Wang Manqiao, Luan Rong, Liu Boshi, Gong Yi, Zhao Jinzhi, Chen Xiteng, Yang Qianhui, Liu Jingjie, Liu Juping, Shao Yan, Li Xiaorong
Tianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, People's Republic of China.
Diabetes Metab Syndr Obes. 2024 Mar 8;17:1199-1213. doi: 10.2147/DMSO.S445607. eCollection 2024.
To investigate the 3-months outcomes of patients who underwent intraoperative intravitreal injection of Ozurdex for proliferative diabetic retinopathy (PDR).
This is a prospective randomized controlled clinical trial (ChiCTR2100043399). Seventy-one patients with PDR who had indications for surgery without intravitreal injection history within 3 months preoperatively were enrolled. Patients were randomly divided into three groups based on the medicine injected intraoperatively: Ozurdex, Conbercept, and Control group. The primary outcome is the best-corrected visual acuity (BCVA) within 3 months postoperatively. The secondary outcomes include the intraocular pressure (IOP), mean sensitivity, central retinal thickness and vessels perfusion.
The BCVA and the mean sensitivity improved in the three groups (F = 130.8, P < 0.0001; F = 34.18, P < 0.0001), but there was no statistical difference among the three groups (F = 0.858, P = 0.552; F = 0.964, P = 0.452). The IOP was no significant differences among the three groups within 3 months postoperatively (F = 0.881, P = 0.533). Compared with the other two groups, central retinal thickness (CRT) and outer retinal layer (ORL) thickness decreased significantly in patients of the Ozurdex group (F = 3.037, P = 0.008; F = 2.626, P = 0.018), especially in the diabetic macular edema (DME) patients (F = 2.761, P = 0.0164; F = 2.572, P = 0.0240). In macular region, superficial vascular plexus (SVP), intermediate capillary plexus (ICP) and deep capillary plexus (DCP) perfusion were not shown statistical difference at 3 months postoperatively in the all three groups compared with 1 day postoperatively (P > 0.05).
Compared with the other two groups, anatomical outcomes was improved significantly in Ozurdex group for DR patients. Ozurdex may help to improve the visual acuity and visual sensitivity, and there is no significant difference in the change of IOP and microvascular improvement.
This trial is registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn, registration number ChiCTR2100043399).
研究术中玻璃体内注射Ozurdex治疗增殖性糖尿病视网膜病变（PDR）患者的3个月预后情况。
这是一项前瞻性随机对照临床试验（ChiCTR2100043399）。纳入71例术前3个月内有手术指征且无玻璃体内注射史的PDR患者。根据术中注射药物将患者随机分为三组：Ozurdex组、康柏西普组和对照组。主要结局指标是术后3个月内的最佳矫正视力（BCVA）。次要结局指标包括眼压（IOP）、平均敏感度、视网膜中央厚度和血管灌注。
三组患者的BCVA和平均敏感度均有所改善（F = 130.8, P < 0.0001；F = 34.18, P < 0.0001），但三组之间无统计学差异（F = 0.858, P = 0.552；F = 0.964, P = 0.452）。术后3个月内三组患者的IOP无显著差异（F = 0.881, P = 0.533）。与其他两组相比，Ozurdex组患者的视网膜中央厚度（CRT）和外层视网膜厚度（ORL）显著降低（F = 3.037, P = 0.008；F = 2.626, P = 0.018），尤其是糖尿病性黄斑水肿（DME）患者（F = 2.761, P = 0.0164；F = 2.572, P = 0.0240）。在黄斑区，与术后1天相比，术后3个月时三组患者的浅表血管丛（SVP）、中间毛细血管丛（ICP）和深层毛细血管丛（DCP）灌注均无统计学差异（P > 0.05）。
与其他两组相比，Ozurdex组DR患者的解剖学预后有显著改善。Ozurdex可能有助于提高视力和视觉敏感度，且在眼压变化和微血管改善方面无显著差异。
本试验已在中国临床试验注册中心注册（http://www.chictr.org.cn，注册号ChiCTR2100043399）。
