{"title":"从上市后监测来看，一种新型角膜缘硬性隐形眼镜对Stevens-Johnson综合征患者潜在成本节约的影响","authors":"Kenichi Kimura , Mayumi Ueta , Hideki Fukuoka , Koji Kitazawa , Tsutomu Inatomi , Shigeru Kinoshita , Ryoichi Shiota , Naoki Yamauchi , Jiro Miyazaki , Satomi Sakabayashi , Satoshi Teramukai , Kojiro Imai , Kenji Konomi , Yuichi Uchino , Yoko Ogawa , Takefumi Yamaguchi , Jun Shimazaki , Yoshiyuki Satake , Chie Sotozono","doi":"10.1016/j.ajoint.2025.100101","DOIUrl":null,"url":null,"abstract":"<div><h3>Purpose</h3><div>To investigate the safety, efficacy, and potential-cost-savings of a newly-developed limbal-rigid contact lens (CL) via postmarket surveillance (PMS).</div></div><div><h3>Design</h3><div>Postmarket prospective observational use-results surveillance with cost-savings analysis.</div></div><div><h3>Methods</h3><div>We examined 80 eyes of 68 Stevens-Johnson syndrome (SJS) cases using the newly-developed Suncon Kyoto-CS limbal-rigid CL (Sun Contact Lens). CL-wear-associated best-corrected visual acuity (BCVA), objective signs (i.e., bulbar-conjunctival hyperemia, upper-eyelid conjunctival scarring, eye discharge, keratoconjunctival epithelial defect, corneal opacification, and corneal neovascularization), and subjective symptoms (i.e., dryness and eye pain) at baseline and at 6-months of CL use were measured and compared, with adverse events noted. Potential cost savings from improvements in CL-wear-related BCVA were estimated based on the potential for improvements in each patient's visual-impairment-grade under the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) disability pension plan. Main outcome measures were potential cost savings via use of the CL. Secondary outcome measures were CL safety and efficacy via PMS.</div></div><div><h3>Results</h3><div>At 6-months of CL use, the median BCVA in the CL-fitted eyes improved from 1.30 to 0.70 logMAR compared to that of spectacle correction at baseline (<em>P</em> < 0.001), and improvement of bulbar-conjunctival hyperemia, dryness, and eye pain was observed (<em>P</em> < 0.001, <em>P</em> < 0.001, and <em>P</em> < 0.001, respectively). No serious adverse events occurred. Potential-cost-savings analysis showed visual-impairment-grade improvement in 18 (28.6 %) of 63 patients. Considering the financial amount of the PMDA disability pension, estimated total potential cost savings was >6.9-million U.S. dollars.</div></div><div><h3>Conclusion</h3><div>The newly-developed limbal-rigid CL was found safe and effective for treating SJS-associated ocular sequelae, and potentially reduces disability-pension costs.</div></div>","PeriodicalId":100071,"journal":{"name":"AJO International","volume":"2 1","pages":"Article 100101"},"PeriodicalIF":0.0000,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Impact of a novel limbal-rigid contact lens on potential cost savings in Stevens-Johnson syndrome patients from postmarket surveillance\",\"authors\":\"Kenichi Kimura , Mayumi Ueta , Hideki Fukuoka , Koji Kitazawa , Tsutomu Inatomi , Shigeru Kinoshita , Ryoichi Shiota , Naoki Yamauchi , Jiro Miyazaki , Satomi Sakabayashi , Satoshi Teramukai , Kojiro Imai , Kenji Konomi , Yuichi Uchino , Yoko Ogawa , Takefumi Yamaguchi , Jun Shimazaki , Yoshiyuki Satake , Chie Sotozono\",\"doi\":\"10.1016/j.ajoint.2025.100101\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Purpose</h3><div>To investigate the safety, efficacy, and potential-cost-savings of a newly-developed limbal-rigid contact lens (CL) via postmarket surveillance (PMS).</div></div><div><h3>Design</h3><div>Postmarket prospective observational use-results surveillance with cost-savings analysis.</div></div><div><h3>Methods</h3><div>We examined 80 eyes of 68 Stevens-Johnson syndrome (SJS) cases using the newly-developed Suncon Kyoto-CS limbal-rigid CL (Sun Contact Lens). CL-wear-associated best-corrected visual acuity (BCVA), objective signs (i.e., bulbar-conjunctival hyperemia, upper-eyelid conjunctival scarring, eye discharge, keratoconjunctival epithelial defect, corneal opacification, and corneal neovascularization), and subjective symptoms (i.e., dryness and eye pain) at baseline and at 6-months of CL use were measured and compared, with adverse events noted. Potential cost savings from improvements in CL-wear-related BCVA were estimated based on the potential for improvements in each patient's visual-impairment-grade under the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) disability pension plan. Main outcome measures were potential cost savings via use of the CL. Secondary outcome measures were CL safety and efficacy via PMS.</div></div><div><h3>Results</h3><div>At 6-months of CL use, the median BCVA in the CL-fitted eyes improved from 1.30 to 0.70 logMAR compared to that of spectacle correction at baseline (<em>P</em> < 0.001), and improvement of bulbar-conjunctival hyperemia, dryness, and eye pain was observed (<em>P</em> < 0.001, <em>P</em> < 0.001, and <em>P</em> < 0.001, respectively). No serious adverse events occurred. Potential-cost-savings analysis showed visual-impairment-grade improvement in 18 (28.6 %) of 63 patients. Considering the financial amount of the PMDA disability pension, estimated total potential cost savings was >6.9-million U.S. dollars.</div></div><div><h3>Conclusion</h3><div>The newly-developed limbal-rigid CL was found safe and effective for treating SJS-associated ocular sequelae, and potentially reduces disability-pension costs.</div></div>\",\"PeriodicalId\":100071,\"journal\":{\"name\":\"AJO International\",\"volume\":\"2 1\",\"pages\":\"Article 100101\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2025-01-22\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"AJO International\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2950253525000048\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"AJO International","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2950253525000048","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
目的通过上市后监测（PMS）研究新研制的角膜缘硬性隐形眼镜（CL）的安全性、有效性和潜在的成本节约。设计上市后前瞻性观察性使用结果监测与成本节约分析。方法对68例Stevens-Johnson综合征（SJS）患者的80只眼进行检查，采用新研制的Suncon Kyoto-CS角膜缘刚性太阳隐形眼镜（Sun Contact Lens）。在基线和使用CL 6个月时测量并比较CL配戴相关最佳矫正视力（BCVA）、客观体征（即球结膜充血、上睑结膜瘢痕、眼排出物、角膜结膜上皮缺损、角膜混浊和角膜新生血管）和主观症状（即干燥和眼痛），并记录不良事件。根据日本药品和医疗器械管理局（PMDA）残疾养老金计划，根据每位患者视力受损等级的改善潜力，估计了cl佩戴相关BCVA改善的潜在成本节约。主要结果测量是通过使用CL节省的潜在成本。次要结局指标是经PMS检测的CL安全性和有效性。结果使用CL 6个月后，与基线矫正时相比，CL配戴眼的中位BCVA从1.30 logMAR提高到0.70 logMAR (P <；0.001)，观察到球结膜充血、干燥和眼痛的改善(P <；0.001, P <；0.001, P <；分别为0.001)。未发生严重不良事件。潜在成本节约分析显示，63例患者中有18例（28.6%）的视力受损等级得到改善。考虑到PMDA残疾养恤金的财务金额，估计潜在的总成本节省为690万美元。结论新研制的角膜缘刚性巩膜移植治疗sjs相关眼部后遗症安全有效，可降低残疾抚恤金费用。
Impact of a novel limbal-rigid contact lens on potential cost savings in Stevens-Johnson syndrome patients from postmarket surveillance
Purpose
To investigate the safety, efficacy, and potential-cost-savings of a newly-developed limbal-rigid contact lens (CL) via postmarket surveillance (PMS).
Design
Postmarket prospective observational use-results surveillance with cost-savings analysis.
Methods
We examined 80 eyes of 68 Stevens-Johnson syndrome (SJS) cases using the newly-developed Suncon Kyoto-CS limbal-rigid CL (Sun Contact Lens). CL-wear-associated best-corrected visual acuity (BCVA), objective signs (i.e., bulbar-conjunctival hyperemia, upper-eyelid conjunctival scarring, eye discharge, keratoconjunctival epithelial defect, corneal opacification, and corneal neovascularization), and subjective symptoms (i.e., dryness and eye pain) at baseline and at 6-months of CL use were measured and compared, with adverse events noted. Potential cost savings from improvements in CL-wear-related BCVA were estimated based on the potential for improvements in each patient's visual-impairment-grade under the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) disability pension plan. Main outcome measures were potential cost savings via use of the CL. Secondary outcome measures were CL safety and efficacy via PMS.
Results
At 6-months of CL use, the median BCVA in the CL-fitted eyes improved from 1.30 to 0.70 logMAR compared to that of spectacle correction at baseline (P < 0.001), and improvement of bulbar-conjunctival hyperemia, dryness, and eye pain was observed (P < 0.001, P < 0.001, and P < 0.001, respectively). No serious adverse events occurred. Potential-cost-savings analysis showed visual-impairment-grade improvement in 18 (28.6 %) of 63 patients. Considering the financial amount of the PMDA disability pension, estimated total potential cost savings was >6.9-million U.S. dollars.
Conclusion
The newly-developed limbal-rigid CL was found safe and effective for treating SJS-associated ocular sequelae, and potentially reduces disability-pension costs.
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