Torjani Ava, Mahmoudzadeh Raziyeh, Salabati Mirataollah, Cai Louis, Hsu Jason, Garg Sunir, Ho Allen C, Yonekawa Yoshihiro, Kuriyan Ajay E, Starr Matthew R
Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, Pennsylvania.
Wills Eye Hospital, Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, Pennsylvania.
Ophthalmol Sci. 2022 Sep 23;3(1):100226. doi: 10.1016/j.xops.2022.100226. eCollection 2023 Mar.
To identify baseline ocular and systemic factors associated with central subfield thickness (CST) fluctuations in patients with diabetic macular edema (DME) using data from Diabetic Retinopathy Clinical Research Protocols T and V.
Post hoc analysis of clinical trial databases.
Patients in Protocols T and V.
The standard deviation (SD) of all recorded CSTs for each patient during each Protocol's study period was calculated. The CST SD (corresponding to CST fluctuations) for each patient was analyzed against baseline ocular and systemic factors using linear regression analyses. Each Protocol was analyzed separately.
Factors associated with CST fluctuations.
A total of 1197 eyes of 1197 subjects were included. In Protocol T (559 eyes, mean CST SD was 56.4 ± 35.1 microns), using multivariate linear regression analysis, baseline urine albumin/creatine ratio (for every 1000 mg/g, CST point estimate 3.50, 95% confidence interval [CI] 0.58 to 6.43, = 0.0190), and baseline CST (for every 10 microns, 0.87, 95% CI 0.58 to 1.16, < 0.0001) were positively associated with CST fluctuations. Baseline visual acuity (for every 10 ETDRS letters, -9.52, 95% CI -11.89 to -7.15, < 0.0001) was negatively associated with CST fluctuations. In Protocol V (638 eyes, mean CST SD 36.6 ± 28.4 microns), gender (female, 2.18, 95% CI 0.30 to 4.06, = 0.0227), baseline CST (for every 10 microns, 2.51, 95% CI 2.21 to 2.82, < 0.0001), systolic blood pressure (for every 1 mm of mercury, 0.11, 95% CI 0.01 to 0.21, = 0.0261), and observation with deferred anti-VEGF injections (5.04, 95% CI 2.51 to 7.58, < 0.0001) were positively associated with CST fluctuations. Type 2 diabetes (-7.37, 95% CI -13.64 to -1.11, = 0.0209) and prompt anti-VEGF injections (-6.51, 95% CI -9.07 to -3.96, < 0.0001) were negatively associated with CST fluctuations.
Worse visual acuity at baseline, baseline renal disease, hypertension, female gender, type 1 diabetes, and delayed anti-VEGF treatment may be associated with increased CST fluctuations in patients with DME. Addressing these parameters may limit CST fluctuations and help identify patients requiring more frequent monitoring or treatment.
利用糖尿病视网膜病变临床研究方案T和V的数据，确定与糖尿病性黄斑水肿（DME）患者中心子野厚度（CST）波动相关的基线眼部和全身因素。
临床试验数据库的事后分析。
方案T和V中的患者。
计算每个方案研究期间每位患者所有记录的CST的标准差（SD）。使用线性回归分析，针对基线眼部和全身因素分析每位患者的CST SD（对应于CST波动）。每个方案分别进行分析。
与CST波动相关的因素。
共纳入1197名受试者的1197只眼。在方案T（559只眼，平均CST SD为56.4±35.1微米）中，采用多变量线性回归分析，基线尿白蛋白/肌酐比值（每1000mg/g，CST点估计值为3.50，95%置信区间[CI]为0.58至6.43，P = 0.0190）和基线CST（每10微米，0.87，95%CI为0.58至1.16，P < 0.0001）与CST波动呈正相关。基线视力（每10个ETDRS字母，-9.52，95%CI为-11.89至-7.15，P < 0.0001）与CST波动呈负相关。在方案V（638只眼，平均CST SD为36.6±28.4微米）中，性别（女性，2.18，95%CI为0.30至4.06，P = 0.0227）、基线CST（每10微米，2.51，95%CI为2.21至2.82，P < 0.0001）、收缩压（每1毫米汞柱，0.11，95%CI为0.01至0.21，P = 0.0261）以及延迟抗VEGF注射观察（5.04，95%CI为2.51至7.58，P < 0.0001）与CST波动呈正相关。2型糖尿病（-7.37，95%CI为-13.64至-1.11，P = 0.0209）和及时抗VEGF注射（-6.51，95%CI为-9.07至-3.96，P < 0.0001）与CST波动呈负相关。
基线视力较差、基线肾病、高血压、女性性别、1型糖尿病以及延迟抗VEGF治疗可能与DME患者CST波动增加有关。关注这些参数可能会限制CST波动，并有助于识别需要更频繁监测或治疗的患者。
