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Enhanced recovery after surgery program involving preoperative dexamethasone administration for head and neck surgery with free tissue transfer reconstruction: Single-center prospective observational study.
Imai, T, Kurosawa, K, Asada, Y, Momma, Y, Takahashi, M, Satake, N, Azuma, M, Suzuki, A, Sasaki, M, Morita, S, et al
Surgical oncology. 2020;:197-205
Abstract
BACKGROUND There are few reports on Enhanced Recovery After Surgery (ERAS)-based perioperative management following head and neck surgery with free tissue transfer reconstruction (HNS-FTTR). Here, we prospectively evaluated our ERAS program involving preoperative glucocorticoid administration in HNS-FTTR. METHODS This prospective study included 60 patients who underwent HNS-FTTR at the Miyagi Cancer Center from June 2017 to December 2018. Their treatment plan included receiving perioperative management in accordance with our head and neck ERAS program. Major outcomes of hospitalization periods, early mobilization, early enteral nutrition, and patient satisfaction were assessed, and blood date and vital signs were compared with control patients who underwent HNS-FTTR from January 2014 to September 2016 at our institution before ERAS was implemented. RESULTS The duration of hospital stay and the duration until completion of the discharge criteria was a median of 25 days and 17 days, respectively. Early mobilization was achieved in 86.0% of the patients at postoperative-day (POD)1 and 96.5% at POD2. Enteral nutrition was started in 80.1% at POD1 and 100% at POD2. Postoperative pain was controlled at mean VAS scores of 1.51-3.13. Clavien-Dindo grade II or higher postoperative complications were evident in 27.6% of the patients. The mean QOR40 score was 179.6 preoperatively, 146.1 at POD3, and 167.8 at POD7. Compared with the control group, there were significantly lower C-reactive protein levels, higher albumin levels, a lower body temperature, a lower neutrophil-to-lymphocyte ratio, less body weight fluctuation, and fewer incidences of decreased blood pressure in the ERAS group. CONCLUSION Patients who underwent HNS-FTTR with ERAS-based perioperative management achieved early mobilization, early enteral nutrition, favorable pain control, remarkable recovery of patient satisfaction at POD7, and there was evidence of better hemodynamic stability and less inflammatory response compared with control patients.
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Baseline SD-OCT characteristics of diabetic macular oedema patterns can predict morphological features and timing of recurrence in patients treated with dexamethasone intravitreal implants.
Eandi, CM, De Geronimo, D, Giannini, D, Polito, MS, Tosi, GM, Neri, G, Le Mer, Y, Varano, M, Parravano, M
Acta diabetologica. 2020;(7):867-874
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Abstract
AIMS: To evaluate the timing and spectral-domain optical coherence tomography (SD-OCT) features of diabetic macular oedema (DME) recurrence according to baseline OCT patterns in patients treated with dexamethasone implant (DEX-I). METHODS This is a retrospective observational study (72 eyes/65 patients). Best-corrected visual acuity, timing of DME recurrence, and SD-OCT pattern [intraretinal cysts (IRC), IRC plus subretinal fluid (mixed), external limiting membrane (ELM), ellipsoid (IS/OS) layer integrity] were assessed at baseline and monthly until first DME recurrence. RESULTS Forty-two (58.3%) and 30 (41.6%) DME eyes had an IRC and mixed DME pattern at baseline, respectively. Twenty-four out of thirty mixed eyes (80%) relapsed without subretinal fluid. At baseline, mixed eyes showed similar changes in ELM and IS/OS (60 and 76.6% of eyes, respectively) versus IRC eyes (42.8 and 80.9% of eyes). After DME recurrence, more mixed eyes at baseline showed ELM and IS/OS changes (63.3 and 86.6%) than IRC eyes (50 and 76.2%). 33.3% of mixed eyes had DME recurrence at ≥ 6 months from first DEX-I implant versus 19% of IRC eyes. CONCLUSIONS Mixed DME eyes were treated with DEX-I relapse later and more frequently without subretinal fluid than IRC eyes. SD-OCT characteristics of different DME patterns at baseline can predict morphological features and timing of DME recurrence.
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Effectiveness and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema: A Real-World Experience.
Mello Filho, P, Andrade, G, Maia, A, Maia, M, Biccas Neto, L, Muralha Neto, A, Moura Brasil, O, Minelli, E, Dalloul, C, Iglicki, M
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde. 2019;(1):9-16
Abstract
INTRODUCTION There are few real-life studies on the intravitreal 0.7-mg dexamethasone implant for the treatment of diabetic macular edema (DME) conducted in Latin America. We aimed to assess the effectiveness and safety of this implant in clinical practice. METHODS Twenty-seven centers from Brazil and one from Argentina provided information on patients with DME treated with Ozurdex. The efficacy outcome variables were best-corrected visual acuity (BCVA) in Snellen and central retinal thickness (CRT). Safety was assessed by the elevation in intraocular pressure (IOP), occurrence of cataracts, and adverse events. RESULTS A total of 329 eyes (both treated cases and naïve eyes) from 282 patients underwent treatment. The time since diagnosis of DME ranged from 1 to 156 months. The median BCVA was 0.7 logMAR/50 letters at baseline and 0.3 logMAR/70 letters after treatment (both p < 0.001). Median CRT values decreased from 425 µm at baseline to 270 µm after treatment (p < 0.001). Increases in IOP of at least 10 mm Hg were observed in 7.4% of eyes, and 4% of eyes had cataract evolution. No cases of endophthalmitis were reported. CONCLUSION These real-life results suggest that the intravitreal dexamethasone implant is effective and safe for eyes with DME.
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Adjunctive dexamethasone implant in patients with atopic dermatitis and retinal detachment undergoing vitrectomy and silicone oil tamponade: an interventional case series.
Cho, AR, Yoon, YH
BMC ophthalmology. 2019;(1):86
Abstract
BACKGROUND To report the clinical course and outcomes of adjunctive dexamethasone implants in patients with atopic dermatitis (AD) and retinal detachment (RD) undergoing vitrectomy and silicone oil tamponade. METHODS This retrospective, interventional case series included AD patients with RD and various degrees of proliferative vitreoretinopathy (PVR) who were scheduled to undergo vitrectomy. Following total vitrectomy and retinopexy, silicone oil tamponade was performed. Finally, an intraocular dexamethasone implant was injected intravitreally. Anatomical and functional outcomes were assessed at 12 months, and extended follow-up data were also collected. RESULTS Seven eyes from six patients (five male, one female) were included. The median age was 29 (range, 20-38) years. Preoperatively, six eyes were pseudophakic, two eyes had a history of previous vitreoretinal surgery, and one had uveitis. Postoperatively, best-corrected visual acuity improved in two eyes, worsened in one, and remained similar in four. Retinal attachment was maintained in all eyes at 12 months. The major complication was an increase in postoperative intraocular pressure in six eyes, requiring either medical or surgical treatment. During the extended follow-up period (15-37 months), retinas remained attached in all eyes and stable visual acuity was maintained in five. CONCLUSIONS Injection of an intraoperative dexamethasone implant to silicone oil-filled eyes appears tolerable and may be beneficial in the surgical management of AD patients with RD and PVR.
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Anatomic Response to Intravitreal Dexamethasone Implant and Baseline Aqueous Humor Cytokine Levels in Diabetic Macular Edema.
Figueras-Roca, M, Sala-Puigdollers, A, Zarranz-Ventura, J, Alba-Linero, C, Alforja, S, Esquinas, C, Molins, B, Adán, A
Investigative ophthalmology & visual science. 2019;(5):1336-1343
Abstract
PURPOSE To determine whether baseline cytokine aqueous humor (AH) levels are associated with diabetic macular edema (DME) anatomic response to dexamethasone intravitreal implant (DEX) injection. METHODS This was a prospective cohort study of DME cases receiving DEX treatment. Seventy patients were recruited with center-involving DME with spectral-domain (SD) optical coherence tomography (OCT) detection of central macular thickness (CMT) ≥300 μm on macular cube 518 × 128-μm scan protocol (Cirrus SD-OCT). DEX injection and anterior chamber tap to obtain an AH sample were performed at the same time. Multiplex immunoassay was carried out for interleukin (IL)-1β, IL-3, IL-6, IL-8, IL-10; monocyte chemoattractant protein (MCP)-1; interferon gamma-induced protein (IP)-10; tumor necrosis factor (TNF)-α; and vascular endothelial growth factor (VEGF). A follow-up visit and OCT exam were undertaken 6 to 8 weeks afterward. The association between AH cytokine baseline levels and change in CMT and macular volume (MV) was defined as main outcome measure. RESULTS Multivariate linear regression analysis showed a higher decrease in MV to be associated (Rs of 0.512) with four baseline items: higher MCP-1 (β = -0.4; P = 0.028), higher CMT (β = -0.003; P = 0.024), decreased visual acuity (β = -0.7; P = 0.040), and a diffuse retinal thickening (DRT) OCT pattern (β = -1.3; P < 0.001). Logistic regression found DRT also to be associated with higher odds of a good MV response (odds ratio, 31.96; 95% confidence interval [CI] 7.11-143.72; P < 0.001). CONCLUSIONS Even though visual acuity response and anatomic effect are not always correlated in DME, we found that baseline elevated MCP-1 AH levels and DRT pattern were biomarkers that predicted a future favorable anatomic response to DEX.
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Sequential Dexamethasone and Aflibercept Treatment in Patients with Diabetic Macular Edema: Structural and Functional Outcomes at 52 Weeks.
Hernández-Bel, L, Cervera-Taulet, E, Navarro-Palop, C, Castro-Navarro, V, Chiarri-Toumit, C, Montero-Hernández, J
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde. 2019;(2):98-104
Abstract
OBJECTIVE The aim of this paper is to compare intravitreous aflibercept versus dexamethasone implant followed by aflibercept (sequential treatment group) in patients with diabetic macular edema (DME). METHODS We conducted an observational retrospective study in naïve DME patients, 15 treated only with aflibercept (a monthly injection for the first 5 consecutive doses, followed by an injection every 2 months), and 15 treated with a single dexamethasone implant followed by bimonthly aflibercept. Best-corrected visual acuity (BCVA), central macular thickness (CMT), and qualitative features as well as adverse events were assessed at baseline and at 2, 6, and 12 months. RESULTS BCVA increased from 70.8 ± 4.1 to 83.5 ± 2.7 letters with aflibercept and from 75.6 ± 2.7 to 86.5 ± 2.5 with sequential treatment (p = 0.551). CMT decreased from 411 ± 26.1 to 288.1 ± 10.5 with aflibercept and from 411.4 ± 24.3 to 260.8 ± 17.9 in the sequential treatment group. The differences between the 2 groups, in terms of visual gain and decreased MT, were not statistically significant (p > 0.05). Nine and 6 injections and 9 and 7 monitoring visits were performed. CONCLUSION Sequential treatment in DME, starting with dexamethasone and followed by aflibercept, is a promising alternative that can reduce the treatment burden in the first year without statistically significant differences in terms of visual gain and decreased MT compared to aflibercept only.
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OCT Biomarkers as Functional Outcome Predictors in Diabetic Macular Edema Treated with Dexamethasone Implant.
Zur, D, Iglicki, M, Busch, C, Invernizzi, A, Mariussi, M, Loewenstein, A, ,
Ophthalmology. 2018;(2):267-275
Abstract
PURPOSE Identification and characterization of patients with diabetic macular edema (DME) are important for individualizing treatment and optimizing outcome. We investigated OCT biomarkers for DME treated by intravitreal dexamethasone (DEX) implant. DESIGN Multicenter, retrospective, observational cohort study. PARTICIPANTS A total of 299 eyes from 284 patients treated with DEX implant for DME (naïve, n = 209; refractory, n = 90). Baseline best-corrected visual acuity (BCVA) was between 0.3 and 1.0 on a logarithm of minimum angle of resolution visual chart. METHODS The OCT scans previous to DEX implants were evaluated for submacular fluid, size and location of cystoid changes, inner segment-outer segment (IS-OS) continuity, quantity and location of hyperreflective foci (HRF), vitreomacular interface abnormalities, and epiretinal membrane. The BCVA and central macular thickness were recorded at baseline and at 1, 2, and 4 months after treatment with DEX implants. Correlations between OCT measures and visual outcome were analyzed using the generalized estimating equations procedure. MAIN OUTCOME MEASURES The correlation between spectral-domain (SD) OCT measures at baseline and BCVA response (mean change from baseline; categorized improvement [<5, 5-9, or ≥10; Early Treatment Diabetic Retinopathy Study letters] in BCVA) after treatment with a DEX implant. RESULTS The presence of subretinal fluid (odds ratio [OR], 1.98; 95% confidence interval [CI], 1.23-3.20; P = 0.01), absence of HRF (OR, 3.66; 95% CI, 1.40-9.62; P = 0.01), and integrity of the IS-OS layer (OR, 2.09; 95% CI, 1.30-3.37; P = 0.003) were all predictive of better visual outcome after treatment with DEX implants. Although eyes with naïve DME gained more vision than refractory eyes (P < 0.001), the predictive value of OCT findings did not differ according to this classification. CONCLUSIONS Spectral-domain OCT is useful in identifying various imaging findings in DME. Among eyes with DME, those with submacular fluid, no HRF, and a continuous IS-OS layer responded better to DEX implants than those without these features. These findings call for further study of combinations of OCT and metabolic biomarkers.
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Real-World Assessment of Dexamethasone Intravitreal Implant in DME: Findings of the Prospective, Multicenter REINFORCE Study.
Singer, MA, Dugel, PU, Fine, HF, Capone, A, Maltman, J
Ophthalmic surgery, lasers & imaging retina. 2018;(6):425-435
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BACKGROUND AND OBJECTIVE Dexamethasone intravitreal implant (DEX) (Ozurdex; Allergan plc, Dublin, Ireland) is approved for the treatment of diabetic macular edema (DME). This study assessed the real-world effectiveness, safety, and reinjection interval of DEX in adult patients with DME. PATIENTS AND METHODS This was a phase 4, prospective, multicenter (18 U.S. sites), observational study. RESULTS The study population comprised 177 patients (180 eyes; 93.8% previously treated). Baseline mean best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were 54.4 letters and 424.6 μm, respectively. DEX was administered as monotherapy or with other DME therapy (55%/45%). The mean reinjection interval was 5.0 months. Mean maximum BCVA change from baseline after the first three DEX injections was +9.1 letters, +7.7 letters, and +7.0 letters, respectively (P < .001); 36.0% of eyes achieved 15-letter or greater BCVA improvement. Mean maximum CRT change from baseline was -137.7 μm (P < .001). CONCLUSION DEX used alone or with other DME therapy improved visual and anatomic outcomes in DME patients in clinical practice, with no new safety concerns. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:425-435.].
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Safety and long-term efficacy of repeated dexamethasone intravitreal implants for the treatment of cystoid macular edema secondary to retinal vein occlusion with or without a switch to anti-VEGF agents: a 3-year experience.
Blanc, J, Deschasse, C, Kodjikian, L, Dot, C, Bron, AM, Creuzot-Garcher, C
Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie. 2018;(8):1441-1448
Abstract
PURPOSE To evaluate the safety and efficacy of repeated dexamethasone intravitreal implants (DEX implants) over 3 years in eyes with macular edema (ME) secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). METHODS We conducted a 3-year, retrospective, multicenter study that included adult patients with ME secondary to BRVO or CRVO treated with first-line DEX implants. Patients were divided into two different subgroups: patients who received DEX implant injections only (group 1) and those who received DEX implants first and then were switched to anti-VEGF agents (group 2). Primary endpoints were changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) from baseline to month 6 and month 36. Secondary endpoints included changes in both BCVA and CRT after each DEX implant and adverse events, particularly cataract extraction and elevated intraocular pressure (IOP). RESULTS Sixty-six patients with a median [IQR (interquartile ratio)] age of 72 [65.0; 81.1] years were included (40.9% BRVO, 59.1% CRVO), who received a median of 5.0 [min, 1.0; max, 10.0] DEX implants over 3 years. Median [IQR] time to retreatment was 4.8 [4.2; 6.0] months. The median [IQR] improvements in BCVA from baseline until months 6 and 36 were respectively + 10.0 [0; + 20.0] letters (P = 0.040) and + 10.0 [- 8.7; + 20.0] letters (P = 0.364) in the whole population. In group 1, the results were similar, whereas in group 2, BCVA significantly increased at M36 compared with baseline (P = 0.003). The median [IQR] CRT reductions from baseline to months 6 and 36 were respectively - 227.5 [- 337.0; - 52.7] μm and - 224.0 [- 405.0; - 83.8] μm (P < 0.001) in the whole population. Results were similar in both groups. The most common adverse events were cataract extraction (70.4%) and elevated IOP (54.5%). No other serious local complications were observed. Treatment was switched to anti-VEGF agents in 16 (24.2%) patients. CONCLUSIONS DEX implants are an effective treatment for BRVO and CRVO-associated ME over 3 years. It is a valid treatment even though complications remain frequent. However, functional efficacy seems to decrease with time and repeated injections.
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Effectiveness and safety of dexamethasone implants for postsurgical macular oedema including Irvine-Gass syndrome: the EPISODIC-2 study.
Bellocq, D, Pierre-Kahn, V, Matonti, F, Burillon, C, Voirin, N, Dot, C, Akesbi, J, Milazzo, S, Baillif, S, Soler, V, et al
The British journal of ophthalmology. 2017;(3):333-341
Abstract
AIM: To assess the effectiveness of intravitreal dexamethasone implants for treating postsurgical macular oedema (PSMO) including Irvine-Gass syndrome and determining the predictive factors of treatment response. METHODS Descriptive, observational, retrospective, consecutive, uncontrolled, multicentre, national case series. One hundred patients were included between April 2011 and June 2014, with a minimum of 1-year follow-up. Patients received dexamethasone implant 0.7 mg at baseline. Clinical characteristics, best-corrected visual acuity (BCVA), central subfield macular thickness (CSMT) and intraocular pressure were measured at each visit. The main outcome measure was the change in BCVA (Early Treatment of Diabetic Retinopathy Study (ETDRS) letters: L). An analysis of predictive factors of treatment response is also provided. RESULTS Mean improvement in BCVA was 9.6 (±10.6) L at month 6 and 10.3 (±10.7) L at month 12 (p<0.001). The proportion of eyes with gains in BCVA of 15 or more letters was 32.5% and 37.5% at months 6 and 12, respectively. The mean reduction in CSMT was 135.2 and 160.9 µm at months 6 and 12, respectively (p<0.001). Thirty-seven per cent of patients did not need a second injection after the first injection during follow-up. The presence of at least one PSMO risk factor decreases the probability of a gain in visual acuity (VA) ≥10 L (p=0.006). Initial VA ≤50 L at baseline and non-naïve status decrease the probability of having only one injection during follow-up (p=0.044). CONCLUSIONS The significant gain in BCVA from baseline achieved at month 6 was maintained at month 12 after intravitreal injection of dexamethasone implant. Naïve status seems to be a good predictive factor of treatment response.