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- The Challenges of Setting Up a Clinical Study with the New European Union Medical Device Regulation.Publication . Rêgo, Sílvia; Dutra-Medeiros, Marco; Nunes, Francisco
- Predictive Factors of Long-Term Visual Outcomes After Primary Descemet's Membrane Endothelial Keratoplasty (DMEK): Retrospective Study.Publication . Moura-Coelho, Nuno; Papa-Vettorazzi, Renato; Dias-Santos, Arnaldo; Cunha, João Paulo; Dutra-Medeiros, Marco; Manero, Felicidad; Güell, José LuisPurpose: To determine predictive factors of higher levels of best-corrected visual acuity (BCVA) in the long-term after primary Descemet's membrane endothelial keratoplasty (DMEK). Methods: Retrospective, single-surgeon case series of 129 successful primary DMEK eyes without graft failure and with a minimum postoperative follow-up of 12 months. Mixed effect model for repeated measurements (MMRM) analysis was performed to determine recipient, donor, surgical and postoperative factors associated with BCVA ≤ 0.10 logMAR (≥ 20/25 Snellen). Results: After primary DMEK, there was a statistically significant improvement in BCVA with a global reduction in logMAR BCVA (p < 0.00001). There was also a global tendency towards increasing proportion of eyes with BCVA ≤ 0.10 logMAR at all time points (p < 0.00001), from 1.6% before DMEK to 64.4% in eyes with more than 5 years of F-U. Absence of retinal disease was associated with a decrease of 0.10 logMAR in postoperative BCVA after primary DMEK, maintaining constant the rest of variables (p < 0.001). The variables age (OR 0.960), postoperative time (OR 1.083), preoperative BCVA ≥ 0.375 logMAR (OR 0.162) and indication for DMEK (OR 5.412) were included in the predictive MMRM model of BCVA ≤ 0.10 logMAR. Conclusion: Primary DMEK is associated with statistically and clinically significant improvement in BCVA that occur early in the postoperative period and are continuous over time. Eyes with retinal comorbidities have increased risk of worse postoperative BCVA after DMEK. Younger recipient age, Fuchs' dystrophy eyes and eyes with better preoperative BCVA are more likely to achieve postoperative BCVA ≤ 0.10 logMAR.
- Inflammatory Biomarkers in Diabetic Macular Edema.Publication . Campos, António; Furtado, Maria João; Carneiro, Ângela; Meireles, Angelina; Neves, Carlos; Ambrósio, António Francisco; Leal, Inês; Figueira, João; Marques, João Pedro; Henriques, José; Falcão, Manuel; Gomes, Nuno; Flores, Rita; Silva, Rufino; Pessoa, BernardeteDiabetic retinopathy (DR) is a major complication of both Type 1 and Type 2 diabetes mellitus (T1DM and T2DM). Disease progression can result in visual impairment, primarily due to diabetic macular edema (DME) or proliferative diabetic retinopathy (PDR). Although several ocular treatments are available for DME, a subset of patients fails to respond, reflecting the multifactorial, complex, and systemic nature of DR. Inflammatory biomarkers can be classified according to different characteristics, including imaging biomarkers-most commonly assessed using optical coherence tomography (OCT)-and molecular biomarkers, which are defined by their biochemical and biophysical properties. Pro- and anti-inflammatory cytokines, chemokines, adipokines, and inflammation-related enzymes are recognized as key inflammatory biomarkers and can be detected in the vitreous humour, aqueous humour, tears, serum, and other biological tissues. The identification and characterization of reliable biomarkers may help determine disease severity, monitor disease progression, and predict the risk of specific outcomes, thereby aiding in the prevention of end-stage disease (prognostic biomarkers). In addition, biomarkers may serve as predictive tools for therapeutic response, guiding personalized treatment strategies and enabling ongoing monitoring. This review provides a comprehensive overview of the role of inflammatory biomarkers in the diagnosis and management of DR and DME.
- Short-Term Refractive and Safety Outcomes of Implantable Collamer Lens ImplantationPublication . Cunha, Bruna; Gil, Pedro; Lopes, Edgar; Hipólito-Fernandes, Diogo; Crisóstomo, Sara; Maduro, Vitor; Alves, Nuno; Feijão, JoãoINTRODUCTION: To evaluate the short-term visual and refractive outcomes of V4c-V5 implantable collamer lens implantation, and its safety profile in myopia and myopic astigmatism correction. METHODS: Retrospective unicentric observational study of patients with Implantable collamer lens implantation. Main outcome measures at 6 months were safety, efficacy, predictability, endothelial cell count loss, intraocular pressure variation and central vault. Adverse effects and complications were assessed. RESULTS: Eighty-five eyes of 48 patients were included in the study. Postoperative uncorrected distance visual acuity was 0.05±0.11, with an efficacy index of 1.03±0.22; the safety index was 1.10±0.20. Postoperative manifest spherical equivalent was within ±0.50 D of intended target in 8.8% of eyes, and within ±1.00 D in 94.5% of eyes. Mean endothelial cell density loss was 2.34%±11.43%. Despite being statistically significant, the increase in intraocular pressure of preoperative 12.82 to 14.3 mmHg postoperative was not clinically significant. Mean central vault was 524.06±185.71 μm. Two eyes underwent lens explantation due to high vault and postoperative inflammation, and one toric lens was exchanged due to significant axis misalignment. No cases of pupillary block, chronic hypertension, cataract or lens opacity were reported. CONCLUSION: Implantable collamer lens V4c-V5 implantation demonstrated good visual and refractive outcomes, with a favorable safety profile, for the correction of myopia and myopic astigmatism.
- Outcomes of Orbital Decompression Surgery for Thyroid Eye Disease: Clinical and Computed Tomography-Based AnalysisPublication . Guedes-Mota, Catarina; Brandão, Pedro; Maleita, Diogo; Magriço, Ana; Duarte, AnaINTRODUCTION: Orbital decompression surgery has been widely used in thyroid eye disease (TED). It is performed in the active stage, in sight-threatening cases of dysthyroid compressive optic neuropathy (DON), or severe corneal exposure unresponsive to steroids, and also during the quiescent phase to address proptosis. The purpose of this study is to analyze both clinical and imagiological outcomes of patients with TED who underwent orbital decompression. METHODS: A retrospective analysis of patients undergoing orbital decompression in Centro Hospitalar Universitário de Lisboa Central and Hospital Cuf Descobertas, between 2018 and 2021, was performed. Demographic and clinical data were collected. The procedures included lateral, inferior-medial, balanced (lateral and medial) and three-wall decompressions. Main clinical outcomes included best corrected visual acuity (BCVA), proptosis reduction and complications. A group of patients underwent orbital computed tomography (CT) scanning before and after surgery, and differences in globe displacement in the horizontal, vertical and anteroposterior planes were measured for each type of surgery. RESULTS: Forty-six orbits from 28 patients (18 females and 10 males) underwent decompression surgery. Mean age at time of surgery was 49.43 ± 11.63 years old. Orbital decompression was performed during the inactive phase in 19 patients (67.4%) and was required to treat sight-threatening active TED in 9 patients (32.6%). Lateral, inferior-medial, balanced and three-wall decompression were carried out in 12 (26.1%), 8 (17.4%), 14 (30.4%) and 12 (26.1%) orbits, respectively. From baseline, statistically significant improvements were observed after surgery in logMAR BCVA (p<0.05) and proptosis (p<0.001). Larger proptosis reduction occurred in three-wall decompression, followed by balanced decompression (p<0.001). New-onset strabismus occurred in 3 of the 28 patients (10.7%): 1 endoscopic inferior-medial decompression, 1 three-wall decompression with an endoscopic approach to the inferior and medial walls and 1 transorbital three-wall decompression. All the 3 cases presented DON non-reversible with high dose intravenous steroids. CONCLUSION: Orbital decompression is an effective procedure to address proptosis in TED, being also an important resource in cases of DON unresponsive to systemic steroids. The reduction in proptosis is associated with the number of orbital walls addressed. An individualized approach is crucial during surgical planning in TED cases
- Iridociliary Body Plasmacytoma: A Case-Report and a Focused Review of LiteraturePublication . Guedes-Mota, Catarina; Rebelo, Ana; Pinto Proença, Rita; Costa, Livio; Vieira, Luisa; Magriço, AnaExtramedullary plasmacytomas associated with multiple myeloma (MM) are rare, and involvement of the eye and adnexae is even rarer, with an incidence of less than 1%. We describe the case of a 56-year-old male, with a history of refractory MM and sacral plasmacytoma, who presented with reduced visual acuity and redness in the right eye. Biomicroscopy revealed an amelanotic temporal and inferotemporal iris mass, involving the anterior chamber angle from 6 to 10 o’clock, with intrinsic vascularization. A presumed diagnosis of iridociliary body plasmacytoma was established, which was later confirmed by fine-needle aspiration biopsy. The tumor responded well to immunochemotherapy, and the patient became asymptomatic. However, despite treatment efforts, the patient passed away shortly after due to widespread systemic MM progression with central nervous system (CNS) involvement. This case highlights the challenges associated with managing extramedullary disease and the need for further research and treatment strategies to address this aggressive manifestation of MM.
- Thickness Profile of the Ganglion Cell Complex and Choroid in Patients with Persistent Diabetic Macular Edema.Publication . Condelipes, Ana; Correia, Daniela; Fernandes, Inês; Silva, Tiago; Correia, Eduardo; Pereira, Bruno; Camacho, PedroPurpose: About 40 % of patients with diabetic macular edema (DME) do not respond optimally to first-line treatment with intravitreal injection of anti-vascular endothelial growth factor (AVEGF). Evidence suggests that additional vascular and neurodegenerative mechanisms may be involved. This study aimed to characterise the thickness of the Ganglion Cell Complex (GCC) and investigate the Choroidal Vascularity Index (CVI) in patients with different patterns of therapeutic response to AVEGF DME. Methods: This cross-sectional study included 27 diabetic patients into 3 different groups based on their response to AVEGF therapy: control group, responder DME group, and persistent DME group. The study's approach to vascular and neurodegenerative imaging biomarkers involved three steps: (1) Automatic quantification of GCC thickness, with manual correction when necessary; (2) Semi-automatic measurement of choroidal thickness; and (3) Analysis of choroidal area and choroidal luminal area using ImageJ software to calculate the CVI. Results: In the overall characterization of the sample, a significant difference was observed only in the Best Corrected Visual Acuity (BCVA). There was a significant difference in Average Retinal Thickness (1 mm, 3 mm, and 6 mm) between the 3 groups and in GCC thickness at 1 mm. BCVA was negatively correlated with mean retinal thickness, while CVI showed a potential positive correlation with BCVA. Conclusions: While demographic and general clinical characteristics showed minimal differences across the groups, important differences in GCC and choroidal characteristics were observed. GCC (1 mm) may be interesting to explore in predicting visual outcomes after treatment, and CVI may impact visual gain.
- A Review of Digital Eye Strain: Binocular Vision Anomalies, Ocular Surface Changes, and the Need for Objective Assessment.Publication . Barata, Maria João; Aguiar, Pedro; Grzybowski, Andrzej; Moreira-Rosário, André; Lança, Carla(1) Background: This study investigates the impact of digital device usage on the visual system, with a focus on binocular vision. It also highlights the importance of objective assessment in accurately diagnosing and guiding therapeutic approaches for Digital Eye Strain Syndrome (DESS). (2) Methods: A comprehensive narrative review was conducted to synthesize existing evidence. The methodological quality of observational and case-control studies was assessed using the Newcastle-Ottawa scale, while randomized controlled trials (RCTs) were evaluated using the Cochrane risk-of-bias (RoB 2) tool. (3) Results: Fifteen articles were included in this review, with a predominant focus on binocular vision anomalies, particularly accommodative and vergence dysfunctions, as well as ocular surface anomalies related to DESS. Clinical assessments relied primarily on symptom-based questionnaires, which represent a significant limitation. The included studies were largely observational, with a lack of longitudinal and RCTs. In contrast, research in dry eye disease has been more comprehensive, with multiple RCTs already conducted. (4) Therefore, it is essential to develop validated objective metrics that support accurate clinical diagnosis and guide evidence-based interventions. Conclusions: It remains unclear whether changes in binocular vision are a cause or consequence of DESS. However, prolonged screen time can exacerbate pre-existing binocular vision anomalies due to continuous strain on convergence and accommodation, leading to symptoms. Future research should prioritize prospective longitudinal studies and well-designed RCTs that integrate objective clinical measures to elucidate causal relationships and improve diagnostic and therapeutic frameworks.
- Eyelid Arteriovenous Malformation With Orbital Fistula: Literature Review and Case Report.Publication . Ludovico, Inês; Rodrigues Alves, Nuno; Neves, Tiago; Fragata, Isabel; Magriço, AnaOrbital arteriovenous malformations (AVMs) are rare entities, either congenital or acquired, that can significantly impair ocular function and aesthetics. Diagnostic evaluation requires multimodal imaging, and treatment is extremely complex, not only due to the limited information available in the literature, but also because of the high recurrence rate of the lesion, therefore requiring a multidisciplinary approach. Treatment involves a multimodal approach, often requiring AVM embolization followed by surgical excision. Endovascular embolization with agents such as ethylene-vinyl alcohol (Onyx®) or N-hexyl cyanoacrylate (Magic Glue®) should be ideally performed prior to subsequent surgical approaches. Recurrence is frequent, especially when nidus occlusion is incomplete, underscoring the importance of long-term follow-up and reintervention when necessary. We present a review of the recent literature and a clinical case of a left upper eyelid AVM associated with an orbital fistula in a young patient, managed with endovascular embolization and surgical excision.
- Detection of Elusive DNA Copy-Number Variations in Hereditary Disease and Cancer Through the Use of Noncoding and Off-Target Sequencing Reads.Publication . Quinodoz, Mathieu; Kaminska, Karolina; Cancellieri, Francesca; Han, Ji Hoon; Peter, Virginie G; Celik, Elifnaz; Janeschitz-Kriegl, Lucas; Schärer, Nils; Hauenstein, Daniela; György, Bence; Calzetti, Giacomo; Hahaut, Vincent; Custódio, Sónia; Sousa, Ana Cristina; Wada, Yuko; Murakami, Yusuke; Fernández, Almudena Avila; Hernández, Cristina Rodilla; Minguez, Pablo; Ayuso, Carmen; Nishiguchi, Koji M; Santos, Cristina; Santos, Luisa Coutinho; Tran, Viet H; Vaclavik, Veronika; Scholl, Hendrik P N; Rivolta, CarloCopy-number variants (CNVs) play a substantial role in the molecular pathogenesis of hereditary disease and cancer, as well as in normal human interindividual variation. However, they are still rather difficult to identify in mainstream sequencing projects, especially involving exome sequencing, because they often occur in DNA regions that are not targeted for analysis. To overcome this problem, we developed OFF-PEAK, a user-friendly CNV detection tool that builds on a denoising approach and the use of "off-target" DNA reads, which are usually discarded by sequencing pipelines. We benchmarked OFF-PEAK on data from targeted sequencing of 96 cancer samples, as well as 130 exomes of individuals with inherited retinal disease from three different populations. For both sets of data, OFF-PEAK demonstrated excellent performance (>95% sensitivity and >80% specificity vs. experimental validation) in detecting CNVs from in silico data alone, indicating its immediate applicability to molecular diagnosis and genetic research.