Objective To evaluate the effect of releasable sutures on shallow anterior chamber, filtering bleb and long-term intraocular pressure (IOP). Methods We searched MEDLINE (1971 to 2007), OVID (1971 to 2007) and National Science and Technology Library (1971 to 2007). Randomized controlled trials (RCTs) of the effect of releasable sutures on trabeculectomy were collected. Study selection and assessment, data collection and analyses were undertaken and cross-checked by two reviewers. Meta-analyses were performed with The Cochrane Collaboration’s RevMan 4.2.10 software. Results Six RCTs involving 341 eyes were included. Significant differences were observed in the reduction of postoperative shallow anterior chamber (RD –0.23, 95%CI –0.31 to –0.14, Plt;0.000 01) and functional filtering blebs (RD –0.15, 95%CI –0.27 to –0.02, P=0.02). But, no differences were observed for the control of long-term IOP (SMD –0.13, 95%CI –0.37 to 0.10, P=0.27). Conclusion The evidence currently available showed that releasable sutures could reduce the incidence of shallow anterior chamber and has no beneficial effect in controlling long-term IOP. The current evidence is insufficient to define the efficacy of maintaining functional filtering blebs. Further large-scale, high-quality randomized controlled trials are needed.
Objectives To evaluate the quality of ophthalmic clinical practice guidelines in China by using the AGREE Ⅱ instrument. Methods CBM, CNKI, VIP, and WanFang Data databases were electronically searched to collect Chinese guidelines for ophthalmology from inception to December 2017. Three reviewers independently evaluated the included guidelines using the AGREE Ⅱ instrument. Results A total of 60 Chinese clinical guidelines for ophthalmology were included. The average scores of the six domains including scope and purpose, stakeholder involvement, rigorism of development, clarity of presentation, applicability and editorial independence were 66.4%, 24.6%, 13.5%, 67.4%, 14.5%, and 19.3%, respectively. The guidelines published from 2013 to 2017 scored higher than those published previously in all areas except for domain 4 clarity of presentation. Conclusions The quality of current ophthalmic clinical practice guidelines in China is low, and there is still a big gap between them and the international guidelines. Guidelines developers should place more emphasis on developing regulations to improve stakeholder involvement, rigorism of development, applicability and editorial independence.
In 2019, the national government issued the document "Implementation Plan for Supporting the Construction of the Boao Lecheng International Medical Tourism Pilot Area", which allowed the use of innovative drugs and medical devices in medical institution of Boao Lecheng. These medical products had been designed to meet urgent clinical requirements and had been approved by regulatory authorities overseas. Through the use of these medical products, real-world data were generated in the routine clinical practice, based on which real-world evidence might be produced for regulatory decision-making by using scientific and rigorous methods. In March 2020, the first medical device product using domestic real-world data was approved, suggesting that the real-world data initiative in Boao Lecheng achieved initial success. This work also provided important experience for promoting the practice of medical device regulatory decision-making based on real-world evidence in China. Here, we shared the preliminary experiences from the study on the first approved medical device product and discussed the issues on developing a real-world data research framework in Boao Lecheng in attempt to offer insights for future studies.