Ruiz-Moreno, J.M. (José María)
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- A multiple stakeholder multicriteria decision analysis in diabetic macular edema management: the MULTIDEX‑EMD study(Springer, 2020) Zulueta, J. (Jacinto); Zarranz-Ventura, J. (Javier); Peralta, G. (Gemma); Casado, M. A. (Miguel Ángel); Rodríguez‑Maqueda, M. (Mariano); Ortiz, P. (Pere); Llorente, I. (Iñaki); Álvarez, E. (Eloísa); Garcia-Layana, A. (Alfredo); Trillo, J.L. (José Luis); Poveda, J.L. (José Luis); Mur, C. (Carlos); Martínez‑Olmos, J.(José); Martínez, M. (Mercedes); Martínez‑Sesmero, J.M. (José Manuel); de-Andrés‑Nogales, F. (Fernando); Ignacio, E. (Emilio); Udaondo, P. (Patricia); Cervera, E. (Enrique); Ruiz-Moreno, J.M. (José María)Background The clinical and economic management of retinal diseases has become more complex following the introduction of new intravitreal treatments. Multicriteria decision analysis (MCDA) ofers the potential to overcome the challenges associated with traditional decision-making tools. Objectives A MCDA to determine the most relevant criteria to decision-making in the management of diabetic macular edema (DME) based on the perspectives of multiple stakeholders in Spain was developed. This MCDA was termed the MULTIDEX-EMD study. Methods Nineteen stakeholders (7 physicians, 4 pharmacists, 5 health authorities and health management experts, 1 psychologist, and 2 patient representatives) participated in this three-phase project. In phase A, an advisory board defned all of the criteria that could infuence DME treatment decision-making. These criteria were then screened using a discrete choice experiment (DCE) (phase B). Next, a multinomial logit model was ftted by applying the backward elimination algorithm (relevant criteria: p value<0.05). Finally, the results were discussed in a deliberative process (phase C). Results Thirty-one criteria were initially defned (phase A) and grouped into 5 categories: efcacy/efectiveness, safety, organizational and economic impact, patient-reported outcomes, and other therapeutic features. The DCE results (phase B) showed that 10 criteria were relevant to the decision-making process for a 50- to 65-year-old DME patient: mean change in best corrected visual acuity (p value<0.001), percentage of patients with an improvement of ≥15 letters (p value<0.001), efect duration per administration (p value=0.008), retinal detachment (p value<0.001), endophthalmitis (p value=0.012), myocardial infarction (p value<0.001), intravitreal hemorrhage (p value=0.021), annual treatment cost per patient (p value=0.001), health-related quality of life (HRQoL) (p value=0.004), and disability level (p value=0.021). Conclusions From a multi-stakeholder perspective, the selection of an appropriate treatment for DME patients should guarantee patient safety and maximize the visual acuity improvement and treatment efect duration. It should also contribute to system sustainability by being afordable, it should have a positive impact on HRQoL, and it should prevent disability.
- Management of wet age-related macular degeneration in Spain: Challenges for treat and extend implementation in routine clinical practice(Hindawi Limited, 2019) Arias-Barquet, L. (L.); Monclús-Arbona, L. (L.); García-Arumí, J. (J.); Garcia-Layana, A. (Alfredo); Figueroa, M.S. (Marta S.); The Spanish AMD Multicenter Group; Ruiz-Moreno, J.M. (José María)Purpose. To ascertain wet AMD (wAMD) management patterns in Spain. Methods. A two-round Delphi study conducted through a questionnaire-based survey designed from literature review and validated by an independent Steering Committee. Results. Forty-nine retina specialists experienced in wAMD participated by answering the two-round study questionnaire. Retina specialists are the main responsible for wAMD diagnosis and monitoring, including visits and associated procedures, with a median time per visit of 15 minutes. Standard treatment strategies are based on anti-VEGF administration, including standard loading dose administration followed by maintenance with aflibercept or ranibizumab (81% of patients). Although treat and extend (T&E) dosing strategy is considered as optimal for wAMD management (78% of the panelists), the main routine healthcare limitations (i.e., visits overload, reduced staff, short visit time, coordination issues, lack of facilities) conduct to self-defined “flexible” strategies, based on T&E and pro-re-nata (PRN) protocols. Conclusion. Proactive treatment patterns (T&E) are the preferred ones by the retina specialists in Spain. However, their proper implementation is difficult due to healthcare resource limitations, as well as organisation and logistic issues. The use of anti-VEGF agents with longer duration of action could facilitate the use of strict T&E approaches according to routine clinical practices.
- Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT): a prospective, non-randomized, and multicenter study(2023) Arias-Barquet, L. (L.); Garcia-Layana, A. (Alfredo); Durán, M.A. (Mónica Ascencio); Araiz-Iribarren, J. (Javier); Adan, A. (Alfredo); Lafuente, M. (María); Ruiz-Moreno, J.M. (José María)Objective: To assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies. Methods: This was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values. Results: Thirty-one eyes from 31 patients were included in the study. Mean age was 68.0 +/- 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 +/- 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 +/- 12.3 letters at baseline to 62.4 +/- 17.0 letters at month-24 (p = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 +/- 10.2 letters at baseline to 61.5 +/- 17.9 letters at month-24 (p = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 +/- 135.1 mu m at baseline to 333.4 +/- 135.6 at month-24 (p < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 +/- 2.7 mm(3) at baseline to 9.6 +/- 2.9 mm(3) (p = 0.0027) at month-24. Among the 31 study eyes, 19 (61.3%) required an additional treatment for DME. Throughout the study, 9 (29.0%) eyes required ocular hypotensive medication for controlling their intraocular-pressure and 5 (16.1%) eyes underwent cataract surgery. Conclusions: In DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events.
- Myopic maculopathy: Current status and proposal for a new classification and grading system (ATN)(Elsevier BV, 2019) Montero, J.A. (Javier A.); Arias, L. (Luis); Garcia-Layana, A. (Alfredo); Flores-Moreno, I. (Ignacio); Ruiz-Moreno, J.M. (José María); Ruiz-Medrano, J. (Jorge)Myopia is a highly frequent ocular disorder worldwide and pathologic myopia is the 4th most common cause of irreversible blindness in developed countries. Pathologic myopia is especially common in East Asian countries. Ocular alterations associated with pathologic myopia, especially those involving the macular area—defined as myopic maculopathy—are the leading causes of vision loss in patients with pathologic myopia. High myopia is defined as the presence of a highly negative refractive error (>−6 to −8 diopters) in the context of eye elongation (26–26.5 mm). Although the terms high myopia and pathologic myopia are often used interchangeably, they do not refer to the same eye disease. The two key factors driving the development of pathologic myopia are: 1) elongation of the axial length and 2) posterior staphyloma. The presence of posterior staphyloma, which is the most common finding in patients with pathologic myopia, is the key differentiating factor between high and pathologic myopia. The occurrence of staphyloma will, in most cases, eventually lead to other conditions such as atrophic, traction, or neovascular maculopathy. Posterior staphyloma is for instance, responsible for the differences between a myopic macular hole (MH)—with and without retinal detachment—and idiopathic MH. Posterior staphyloma typically induces retinal layer splitting, leading to foveoschisis in myopic MH, an important differentiating factor between myopic and emmetropic MH. Myopic maculopathy is a highly complex disease and current classification systems do not fully account for the numerous changes that occur in the macula of these patients. Therefore, a more comprehensive classification system is needed, for several important reasons. First, to more precisely define the disease stage to improve follow-up by enabling clinicians to more accurately monitor changes over time, which is essential given the progressive nature of this condition. Second, unification of the currently-available classification systems would establish standardized classification criteria that could be used to compare the findings from international multicentric studies. Finally, a more comprehensive classification system could help to improve our understanding of the genetic origins of this disease, which is clearly relevant given the interchangeable—but erroneous—use of the terms high and pathologic myopia in genetic research
- Genetic and environmental factors related to the development of myopic maculopathy in Spanish patients(2020) González-Zamora, J. (Jorge); Arias, L. (Luis); Hernandez-Sanchez, M. (María); Maestre-Rellan, L. (Leyre); Velazquez-Villoria, A. (Alvaro); Llorente-González, S. (Sara); Garcia-Layana, A. (Alfredo); Fernández-Sanz, G. (Guillermo); Bilbao-Malavé, V. (Valentina); Berrozpe-Villabona, C. (Clara); Araiz-Iribarren, J. (Javier); Bezunartea, J. (Jaione); Carreño, E. (Ester); Fernandez-Robredo, P. (Patricia); Flores-Moreno, I. (Ignacio); Recalde, S. (Sergio); Ruiz-Moreno, J.M. (José María); Ruiz-Medrano, J. (Jorge)High myopia and the subsequent degenerative changes of the retina, choroid, and sclera, known as myopic maculopathy (MM), are a serious visual problem in many Asian countries, and are beginning to be so in the south of Europe, especially in the Mediterranean. It is therefore necessary to carry out genetic and environmental studies to determine the possible causes of this disease. This study aims to verify if the genetic factors that have been most related to Asian populations are also associated in two Spanish cohorts. Eight SNPs from six genes (PAX6, SCO2, CCDC102B, BLID, chromosome 15q14, and COL8A1) along with demographic, ophthalmic and environmental factors were analysed in two cohorts from a total of 365 highly myopic subjects and 177 control subjects. The genetic analysis showed that COL8A1 SNP rs13095226 was associated with the development of choroidal neovascularization (CNV) and also seems to play an important role in the increase of axial length. The SNP rs634990 of chromosome 15q14 also showed a significant association with MM, although this was lost after the Bonferroni correction. Additional demographic and environmental factors, namely age, sex, smoking status, and pregnancy history, were also found to be associated with MM and CNV in this population.