suffered from allergic conjunctivitis. Mean follow-up time was 2.1 ± 0.6 months. Comparing the first and last visits, all parameters showed significant improvement after Tixel treatment: mean SPEED II scores (16.5 ± 5.9 to 11.8 ± 6.7, p < 0.001), CSS (2.0 ± 1.3 to 0.5 ± 0.9, p < 0.001), TBUT (2.7 ± 0.8 s to 6.5 ± 2.2 s, p < 0.001), MGD score (2.7 ± 0.5 to 1.2 ± 0.4, p < 0.001), and rate of lubricant use (3.4 ± 2.4 per day to 1.9 ± 2.0, p < 0.001). VA also improved (0.10 ± 0.11 logMAR to 0.08 ± 0.10 logMAR, p < 0.05). No major side effects were observed.
In this pilot study Tixel treatment induced significant improvement of signs and symptoms among patients with DED due to MGD. Benefits persisted for at least one month. Further randomized controlled double-blinded studies are needed.
研究热机械皮肤设备对眼睑区域治疗对患有因睑板腺功能障碍（MGD）导致的干眼症（DED）的患者的临床体征和症状的影响。
招募了 40 名年龄在 45 岁或以上的因 MGD 而患有 DED 的患者。每位患者的双眼（n=80）均接受了三次 Tixel 设备（Novoxel ® ，以色列）治疗，每次治疗间隔 2 周。治疗应用于上下眼睑，强度、尖端突出距离和接触时间相同。治疗停止后，每 2 周进行另外两次随访。在每次就诊时通过 SPEED II 问卷、泪膜破裂时间（TBUT）、角膜染色评分（CSS）、MGD 评分和润滑剂使用频率评估 DED 状态。在第一次和最后一次就诊时记录视力（VA）。
平均年龄为 64.3±12.4 岁，72.5%（n=29）为女性。45%（n=18）有睑缘炎病史，12.5%（n=5）有睑板腺囊肿，17.5%（n=7）患有过敏性结膜炎。平均随访时间为 2.1±0.6 个月。与第一次和最后一次就诊相比，Tixel 治疗后所有参数均显著改善：SPEED II 评分平均值（16.5±5.9 至 11.8±6.7，p<0.001）、CSS（2.0±1.3 至 0.5±0.9，p<0.001）、TBUT（2.7±0.8 秒至 6.5±2.2 秒，p<0.001）、MGD 评分（2.7±0.5 至 1.2±0.4，p<0.001）和润滑剂使用频率（3.4±2.4 次/天至 1.9±2.0 次/天，p<0.001）。VA 也有所改善（0.10±0.11 logMAR 至 0.08±0.10 logMAR，p<0.05）。未观察到主要不良反应。
在这项初步研究中，Tixel 治疗可显著改善因 MGD 导致的 DED 患者的体征和症状。益处至少持续一个月。需要进一步进行随机对照双盲研究。
