Lo Giudice Giuseppe, Avarello Antonio, Campana Gianluca, Galan Alessandro
1 San Paolo Ophthalmic Center, San Antonio Hospital, Padua - Italy.
2 Department of General Psychology, University of Padua, Padua - Italy.
Eur J Ophthalmol. 2018 Jan;28(1):74-79. doi: 10.5301/ejo.5000989.
To evaluate the early effects of dexamethasone (DEX) intravitreal implants in patients with diabetic macular edema (DME).
This was a prospective, single-arm, interventional clinical series. Eighteen patients (18 eyes) with chronic/recalcitrant or naive DME were included. Patients underwent single DEX intravitreal implant. Clinical assessments, including ophthalmologic examination, central retinal thickness (CRT) measurement by spectral-domain optical coherence tomography (SD-OCT) scan, best-corrected visual acuity (BCVA), and intraocular pressure (IOP) were carried out at baseline, 1-3 hours, and then 3, 7, and 30 days after treatment. The main outcome was change in CRT on SD-OCT, while secondary outcome measures included visual acuity (VA) and changes in IOP following implant.
Mean CRT significantly decreased from 565 ± 171 µm at baseline to 310 ± 89 µm at end of follow-up (p<0.001), with reduction becoming evident 1-3 hours after injection. Mean BCVA also significantly improved 7 days and 30 days after treatment up to 0.14 logMAR (p<0.05). All patients had a controlled IOP after the injection with only 1/18 eyes having a transient increase in IOP during follow-up.
This is the first study showing very early effects of DEX implants on CRT reduction and VA improvement in DME.
评估地塞米松(DEX)玻璃体内植入物对糖尿病性黄斑水肿(DME)患者的早期疗效。
这是一项前瞻性、单臂、介入性临床系列研究。纳入18例慢性/顽固性或初发性DME患者(18只眼)。患者接受单次DEX玻璃体内植入。在基线、治疗后1 - 3小时、以及治疗后3、7和30天进行临床评估,包括眼科检查、通过光谱域光学相干断层扫描(SD - OCT)测量中心视网膜厚度(CRT)、最佳矫正视力(BCVA)和眼压(IOP)。主要结局是SD - OCT上CRT的变化,次要结局指标包括视力(VA)以及植入后IOP的变化。
平均CRT从基线时的565±171µm显著降至随访结束时的310±89µm(p<0.001),注射后1 - 3小时减少就很明显。平均BCVA在治疗后7天和30天也显著改善,提高了0.14 logMAR(p<0.05)。所有患者注射后眼压得到控制,随访期间只有1/18只眼眼压有短暂升高。
这是第一项显示DEX植入物对DME患者CRT降低和VA改善有非常早期疗效的研究。