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Comparison of dexamethasone intravitreal implant and intravitreal triamcinolone acetonide for the treatment of pseudophakic cystoid macular edema in diabetic patients

机译:地塞米松玻璃体内植入物和玻璃体内曲安奈德治疗糖尿病性假晶状体囊性黄斑水肿的比较

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Background and objective: Our objective was to investigate the efficacy and safety of dexamethasone (DEX) implant for the treatment of pseudophakic cystoid macular edema (PCME) in diabetic patients. Study design: This was a prospective, non-randomized, interventional case series of 43 participants. Eighteen patients were enrolled in the DEX implant group and 25 were enrolled in an intravitreal triamcinolone acetonide (IVTA) group. Main outcome measures: The primary efficacy measurement was the percentage of patients who gained improvements of more than ten letters in best corrected visual acuity (BCVA) during 6 months of follow-up. Other efficacy measurements included change in BCVA, change in central macular thickness (CMT), and number of retreatments. The primary safety evaluation was the percentage of patients with intraocular hypertension and variation in intraocular pressure (IOP) during 6 months of follow-up. Other adverse events, such as conjunctival hemorrhage, eye pain, secondary infection, endophthalmitis, noninfectious inflammation, retinal detachment, and implant migration, were also recorded during follow-up. Results: At month 1, we observed that the percentage of patients gaining improvement of more than ten letters was similar in both groups (P=0.625). As patients in the IVTA group were retreated several times, this effect persisted throughout the study (P=0.941 at month 2, P=0.553 at month 3, P=0.856 at month 6). Variations in CMT were noticed at week 1 and reached their maximum at month 1. No significant difference was found between the two groups (P=0.831 at week 1, P=0.783 at month 1). At month 1, the variation in IOP reached its maximum in the DEX implant group and then decreased slightly. However, in the IVTA group, it increased continuously throughout the study. Conjunctival hemorrhage and eye pain were found in both groups, but both were rated as mild in severity, and no significant difference was found (P=0.184, P=0.766, respectively). Conclusion: Both IVTA and DEX implants could effectively restore visual function and recover morphological change in diabetic patients with PCME for at least 6 months, but repeated intravitreal injection was required in the IVTA group. DEX implant is well tolerated. We suggest that intravitreal injection of DEX implant is a promising new therapeutic option for diabetic patients with PCME.
机译:背景与目的:我们的目的是研究地塞米松(DEX)植入物在糖尿病患者中治疗假性晶状体囊样黄斑水肿(PCME)的有效性和安全性。研究设计:这是一个前瞻性,非随机,干预性病例系列研究,共有43名参与者。 DEX植入物组18例,玻璃体内曲安奈德(IVTA)组25例。主要结局指标:主要疗效指标是随访6个月内,最佳矫正视力(BCVA)改善超过10个字母的患者百分比。其他功效测量包括BCVA的变化,中央黄斑厚度(CMT)的变化以及再治疗的次数。主要安全性评估是随访6个月内眼内高压患者的比例和眼内压(IOP)的变化。在随访期间还记录了其他不良事件,如结膜出血,眼痛,继发感染,眼内炎,非感染性炎症,视网膜脱离和植入物迁移。结果:在第1个月,我们观察到两组患者获得超过十个字母的改善的百分比相似(P = 0.625)。随着IVTA组患者的治疗数次,这种效果在整个研究中一直持续(第2个月P = 0.941,第3个月P = 0.553,第6个月P = 0.856)。 CMT的变化在第1周注意到,并在第1个月达到最大值。两组之间没有发现显着差异(第1周的P = 0.831,第1个月的P = 0.783)。在第1个月,DEX植入物组的IOP变化达到最大,然后略有下降。但是,在IVTA组中,整个研究过程中它持续增加。两组均发现结膜出血和眼痛,但严重程度均被定为轻度,差异无统计学意义(分别为P = 0.184,P = 0.766)。结论:IVTA和DEX植入物均可有效恢复糖尿病PCME患者的视觉功能并恢复其形态变化至少6个月,但IVTA组需要重复玻璃体内注射。 DEX植入物耐受性良好。我们建议玻璃体腔内注射DEX植入物是PCME糖尿病患者的有希望的新治疗选择。

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