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一项关于管内植入地塞米松眼用插入剂(0.4毫克)治疗屈光性晶状体置换术(RLE)患者术后炎症有效性和安全性的随机、对照、前瞻性研究。

A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE).

作者信息

Larsen Jacob, Whitt Travis, Parker Briana, Swan Russell

机构信息

Clinical Research, Vance Thompson Vision, Bozeman, MT, USA.

Department of Optometry, Vance Thompson Vision, Bozeman, MT, USA.

出版信息

Clin Ophthalmol. 2021 May 27;15:2211-2217. doi: 10.2147/OPTH.S311070. eCollection 2021.

DOI:10.2147/OPTH.S311070
PMID:34079218
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8166314/
Abstract

PURPOSE

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4 mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral RLE surgery.

METHODS

This is a prospective, open-label, interventional, randomized, controlled study in 20 subjects who underwent bilateral RLE. Each patient served as their own control with one eye randomized to the intracanalicular insert (Group A) placed at the time of surgery and the contralateral randomized to topical corticosteroid drops (Group B). All eyes received intracameral moxifloxacin at the time of surgery, and post-operatively, topical moxifloxacin QID for one week and topical NSAID daily for four weeks. Post-operative evaluations were performed on Day 1, Week 1, and Week 4-8.

RESULTS

Twenty patients participated. At 4-8 weeks post-operation, 90% of patients evaluated with the COMTOL questionnaire preferred the intracanalicular insert while 10% preferred the topical steroid. Comparative analysis using the visual analog scale showed no difference in pain between the study and control group. No statistical difference was shown in post-operative corneal staining, anterior chamber cell count, anterior chamber flare or intraocular pressure. Mean LogMAR UCVA at 4-8 weeks post-operation was 0.06 (± 0.230) in the study group and 0.065 (± 0.241) in the control group, which was not statistically or clinically different (p > 0.05).

CONCLUSION

Patients undergoing bilateral RLE expressed a strong preference towards the use of an intracanalicular insert over a topical steroid for post-operative steroid treatment. There was no clinically or statistically significant difference in outcomes, including rate of cystoid macular edema, visual acuity and elevation of intraocular pressure.

NATIONAL CLINICAL TRIAL NUMBER

摘要

目的

在双侧屈光性晶状体置换(RLE)手术后,比较患眼使用管内插入式地塞米松(0.4毫克)与对侧眼使用标准类固醇滴眼液方案的患者偏好及治疗效果。

方法

这是一项针对20例接受双侧RLE手术患者的前瞻性、开放标签、干预性、随机对照研究。每位患者均以自身作为对照,一只眼睛随机分配至手术时植入管内插入物(A组),对侧眼睛随机分配至局部使用皮质类固醇滴眼液(B组)。所有眼睛在手术时均接受前房内莫西沙星治疗,术后局部使用莫西沙星每日四次,持续一周,局部使用非甾体抗炎药每日一次,持续四周。在术后第1天、第1周和第4 - 8周进行术后评估。

结果

20例患者参与研究。术后4 - 8周,使用COMTOL问卷评估时,90%的患者更倾向于管内插入物,而10%的患者更倾向于局部类固醇。使用视觉模拟量表进行的比较分析显示,研究组和对照组在疼痛方面无差异。术后角膜染色、前房细胞计数、前房闪光或眼压方面均未显示出统计学差异。术后4 - 8周,研究组平均LogMAR最佳矫正视力(UCVA)为0.06(±0.230),对照组为0.065(±0.241),在统计学或临床上均无差异(p>0.05)。

结论

接受双侧RLE手术的患者在术后类固醇治疗方面,相较于局部类固醇,更强烈倾向于使用管内插入物。在包括黄斑囊样水肿发生率、视力和眼压升高等结果方面,无临床或统计学显著差异。

国家临床试验编号

04549935。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/1387797e8a59/OPTH-15-2211-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/d3e7a2933f5a/OPTH-15-2211-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/6d30e8f24c46/OPTH-15-2211-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/44dde87f9e59/OPTH-15-2211-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/1387797e8a59/OPTH-15-2211-g0004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/d3e7a2933f5a/OPTH-15-2211-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/6d30e8f24c46/OPTH-15-2211-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/44dde87f9e59/OPTH-15-2211-g0003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9c5a/8166314/1387797e8a59/OPTH-15-2211-g0004.jpg

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