透明质酸钠/硫酸软骨素钠(Sodium hyaluronate/chondroitin sulfate sodium) - 在研适应症：白内障后无晶状体，晶状体疾病_专利_临床

概要

基本信息

药物类型

小分子化药

别名

ヒアルロン酸ナトリウム、コンドロイチン硫酸エステルナトリウム、DisCoVisc、SHELLGAN

+ [2]

靶点-

作用机制-

治疗领域

眼部疾病

在研适应症

白内障后无晶状体晶状体疾病

非在研适应症-

原研机构

Alcon Japan Ltd.

在研机构

Seikagaku Corp.Alcon Japan Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期

日本 (2009-08-20),

晶状体疾病

最高研发阶段(中国)-

特殊审评-

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关联

2

项与透明质酸钠/硫酸软骨素钠相关的临床试验

NCT01813565 / TerminatedN/A

The Efficacy of Additional Intravesical Instillation of Hyaluronic Acid/Chondroitin Sulfate to Transurethral Resection of Bladder Ulcer in Patients With Interstitial Cystitis/Bladder Pain Syndrome.

The purpose of this study is to evaluate efficacy and safety of additional hyaluronic acid/chondroitin sulfate to transurethral resection of bladder ulcer in patient with interstitial cystitis.

开始日期2013-03-20

申办/合作机构

Asan Medical Center

NCT00763360 / Completed临床4期

To Compare the Ability of DiscoVisc® Ophthalmic Viscosurgical Device (OVD) to Protect the Corneal Endothelium and Maintain Anterior Chamber Space With Healon® and Amvisc® PLUS During Cataract Surgery.

The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.

开始日期2008-05-01

申办/合作机构

Alcon Research Ltd.

100 项与透明质酸钠/硫酸软骨素钠相关的临床结果

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100 项与透明质酸钠/硫酸软骨素钠相关的转化医学

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100 项与透明质酸钠/硫酸软骨素钠相关的专利（医药）

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20

项与透明质酸钠/硫酸软骨素钠相关的文献（医药）

2023-12-01·Canadian Journal of Ophthalmology

Effect of low and passive flow on OVD thermal properties during phacoemulsification

Article

作者: Pettey, Jeff H ; Barlow, William R ; Jensen, Nathan R ; Murri, Michael S ; Olson, Randall J ; Ungricht, Emilie L ; Harris, Jacob T

OBJECTIVETo study the thermal properties and response magnitude of a forced-infusion phacoemulsification machine on 4 ophthalmic viscosurgical devices (OVDs).DESIGNExperimental study.METHODSA phacoemulsification tip, thermocouple, and gauge were placed into an artificial anterior chamber with balanced saline solution (BSS) or approximately 0.1 mL of OVD. Once the thermocouple measured a consistent temperature, the pedal was engaged for 60 seconds; then the tip was removed. The machine was cooled for 5 minutes and flushed with BSS to return to baseline. This was repeated 10 times for each OVD. The research consisted of 2 scenarios: vacuum-blocked flow rate and low aspiration flow rate.RESULTSAll OVDs showed greater temperature changes than BSS. In the vacuum-blocked scenario, these increases were statistically significant. The medium viscosity dispersive OVD (DiscoVisc) reached temperatures exceeding 60°C. In the low-flow scenario, HEALON5 and DisCoVisc were significantly different at 5 seconds and only HEALON5 at 10 seconds. No temperature increases over BSS were greater than 1.0°C.CONCLUSIONSThe dispersive, cohesive, and viscoadaptive OVDs demonstrated higher temperature changes than BSS but did not reach the threshold for corneal incision contracture. The study team verified the need for at least a minimal flow rate before ultrasound, which is especially evident in the first 10 seconds, because a flow rate of only 20 mL/minute mitigated OVD-related thermal effects. Understanding thermal responses enables corneal incision contracture risk reduction.

2023-11-18·International Journal of Ophthalmology

Transient vacuolar changes of the crystalline lens in patients using a dispersive ophthalmic viscosurgical device

Article

作者: Lin, Zhuo-Ling ; Li, Jing ; Chen, Wei-Rong ; Chen, Wan ; Zhou, Yue ; Chen, Hui ; Zhang, Yu

AIM: To report the clinical prognosis and pathological findings of accidental lens vacuolar changes in eyes with intraoperative exposure to a dispersive ophthalmic viscosurgical device (OVD). METHODS: Two patients who developed transient lens vacuolar changes during uneventful persistent pupillary membrane (PPM) removal surgery were presented and followed up. This event was speculated to be associated with an intraoperative dispersive OVD DisCoVisc (hyaluronic acid 1.6%-chondroitin sulfate 4.0%) exposure. Then, to provide the pathological basis for our speculation, another four cataract patients were randomly exposed to different OVDs, and their anterior lens capsules were investigated with transmission electron microscopy (TEM). RESULTS: After months, the subcapsular vacuoles in both PPM cases were gradually disappeared without visual deterioration. For the cataract patients, similar lens changes were observed intraoperatively in those exposed to a dispersive DisCoVisc but not a cohesive OVD IVIZ (sodium hyaluronate gel 1.0%). In addition, marked ultrastructural changes, including chromatin condensation, extensive cytoplasmic vacuoles, and obvious intercellular space between lens epithelial cells in the anterior lens capsules of all eyes exposed to DisCoVisc, were observed by TEM. CONCLUSION: The lens vacuolar changes may be associated with a dispersive OVD exposure. Therefore, it is not preferable to use dispersive OVDs in patients with transparent lenses or without the intention of lens extraction. In addition, close follow-ups instead of immediate lens extraction are recommended for the occurrence of similar lens lesions.

2023-01-01·Clinical ophthalmology (Auckland, N.Z.)

Corneal Outcomes Following Cataract Surgery Using Ophthalmic Viscosurgical Devices Composed of Chondroitin Sulfate-Hyaluronic Acid: A Systematic Review and Meta-Analysis.

Review

作者: Hsiao, Chia-Wen ; Ferko, Nicole C ; Ghafouri, Rana ; Cheng, Hang ; Ayres, Brandon D

BackgroundOphthalmic viscosurgical devices (OVDs) are commonly used during cataract surgery to protect the corneal endothelium. A systematic literature review and meta-analysis were conducted to assess the clinical evidence of OVDs composed of chondroitin sulfate-hyaluronic acid (CS-HA) versus other OVDs in maintaining endothelial cell density (ECD) and corneal thickness (CT).MethodsMEDLINE and EMBASE databases were searched from 2000 to 2020. Randomized controlled trials (RCTs, N ≥ 20 per group) comparing an OVD containing CS-HA (ie, VISCOAT^®, DuoVisc^® or DisCoVisc^®) to any other OVD were included. The identified comparators were limited to the OVDs found in the literature, which included those composed of HA-only or hydroxypropyl methylcellulose (HPMC). Outcomes of focus included changes in ECD (baseline to 3 months) and CT (baseline to 24 hours). Meta-analyses were performed using R software, to assess mean differences (MD) in ECD and CT change between CS-HA OVDs and HA-only or HPMC OVDs.ResultsA total of 966 abstracts were screened, and data were extracted from 12 RCTs. Meta-analyses using a random-effects model revealed significantly lower percent (%) decrease in ECD for CS-HA OVDs compared to both HA-only (MD: -4.10%; 95% CI: -5.81 to -2.40; p < 0.0001; 9 studies) and HPMC (MD: -6.47%; 95% CI: -10.41 to -2.52; p = 0.001; 2 studies) products. Similarly, % CT increase was significantly lower with CS-HA than with HA-only OVDs (MD: -3.22%; 95% CI: -6.24% to -0.20%; p = 0.04; 4 studies). However, there were no significant differences when comparing % CT change between CS-HA and HPMC OVDs (MD: 2.65%; 95% CI: -0.43% to 0.95%; p = 0.4; 2 studies).ConclusionCS-HA OVDs lead to less postoperative loss of endothelial cells and may better protect corneal endothelium during cataract surgery, relative to other OVDs. Future randomized studies may be needed to solidify these findings.

100 项与透明质酸钠/硫酸软骨素钠相关的药物交易

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研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
白内障后无晶状体	日本	Seikagaku Corp.	2016-02-15
晶状体疾病	日本	Alcon Japan Ltd.	2009-08-20

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT00763360 (CTgov)	临床4期	白内障	184	DisCoVisc® (DisCoVisc®)	網選繭壓繭壓願製範餘(窪範窪艱構夢願蓋獵獵) = 選憲製顧糧壓遞觸觸衊憲廠願齋糧鹽憲鹽壓觸 (壓淵簾膚衊糧襯醖膚艱, 鑰齋淵遞網餘鑰願鹽壓 ~ 範壓繭襯餘衊築鏇製網) 更多	-	2012-01-24
				Healon (Healon)	網選繭壓繭壓願製範餘(窪範窪艱構夢願蓋獵獵) = 鏇蓋遞鏇夢餘遞簾蓋夢憲廠願齋糧鹽憲鹽壓觸 (壓淵簾膚衊糧襯醖膚艱, 襯鹹壓膚廠選夢遞淵衊 ~ 顧衊遞艱築繭觸製糧蓋) 更多