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Abstract：
UNASSIGNED: To investigate the 3-months outcomes of patients who underwent intraoperative intravitreal injection of Ozurdex for proliferative diabetic retinopathy (PDR).
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: This trial is registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn, registration number ChiCTR2100043399).
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
UNASSIGNED: This trial is registered with the Chinese Clinical Trial Registry (http://www.chictr.org.cn, registration number ChiCTR2100043399).
摘要：
■目的探讨术中玻璃体内注射Ozurdex治疗增殖性糖尿病视网膜病变（PDR）患者3个月的预后。
■这是一项前瞻性随机对照临床试验（ChiCTR2100043399）。纳入71例术前3个月内无玻璃体内注射史的手术指征的PDR患者。根据术中注射的药物将患者随机分为三组：Ozurdex，Conbercept,和对照组。主要结果是术后3个月内的最佳矫正视力（BCVA）。次要结果包括眼内压（IOP），平均敏感度，视网膜中央厚度和血管灌注。
■三组的BCVA和平均敏感性均得到改善（F=130.8，P<0.0001；F=34.18，P<0.0001），3组间比较差异无统计学意义(F=0.858,P=0.552;F=0.964,P=0.452)。术后3个月内3组眼压比较差异无统计学意义(F=0.881,P=0.533)。与其他两组相比，Ozurdex组患者视网膜中央厚度(CRT)和视网膜外层厚度(ORL)明显下降(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，浅血管丛（SVP），术后3个月，3组中层毛细血管丛（ICP）和深层毛细血管丛（DCP）灌注与术后1天比较，差异无统计学意义（P>0.05）。
■与其他两组相比，Ozurdex组DR患者的解剖学结局明显改善.Ozurdex可能有助于提高视敏度和视觉敏感度，而在眼压的变更和微血管改良方面无显著差别。
■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)。
■这是一项前瞻性随机对照临床试验（ChiCTR2100043399）。纳入71例术前3个月内无玻璃体内注射史的手术指征的PDR患者。根据术中注射的药物将患者随机分为三组：Ozurdex，Conbercept,和对照组。主要结果是术后3个月内的最佳矫正视力（BCVA）。次要结果包括眼内压（IOP），平均敏感度，视网膜中央厚度和血管灌注。
■三组的BCVA和平均敏感性均得到改善（F=130.8，P<0.0001；F=34.18，P<0.0001），3组间比较差异无统计学意义(F=0.858,P=0.552;F=0.964,P=0.452)。术后3个月内3组眼压比较差异无统计学意义(F=0.881,P=0.533)。与其他两组相比，Ozurdex组患者视网膜中央厚度(CRT)和视网膜外层厚度(ORL)明显下降(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，浅血管丛（SVP），术后3个月，3组中层毛细血管丛（ICP）和深层毛细血管丛（DCP）灌注与术后1天比较，差异无统计学意义（P>0.05）。
■与其他两组相比，Ozurdex组DR患者的解剖学结局明显改善.Ozurdex可能有助于提高视敏度和视觉敏感度，而在眼压的变更和微血管改良方面无显著差别。
■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)。
