Han Gyule, Lim Dong Hui, Yoo Young Sik, Shin Eun Hye, Park Jong Yup, Kim Dohyoung, Kim Pyungkyu, Chung Tae-Young
Department of Ophthalmology, Sungkyunkwan University, Samsung Medical Hospital, Seoul, South Korea.
Samsung Advanced Institute for Health Sciences and Technology, Sungkyunkwan University, Seoul, South Korea.
Ophthalmol Sci. 2022 Nov 2;3(2):100242. doi: 10.1016/j.xops.2022.100242. eCollection 2023 Jun.
OBJECTIVE: To evaluate the efficacy and safety of transcutaneous electrical stimulation (TES) for the prevention of dry eye after photorefractive keratectomy (PRK). DESIGN: Prospective, single-center, single-blinded, parallel group, placebo-controlled, randomized clinical trial. PARTICIPANTS: Between February 2020 and October 2020, patients at the Samsung Medical Center scheduled to undergo PRK to correct myopia were screened and enrolled. METHODS: The participants in the TES group were instructed to use the electrical stimulation device (Nu Eyne 01, Nu Eyne Co) at the periocular region after the operation, whereas those in the control group were to use the sham device. Dry eye symptoms were evaluated preoperatively and postoperatively at weeks 1, 4, and 12 using the Ocular Surface Disease Index (OSDI) questionnaire, the 5-Item Dry Eye Questionnaire (DEQ-5), and the Standard Patient Evaluation for Eye Dryness II (SPEED II) questionnaire. Dry eye signs were assessed using tear break-up time (TBUT), total corneal fluorescein staining (tCFS), and total conjunctival staining score according to the National Eye Institute/Industry scale. The pain intensity was evaluated using a visual analog scale. MAIN OUTCOME MEASURES: Primary outcomes were OSDI and TBUT. RESULTS: Twenty-four patients were enrolled and completed follow-up until the end of the study (12 patients in the TES group, 12 patients in the control group). Refractive outcomes and visual acuity were not different between the groups. No serious adverse event was reported with regard to device use. No significant difference in OSDI and SPEED II questionnaires and the DEQ-5 was observed between the groups in the 12th week after surgery. The TBUT scores 12 weeks after the surgery were 9.28 ± 6.90 seconds in the TES group and 5.98 ± 2.55 seconds in the control group with significant difference ( = 0.042). The tCFS and total conjunctival staining score were significantly lower in the TES group than in the control group at postoperative 4 weeks. Pain intensity at the first week was significantly lower in the TES group than in the control group by 65% ( = 0.011). CONCLUSION: The application of TES is safe and effective in improving dry eye disease after PRK. FINANCIAL DISCLOSURES: The author(s) have no proprietary or commercial interest in any materials discussed in this article.
目的：评估经皮电刺激（TES）预防准分子激光角膜切削术（PRK）后干眼症的疗效和安全性。 设计：前瞻性、单中心、单盲、平行组、安慰剂对照、随机临床试验。 参与者：2020年2月至2020年10月期间，对三星医疗中心计划接受PRK矫正近视的患者进行筛查并纳入研究。 方法：TES组参与者在术后被指导在眼周区域使用电刺激设备（Nu Eyne 01，Nu Eyne公司），而对照组使用假设备。术前以及术后第1、4和12周使用眼表疾病指数（OSDI）问卷、5项干眼问卷（DEQ - 5）和标准干眼患者评估II（SPEED II）问卷评估干眼症状。使用泪膜破裂时间（TBUT）、角膜总荧光素染色（tCFS）以及根据美国国立眼科研究所/行业标准的结膜总染色评分评估干眼体征。使用视觉模拟量表评估疼痛强度。 主要观察指标：主要结局指标为OSDI和TBUT。 结果：24名患者入组并完成随访直至研究结束（TES组12例，对照组12例）。两组的屈光结局和视力无差异。未报告与设备使用相关的严重不良事件。术后第12周，两组在OSDI、SPEED II问卷和DEQ - 5方面无显著差异。术后12周，TES组的TBUT评分为9.28±6.90秒，对照组为5.98±2.55秒，差异有统计学意义（P = 0.042）。术后4周，TES组的tCFS和结膜总染色评分显著低于对照组。TES组第一周的疼痛强度比对照组显著低65%（P = 0.011）。 结论：TES应用于改善PRK术后干眼症安全有效。 财务披露：作者对本文讨论的任何材料均无专利或商业利益。
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