Dataset Information

China Glaucoma Treatment Pattern Study I-Primary Angle-Closure Glaucoma: protocol for a multicentre, retrospective, observational study.

ABSTRACT:

Introduction

Primary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness globally, and the number of patients with PACG rises every year. Yet, there is a lack of knowledge about the clinical characteristics, therapeutic options and profile of patients with PACG in China. Hence, we design the China Glaucoma Treatment Pattern Study Ⅰ-Primary Angle-Closure Glaucoma (Ch-GTPⅠ). The objective of this paper is to describe the design and methodology of Ch-GTP. The aim of this study is to characterise the profile and trend associated with initial PACG treatment for the last 10 years in China.

Methods

Ch-GTPⅠ is a national multicentre retrospective observational study that will randomly sample from 50 hospitals throughout China. Over 7000 patient records hospitalised for initial PACG treatment from 2011 to 2020 will be selected randomly. The data from electronic medical records will be uploaded to an encrypted online platform that will receive and collate data from all collaborating hospitals. Data abstraction and monitoring will be performed in a standardised manner by trained statisticians to ensure consistency. Systematic data cleaning will also be conducted by statisticians to ensure data integrity before final data storage. The outcomes will include four broad categories: (1) demographics, (2) clinical characteristics, (3) therapeutic strategies and procedures and (4) early outcomes at discharge. The demographic characteristics and early outcomes will be summarised using descriptive statistics. Comparative analyses of characteristics and treatment pattern changing trends for different regions and years will be used to test for significant differences (t-test or Mann-Whitney U test).

Ethics and dissemination

The collaborating hospitals obtained local approval based on a standard ethics application from internal ethics committees or acknowledged an existent ethics approval of the leading institution with approval from internal ethics committees. Due to the retrospective nature, written informed consent from patients was waived by the ethics committee. The results will be published in academic journals and presented at national and international academic conferences.

Trial registration number

ChiCTR2100054643.

SUBMITTER: Chen J

PROVIDER: S-EPMC10083785 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature

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Publications

China Glaucoma Treatment Pattern Study I-Primary Angle-Closure Glaucoma: protocol for a multicentre, retrospective, observational study.

Chen Jinyuan J Du Jie J Xing Xiaoli X Liu Danyan D Jia Zhiyang Z Zheng Yajuan Y Wang Dan D Guo Wenyi W Jiang Jian J Duan Guoping G Tang Li L Wu Zhengzheng Z Lv Peng P Ma Jianjun J Zhu Yihua Y Liang Yuanbo Y Sun Xin X He Mingguang M

BMJ open 20230404 4

<h4>Introduction</h4>Primary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness globally, and the number of patients with PACG rises every year. Yet, there is a lack of knowledge about the clinical characteristics, therapeutic options and profile of patients with PACG in China. Hence, we design the China Glaucoma Treatment Pattern Study Ⅰ-Primary Angle-Closure Glaucoma (Ch-GTPⅠ). The objective of this paper is to describe the design and methodology of Ch-GTP. The aim of t ...[more]

PMID: 37015785

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Project description:OBJECTIVE:To evaluate the association between coagulation function and patients with primary angle closure glaucoma (PACG). DESIGN:A retrospective, hospital-based, case-control study. SETTING:Shanghai, China. PARTICIPANTS:A total of 1778 subjects were recruited from the Eye & ENT Hospital of Fudan University from January 2010 to December 2015, including patients with PACG (male=296; female=569) and control subjects (male=290; female=623). OUTCOME MEASURES:Sociodemographic data and clinical data were collected. The one-way analysis of variance test was used to compare the levels of laboratory parameters among the mild, moderate and severe PACG groups. Multivariate logistic regression analyses were performed to identify the independent risk factors for PACG. The nomogram was constructed based on the logistic regression model using the R project for statistical computing (R V.3.3.2). RESULTS:The activated partial thromboplastin time (APTT) of the PACG group was approximately 4% shorter (p<0.001) than that of the control group. The prothrombin time (PT) was approximately 2.40% shorter (p<0.001) in patients with PACG compared with the control group. The thrombin time was also approximately 2.14% shorter (p<0.001) in patients with PACG compared with the control group. The level of D-dimer was significantly higher (p=0.042) in patients with PACG. Moreover, the mean platelet volume (MPV) of the PACG group was significantly higher (p=0.013) than that of the control group. A similar trend was observed when coagulation parameters were compared between the PACG and control groups with respect to gender and/or age. Multiple logistic regression analyses revealed that APTT (OR=1.032, 95% CI 1.000 to 1.026), PT (OR=1.249, 95% CI 1.071 to 1.457) and MPV (OR=1.185, 95% CI 1.081 to 1.299) were independently associated with PACG. CONCLUSION:Patients with PACG had a shorter coagulation time. Our results suggest that coagulation function is significantly associated with patients with PACG and may play an important role in the onset and development of PACG.

Project description:PurposePLEKHA7 and COL11A1 were genotyped for single-nucleotide polymorphisms (SNPs) to investigate the possible association of these two genes with primary angle-closure glaucoma (PACG) and disease severity.MethodA total of 51 PACG cases and 51 normal controls were recruited. Twelve SNPs in the PLEKHA7 (rs216489, rs1027617, rs366590, rs11024060, rs6486330, rs11024097, and rs11024102) and COL11A1 (rs1676484, rs3753841, rs12138977, rs2126642, and rs2622848) genes were genotyped by direct Sanger sequencing. Distributions of allele frequencies and genotype frequencies in cases and controls, as well as in mild, moderate, and severe subgroups, were compared based on mean defect (MD ≤ 6.00 dB, 6 dB < MD ≤ 12 dB, and MD > 12 dB were considered mild, moderate, and severe, respectively). Independent Student's t-tests and chi-square tests were used to compare characteristics of PACG cases and controls. Chi-square tests were used to compare the distribution of allele frequencies in cases and controls and in MD-based subgroups with various degrees of glaucoma severity. Binary logistic regression was used to compare the distribution of genotype frequencies and calculate odds ratios (OR) with confidence intervals (CI).ResultThree of the 12 SNPs in COL11A1, rs1676486 (P=0.026, OR = 2.089, 95% CI = 1.092-3.996), rs3753841 (P=0.036, OR = 1.886, 95% CI = 1.038-3.426), and rs12138977 (P=0.024, OR = 2.133, 95% CI = 1.104-4.123) were found to have a significant association with PACG. Furthermore, in the subgroup analysis, rs1676486 (P=0.018, OR = 2.416, 95% CI = 1.284-4.544; P=0.011, OR = 2.119, 95% CI = 1.204-3.729), rs12138977 (P=0.009, OR = 2.158, 95% CI = 1.287-3.618; P=0.006, OR = 1.962, 95% CI = 1.239-3.106), and rs3753841 (P=0.007, OR = 2.550, 95% CI = 1.344-4.839) showed statistically significant differences between moderate/severe groups and controls.ConclusionOur data suggested that COL11A1 rs1676484, rs3753841, and rs12138977 polymorphisms may be of value for further study as potential gene-dependent risk factors for developing PACG. Moreover, COL11A1 rs1676484 and rs12138977 polymorphisms might be associated with PACG disease severity.

Dataset Information

China Glaucoma Treatment Pattern Study I-Primary Angle-Closure Glaucoma: protocol for a multicentre, retrospective, observational study.

Introduction

Methods

Ethics and dissemination

Trial registration number

Publications

China Glaucoma Treatment Pattern Study I-Primary Angle-Closure Glaucoma: protocol for a multicentre, retrospective, observational study.

Similar Datasets

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