The anatomical success rate without further interventions of 45.8% (22 of 48 patients) seems unsatisfactory. However, in evaluating the potential of Densiron, it should be considered that all patients in this study had previous surgery with standard procedures, including silicone oil, which had already failed. Intraoperative laser photocoagulation of the periphery of the upper quadrants might reduce the risk of retinal re-detachments.
Introduction: The Retro-IDEAL (ILUVIEN Implant for chronic DiabEtic MAcuLar edema) study is a retrospective study designed to assess real-world outcomes achieved with the ILUVIEN® (0.19 mg fluocinolone acetonide (FAc)) in patients with chronic diabetic macular edema (DME) in clinical practices in Germany. Methods: This study was conducted across 16 sites in Germany and involved 81 eyes (63 patients) with persistent or recurrent DME and a prior suboptimal response to a first-line intravitreal therapy (primarily anti-VEGF intravitreal therapies). Results: Patients were followed-up for 30.8 ± 11.3 months (mean ± standard deviation) and had a mean age of 68.0 ± 10.4 years. Best-recorded visual acuity (BRVA) improved by +5.5 letters at month 9 (P ⩽ 0.005, n=56; from a baseline of 49 letters) and this was maintained through to month 30 (P ⩽ 0.05, n = 42). There was a concurrent improvement in central macular thickness with a reduction from 502 µm at baseline to 338 µm at year 1 (P ⩽ 0.0001, n = 43). This effect was sustained to year 3 (i.e. 318 µm; P ⩽ 0.0001, n = 29). Mean intraocular pressure (IOP) remained constant between baseline and year 3 with a peak change of 1.9 mm Hg occurring at year 1. Elevated IOP was observed in a similar
Primary anatomical success rate of 33.3% was less encouraging than as expected. Especially, re-detachments within the posterior staphyloma in highly myopic patients were common during Densiron endotamponade. However, the surgical success increased to 75% after reintervention, even without the use of an additional encircling band. The observed adverse effects and the functional outcomes do not contraindicate the use of Densiron as an internal tamponade for a period of 3 months.
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