Burgess Philip I, Koay Peter, Clark Patricia
St John's Hospital, Livingston, UK.
Cornea. 2008 May;27(4):391-4. doi: 10.1097/ICO.0b013e318160d030.
To evaluate the clinical efficacy, retention rates, and complications of SmartPlug insertion compared with silicone punctal plugs in patients with dry eye.
Thirty-six eyes with subjective symptoms of dry eye in addition to a tear film breakup time (TBUT) <5 seconds and evidence of ocular surface damage on rose Bengal or fluorescein staining were included. Treated eyes were randomized to either a silicone plug or SmartPlug inferior punctal occlusion. Pre- and posttreatment evaluations included subjective symptom scoring, tear meniscus height, TBUT, Schirmer test, fluorescein and rose Bengal staining, and artificial tear use.
After a mean follow-up period of 11.2 weeks, both the silicone plug- and SmartPlug-treated eyes showed significant improvement in symptom scoring (P = 0.002 and P = 0.005, respectively), TBUT (P = 0.035 and P = 0.009, respectively), and fluorescein (P = 0.024 and P = 0.016, respectively) and rose Bengal (P = 0.008 and P = 0.046, respectively) staining. There was no significant difference in these parameters between the 2 plugs. SmartPlug-, but not the silicone plug-treated eyes showed significant improvement in mean tear meniscus height (P = 0.037). The use of artificial tear supplements was reduced in 10 (55.6%) silicone- and 11 (61.1%) SmartPlug-treated eyes. Minor complications related to plug insertion were experienced in 4 (22%) silicone- and 2 (11%) SmartPlug-treated eyes. Spontaneous plug loss occurred with 6 (33%) silicone plugs.
This prospective randomized trial shows that SmartPlug insertion has equivalent clinical efficacy to the use of conventional silicone plugs. Both SmartPlug and silicone plug use can reduce dependency on tear supplements in >55% of patients with dry eye.
评估与硅胶泪小点栓相比，SmartPlug植入术在干眼症患者中的临床疗效、留存率及并发症。
纳入36只眼，这些眼除了泪膜破裂时间（TBUT）<5秒外，还有干眼症主观症状，且在孟加拉玫瑰红或荧光素染色时有眼表损伤证据。将治疗眼随机分为硅胶栓或SmartPlug下泪小点阻塞组。治疗前和治疗后的评估包括主观症状评分、泪河高度、TBUT、泪液分泌试验、荧光素和孟加拉玫瑰红染色以及人工泪液使用情况。
平均随访11.2周后，硅胶栓治疗组和SmartPlug治疗组的眼在症状评分（分别为P = 0.002和P = 0.005）、TBUT（分别为P = 0.035和P = 0.009）、荧光素染色（分别为P = 0.024和P = 0.016）及孟加拉玫瑰红染色（分别为P = 0.008和P = 0.046）方面均有显著改善。两种栓在这些参数上无显著差异。SmartPlug治疗组而非硅胶栓治疗组的平均泪河高度有显著改善（P = 0.037）。10只（55.6%）硅胶栓治疗眼和11只（61.1%）SmartPlug治疗眼的人工泪液补充使用量减少。4只（22%）硅胶栓治疗眼和2只（11%）SmartPlug治疗眼出现与栓植入相关的轻微并发症。6只（33%）硅胶栓出现自发栓丢失。
这项前瞻性随机试验表明，SmartPlug植入术与使用传统硅胶栓具有同等临床疗效。SmartPlug和硅胶栓的使用均可使超过55%的干眼症患者减少对泪液补充剂的依赖。
