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- Endogenous endophthalmitis secondary to erysipelasPublication . Costa, JF; Marques, JP; Marques, M; Quadrado, MJA 64-year-old woman with chronic right arm lymphoedema presented with progressive and painful vision loss in the right eye following diagnosis of erysipelas in the ipsilateral arm. Visual acuity was light perception. Biomicroscopy revealed marked conjunctival injection, decreased corneal transparency and an inflammatory mass in the anterior chamber, which precluded fundoscopy. The ocular ultrasonography features were consistent with acute endophthalmitis, and the patient was admitted to the hospital. A systemic evaluation, including complete physical examination, echocardiography and blood tests, ruled out other sources of infection besides the cutaneous site. Blood cultures were positive for group A Streptococcus. A diagnosis of unilateral acute endophthalmitis due to group A Streptococcus bacteraemia secondary to erysipelas was made and successfully treated with optimal medical care, including prompt intravitreal and systemic antibiotic administration. Despite resolution of the infectious process, visual acuity did not improve.
- Treatment of Retinal Vein Occlusion with Ranibizumab in Clinical Practice: Longer-Term Results and Predictive Factors of Functional OutcomePublication . Farinha, C; Marques, JP; Almeida, E; Baltar, A; Santos, AR; Melo, P; Costa, M; Figueira, J; Cachulo, ML; Pires, I; Silva, RTo evaluate long-term results and predictors of efficacy in patients with macular edema due to retinal vein occlusion (RVO) treated with intravitreal ranibizumab in a clinical practice setting.
- Long-Term Management of RAP Lesions in Clinical Practice: Treatment Efficacy and Predictors of Functional ImprovementPublication . Marques, MF; Marques, JP; Gil, J; Costa, J; Almeida, E; Cachulo, Mz; Pires, I; Figueira, J; Silva, RPURPOSE: To evaluate the long-term efficacy of ranibizumab in the treatment of retinal angiomatous proliferation (RAP) and to identify predictors of functional outcome. METHODS: Retrospective case series comprised 79 eyes of 68 consecutive patients with RAP followed up ≥36 months. Primary end-points were best-corrected visual acuity (BCVA) and central macular thickness (CMT) variation at 36 months and at the last visit. RESULTS: Mean follow-up time was 59.8 ± 16.0 months. All eyes were treated with pro re nata ranibizumab, with (n = 33) or without (n = 46) photodynamic therapy (PDT). Stabilization or improvement in BCVA was observed in 50.6% of the patients at 36 months, and in 40.5% at the end of the follow-up, where 20.3% preserved reading vision. A significant decrease in CMT was observed at 36 months (p < 0.001), but not at the end of the follow-up. Geographic atrophy (GA) was present in 59.5% of the eyes at the final visit. Baseline subretinal fluid was associated with better visual outcomes (p = 0.001). Results of combination treatment with intravitreal ranibizumab and PDT did not significantly differ from ranibizumab monotherapy. CONCLUSION: Modest functional outcomes can be expected from the long-term treatment of RAP lesions in clinical practice, most likely due to the advent of GA. Baseline subretinal fluid positively correlated with final BCVA.
- Visual and ocular motor function in the atypical form of neurodegeneration with brain iron accumulation type IPublication . Jesus-Ribeiro, J; Farinha, C; Amorim, M; Matos, A; Reis, A; Lemos, J; Castelo-Branco, M; Januário, CBACKGROUND/AIMS: Neurodegeneration with brain iron accumulation (NBIA) type I is a rare disease that can be divided into a classical or atypical variant, according to age of onset and clinical pattern. Neuro-ophthalmological involvement has been documented in the classical variant but only anecdotically in the atypical variant. We sought to describe the visual and ocular motor function in patients with atypical form of NBIA type I. METHODS: Cross-sectional study, including patients with genetically confirmed NBIA type I and classified as atypical variant, who underwent ophthalmological examination with best corrected visual acuity (BCVA), optical coherence tomography (OCT), fundus autofluorescence (FAF), electroretinography (ERG), visual evoked potentials (VEP) and video-oculography. RESULTS: Seven patients with a mean BCVA of 0.12±0.14 logMAR were included. Only two patients showed structural evidence of advanced retinopathy in OCT and FAF, and there were no cases of optic atrophy. ERG data, however, showed abnormal scotopic and/or photopic responses in all patients. VEP were normal in all three patients. Ocular fixation was markedly unstable (eg, increased rate of saccadic pulses) in the majority of patients (5). Additional mild ocular motor disturbances included low gain pursuit (2), hypermetric saccades (1), low gain optokinetic (2) and caloric and rotatory responses (3). CONCLUSION: Functional retinal changes associated with marked instability of ocular fixation should be included in the clinical spectrum of NBIA, particularly in the atypical form.
- Protocol for a randomised, double-masked, sham-controlled phase 4 study on the efficacy, safety and tolerability of intravitreal aflibercept monotherapy compared with aflibercept with adjunctive photodynamic therapy in polypoidal choroidal vasculopathy: the ATLANTIC studyPublication . Marques, JP; Farinha, C; Costa, MÂ; Ferrão, Â; Nunes, S; Silva, RPURPOSE: The purpose of this study is to compare the efficacy and safety of intravitreal aflibercept (IVA) with sham photodynamic therapy (sPDT) versus IVA with verteporfin PDT (vPDT) in a Caucasian population with treatment-naive polypoidal choroidal vasculopathy (PCV), enrolling into a treat and extend (T&E) regimen. METHODS AND ANALYSIS: Randomised, double-masked, sham-controlled, multicentre phase 4 investigator-driven clinical trial. The primary outcomes are (1) change in best-corrected visual acuity (BCVA) from baseline and (2) polyp regression at week 52, assessed by indocyanine green angiography (ICGA). Fifty patients with treatment-naive PCV will be recruited from Portuguese and Spanish clinical sites. Eligible patients will receive monthly IVA for 3 months (week 0, week 4 and week 8). At week 16, all patients will repeat ICGA and undergo central randomisation (1:1 ratio) into one of the following groups: Group 1-IVA T&E + vPDT; Group 2-IVA T&E + sPDT. PDT will be performed at week 16, week 28 and week 40 in the presence of active polyps. After week 16, the presence of macular fluid on optical coherence tomography will determine the schedule of observations. When present, the interval between visits/injections will decrease 2 weeks (minimum 6 weeks). When not, the interval between visits/injections will increase 2 weeks (maximum 12 weeks). Efficacy will be evaluated based on BCVA, central retinal thickness and polyp regression. Safety parameters will include assessment of intraocular pressure, adverse events and serious adverse events. ETHICS AND DISSEMINATION: This study was designed and shall be implemented and reported in accordance with the International Conference on Harmonisation (ICH) Harmonised Tripartite Guidelines for Good Clinical Practice, with applicable local regulations and with the ethical principles laid down in the Declaration of Helsinki. The study received approval from Comissão de Ética para a Investigação Clínica and Comité Ético de investigación Clínica del Hospital Universitari de Bellvitge. TRIAL REGISTRATION NUMBER: This study is registered under the EudraCT number: 2015-001368-20 and the ClinicalTrials.gov Identifier: NCT02495181.
- Retinopatia da Prematuridade numa Unidade de Cuidados Intensivos Neonatais: Experiência de Oito AnosPublication . Moinho, R; Morais, S; Monteiro, M; Mimoso, GIntrodução: A retinopatia da prematuridade ocorre por inadequada vascularização da retina dos recém-nascidos prematuros. É uma doença multifatorial, com risco inversamente proporcional à idade gestacional e ao peso de nascimento. Objetivos: Caracterizar uma amostra de prematuros com critérios de observação oftalmológica e identificar os principais fatores de risco de retinopatia da prematuridade. Métodos: Estudo descritivo de análise retrospetiva. Consulta dos processos dos prematuros internados de 2005 a 2012 com critérios de observação oftalmológica e colheita de dados demográficos, fatores de risco, observação oftalmológica, estadio da retinopatia e tratamento. Análise estatística: SPSS®v21, significância: p<0,05. Resultados: Obtiveram-se 343 prematuros, 54% do sexo masculino. A incidência de retinopatia foi 15,5%, grave em 2,6%. O grupo com retinopatia teve média de idade gestacional de 27,5±1,9 semanas e peso de nascimento de 937±264 gramas e o grupo sem retinopatia teve, respetivamente, 29,8±1,9 semanas e 1216 ± 277 gramas (p<0,001). Os fatores com diferença entre os dois grupos foram: oxigenoterapia (p<0,001), ventilação invasiva (p=0,003) e sua duração (p<0,001), surfactante (p<0,001), dificuldade respiratória (p<0,001), sépsis tardia (p=0,019), persistência do canal arterial (p<0,001) e seu tratamento médico (p<0,001). A regressão logística mostrou que a idade gestacional é o fator de risco com maior repercussão na ocorrência de retinopatia (OR:0,542). O grau máximo de retinopatia foi 3 com doença plus, tendo 8 prematuros sido submetidos a cirurgia. Discussão e conclusão: A incidência de retinopatia foi inferior a outros estudos. Confirma-se a importância de alguns fatores de risco, sendo a idade gestacional o fator mais determinante.
- A Nonrandomized, Open-Label, Multicenter, Phase 4 Pilot Study on the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (RESPOND)Publication . Figueira, J; Henriques, J; Amaro, M; Rosas, V; Alves, D; Cunha-Vaz, JPURPOSE: The aim of this study was to assess the effectiveness and safety of ILUVIEN® in patients with chronic diabetic macular edema (DME) who were insufficiently responsive to prior therapies. METHODS: This is a prospective, nonrandomized, multicenter, open-label, phase 4 pilot study assessing the effectiveness and safety of ILUVIEN® involving 12 patients insufficiently responsive to available therapies. Assessments were performed at screening, baseline, week 1, and months 1, 3, 6, 9, and 12. Demographics, medical/ophthalmic history, prior laser, anti-VEGF, and steroid treatments, and lab tests were recorded at screening. A complete ophthalmic examination and SD-OCT were performed at screening and at all follow-up visits. RESULTS: The patients showed improvements in best-corrected visual acuity (+3.7 letters), with greater improvement among pseudophakic patients (+6.8 letters) compared with phakic patients (-2.5 letters) 12 months after ILUVIEN®. The mean central subfield thickness decrease from baseline to month 12 was statistically significant, with a rapid reduction in the first week. Regarding safety, only 2 patients showed an intraocular pressure (IOP) increase over 25 mm Hg during the study, and the rise in IOP was well managed with eye drops only. CONCLUSIONS: This prospective and pilot study suggests that ILUVIEN® is safe and may be considered effective for chronic DME patients insufficiently responsive to other available therapies as it showed a rapid and sustained improvement of macular edema obtained after treatment with ILUVIEN®.
- Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgeryPublication . Labetoulle, M; Findl, O; Malecaze, F; Alió, J; Cochener, B; Lobo, C; Lazreg, S; Hartani, D; Colin, J; Tassignon, MJ; Behndig, ABACKGROUND/AIMS: To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen. METHODS: In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety. RESULTS: Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups. CONCLUSIONS: Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane. TRIAL REGISTRATION NUMBER: NCT02101359; Results.
- Comparison of diabetic retinopathy classification using fluorescein angiography and optical coherence tomography angiographyPublication . Soares, M; Neves, C; Marques, I; Pires, I; Schwartz, C; Costa, MÂ; Santos, T; Durbin, M; Cunha-Vaz, JPURPOSE: To analyse and compare the classification of eyes with diabetic retinopathy using fluorescein angiography (FA) and optical coherence tomography angiography (OCTA) performed either with AngioPlex or AngioVue. METHODS: This was an observational cross-sectional study of 50 eyes from 26 diabetic subjects. Two independent graders classified the FA angiograms, to assess the presence and severity of several characteristics according to the ETDRS Report 11, and a similar evaluation was performed for each 3×3 mm OCTA image from the superficial retinal layer and for the full retina slab. RESULTS: Percentages of non-gradable images for the outline of foveal avascular zone (FAZ) in the central subfield (CSF) were 29.0% for FA, 12.0% for AngioVue and 3.0% for AngioPlex. For capillary loss, percentages of non-gradable images in the CSF were 25.0% for FA, 11% for AngioVue and 0.0% for AngioPlex. For the inner ring (IR), percentages of non-gradable images were 12.5% for FA, 11.5% for AngioVue and 0.5% for AngioPlex. Agreement between graders was substantial for outline of FAZ. For capillary loss, the agreement was fair for the CSF, and moderate for the IR. CONCLUSIONS: The OCTA allows better discrimination of the CSF and parafoveal macular microvasculature than FA, especially for FAZ disruption and capillary dropout, without the need of an intravenous injection of fluorescein. In addition, FA had also a higher number of non-gradable images. The OCTA can replace with advantage the FA, as a non-invasive and more sensitive procedure for detailed morphological evaluation of central macular vascular changes. TRIAL REGISTRATION NUMBER: NCT02391558, Pre-results.
- Real-world outcomes of anti-VEGF treatment for retinal vein occlusion in PortugalPublication . Vaz-Pereira, S; Marques, I; Matias, JG; Mira, F; Ribeiro, L; Flores, RPURPOSE: Retinal vein occlusion (RVO) is an important cause of visual disability in the modern world. We aim to evaluate the real-world outcomes of patients with RVO treated with anti-vascular endothelial growth factor (VEGF) in Portugal. METHODS: We performed a retrospective, observational, multicenter study including 8 centers across Portugal and 200 patients treated with either ranibizumab or bevacizumab. Data were collected at 3 time points: time of diagnosis (0 time point) and 6 and 12 months after initiating treatment. Demographic and clinical data were collected. RESULTS: Median visual acuity (VA) and central macular thickness (CMT) improved in the branch RVO (BRVO), central RVO (CRVO), bevacizumab, and ranibizumab groups at 6 and 12 months compared to baseline, with CMT improving further only in the CRVO and ranibizumab groups between 6 and 12 months (p = 0.002 and p = 0.001, respectively). The CMT was lower in the ranibizumab group compared to the bevacizumab group both at 6 and 12 months (p<0.02). Median CMT improved in both the good and poor baseline VA groups at 6 and 12 months compared to baseline (p<0.001). Median VA only improved for the group with poor baseline VA at 6 and 12 months of follow-up (p<0.001). Regression analysis identified several baseline variables as predictors of visual outcomes at 6 and 12 months, with different results depending on the analyzed group. CONCLUSIONS: Both treatments were effective, although less effective than results reported in clinical trials. The morphologic response was better with ranibizumab compared to bevacizumab, although functionally there were no differences.