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1.
BMC Ophthalmol ; 23(1): 320, 2023 Jul 14.
Artigo em Inglês | MEDLINE | ID: mdl-37452330

RESUMO

BACKGROUND: To determine the effect of ketorolac tromethamine 0.5% in preventing post-phacoemulsification macular thickening. This randomized clinical trial. patients randomized 1:1 to receive either topical ketorolac three times a day or a placebo. METHODS: A total of 101 eyes of 101 diabetic patients who were scheduled for phacoemulsification and had normal macular contour and thickness enrolled consecutively. The topical ketorolac and placebo were prescribed on the day before surgery and continued up to 4 weeks after surgery. Patients with proliferative diabetic retinopathy, a history of intravitreal injection in less than three months, a history of macular photocoagulation in less than 6 months, and any other concomitant ocular pathologies were excluded. Central macular thickness (CMT) and best corrected visual acuity (BCVA) was recorded in the follow-ups of 6, 12, and 24 weeks after the surgery and compared with the controls. RESULTS: 49 eyes in the case group and 52 eyes in the control group were analyzed. Mean BCVA was significantly improved in both groups at all follow-ups (P < 0.001 for all). There was no statistically significant difference regarding the BCVA in different time points except week 12 (P = 0.028) among the study group. In the case and control groups, CMT was increased at all follow-ups (P < 0.05). There was no statistically significant difference when comparing the two groups regarding the mean of CMT at any time point postoperatively (P > 0.05 for all). CONCLUSION: Based on our findings, topical ketorolac tromethamine 0.5% is not effective in the prevention of post-phacoemulsification macular thickening in diabetic patients. TRAIL REGISTRATION: The study protocol was registered into www. CLINICALTRIAL: gov with the RCT registration number NCT03551808. (2018/06/11 ) CLINICAL TRIAL REGISTRATION NUMBER: NCT03551808.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Facoemulsificação , Humanos , Cetorolaco de Trometamina/uso terapêutico , Cetorolaco/uso terapêutico , Resultado do Tratamento , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Acuidade Visual , Retinopatia Diabética/complicações , Retinopatia Diabética/tratamento farmacológico , Tomografia de Coerência Óptica
2.
Eye (Lond) ; 37(10): 2077-2081, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-36273040

RESUMO

BACKGROUND/OBJECTIVES: Pseudophakic macular oedema remains the most common sight-threatening complication following cataract surgery. This study aims to assess the effect of intraoperative subconjunctival steroids on the rate of pseudophakic cystoid macular oedema. METHODS: A retrospective, observational database study of 20 066 consecutive phacoemulsification surgeries. The incidence of pseudophakic cystoid macular oedema was compared in eyes that did and did not receive intraoperative subconjunctival steroid injection during routine cataract surgery. RESULTS: Intraoperative subconjunctival injection of dexamethasone or betamethasone sodium phosphate significantly reduced the odds of developing pseudophakic cystoid macular oedema across the cohort (odds ratio: 0.67; 95% confidence interval: 0.46-0.98, p = 0.039). The effect of subconjunctival steroids on pseudophakic macular oedema remained independently associated on multivariate logistic regression analysis (p = 0.028). CONCLUSION: This study demonstrates that administration of intraoperative subconjunctival steroid injection is associated with a reduced incidence of pseudophakic cystoid macular oedema in routine, uncomplicated cataract surgery.


Assuntos
Catarata , Edema Macular , Facoemulsificação , Humanos , Catarata/complicações , Estudos de Coortes , Incidência , Edema Macular/epidemiologia , Edema Macular/etiologia , Edema Macular/prevenção & controle , Facoemulsificação/efeitos adversos , Pseudofacia , Estudos Retrospectivos
3.
Int Ophthalmol ; 43(1): 271-284, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-36065039

RESUMO

INTRODUCTION: To compare the efficacy and safety of non-steroidal anti-inflammatory drugs (NSAID), corticosteroid (CS), and a combination of both drugs to prevent cystoid macular edema (CME) after cataract surgery. METHODS: We searched Pubmed, Cochrane Library, and Embase electronic databases to assess the relevant randomized controlled trials (RCTs) up to 28 April 2021. Network meta-analysis was registered on PROSPERO (CRD42020182520). RESULTS: Twenty-four RCTs were included in this review. The NSAID and combination of both drugs were significantly reduced the risk of developing CME than CS alone in non-diabetics and mix populations. In the ranking profiles, the combination therapy showed a significant advantage over the single drugs and was less likely to develop CME. Diclofenac was the most likely to reduce the odds of developing CME compared with bromfenac and nepafenac. Dexamethasone was the most likely to reduce the odds of developing CME compared with betamethasone and fluorometholone. CONCLUSION: NSAID combination with CS has significantly reduced the risk of developing CME postoperatively than the single drug. Diclofenac was superior to bromfenac and nepafenac in preventing CME. Dexamethasone was superior to betamethasone and fluorometholone in preventing CME.


Assuntos
Extração de Catarata , Catarata , Edema Macular , Humanos , Edema Macular/etiologia , Edema Macular/prevenção & controle , Edema Macular/tratamento farmacológico , Fluormetolona , Diclofenaco , Extração de Catarata/efeitos adversos , Resultado do Tratamento , Anti-Inflamatórios não Esteroides/uso terapêutico , Corticosteroides/uso terapêutico , Dexametasona , Betametasona
4.
BMC Ophthalmol ; 22(1): 492, 2022 Dec 16.
Artigo em Inglês | MEDLINE | ID: mdl-36522705

RESUMO

BACKGROUND: The goal of this work is to assess progression of diabetic macular edema (DME) following intravitreal ranibizumab injection compared to subtenon triamcinolone acetonide injection at cataract operation. METHODS: Retrospective analysis of 73 eyes of 65 participant with DME, with central macular thickness (CMT) ≥ 300 µm. The included eyes were separated into three groups; phacoemulsification with intravitreal Ranibizumab injection group, phacoemulsification with subtenon Triamcinolone acetonide injection group and phacoemulsification only group. Main measures involved best corrected visual acuity (BCVA) one week, one month and three months post-operative. The CMT was compared preoperative and postoperative (one and three months). RESULTS: After 1 month of operation, there was a statistical substantial distinction in the median of CMT between ranibizumab & control group (p < 0.001), between subtenon TA & control group (p < 0.001) and in ranibizumab and subtenon TA group (p = 0.023). After 3 months, the variance between ranibizumab & control group was considerable (p < 0.0001) and the variance between subtenon TA & control group was considerable (p = 0.030). CONCLUSIONS: Combined phacoemulsification with intravitreal injections of ranibizumab or subtenon triamcinolone acetonide may prevent further progression in CMT in individuals with DME following cataract operation.


Assuntos
Catarata , Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Ranibizumab/uso terapêutico , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Injeções Intravítreas , Estudos Retrospectivos , Acuidade Visual , Triancinolona Acetonida/uso terapêutico , Glucocorticoides/uso terapêutico , Catarata/complicações , Resultado do Tratamento
5.
Medicina (Kaunas) ; 58(11)2022 Nov 17.
Artigo em Inglês | MEDLINE | ID: mdl-36422204

RESUMO

Background and Objectives: The purpose of this study was to compare the effect of topical bromfenac and dexamethasone on the intraocular concentration of interleukin 6 (IL-6) and incidence of pseudophakic cystoid macular oedema (PCME) after cataract surgery in patients with non-proliferative diabetic retinopathy (NPDR). Materials and Methods: Ninety eyes of patients with mild-to-moderate NPDR that underwent phacoemulsification cataract surgery were divided into three groups. A detailed description of the clinical study protocol is described later in paper. In short, Group 1 received topical bromfenac (0.9 mg/mL), Group 2 dexamethasone (1 mg/mL), and Group 3 placebo, both preoperatively and postoperatively. Additionally, all patients received combined topical steroid and antibiotic drops (dexamethasone, neomycin and polymyxin B) 3 weeks postoperatively. On the day of the surgery, aqueous humour samples (0.1-0.2 mL) were obtained and IL-6 concentrations were analysed. Central foveal subfield thickness (CFT) measured using spectral-domain optical coherence tomography (SD-OCT) was analysed preoperatively and postoperatively. Results: There was no significant difference in IL-6 concentrations between groups. Postoperative CFT was significantly lower in the dexamethasone group compared to the placebo group. In addition, the correlation between IL-6 and CFT was statistically significant in the dexamethasone group. No patient developed PCME in any of the three groups. No adverse events were reported during the study. Conclusion: Topical bromfenac and dexamethasone have no significant effect on intraocular IL-6 concentration in patients with NPDR. Topical bromfenac is not more effective than topical dexamethasone in reducing postoperative CFT in patients with NPDR.


Assuntos
Catarata , Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Dexametasona/uso terapêutico , Retinopatia Diabética/complicações , Interleucina-6 , Edema Macular/etiologia , Edema Macular/prevenção & controle
6.
Cutan Ocul Toxicol ; 41(4): 310-317, 2022 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-36308286

RESUMO

PURPOSE: To evaluate the efficacy and safety of topical dexamethasone (DEX) eye drops in combination with a single perioperative subtenon triamcinolone acetonide (sTA) injection versus conventional topical DEX eye drops in the prevention of ocular inflammation and cystoid macular edema following cataract surgery. MATERIALS AND METHODS: Medical records of 245 eyes of 245 patients who underwent uncomplicated cataract surgery were analyzed in this retrospective controlled clinical study. Topical DEX eye drops were administered to 128 eyes routinely postoperatively, and 117 eyes were given a single dose of sTA (40 mg/ml) together with topical DEX eye drops for postoperative care. Postoperative topical antibiotic prophylaxis was applied to all eyes. The primary outcomes were anterior chamber (AC) cells and flare, central macular thickness (CMT), best corrected visual acuity (BCVA), and intraocular pressure (IOP) measurements on day 7, day 30, day 90, and day 180 following surgery. RESULTS: Although CMT increased in the DEX group, no increment was observed in the DEX + sTA treated group for all follow-up periods (on day 7 (+1.3 ± 18.6 and -8.7 ± 21.9 µm, p = 0.038), on day 30 (+20.5 ± 58.4 and -4.1 ± 25.2 µm, p = 0.009), on day 90 (+7.2 ± 19.9 and -5.7 ± 30.6 µm, p = 0.029), and on day 180 (+8.2 ± 22.6 and -6.4 ± 32.9 µm, p = 0.032)). There was no significant difference in terms of AC cells and flare between the two groups during the entire follow-up period (p > 0.05). Significant improvement in BCVA was observed in the DEX + sTA group at day 30 (p = 0.008). IOP differences were comparable, and both groups had high ocular tolerance. There were no severe adverse effects recorded. CONCLUSIONS: Topical DEX eye drops in combination with single dose perioperative injection of sTA have robust efficacy in preventing ocular inflammation and the development of cystoid macular edema following uncomplicated cataract surgery.


Assuntos
Catarata , Edema Macular , Humanos , Triancinolona Acetonida , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Soluções Oftálmicas/uso terapêutico , Estudos Retrospectivos , Glucocorticoides , Acuidade Visual , Dexametasona , Inflamação/tratamento farmacológico , Inflamação/prevenção & controle , Inflamação/induzido quimicamente , Catarata/induzido quimicamente , Resultado do Tratamento
7.
J Cataract Refract Surg ; 48(5): 555-563, 2022 05 01.
Artigo em Inglês | MEDLINE | ID: mdl-34417781

RESUMO

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema after cataract surgery in diabetic patients. SETTING: 7 ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective trial-based cost-effectiveness analysis using data from a European multicenter randomized clinical trial. METHODS: Diabetic patients (n = 163) undergoing uneventful cataract surgery were randomized to perioperative subconjunctival triamcinolone acetonide (n = 36), perioperative intravitreal bevacizumab (n = 36), combination treatment (n = 45), or no additional treatment (control group, n = 46). The cost analysis was performed from a healthcare perspective within a 12-week postoperative time horizon. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER; cost per QALY). RESULTS: The mean total healthcare costs and QALYs were as follows: triamcinolone group €1827 (U.S. dollars [$] 2295)/0.166; bevacizumab group €2050 ($2575)/0.144; combination group €2027 ($2546)/0.166; and control group €2041 ($2564)/0.156. Bevacizumab and control treatment were most costly and least effective. The ICER was €321 984 ($404 503) per QALY for the combination group compared with that of the triamcinolone group. Assuming the willingness-to-pay as €20 000 ($25 126) per QALY, the cost-effectiveness probability was 70% and 23% in the triamcinolone and combination groups, respectively. No patient who received triamcinolone developed clinically significant macular edema (CSME). A secondary cost-effectiveness analysis based on this outcome showed a clear preference for triamcinolone. CONCLUSIONS: In diabetic patients, subconjunctival triamcinolone was effective in preventing CSME after cataract surgery. The cost-effectiveness analysis showed that triamcinolone is also cost-effective.


Assuntos
Catarata , Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Bevacizumab/uso terapêutico , Catarata/complicações , Análise Custo-Benefício , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Glucocorticoides/uso terapêutico , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Estudos Prospectivos , Resultado do Tratamento , Triancinolona Acetonida/uso terapêutico , Acuidade Visual
8.
Eur J Ophthalmol ; 32(1): 205-212, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33726537

RESUMO

PURPOSE: To compare effect of topical Nepafenac versus intravitreal Ranibizumab on macular thickness after cataract surgery in diabetic patients with no preoperative macular edema. PATIENTS AND METHODS: A prospective randomized controlled study recruited diabetic patients with visually significant cataract and no diabetic macular edema (DME). Patient underwent uncomplicated phacoemulsification with IOL implantation and were randomly assigned to receive post-operative topical Nepafenac, intra-operative intravitreal Ranibizumab, or no prophylactic treatment. Changes in subfoveal and perifoveal macular thickness were assessed by SD-OCT. RESULTS: The mean central macular thickness showed a significant increase in all study groups 1 week and 1 month postoperative when compared to baseline. At 3 months postoperative, there was a significant difference between Nepafenac and Control group (p = 0.017), Ranibizumab and Control groups (p = 0.009) with no significant difference between Nepafenac and Ranibizumab group (p = 0.545) regarding CMT. Comparable results could be detected as regarding peri-foveal macular thickness changes. Concerning BCVA, there was a significant difference between topical Nepafenac/control (p = 0.001) and intravitreal Ranibizumab/control (p = 0.004) at 1-week visit. No significant difference in BCVA was observed between Nepafenac and Ranibizumab group throughout the whole study period. In postoperative visits, cystoid macular edema occurred in three patients (7.9%) in Nepafenac group, one patient (2.7%) in Ranibizumab group, and seven patients (17.07%) in control group. CONCLUSION: Both postoperative topical Nepafenac and intra-operative intra-vitreal Ranibizumab are effective adjunctive to phacoemulsification in diabetic patients for prophylaxis of macular edema.


Assuntos
Catarata , Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Anti-Inflamatórios não Esteroides/uso terapêutico , Benzenoacetamidas , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/tratamento farmacológico , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Fenilacetatos , Estudos Prospectivos , Ranibizumab/uso terapêutico , Tomografia de Coerência Óptica , Acuidade Visual
9.
Klin Monbl Augenheilkd ; 239(5): 702-708, 2022 May.
Artigo em Inglês, Alemão | MEDLINE | ID: mdl-34198349

RESUMO

BACKGROUND: Newly developed intraretinal cystoid changes after vitrectomy with membrane peeling for removal of epiretinal membranes have the potential to lead to worse postsurgical results compared to patients without. The aim of the present study was to evaluate the feasibility of additional periocular application of triamcinolone acetonide as a routine adjunct at the end of vitrectomy with membrane peeling, and to compare the presence of postsurgical intraretinal cystoid changes in the first 3 months after surgery among patients with idiopathic epiretinal membranes to a historical group of patients that did not receive triamcinolone acetonide. PATIENTS AND METHODS: The medical records of 41 eyes of 41 patients that underwent 23 G or 25 G pars plana vitrectomy with membrane peeling for removal of epiretinal membranes and additional periocular triamcinolone acetonide application at the end of surgery were retrospectively reviewed. Optical coherence tomography findings during routine follow-ups at 3 - 5 days, 1 month, and 3 months and visual acuity at 3 months after surgery were evaluated and compared to preoperative findings. Furthermore, postsurgical intraocular pressure was assessed. RESULTS: Periocular triamcinolone acetonide at the end of surgery was well tolerated among all patients. In total, 10% of patients had an increased intraocular pressure at least at one follow-up. Best-corrected visual acuity improved in 91% of patients with idiopathic epiretinal membranes with a mean improvement of + 3 ± 2 lines (Snellen) and was comparable to a historic group of patients (p = 0.307). Early transient macular edema could not be detected in any of the patients, while there were cases with this pathology in the historic group of patients, but neither occurrence of newly developed intraretinal cystoid changes nor macular thickness at 3 months after surgery were significantly different between patients with and without triamcinolone acetonide (p = 0.385 and p = 0.879). CONCLUSIONS: Periocularly applied triamcinolone acetonide at the end of vitrectomy with membrane peeling was well tolerated and showed prevention of early transient macular edema but did not prevent the development of new postoperative intraretinal cystoid changes.


Assuntos
Membrana Epirretiniana , Edema Macular , Edema , Membrana Epirretiniana/cirurgia , Glucocorticoides/uso terapêutico , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Estudos Retrospectivos , Tomografia de Coerência Óptica , Triancinolona Acetonida/uso terapêutico , Vitrectomia/métodos
10.
Curr Opin Ophthalmol ; 32(6): 590-598, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34419979

RESUMO

PURPOSE OF REVIEW: The use of intravitreous antivascular endothelial growth factor to prevent center-involved diabetic macular edema (CI-DME) with vision loss and proliferative diabetic retinopathy (PDR) has been investigated and recently reported in two randomized clinical trials. Although both trials showed substantial superiority of aflibercept at preventing the development of vision-threatening complications (VTCs) of CI-DME or PDR compared with sham at 1 or 2 years, without a concomitant benefit in visual acuity outcomes, the interpretation of the results and its application to clinical practice resulted in two disparate opinions. In this review, we discuss these two trials including their similarities and differences, other relevant studies, and considerations regarding the interpretation and the application of these results into clinical practice. RECENT FINDINGS: The Diabetic Retinopathy Clinical Research Retina Network Protocol W and the PANORAMA study demonstrated significantly lower probabilities of developing CI-DME or PDR at 2 years with intravitreous aflibercept compared with sham in eyes with moderate (Protocol W) or moderately severe (PANORAMA) to severe non-PDR (NPDR). However, visual acuity outcomes were not different. SUMMARY: Although intravitreous aflibercept injections reduce the risk of VTCs in eyes with moderate-to-severe NPDR, the absence of visual acuity benefits supports the need for four-year results.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Inibidores da Angiogênese/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/tratamento farmacológico , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Ranibizumab/uso terapêutico , Retina , Literatura de Revisão como Assunto , Fator A de Crescimento do Endotélio Vascular
11.
Zhonghua Yan Ke Za Zhi ; 57(7): 546-551, 2021 Jul 11.
Artigo em Chinês | MEDLINE | ID: mdl-34256476

RESUMO

Cataract surgery can increase the risk of diabetic macular edema (DME) and Irvine-Gass syndrome postoperatively in nonproliferative diabetic retinopathy (NPDR) patients. An accurate distinction between DME and Irvine-Gass syndrome in NPDR patients after cataract surgery is significantly important for the selection of subsequent treatment plans and guarantee of long-term vision quality. This article elaborates the differential diagnosis and prevention of DME, in order to provide a theoretical basis for the timely prevention, accurate diagnosis and standardized treatment of DME in NPDR patients after cataract surgery. (Chin J Ophthalmol, 2021, 57: 546-551).


Assuntos
Extração de Catarata , Catarata , Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Retinopatia Diabética/diagnóstico , Diagnóstico Diferencial , Humanos , Edema Macular/diagnóstico , Edema Macular/etiologia , Edema Macular/prevenção & controle
12.
Sci Rep ; 11(1): 8303, 2021 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-33859243

RESUMO

Macular edema (ME) is the most frequent vision threatening consequence after retinal vein occlusion (RVO). In this study, we evaluate the effect of dexamethasone intravitreal implants (DII, Ozurdex) in a real-life cohort of 99 patients with ME due to RVO. All patients who received DII for ME following RVO between 2011 and 2016 at the University Eye Hospital Freiburg, Germany and who had fully accessible electronic medical records were eligible for this study. Most of the patients included in this study were not treatment-naïve: 61 eyes had received prior anti-VEGF drugs, 6 eyes had received intravitreal corticosteroids (triamcinolone) and 15 had been treated with both; 17 eyes were treatment-naïve. Mean follow-up was 312 ± 310 days. Mean visual acuity (VA) was maintained throughout the observation period (mean VA at baseline: 66.7 ± 23.5 letters; at last observation 64.9 ± 28.3). Central retinal thickness (CRT) decreased from 526 ± 179 µm at baseline to 431 ± 199 µm. Mean intraocular pressure (IOP) increased from 14.4 ± 3.1 mmHg at baseline to 17.1 ± 6.3 mmHg. Cataract surgery was performed in 22% of phakic eyes. DII was used as second-line treatment in the majority of cases in this cohort. The fact that mean VA remained unchanged while mean CRT decreased illustrates that morphologic improvement does not always translate into functional gain. Mean IOP was maintained within normal limits and cataract formation was as expected in this age group.


Assuntos
Dexametasona/administração & dosagem , Implantes de Medicamento/administração & dosagem , Edema Macular/tratamento farmacológico , Oclusão da Veia Retiniana/tratamento farmacológico , Vias de Administração de Medicamentos , Feminino , Seguimentos , Humanos , Edema Macular/etiologia , Edema Macular/prevenção & controle , Masculino , Oclusão da Veia Retiniana/complicações , Estudos Retrospectivos , Fatores de Tempo , Resultado do Tratamento
13.
JAMA Ophthalmol ; 139(7): 701-712, 2021 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-33784735

RESUMO

IMPORTANCE: The role of anti-vascular endothelial growth factor injections for the management of nonproliferative diabetic retinopathy (NPDR) without center-involved diabetic macular edema (CI-DME) has not been clearly established. OBJECTIVE: To determine the efficacy of intravitreous aflibercept injections compared with sham treatment in preventing potentially vision-threatening complications in eyes with moderate to severe NPDR. DESIGN, SETTING, AND PARTICIPANTS: Data for this study were collected between January 15, 2016, and May 28, 2020, from the ongoing DRCR Retina Network Protocol W randomized clinical trial, conducted at 64 US and Canadian sites among 328 adults (399 eyes) with moderate to severe NPDR (Early Treatment Diabetic Retinopathy Study severity level, 43-53), without CI-DME. Analyses followed the intent-to-treat principle. INTERVENTIONS: Eyes were randomly assigned to 2.0 mg of aflibercept injections (n = 200) or sham (n = 199) given at baseline; 1, 2, and 4 months; and every 4 months through 2 years. Between 2 and 4 years, treatment was deferred if the eye had mild NPDR or better. Aflibercept was administered in both groups if CI-DME with vision loss (≥10 letters at 1 visit or 5-9 letters at 2 consecutive visits) or high-risk proliferative diabetic retinopathy (PDR) developed. MAIN OUTCOMES AND MEASURES: Development of CI-DME with vision loss or PDR through May 2020, when the last 2-year visit was completed. RESULTS: Among the 328 participants (57.6% men [230 of 399 eyes]; mean [SD] age, 56 [11] years), the 2-year cumulative probability of developing CI-DME with vision loss or PDR was 16.3% with aflibercept vs 43.5% with sham. The overall hazard ratio for either outcome was 0.32 (97.5% CI, 0.21-0.50; P < .001), favoring aflibercept. The 2-year cumulative probability of developing PDR was 13.5% in the aflibercept group vs 33.2% in the sham group, and the 2-year cumulative probability of developing CI-DME with vision loss was 4.1% in the aflibercept group vs 14.8% in the sham group. The mean (SD) change in visual acuity from baseline to 2 years was -0.9 (5.8) letters with aflibercept and -2.0 (6.1) letters with sham (adjusted mean difference, 0.5 letters [97.5% CI, -1.0 to 1.9 letters]; P = .47). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, among eyes with moderate to severe NPDR, the proportion of eyes that developed PDR or vision-reducing CI-DME was lower with periodic aflibercept compared with sham treatment. However, through 2 years, preventive treatment did not confer visual acuity benefit compared with observation plus treatment with aflibercept only after development of PDR or vision-reducing CI-DME. The 4-year results will be important to assess longer-term visual acuity outcomes. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02634333.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Adulto , Inibidores da Angiogênese/uso terapêutico , Canadá , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Feminino , Humanos , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Ranibizumab/uso terapêutico , Fator A de Crescimento do Endotélio Vascular
14.
Exp Eye Res ; 204: 108453, 2021 03.
Artigo em Inglês | MEDLINE | ID: mdl-33503450

RESUMO

Retinal vein occlusion (RVO) is an intractable eye disease that results in reduced visual acuity, associated with retinal ischemia, hemorrhage, and edema. RVO results in excessive ROS production in the retina, causing inflammation and retinal edema. A free radical scavenger, 4-(4-acetylpiperazin-1-yl)-2-(1H-imidazole-1-yl) aniline (NSP-116), has been reported to demonstrate antioxidative effects and prevent ROS production in the retina. Therefore, NSP-116 may represent a useful drug for treating the pathological symptoms of RVO, such as retinal edema and ischemic symptoms. This study aimed to investigate the effects of NSP-116 in a murine model of RVO. We evaluated the thickness of the retinal layer and the size of the non-perfused area following the oral administration of NSP-116. Moreover, we used western blot analysis to examine the expression levels of vascular endothelial growth factor (VEGF) and tumor necrosis factor (TNF)-α, after NSP-116 administration, and examined the localization of 8-hydroxy-2'-deoxyguanosine (8-OHdG), by immunostaining. The findings indicate that NSP-116 suppressed retinal edema and expansion the non-perfused area by suppressing the increased expression of VEGF, TNF-α, and 8-OHdG in the murine RVO model. In conclusion, the oral administration of NSP-116 may serve as an effective pharmacological treatment for the pathological symptoms of RVO.


Assuntos
Compostos de Anilina/uso terapêutico , Modelos Animais de Doenças , Sequestradores de Radicais Livres/uso terapêutico , Imidazóis/uso terapêutico , Oclusão da Veia Retiniana/prevenção & controle , 8-Hidroxi-2'-Desoxiguanosina/metabolismo , Administração Oral , Animais , Western Blotting , Angiofluoresceinografia , Edema Macular/diagnóstico por imagem , Edema Macular/metabolismo , Edema Macular/fisiopatologia , Edema Macular/prevenção & controle , Camundongos , Fluxo Sanguíneo Regional/fisiologia , Oclusão da Veia Retiniana/diagnóstico por imagem , Oclusão da Veia Retiniana/metabolismo , Oclusão da Veia Retiniana/fisiopatologia , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular/metabolismo
15.
J Cataract Refract Surg ; 47(3): 331-339, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33009281

RESUMO

PURPOSE: To investigate the cost-effectiveness of prophylactic treatments against cystoid macular edema (CME) after cataract surgery in patients without diabetes. SETTING: Seven ophthalmology clinics in the Netherlands and Belgium. DESIGN: Prospective cost-effectiveness analysis using data from a European multicenter randomized clinical trial (ESCRS PREMED). METHODS: Patients without diabetes planned for expected uneventful cataract surgery were randomized to topical bromfenac (Yellox, n = 242), topical dexamethasone (n = 242), or a combination treatment (n = 238). All relevant resources from a healthcare perspective were included in the cost analysis within a time horizon of 12 weeks postoperatively. The main effectiveness outcome was quality-adjusted life years (QALYs). The main cost-effectiveness outcome was the incremental cost-effectiveness ratio (ICER) based on the cost per QALY. RESULTS: The study comprised 722 patients without diabetes. Total healthcare costs and QALYs were € 447 (US $562) and 0.174 in the bromfenac group, €421 (US $529) and 0.179 in the dexamethasone group, and €442 (US $565) and 0.182 in the combination group. Bromfenac was most costly and least effective (ie, strongly dominated). The ICER was €6544 (US $8221) per QALY for the combination group compared with the dexamethasone group. Assuming that the willingness to pay is € 20 000 (US $25 126) per QALY, the cost-effectiveness probability was 3%, 32%, and 65% in the bromfenac, dexamethasone, and combination groups, respectively. CONCLUSIONS: In patients without diabetes, combination treatment with topical bromfenac and dexamethasone was effective and cost-effective in preventing CME after cataract surgery compared with treatment with either drug alone.


Assuntos
Catarata , Diabetes Mellitus , Edema Macular , Análise Custo-Benefício , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/prevenção & controle , Países Baixos , Estudos Prospectivos
16.
Curr Opin Ophthalmol ; 32 Suppl 1: S1-S12, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33273209

RESUMO

PURPOSE OF REVIEW: Advances in pharmacology offer freedom from topical medical therapy without compromise of anti-inflammatory and antimicrobial coverage in the perioperative period. In this review, we describe the basis for dropless cataract surgery with the goal of improving outcomes and the patient experience. RECENT FINDINGS: Phacoemulsification outcomes depend largely on surgeon skill but also on adherence to a complex multidrug regimen of perioperative anti-inflammatory and antimicrobial therapy to prevent sight-threatening complications such as cystoid macular edema or endophthalmitis. Successful administration of this regimen can be limited by noncompliance, difficulty administering eye drops, bioavailability, and side effects, among others. The recent development of sustained-release formulations of dexamethasone - one an intracanalicular insert and the other an intraocular suspension - can provide sustained tapering doses of dexamethasone while reducing or eliminating the need for anti-inflammatory eye drop therapy. Similarly, mounting evidence compellingly demonstrates that intracameral antibiotic use intraoperatively is at least as effective as topical antibiotics in preventing endophthalmitis. SUMMARY: Sustained-release dexamethasone coupled with intracameral antibiotics at the time of phacoemulsification can provide antimicrobial and anti-inflammatory prophylaxis without the need for topical eye drop medications. This approach has the potential to improve compliance with therapy, visual acuity outcomes, and the overall patient experience.


Assuntos
Antibacterianos/administração & dosagem , Dexametasona/administração & dosagem , Glucocorticoides/administração & dosagem , Satisfação do Paciente/estatística & dados numéricos , Facoemulsificação/métodos , Complicações Pós-Operatórias/prevenção & controle , Preparações de Ação Retardada , Endoftalmite/prevenção & controle , Humanos , Edema Macular/tratamento farmacológico , Edema Macular/prevenção & controle , Corpo Vítreo/efeitos dos fármacos
17.
Eur J Ophthalmol ; 31(3): 1216-1224, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-32530705

RESUMO

PURPOSE: We aimed to perform a systematic literature search on the latest evidence of the role of statin in reducing diabetic retinopathy and its need for intervention. METHODS: A comprehensive search on cohort studies/clinical trials that assess statins and diabetic retinopathy up until August 2019 was performed. The outcome measured was the incidence of diabetic retinopathy and its need for intervention. RESULTS: There were 558.177 patients from six studies. Statin was associated with a lower incidence of diabetic retinopathy (hazard ratio: 0.68 (0.55, 0.84), p < 0.001; I2: 95%). For the subtypes of diabetic retinopathy, statin lowers the incidence of proliferative diabetic retinopathy (hazard ratio: 0.69 (0.51, 0.93), p = 0.01; I2: 90%), non-proliferative diabetic retinopathy (hazard ratio: 0.80 (0.66, 0.96), p = 0.02; I2: 93%), and diabetic macular edema (hazard ratio: 0.56 (0.39, 0.80), p = 0.002; I2: 82%). Statin was associated with a reduced need for retinal laser treatment with a hazard ratio of 0.70 (0.64, 0.76) (p < 0.001; I2: 0%), intravitreal injection with a hazard ratio of 0.82 (0.79, 0.85) (p < 0.001; I2: 0%), and vitrectomy with a hazard ratio of 0.64 (0.48, 0.85) (p < 0.001; I2: 75%). Overall, statin was associated with a reduced need for intervention for diabetic retinopathy with a hazard ratio of 0.72 (0.64, 0.80) (p < 0.001; I2: 73%). The regression-based Egger's test showed statistically significant small-study effects for non-proliferative diabetic retinopathy (p = 0.011) outcomes. CONCLUSION: Statin was associated with a decreased risk of diabetic retinopathy and its subtypes. Statin also reduced the need for intervention with retinal laser treatment, intravitreal injection, and vitrectomy.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Inibidores de Hidroximetilglutaril-CoA Redutases , Edema Macular , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/epidemiologia , Retinopatia Diabética/prevenção & controle , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/uso terapêutico , Incidência , Injeções Intravítreas , Edema Macular/tratamento farmacológico , Edema Macular/epidemiologia , Edema Macular/prevenção & controle , Vitrectomia
18.
Ophthalmic Surg Lasers Imaging Retina ; 51(3): 170-178, 2020 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-32211907

RESUMO

BACKGROUND AND OBJECTIVE: To determine the safety and efficacy of intravitreal aflibercept injection (IAI) in patients with diabetic retinopathy (DR) in the prevention of macular edema (ME) following cataract surgery. PATIENTS AND METHODS: This phase 2, prospective, interventional, single-masked, randomized trial at a single academic center included 30 patients who were 18 years of age or older with nonproliferative DR and undergoing cataract surgery with phacoemulsification. Patients received 2 mg intravitreal aflibercept (0.05 mL) or sham injection during cataract surgery. Main outcome measures included treatment adverse events (AEs), best-corrected visual acuity (BCVA), and incidence of ME (defined as presence of cystoid abnormalities as detected by optical coherence tomography at any follow-up visit), a 30% or greater increase from preoperative baseline in central subfield macular thickness, or a BCVA decrease of more than 5 ETDRS letters from Day 7 due to retinal thickening. RESULTS: There were similar incidences of AEs between the two groups and no clinically serious ocular AEs in either group. The IAI group had fewer ME events at Day 14 (13% vs. 53%; P = .022), but there was no significant difference in ME events at Day 30 (27% vs. 60%; P = .057), Day 60 (27% vs. 60%; P = .057), or Day 90 (40% vs. 67%; P = .161). Compared to the study group, the control group had a significantly greater increase in central subfield thickness (CST) at Day 30 (50.05 µm vs. 7.95 µm; P = .040) and Day 60 (56.45 µm vs. 3.02 µm; P = .010). However, the difference in CST between groups was no longer significant at Day 90 (50.31 µm vs. 18.48 µm; P = .12). There were no significant differences in BCVA gains between the IAI and sham group at the end of the follow-up period (Day 90, ETDRS letters: 9.88 vs. 8.52; P = .66). CONCLUSIONS: Use of IAI in patients with DR for prevention of ME following cataract surgery showed no significant AEs. Although there were significant differences in ME incidence and retinal thickness at periods of time, there was no clinically meaningful benefit in terms of VA. Further larger trials are needed to validate these findings. [Ophthalmic Surg Lasers Imaging Retina. 2020;51:170-178.].


Assuntos
Extração de Catarata , Catarata/complicações , Retinopatia Diabética/complicações , Edema Macular/prevenção & controle , Cuidados Pré-Operatórios/métodos , Receptores de Fatores de Crescimento do Endotélio Vascular/administração & dosagem , Proteínas Recombinantes de Fusão/administração & dosagem , Idoso , Idoso de 80 Anos ou mais , Inibidores da Angiogênese/administração & dosagem , Retinopatia Diabética/diagnóstico , Feminino , Angiofluoresceinografia , Seguimentos , Fundo de Olho , Humanos , Injeções Intravítreas , Macula Lutea/patologia , Edema Macular/diagnóstico , Edema Macular/etiologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Receptores de Fatores de Crescimento do Endotélio Vascular/antagonistas & inibidores , Método Simples-Cego , Tomografia de Coerência Óptica , Resultado do Tratamento , Acuidade Visual
19.
J Cataract Refract Surg ; 46(3): 350-354, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32142038

RESUMO

PURPOSE: To determine the rate of postoperative cystoid macular edema (CME) in patients undergoing cataract surgery treated with intraoperative intracameral and postoperative topical nonsteroidal antiinflammatory drugs (NSAIDs) without steroids. SETTING: Academic outpatient surgery center Wake Forest Baptist Health in Bermuda Run, NC. DESIGN: Retrospective cohort study. METHODS: A retrospective chart review was performed. Patients were identified through a medical record search tool using criteria of the Current Procedural Terminology code (66984), a single surgeon, and a date range from January 1, 2016, through December 31, 2017. Medical records were reviewed to determine intraoperative and postoperative medication regimen, visual outcome, and development of postoperative CME. Patients with a history of uveitis, diabetic macular edema, retinal vein occlusions, epiretinal membranes, vitreomacular traction, or any prior macular edema were excluded. In addition, any patients with less than 6 weeks of postoperative follow-up were excluded. RESULTS: Overall, 824 patient records were reviewed, and the analysis included 504 eyes. Of these, 2 eyes developed postoperative CME (rate = 0.40%, 95% CI 0.0005 to 0.0143). CONCLUSIONS: The rate of CME in patients treated with intraoperative and postoperative NSAIDs without steroids was low and below the historical rates derived from a literature review of CME development with the use of steroids.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Edema Macular/epidemiologia , Facoemulsificação , Complicações Pós-Operatórias/epidemiologia , Pseudofacia/etiologia , Administração Oftálmica , Adulto , Idoso , Idoso de 80 Anos ou mais , Benzofenonas/uso terapêutico , Bromobenzenos/uso terapêutico , Feminino , Humanos , Cuidados Intraoperatórios , Cetorolaco/uso terapêutico , Edema Macular/prevenção & controle , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas , Fenilefrina/uso terapêutico , Cuidados Pós-Operatórios , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Acuidade Visual
20.
Korean J Ophthalmol ; 34(1): 46-55, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32037749

RESUMO

PURPOSE: To investigate the effect of 0.1% bromfenac sodium hydrate ophthalmic solution for prevention of macular edema after cataract surgery in patients with diabetes. METHODS: A retrospective analysis of 75 patients with diabetes who underwent cataract surgery was performed. Thirty-eight patients (52 eyes) were instilled with 0.1% bromfenac solution (bromfenac group) and 37 patients (46 eyes) were not (control group). RESULTS: There were no significant preoperative between-group differences. Compared to the control group, at 1 month after surgery, the bromfenac group showed slightly better best-corrected visual acuity (0.12 ± 0.12 vs. 0.32 ± 0.42, p = 0.142), lower central macular thickness (265.58 ± 31.28 vs. 314.15 ± 76.11 µm, p < 0.001), and lower macular volume (8.46 ± 0.60 vs. 9.14 ± 1.53 mm³, p = 0.022). There were no significant differences between the two groups at 4 and 6 months postoperatively (p > 0.05). Mean changes in central macular thickness showed significant differences at 1 and 4 months postoperatively (-1.44 ± 11.72 and 10.44 ± 22.48 µm in bromfenac group vs. 47.19 ± 70.24 and 31.69 ± 48.04 µm in control group, p < 0.001 and p = 0.016) and mean changes in macular volume showed a significant difference at 1 month postoperatively (-0.08 ± 0.47 mm³ in bromfenac group vs. 0.58 ± 1.28 mm³ in control group, p < 0.001). There were no significant differences thereafter (p > 0.05). CONCLUSIONS: Treatment with 0.1% bromfenac sodium hydrate ophthalmic solution showed good efficacy for preventing cystoid macular edema early after cataract surgery in patients with diabetes.


Assuntos
Benzofenonas/administração & dosagem , Bromobenzenos/administração & dosagem , Extração de Catarata , Catarata/complicações , Retinopatia Diabética/tratamento farmacológico , Edema Macular/prevenção & controle , Acuidade Visual , Anti-Inflamatórios não Esteroides/administração & dosagem , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Humanos , Edema Macular/diagnóstico , Edema Macular/etiologia , Masculino , Pessoa de Meia-Idade , Soluções Oftálmicas/administração & dosagem , Período Pós-Operatório , Estudos Retrospectivos , Tomografia de Coerência Óptica/métodos , Resultado do Tratamento
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