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治疗性HL隐形眼镜与标准绷带式隐形眼镜治疗角膜水肿的前瞻性、多中心、随机、交叉研究。

Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study.

作者信息

Daphna Ofer, Mimouni Michael, Keshet Yariv, Ben Ishai Meydan, Barequet Irina S, Knyazer Boris, Mrukwa-Kominek Ewa, Zarnowski Tomasz, Chen-Zion Malca, Marcovich Arie

机构信息

EyeYon Medical, Ness Tziona, Israel.

Department of Ophthalmology, Rambam Health Care Campus, Affiliated to the Bruce and Ruth Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.

出版信息

J Ophthalmol. 2020 Sep 21;2020:8410920. doi: 10.1155/2020/8410920. eCollection 2020.

DOI:10.1155/2020/8410920
PMID:33014443
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7525312/
Abstract

INTRODUCTION

To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema.

METHODS

Prospective, multicenter, randomized, crossover study. Chronic corneal edema patients were randomized to one of two arms. The first arm was fitted with the Therapeutic Hyper-CL™ lens while the second arm was fitted with a standard soft bandage contact lens. Both arms were treated with 5% sodium chloride 6 times a day. After a 7-day treatment period, there was a 7-day washout period, after which the arms were crossed over. Patients were evaluated at days 0 (baseline), 7 (following first treatment allocation), 14 (following washout), and 21 (following second treatment allocation). The primary outcomes were 3 lines of BCVA (best corrected visual acuity) improvement.

RESULTS

In total, 49 patients were enrolled. There was significantly greater BCVA improvement rate >3 lines (30.4% versus 17.4%, =0.04) in the Therapeutic Hyper-CL™ lens group. The mean change in BCVA lines was significantly greater for the Therapeutic Hyper-CL™ lens (3.4 ± 6.7 versus 0.9 ± 2.3, =0.02).

CONCLUSIONS

The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride. This trial is registered with NCT02660151.

摘要

引言

比较Therapeutic Hyper-CL™镜片与标准绷带式隐形眼镜(PureVision B&L)治疗慢性角膜水肿的安全性和有效性。

方法

前瞻性、多中心、随机、交叉研究。慢性角膜水肿患者被随机分为两组。第一组佩戴Therapeutic Hyper-CL™镜片,第二组佩戴标准软性绷带式隐形眼镜。两组均每天使用6次5%氯化钠溶液。经过7天的治疗期后,有7天的洗脱期,之后两组进行交叉。在第0天(基线)、第7天(首次治疗分配后)、第14天(洗脱期后)和第21天(第二次治疗分配后)对患者进行评估。主要结局指标为最佳矫正视力(BCVA)提高3行。

结果

共纳入49例患者。Therapeutic Hyper-CL™镜片组的BCVA提高率>3行的情况显著更多(30.4%对17.4%,P=0.04)。Therapeutic Hyper-CL™镜片组的BCVA行数平均变化显著更大(3.4±6.7对0.9±2.3,P=0.02)。

结论

与标准绷带式隐形眼镜联合5%氯化钠溶液相比,Therapeutic Hyper-CL™镜片显著提高视力的可能性更高。本试验已在ClinicalTrials.gov注册,注册号为NCT02660151。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/63fea88011ab/joph2020-8410920.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/4477408dc185/joph2020-8410920.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/a5afdecba334/joph2020-8410920.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/63fea88011ab/joph2020-8410920.003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/4477408dc185/joph2020-8410920.001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/a5afdecba334/joph2020-8410920.002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a358/7525312/63fea88011ab/joph2020-8410920.003.jpg

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