Efficacy of Hydroxypropyl Cellulose Ophthalmic Inserts (LACRISERT) in Subsets of Patients With Dry Eye Syndrome: Findings From a Patient Registry
Efficacy of Hydroxypropyl Cellulose Ophthalmic Inserts (LACRISERT) in Subsets of Patients With Dry Eye Syndrome: Findings From a Patient Registry
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DOI：
10.1097/ico.0b013e3181e3f05b
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发表时间：
2010-12-01
期刊：
影响因子：
2.8
通讯作者：
Macy, Jonathan I.
中科院分区：
文献类型：
--
作者：
Luchs, Jodi I.;Nelinson, Donald S.;Macy, Jonathan I.
目的：研究羟丙基纤维素眼用植入物在干眼综合征(DES)及其他并发症患者中的可接受性和有效性。设计：一项多中心、两次访问、开放标签、为期4周的注册研究。参与者：520名患者被纳入意向治疗组。418例患者完成了这项研究，其中86例配戴隐形眼镜，79例确诊为白内障，52例既往白内障手术，22例行准分子激光原位角膜磨镶术，15例青光眼。方法：患者在基线和治疗4周后填写问卷，评估DES症状严重程度的平均变化、眼表疾病指数(OSDI)评分、DES症状的发生频率、日常生活活动(ADL)困难的发生情况以及不同环境条件下的不适频率。从第一次访问到第二次访问，测量平均变化。主要结果测量：症状、OSDI评分和执行ADLS时的难度测量。结果：418名患者完成了研究。与基线相比，这组患者的平均OSDI评分(P=0.0215)以及不适、灼热、干燥、砂砾、刺痛和光敏感等症状有显著改善(P<；0.05)。在共病患者的5个亚类中，配戴隐形眼镜的患者(P<；0.025)、接受过白内障手术的患者(P<；0.04)和激光辅助原位角膜磨镶术(P<；005)的患者的OSDI评分的平均改善是显著的。在这项研究中，被诊断为白内障或青光眼的患者在任何指标上都没有显示出显著的变化。有DES和合并症的患者的症状得到缓解，ADLS和生活质量的改善与无合并症的患者相似。
Purpose: To determine acceptability and efficacy of hydroxypropyl cellulose ophthalmic inserts in patients with dry eye syndrome (DES) and additional comorbidities.Design: A multicenter, 2-visit, open-label, 4-week registry study.Participants: Five hundred twenty patients were recruited to the intent-to-treat group. Four hundred eighteen patients completed the study including 86 contact lens wearers, 79 with cataract diagnosis, 52 with prior cataract surgery, 22 with prior laser-assisted in situ keratomileusis, and 15 with glaucoma.Methods: Patient questionnaires were completed at baseline and after 4 weeks of treatment to assess mean change in severity of DES symptoms, ocular surface disease index (OSDI) scores, frequency of occurrence of DES symptoms, occurrence of difficulty when performing activities of daily living (ADLs), and frequency of discomfort in various environmental conditions. Mean change was measured from visit 1 to visit 2.Main Outcome Measures: Symptoms, OSDI scores, and measure of degree of difficulty when performing ADLs.Results: Four hundred eighteen patients completed the study. Compared with baseline, this population of patients demonstrated statistically significant improvements in mean OSDI scores (P = 0.0215) and symptoms of discomfort, burning, dryness, grittiness, stinging, and light sensitivity (P < 0.05). Mean improvement in OSDI scores of patients in the 5 identified subsets of patients with comorbid conditions were significant for patients using contact lenses (P < 0.025), who had undergone prior cataract surgery (P < 0.04), and with prior laser-assisted in situ keratomileusis surgery (P < 0.05). Patients diagnosed with cataracts or glaucoma did not show significant changes in any measures in this study. Patients with DES and comorbid conditions experienced relief of symptoms and benefit to ADLs and quality of life similar to patients without comorbid conditions.