Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Research Laboratory of Macular Disease, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
BMJ Open. 2021 Dec 6;11(12):e052417. doi: 10.1136/bmjopen-2021-052417.
China has the largest number of adults with diabetes aged 20-79 years (116.4 million) in 2019. Due to the socioeconomic condition or a lack of awareness of diabetic complications, many adults with diabetes have proliferative diabetic retinopathy (PDR) or renal function impairment at their first visit to the clinic for a sudden loss of vision, and pars plana vitrectomy (PPV) is required for their treatment. Risk factors for the outcomes and complications of PPV surgery in PDR patients have been widely explored in many epidemiological studies and clinical trials. However, few prospective studies have analysed the association between renal function and surgical outcomes in PDR.
This is a single-centre, prospective cohort study of PDR patients with type 2 diabetes mellitus who have definite indications for PPV surgery with or without renal function impairment. We will consecutively enrol PDR patients who meet the inclusion and exclusion criteria from November 2020 to December 2023. Each participant will be followed up for at least 6 months after surgery. Clinical data from medical records and vitreous fluid will be collected.Demographic characteristics and study outcomes will be summarised using descriptive statistics. The variation will be described and evaluated using the χ² test or Kruskal-Wallis test. Generalise additive mixed models will be used to explore the association between the renal profile and surgical outcomes including BCVA, and retinal and choroidal microvasculature/microstructure. Multivariate ordinal regression analysis will be used to detect the independent association between renal profile and BCVA changes, and smooth curve fitting will be employed to briefly present the tendency.
The trial has received ethical approval from the West China Hospital of Sichuan University. Results of this trial will be disseminated through publication in peer-reviewed journals and presentations at local and international meetings.
ChiCTR2000039698.
中国是 20-79 岁成年人糖尿病患者数量最多的国家（1.164 亿）。由于社会经济条件或对糖尿病并发症认识不足，许多糖尿病患者在首次因突然视力丧失就诊于诊所时已经患有增生性糖尿病视网膜病变（PDR）或肾功能损害，需要进行玻璃体切除术（PPV）治疗。许多流行病学研究和临床试验广泛探讨了 PDR 患者 PPV 手术结果和并发症的风险因素。然而，很少有前瞻性研究分析了肾功能与 PDR 手术结果之间的关系。
这是一项针对 2 型糖尿病伴 PDR 且有明确行 PPV 手术指征（无论是否伴有肾功能损害）的患者的单中心前瞻性队列研究。我们将连续纳入符合纳入和排除标准的 PDR 患者，纳入时间为 2020 年 11 月至 2023 年 12 月。每个参与者将在手术后至少随访 6 个月。将从病历和玻璃体液中收集临床数据。使用描述性统计方法总结人口统计学特征和研究结果。将使用 χ²检验或 Kruskal-Wallis 检验描述和评估变异。广义加性混合模型将用于探索肾功能谱与包括 BCVA 在内的手术结果之间的关系，以及视网膜和脉络膜微血管/微结构之间的关系。多变量有序回归分析将用于检测肾功能谱与 BCVA 变化之间的独立关联，并用平滑曲线拟合来简要呈现趋势。
该试验已获得四川大学华西医院的伦理批准。试验结果将通过发表在同行评议的期刊和在当地和国际会议上的演讲来传播。
ChiCTR2000039698。
