Browsing by Author "Dutra-Medeiros, M"
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- Dexamethasone Intravitreal Implant (Ozurdex) in Diabetic Macular Edema: Real-World Data Versus Clinical Trials OutcomesPublication . Neves, P; Matias, I; Rodrigues, J; Santos, M; Dutra-Medeiros, M; Martins, DAim: To investigate the safety and efficacy of intravitreal dexamethasone implants (Ozurdex®/DEX) in patients with diabetic macular edema (DME) either naïve or non-naïve to anti-VEGF therapies who switched to DEX implant independent of response to anti-vascular endothelial growth factors (anti-VEGFs). Methods: This was an audit retrospective review of medical records of patients with DME who switched to the DEX intravitreal implant. Patients were divided into 2 groups: patients naïve to antiangiogenic therapy and patients who were previously treated with anti-VEGFs. Data regarding demographics, changes in mean best-corrected visual acuity (BCVA), central macular thickness (CMT), and intraocular pressure (IOP) was collected over 6mo. The demographic data mean changes in BCVA, CMT, and IOP were compared. Six-month follow-up data of 47 patients (57 eyes), who either switched to DEX implant irrespective of response to previous treatments or were treatment naïve before receiving DEX implant, was collected. Results: Improvement in mean BCVA was observed from 1-4mo after injection with a decreased effect at month 6 as expected, with better outcomes in naïve compared to non-naïve patients. A statistically relevant decrease in mean CMT was observed during the follow-up period. An increase in mean IOP was observed in the first 2mo after DEX therapy. The mean number of injections of the overall population during the 6mo was 1.3. A subgroup analysis showed no relevant difference between phakic versus pseudophakic patients relative to measured outcomes. There was no cataract progression during the follow-up period and no adverse events reported. Conclusion: This real-life setting study shows that intravitreal DEX implant is effective and safe. The timings of greater therapeutic impact are concordant with previous studies and suggest that earlier treatment with corticosteroids may have an additional benefit in naïve patients.
- Effectiveness of the Dexamethasone Intravitreal Implant for Treatment of Patients with Diabetic Macular OedemaPublication . Dutra-Medeiros, M; Alkabes, M; Nucci, PDiabetic macular oedema (DMO) is a leading cause of vision loss in the working-age population worldwide. Corticosteroid drugs have been demonstrated to inhibit the expression of both the vascular endothelial growth factor (VEGF) gene and other anti-inflammatory mediators, such as prostaglandins. Triamcinolone, fluocinolone and dexamethasone are the main steroids that have been studied for the treatment of macular oedema. Over the last few years, several studies have suggested an important role for dexamethasone in the management of DMO. The dexamethasone intravitreal implant (DEX implant) (Ozurdex®; Allergan, Inc., Irvine, CA) is a novel approach approved by the US Food and Drug Administration (FDA) and by the EU for the intravitreal treatment of macular oedema after branch or central retinal vein occlusion, and for the treatment of non-infectious uveitis affecting the posterior segment of the eye. We reviewed manuscripts that had investigated the pharmacokinetics, efficacy and safety of the DEX implant regarding DMO treatment.
- First Diabetic Retinopathy Prevalence Study in Portugal: RETINODIAB Study-Evaluation of the Screening Programme for Lisbon and Tagus Valley RegionPublication . Dutra-Medeiros, M; Mesquita, E; Papoila, AL; Genro, V; Raposo, JBACKGROUND/AIMS: In Portugal, so far, there is no study or even accurate data on the prevalence of diabetic retinopathy (DR), based on a large representative sample and on a long-term follow-up. The objective of our study was to determine the prevalence of DR based on a national screening community-based programme. METHODS: A 5-year retrospective analysis of the RETINODIAB screening programme results was implemented in Lisbon and Tagus Valley area between July 2009 and October 2014. We estimated the prevalence of retinopathy for all patients with type 2 diabetes and studied the association between known risk factors and retinopathy emergence at their first screening. RESULTS: Throughout this period, from a total of 103 102 DR readable screening examinations, 52 739 corresponded to patients who attended RETINODIAB screening at entry. Globally, DR was detected in 8584 patients (16.3%). Of these, 5484 patients (10.4%) had mild non-proliferative (NP) DR, 1457 patients (2.8%) had moderate NPDR and 672 (1.3%) had severe NPDR. Finally, 971 patients (1.8%) had proliferative DR requiring urgent referral to an ophthalmologist. The presence of any DR, non-referable DR or referable DR was strongly associated with increasing duration of diabetes and earlier age at diagnosis. CONCLUSIONS: The prevalence rate of DR in our study (16.3%) was slightly lower than other published international data. The RETINODIAB network proved to be an effective screening programme as it improved DR screening in Lisbon and Tagus Valley surrounding area
- Reliability of Classification by Ophthalmologists with Telescreening Fundus Images for Diabetic Retinopathy and Image QualityPublication . Rêgo, S; Dutra-Medeiros, M; Bacelar-Silva, GM; Borges, T; Soares, F; Monteiro-Soares, M
- Screening for Diabetic Retinopathy Using an Automated Diagnostic System Based on Deep Learning: Diagnostic Accuracy AssessmentPublication . Rêgo, S; Dutra-Medeiros, M; Soares, F; Monteiro-Soares, MPurpose: To evaluate the diagnostic accuracy of a diagnostic system software for the automated screening of diabetic retinopathy (DR) on digital colour fundus photographs, the 2019 Convolutional Neural Network (CNN) model with Inception-V3. Methods: In this cross-sectional study, 295 fundus images were analysed by the CNN model and compared to a panel of ophthalmologists. Images were obtained from a dataset acquired within a screening programme. Diagnostic accuracy measures and respective 95% CI were calculated. Results: The sensitivity and specificity of the CNN model in diagnosing referable DR was 81% (95% CI 66-90%) and 97% (95% CI 95-99%), respectively. Positive predictive value was 86% (95% CI 72-94%) and negative predictive value 96% (95% CI 93-98%). The positive likelihood ratio was 33 (95% CI 15-75) and the negative was 0.20 (95% CI 0.11-0.35). Its clinical impact is demonstrated by the change observed in the pre-test probability of referable DR (assuming a prevalence of 16%) to a post-test probability for a positive test result of 86% and for a negative test result of 4%. Conclusion: A CNN model negative test result safely excludes DR, and its use may significantly reduce the burden of ophthalmologists at reading centres.
- The Challenges of Setting Up a Clinical Study with the New European Union Medical Device RegulationPublication . Rêgo, S; Dutra-Medeiros, M; Nunes, F
- Torpedo Maculopathy with an Anisometropic Amblyopia in a 5-Year-Old Caucasian Girl: Case ReportPublication . Dutra-Medeiros, M; Leitão, P; Magriço, A; Toscano, AThe aim of this study is to report a clinical case of asymptomatic female Caucasian children with torpedo maculopathy. A 5-year-old girl was referred to our clinic for routine evaluation. The ophthalmic examination revealed best-corrected visual acuity of 20/20 in both eyes, without any changes in the biomicroscopy. Fundus examination showed normal findings in one eye, whereas in the contralateral eye it disclosed, in the temporal sector of the macular region, a whitish, atrophic, oval chorioretinal lesion with clearly defined margins. Posterior evaluations documented the stability of the lesion. Torpedo maculopathy diagnosis is based on its characteristic shape and peculiar location. The differential diagnosis has to be established versus choroidal lesions (melanoma and nevus), congenital or iatrogenic hyperplasia of the retinal pigment epithelium (RPE) and particularly versus the congenital pigmented lesions associated with Gardner's syndrome.