Correction: The outcome of fluocinolone acetonide intravitreal implant is predicted by the response to dexamethasone implant in diabetic macular oedema

Cicinelli, Maria Vittoria; Rosenblatt, Amir; Grosso, Domenico; Zollet, Piero; Capone, Luigi; Rabiolo, Alessandro; Lattanzio, Rosangela; Loewenstein, Anat; Bandello, Francesco

doi:10.1038/s41433-021-01469-2

Cited by 8 publications

(13 citation statements)

References 37 publications

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“…For this reason, the current literature is poorly useful in supporting our findings. However, our data agreed with the conclusions provided by all the previous safety assessments, which considered a careful IOP monitoring mandatory in FAc implant clinical setting (8)(9)(10)(11)(12)(13)(14).…”

Section: Discussionsupporting

confidence: 91%

“…It is undoubted that the IOP-related complications are more frequent in FAc-treated eyes, compared with DEX implants; taking, for example, a recent study collecting data from a high number of DEX-treated eyes, the cumulative probability of IOP increases ≥21, ≥25 and ≥35 mmHg was found equal to 50-60%, 25-30%, and 6-7% at 12-24 months, respectively, with an overall incidence of IOP-lowering surgery of 0.9% (13). In this scenario, IOP changes registered after DEX implants were found useful to try to predict IOP behavior following FAc implant (8)(9)(10)(11)(12)(13)(14), although few data are available regarding the real predictivity of DEX implant.…”

Section: Introductionmentioning

confidence: 81%

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Intraocular Pressure Changes Are Predictive of Ocular Hypertension Onset After Fluocinolone Acetonide Implant: Significant Cutoffs and the Role of Previous DEX Implant

et al. 2021

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Background: Fluocinolone acetonide (FAc) implant represents a long-term strategy for the management of diabetic macular edema (DME). Because of the 3-year duration, the careful monitoring of the intraocular pressure (IOP) is necessary. The main aim of the study was to provide quantitative IOP cutoffs associated with the onset of IOP increases.Methods: The study was retrospectively conducted with 2-year of follow-up. We separately considered eyes with good IOP control (Group 1), eyes requiring IOP-lowering medications (Group 2) and eyes undergoing IOP-lowering surgery (Group 3). The statistical analysis assessed Delta% IOP changes over the 2-year follow-up. ROC analysis was performed to detect significant cutoffs associated with Group 2 and Group 3. IOP changes occurring after a previously administered dexamethasone (DEX) implant were also evaluated.Results: We included 48 eyes (48 patients), stratified as follows: Group 1 (25/48; 52%), Group 2 (19/48; 40%) and Group 3 (4/48; 8%). ROC analysis performed on IOP values detected 2-months later DEX implant showed a mean Delta IOP increase>24% significantly associated with IOP-lowering medications after FAc implant, whereas a mean Delta IOP increase>35% was significantly associated with IOP-lowering surgery after FAc implant. With respect to IOP changes occurred after FAc implant, our ROC analysis showed a mean Delta IOP increase>8% significantly associated with IOP-lowering medications, whereas a mean Delta IOP increase>15% was significantly associated with IOP-lowering surgery. DEX-related IOP changes showed 52% sensitivity and 100% specificity of FAc-related IOP increases.Conclusions: IOP changes provides clinically relevant cutoffs associated with the onset of FAc-related IOP increases.

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 81%

Intraocular Pressure Changes Are Predictive of Ocular Hypertension Onset After Fluocinolone Acetonide Implant: Significant Cutoffs and the Role of Previous DEX Implant

et al. 2021

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“…Intravitreal injections of FAc may be prescribed directly after anti-VEGF injections [19,27,28] or after additional intravitreal steroid injections (dexamethasone implant or off-label triamcinolone injection) [33][34][35][36].…”

Section: Introductionmentioning

confidence: 99%

“…Indeed, the FDA has approved the FAc implant in DME patients previously treated with a course of corticosteroids in the absence of any clinically significant rise in IOP. A few small studies have investigated the switch from DEX to FAc implants [33][34][35][36]. However, the management of this switch, particularly in regard to the timing of the FAc injection or the need for additional treatment, has not been fully detailed.…”

Section: Introductionmentioning

confidence: 99%

Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant

et al. 2022

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To assess anatomical and functional outcomes after switching from dexamethasone implant (DEXi) to fluocinolone acetonide implant (FAci) in 113 diabetic macular edema eyes, a multicentric retrospective observational study was conducted. Seventy-five eyes (73.5%) were switched 1–8 weeks after their last DEXi. The mean best-corrected visual acuity improved to 59.8 letters at month 4 and remained stable during the follow-up. The mean central macular thickness (CMT) significantly decreased during the follow-up, with a minimum of 320.9 μm at month 3. The baseline CMT was higher in eyes that received the last DEXi >8 weeks versus <8 weeks before the first FAci (p < 0.021). After FAci injection, additional treatments were needed in 37 (32.7%) eyes. A longer diabetes duration (p = 0.009), a longer time between the last DEXi and the first FAci (p = 0.035), and a high baseline CMT (p = 0.003) were risk factors for additional treatments. The mean intraocular pressure was <19 mmHg at all timepoints, with no difference between eyes receiving the last DEXi ≤8 weeks or >8 weeks before the switch. Switching from DEXi to FAci in DME is effective and safe. A short time between the last DEXi and the first FAci reduced CMT fluctuations and the need for early additional treatments.

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“…The calculation was based on the reduction of CRT in patients with diabetic macular edema according to a recent study. 12 …”

Section: Methodsmentioning

confidence: 99%

Long-Term Efficacy of Fluocinolone in Eyes With Iris–lens Diaphragm Disruption and Pcme With Medication Fixed in the Sclera (Mefisto)

Herold

Vounotrypidis

Liegl

et al. 2022

Retina

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The aim of our prospective off-label, interventional clinical trial was to evaluate the efficacy and safety of the fluocinolone-loop-anchoring technique over two years in eyes with iris-lens diaphragm disruption and pseudophakic cystoid macular edema.Methods: In 10 eyes, scleral fixation of fluocinolone implant was performed. Main outcome measures were the development of best-corrected visual acuity (BCVA), central retinal thickness over 24 months, and general safety of the procedure.Results: A significant improvement to 0.57 ± 0.38 log MAR (Snellen 20/80) (range 0-1.30) was observed (P = 0.003) at 1 month. Further improvement to 0.45 ± 036 log MAR (Snellen 20/60) was observed until month 18 (P = 0.081). Mean central retinal thickness decreased by 22% from 601.6 ± 235.5 mm to 449.1 ± 128.9 mm at 1 month. In one patient, the implant has to be removed at Month 7 because of elevated intraocular pressure and one patient after globe rupture had a retinal redetachment at Month 4. Conclusion:In this study, we showed that the treatment of recalcitrant pseudophakic cystoid macular edema with scleral fixated fluocinolone implant in eyes with disruption of the iris-lens diaphragm provides good anatomical and functional results with a reasonable safety profile over 24 months in eyes where pseudophakic cystoid macular edema is otherwise difficult to treat and often left untreated.

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Correction: The outcome of fluocinolone acetonide intravitreal implant is predicted by the response to dexamethasone implant in diabetic macular oedema

Cited by 8 publications

References 37 publications

Intraocular Pressure Changes Are Predictive of Ocular Hypertension Onset After Fluocinolone Acetonide Implant: Significant Cutoffs and the Role of Previous DEX Implant

Intraocular Pressure Changes Are Predictive of Ocular Hypertension Onset After Fluocinolone Acetonide Implant: Significant Cutoffs and the Role of Previous DEX Implant

Management of Patients with Diabetic Macular Edema Switched from Dexamethasone Intravitreal Implant to Fluocinolone Acetonide Intravitreal Implant

Long-Term Efficacy of Fluocinolone in Eyes With Iris–lens Diaphragm Disruption and Pcme With Medication Fixed in the Sclera (Mefisto)

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