Evidence map›Paper›PMID 37768528›Full record

ArticleOphthalmology and therapy2023

A Multicenter Prospective Randomized Controlled Study of a New Corneal Wetting Agent During Ophthalmologic Surgery.

Shijiu Chen, Jingjing Zhang, Jingyi Tian, Can Zhao, Chunli Liu, Xiaolei Sun, Xiang Gao, Ying Zhang, Jun Wang, Na Li and 7 more

Open access · goldAbstract read
In one paragraph

Article in Ophthalmology and therapy, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 37% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Shijiu ChenQingdao University, Qingdao, Shandong, China.
Jingjing Zhang *Qingdao University, Qingdao, Shandong, China.
Jingyi TianEye Institute of Shandong First Medical University, Eye Hospital of Shandong First Medical University (Shandong Eye Hospital), 372 Jingsi Road, Jinan, 250021, Shandong, China.
Can ZhaoEye Institute of Shandong First Medical University, Eye Hospital of Shandong First Medical University (Shandong Eye Hospital), 372 Jingsi Road, Jinan, 250021, Shandong, China.
Chunli LiuEye Institute of Shandong First Medical University, Eye Hospital of Shandong First Medical University (Shandong Eye Hospital), 372 Jingsi Road, Jinan, 250021, Shandong, China.
Xiaolei SunEye Institute of Shandong First Medical University, Eye Hospital of Shandong First Medical University (Shandong Eye Hospital), 372 Jingsi Road, Jinan, 250021, Shandong, China.
Xiang GaoEye Institute of Shandong First Medical University, Eye Hospital of Shandong First Medical University (Shandong Eye Hospital), 372 Jingsi Road, Jinan, 250021, Shandong, China.
Ying ZhangEye Institute of Shandong First Medical University, Eye Hospital of Shandong First Medical University (Shandong Eye Hospital), 372 Jingsi Road, Jinan, 250021, Shandong, China.
Jun WangAffiliated Hospital of Weifang Medical University, School of Clinical Medicine, Weifang Medical University, Weifang, 261000, Shandong, China.
Na LiAffiliated Hospital of Weifang Medical University, School of Clinical Medicine, Weifang Medical University, Weifang, 261000, Shandong, China.
Hong LiuAffiliated Hospital of Weifang Medical University, School of Clinical Medicine, Weifang Medical University, Weifang, 261000, Shandong, China.
Yan GaoEye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University, 5 Yanerdao Road, Qingdao, 266073, Shandong, China.
Xiubin MaEye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University, 5 Yanerdao Road, Qingdao, 266073, Shandong, China.
Jun LiEye Institute of Shandong First Medical University, Qingdao Eye Hospital of Shandong First Medical University, 5 Yanerdao Road, Qingdao, 266073, Shandong, China. doctor_li@126.com.
Aijun DengAffiliated Hospital of Weifang Medical University, School of Clinical Medicine, Weifang Medical University, Weifang, 261000, Shandong, China. dengaijun@hotmail.com.
Ting Wang *Qingdao University, Qingdao, Shandong, China. wt-ting@163.com.
Gongqiang YuanQingdao University, Qingdao, Shandong, China. gqyuan@sdfmu.edu.cn.ORCID http://orcid.org/0000-0003-0809-5502
Shandong Eye Hospital · CNQingdao University · CNWeifang Medical University · CN

Funding

National Natural Science Foundation of China 82271052National Natural Science Foundation of China U20A20386Taishan Scholar Foundation of Shandong Province tsqn202211344
6 · The paper itself

Abstract

introductionA multicenter prospective randomized controlled study was used to investigate the effect and safety of a new corneal wetting agent called the Corneal Surface Viscoelastic Protector (CsVisc, Success Bio-Tech Co., Ltd, China), on the corneal epithelium during ophthalmic surgery by comparison with the commercially available Cornea Protect (CP, Valeant Med Sp. zo. o. Leobendorf, Austria).

methodsThis multicenter prospective randomized controlled study comprised patients scheduled for cataract surgery and pars plana vitrectomy. The patients were randomly assigned to receive either a new corneal wetting agent (CsVisc) or Cornea Protect (CP, Valeant Med Sp. zo. o. Leobendorf, Austria). Optical clarity during surgery, application frequency, duration of effect, diffusion time of corneal wetting agents, fluorescein staining, intraocular pressure (IOP), tear-film break-up time (TBUT), and Schirmer I test (SIT) were assessed. Adverse events were noted on the designated patient case report forms.

resultsA total of 149 eyes (149 patients, mean age 62 years; range 25-80 years) were included in the study. There were 74 eyes in the control group and 75 eyes in the study group. In patients who underwent vitrectomy, the frequency of application was 1.62 ± 1.03 in the study group and 1.39 ± 0.66 in the control group, with no significant difference (P = 0.399), and the duration of effect was 19.16 ± 6.94 min in the study group and 19.06 ± 7.22 min in the control group, with no significant difference (P = 0.835). The optical clarity of the study group was not significantly different from that of the control group (P = 0.485). In patients who underwent cataract surgery, the frequency of application was 1.10 ± 0.38 in the study group and 1.07 ± 0.26 in the control group, and the difference was not significant (P = 0.950). The difference between the duration of effect in the study group (8.32 ± 2.50 min) and the control group (7.63 ± 2.52 min) was not significant (P = 0.310). The difference in optical clarity scores between the two groups was not statistically significant (P = 0.600). Among all patients in this study, the diffusion time of the corneal wetting agent was 14.97 ± 10.07 s in the control group and 11.23 ± 8.41 s in the study group, with a statistically significant difference (p = 0.008). The frequency of adverse events was 20.00% (15/75) in the study group and 14.86% (11/74) in the control group, with no statistically significant difference (P = 0.409). There were no serious adverse events related to the test medical device or causing patients to withdraw from the study.

conclusionsThe CsVisc is safe and effective in preventing intraoperative corneal epithelial damage due to corneal dryness and can be comparable to the CP. In addition, the CsVisc has a shorter diffusion time.

Indexed as

Cataract surgeryCorneal wetting agentPars plana vitrectomy

Identifiers

PMID37768528
PMCPMC10640533
OpenAlexW4387115253

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.