Pareja-Ríos Alicia, Ruiz-de la Fuente-Rodríguez Paloma, Bonaque-González Sergio, López-Gálvez Maribel, Lozano-López Virginia, Romero-Aroca Pedro
University Hospital of the Canary Islands, Santa Cruz de Tenerife, Islas Canarias 38320, Spain.
Wooptix S.L, San Cristobal de La Laguna 38204, Spain.
Int J Ophthalmol. 2018 Jan 18;11(1):77-82. doi: 10.18240/ijo.2018.01.14. eCollection 2018.
To evaluate the safety and efficacy of a dexamethasone (DEX) intravitreal implant for diabetic macular edema (DME).
Totally 113 eyes of 84 patients were divided in three subgroups: naive patients (=11), pseudophakic patients (=72) and phakic patients (=30). Inclusive criterion comprised adult diabetic patients with central fovea thickening and impaired visual acuity resulting from DME for whom previous standard treatments showed no improvement in both central macular thickness (CMT) and best corrected visual acuity (BCVA) after at least 3mo of treatment. Outcome data were obtained from patient visits at baseline and at months 1, 3, 5, 9 and 12 after the first DEX implant injection. At each of these visits, patients underwent measurement of BCVA, a complete eye examination and measurement of CMT and macular volume (MV) carried out with optical coherence tomography (OCT) images.
Seventy-three eyes (64.5%) received a single implant, 30 (26.5%) received two implants and 10 (9%) received three implants. At baseline, average in BCVA, CMT and MV were 43.5±20.8, 462.8±145 and 12.6±2.5 respectively. These values improved significantly at 1mo (BCVA: 47.2±19.5, CMT: 339.6±120, MV: 11.11±1.4) and 3mo (BCVA: 53.2±18.1, CMT: 353.8±141, MV: 11.3±1.3) (≤0.05). At 5mo (BCVA: 50.9±19.8, CMT: 425±150, MV: 12.27±2.3), 9mo (BCVA: 48.4±17.6, CMT: 445.5±170, MV: 12.5±2.3) and 12mo (BCVA: 47.7±18.8, CMT: 413.2±149, MV: 12.03±2.5), improvements in the three parameters were no longer statistically significant and decreased progressively but did not reach baseline values. There were no clinical differences between subgroups. Ocular complications were minimal.
Patients with DEX implants show maximum efficacy at 3mo which then declined progressively, but is still better than baseline values at the end of follow-up.
评估地塞米松（DEX）玻璃体内植入物治疗糖尿病性黄斑水肿（DME）的安全性和有效性。
84例患者的113只眼被分为三个亚组：初治患者（=11例）、人工晶状体眼患者（=72例）和有晶状体眼患者（=30例）。纳入标准包括成年糖尿病患者，因DME导致中心凹增厚且视力受损，经至少3个月的标准治疗后，中心黄斑厚度（CMT）和最佳矫正视力（BCVA）均无改善。结果数据来自首次DEX植入注射后基线以及第1、3、5、9和12个月的患者随访。在每次随访时，患者接受BCVA测量、全面眼部检查，并使用光学相干断层扫描（OCT）图像测量CMT和黄斑体积（MV）。
73只眼（64.5%）接受了单次植入，30只眼（26.5%）接受了两次植入，10只眼（9%）接受了三次植入。基线时，BCVA、CMT和MV的平均值分别为43.5±20.8、462.8±145和12.6±2.5。这些值在第1个月（BCVA：47.2±19.5，CMT：339.6±120，MV：11.11±1.4）和第3个月（BCVA：53.2±18.1，CMT：353.8±141，MV：11.3±1.3）时显著改善（P≤0.05）。在第5个月（BCVA：50.9±19.8，CMT：425±150，MV：12.27±2.3）、第9个月（BCVA：48.4±17.6，CMT：445.5±170，MV：12.5±2.3）和第12个月（BCVA：47.7±18.8，CMT：413.2±149，MV：12.03±2.5），这三个参数的改善不再具有统计学意义，且逐渐下降，但未达到基线值。各亚组之间无临床差异。眼部并发症极少。
接受DEX植入的患者在3个月时显示出最大疗效，随后逐渐下降，但在随访结束时仍优于基线值。
