Wang Songhong, Wu Tiexi, Zhang Yue, Liu Yue, Qin Xuejiao
Department of Ophthalmology, The Second Hospital of Shandong University, Jinan, Shandong, China.
Department of Operating Room, The Second Hospital of Shandong University, Jinan, Shandong, China.
BMJ Open. 2024 Dec 20;14(12):e092002. doi: 10.1136/bmjopen-2024-092002.
In the era of functional intraocular lens (IOL) implantation, it is crucial to investigate the influence of different capsulorhexis sizes (including the diameter of the capsulorhexis, area of the anterior capsule opening, anterior capsule coverage, centration and circularity of the capsulorhexis) on the postoperative outcomes (eg, visual acuity, capsule shrinkage, IOL stability and intraocular pressure) in patients undergoing cataract surgery. This is particularly important in patients with high myopia or diabetes mellitus. The proposed protocol aims to enhance the transparency of our research and offer references for future studies.
A comprehensive search of PubMed, Embase, Cochrane Library, Web of Science, SinoMed, China National Knowledge Infrastructure, Wanfang Data Knowledge Service Platform and China Science and Technology Journal Database is performed from inception to 4 July 2024. Data of individual participants will be collected from relevant clinical trials, both completed and ongoing. The collected data will be analysed using multilevel regression models to examine the association between capsulorhexis size and surgical outcomes. Potential demographic and clinical factors that may influence the results of cataract surgery, including postoperative visual acuity and IOL rotational stability, will also be explored. Any future modification to this protocol will include the date and rationale for the change.
Ethical approval is not required because the study does not involve individual patients. The study results are to be disseminated via professional journals as well as academic media.
CRD42023459903.
在功能性人工晶状体（IOL）植入时代，研究不同连续环形撕囊大小（包括撕囊直径、前囊开口面积、前囊覆盖度、撕囊的中心定位和圆形度）对白内障手术患者术后结局（如视力、晶状体囊膜收缩、人工晶状体稳定性和眼压）的影响至关重要。这在高度近视或糖尿病患者中尤为重要。本拟议方案旨在提高我们研究的透明度，并为未来研究提供参考。
从数据库建库至2024年7月4日，全面检索PubMed、Embase、Cochrane图书馆、Web of Science、中国生物医学文献数据库、中国知网、万方数据知识服务平台和中国科技期刊数据库。将从已完成和正在进行的相关临床试验中收集个体参与者的数据。收集的数据将使用多水平回归模型进行分析，以检验撕囊大小与手术结局之间的关联。还将探索可能影响白内障手术结果的潜在人口统计学和临床因素，包括术后视力和人工晶状体旋转稳定性。本方案未来的任何修改都将包括更改日期和理由。
由于本研究不涉及个体患者，因此无需伦理批准。研究结果将通过专业期刊以及学术媒体进行传播。
CRD42023459903。
