Sadr Ata, Sargazi Meisam, Banaie Shahram, Asani Mahdi, Mehrad Majd Hassan, Mohammadi Seyed Omid, Maleki Alireza
Ophthalmology, Zahedan University of Medical Sciences, Zahedan, IRN.
Clinical Research Development Unit, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, IRN.
Cureus. 2024 Feb 24;16(2):e54829. doi: 10.7759/cureus.54829. eCollection 2024 Feb.
Intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents is accepted as the gold standard treatment for center-involving diabetic macular edema (CI-DME). Adjunctive administration of topical dorzolamide may enhance the therapeutic effects of anti-VEGF agents. In this study, we compared the efficacy of topical dorzolamide plus intravitreal injection of bevacizumab (IVB) versus IVB alone in patients with bilateral DME.
This prospective, randomized contralateral eye study was carried out in a tertiary referral ophthalmology center, Al-Zahra Eye Hospital, Zahedan, Iran, between April 2021 and April 2022. This study included 50 eyes of 25 patients with bilateral DME. All eyes received three consecutive monthly injections of IVB. For each patient, one eye was randomized to instill dorzolamide eye drops three times a day as an intervention, and the other received artificial tear drops as a placebo. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) were evaluated before starting treatment and then monthly for the first three months.
Among 25 included patients, the average age was 56.64 ± 7.97 years, and 48% were female. BCVA did not improve significantly in any groups (P > 0.05). No significant difference was observed in terms of BCVA between the intervention and control groups (P > 0.05). The present study showed a decrease in CMT in both study groups (P < 0.05). At month 3, the decrease in mean CMT from baseline was significantly higher in eyes receiving topical dorzolamide compared to the control group (-88.92 ± 82.90 vs. -37.64 ± 86.16 µM, respectively; P = 0.037). IOP decreased significantly only in eyes receiving dorzolamide (P < 0.001).
The results of the present study indicate that adjunctive administration of topical dorzolamide has a beneficial effect on CMT reduction from baseline, but it did not have an additive effect on BCVA improvement compared to IVB monotherapy.
玻璃体内注射抗血管内皮生长因子(VEGF)药物被公认为治疗累及中心凹的糖尿病性黄斑水肿(CI-DME)的金标准疗法。局部应用多佐胺辅助治疗可能会增强抗VEGF药物的治疗效果。在本研究中,我们比较了局部应用多佐胺联合玻璃体内注射贝伐单抗(IVB)与单纯IVB治疗双侧DME患者的疗效。
本前瞻性、随机对侧眼研究于2021年4月至2022年4月在伊朗扎黑丹的三级转诊眼科中心阿尔-扎赫拉眼科医院进行。本研究纳入了25例双侧DME患者的50只眼。所有眼睛均连续每月接受3次IVB注射。对于每位患者,一只眼睛被随机分配为每天滴注3次多佐胺滴眼液作为干预组,另一只眼睛接受人工泪液作为安慰剂。在开始治疗前以及治疗的前三个月每月评估最佳矫正视力(BCVA)、中心黄斑厚度(CMT)和眼压(IOP)。
在纳入的25例患者中,平均年龄为56.64±7.97岁,48%为女性。任何组的BCVA均未显著改善(P>0.05)。干预组和对照组之间的BCVA无显著差异(P>0.05)。本研究显示两个研究组的CMT均有所下降(P<0.05)。在第3个月时,与对照组相比,接受局部多佐胺治疗的眼睛平均CMT从基线的下降幅度显著更高(分别为-88.92±82.90与-37.64±86.16µM;P=0.037)。仅接受多佐胺治疗的眼睛眼压显著降低(P<0.001)。
本研究结果表明,局部应用多佐胺辅助治疗对从基线降低CMT有有益作用,但与IVB单药治疗相比,对改善BCVA没有附加作用。