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Abstract：
BACKGROUND: The aim of this study was to assess the efficacy and safety of fluocinolone acetonide implant (FAci) injected 1 month after the last dexamethasone intravitreal implant (DEXi) in chronic diabetic macular oedema (DME) patients.
METHODS: Retrospective multicentric study conducted in pseudophakic patients with chronic DME frequently treated with dexamethasone intravitreal implant (DEXi; time to DME recurrence ≤ 6 months), receiving FAci 1 month after the last DEXi, with at least a 6-month follow-up. Best-corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, intraocular pressure (IOP) and additional treatments were assessed on the day of FAci injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months.
RESULTS: A total of 41 eyes from 34 patients were included. At M0, patients\' mean age was 68.7 ± 9.8 years, the mean DME duration was 63.9 ± 22.9 months, the mean interval between two DEXi was 14.2 ± 3.3 weeks. M12 data were available for 71% of patients. At baseline, the mean BCVA, CMT and IOP were 63.2 ± 16.6 letters, 299.4 ± 103.3 µm, and 16.2 ± 4.5 mmHg, respectively, and remained stable during the follow-up. At M12, 14% of patients required additional intravitreal treatments.
CONCLUSIONS: In pseudophakic patients with chronic DME showing good response to DEXi but requiring repeated injections every < 6 months, switching to FAci 1 month after the last DEXi was effective and safe. Further prospective randomized controlled studies are needed to confirm these findings, and to determine the best interval between the last DEXi and the first FAci.
METHODS: Retrospective multicentric study conducted in pseudophakic patients with chronic DME frequently treated with dexamethasone intravitreal implant (DEXi; time to DME recurrence ≤ 6 months), receiving FAci 1 month after the last DEXi, with at least a 6-month follow-up. Best-corrected visual acuity (BCVA), central macular thickness (CMT) on optical coherence tomography, intraocular pressure (IOP) and additional treatments were assessed on the day of FAci injection (M0), 1 (M1) and 3 months (M3) later and then every 3 months.
RESULTS: A total of 41 eyes from 34 patients were included. At M0, patients\' mean age was 68.7 ± 9.8 years, the mean DME duration was 63.9 ± 22.9 months, the mean interval between two DEXi was 14.2 ± 3.3 weeks. M12 data were available for 71% of patients. At baseline, the mean BCVA, CMT and IOP were 63.2 ± 16.6 letters, 299.4 ± 103.3 µm, and 16.2 ± 4.5 mmHg, respectively, and remained stable during the follow-up. At M12, 14% of patients required additional intravitreal treatments.
CONCLUSIONS: In pseudophakic patients with chronic DME showing good response to DEXi but requiring repeated injections every < 6 months, switching to FAci 1 month after the last DEXi was effective and safe. Further prospective randomized controlled studies are needed to confirm these findings, and to determine the best interval between the last DEXi and the first FAci.
摘要：
背景：本研究的目的是评估在慢性糖尿病性黄斑水肿（DME）患者最后一次玻璃体内植入地塞米松（DEXi）1个月后注射醋酸氟轻松（FAci）的疗效和安全性。
方法：在经常接受地塞米松玻璃体内植入物治疗的慢性DME假晶状体患者中进行的回顾性多中心研究（DEXi；DME复发时间≤6个月），在上次DEXi后1个月收到FAci，至少6个月的随访。最佳矫正视力（BCVA），光学相干断层扫描的中央黄斑厚度（CMT），在注射FAci（M0）当天评估眼内压（IOP）和其他治疗，1（M1）和3个月（M3）后，然后每3个月。
结果：共纳入34例患者的41只眼。在M0时，患者的平均年龄为68.7±9.8岁，DME的平均持续时间为63.9±22.9个月，两次DEXi之间的平均间隔为14.2±3.3周.71%的患者可获得M12数据。在基线,平均BCVA，CMT和IOP为63.2±16.6个字母，299.4±103.3µm,16.2±4.5mmHg，分别,并在随访期间保持稳定。在M12时，14%的患者需要额外的玻璃体内治疗。
结论：慢性DME患者对DEXi反应良好，但需要每6个月重复注射一次，在上次DEXi有效且安全的1个月后切换到FAci。需要进一步的前瞻性随机对照研究来证实这些发现，并确定最后一个DEXi和第一个FAci之间的最佳间隔。
方法：在经常接受地塞米松玻璃体内植入物治疗的慢性DME假晶状体患者中进行的回顾性多中心研究（DEXi；DME复发时间≤6个月），在上次DEXi后1个月收到FAci，至少6个月的随访。最佳矫正视力（BCVA），光学相干断层扫描的中央黄斑厚度（CMT），在注射FAci（M0）当天评估眼内压（IOP）和其他治疗，1（M1）和3个月（M3）后，然后每3个月。
结果：共纳入34例患者的41只眼。在M0时，患者的平均年龄为68.7±9.8岁，DME的平均持续时间为63.9±22.9个月，两次DEXi之间的平均间隔为14.2±3.3周.71%的患者可获得M12数据。在基线,平均BCVA，CMT和IOP为63.2±16.6个字母，299.4±103.3µm,16.2±4.5mmHg，分别,并在随访期间保持稳定。在M12时，14%的患者需要额外的玻璃体内治疗。
结论：慢性DME患者对DEXi反应良好，但需要每6个月重复注射一次，在上次DEXi有效且安全的1个月后切换到FAci。需要进一步的前瞻性随机对照研究来证实这些发现，并确定最后一个DEXi和第一个FAci之间的最佳间隔。
