Reporting serious incidents in medical devices used in intraocular surgery: Proposing ideas.

The entry into force of the regulation on medical devices obliges clinicians to identify and report to the Health Authorities possible serious incidents arising from their use. In view of the doubts that may arise as to whether or not it may be considered a serious incident, a working group, set up by members of the Spanish Society of Retina and Vitreo and the cluster of ophthalmology and vision sciences (Cluster4Eye) have prepared a document that aims to guide ophthalmologists about some of the incidents that, in the experience of the work team, are not common or can cause serious damage to the patient's function.

Management of Wet Age-Related Macular Degeneration in Spain: Challenges for Treat and Extend Implementation in Routine Clinical Practice.

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.

Choroidal haemangioma and photodynamic therapy. Anatomical and functional response of patients with choroidal hemangioma treated with photodynamic therapy. / Hemangioma coroideo y terapia fotodinámica. Respuesta anatómica y funcional de los pacientes con hemangioma coroideo tratados con terapia fotodinámica.

OBJECTIVE: To study the effectiveness and limitations of photodynamic therapy (PDT) as treatment of choice in patients with symptomatic circumscribed choroidal haemangioma. METHODS: A retrospective study was conducted on 16 patients (13 men and 3 women, with mean age of 54.88 years) with circumscribed choroidal haemangioma, who attended our centre and were treated with PDT in the last 7 years. RESULTS: All patients had circumscribed choroidal haemangioma, which caused a decrease in visual acuity (VA) secondary to the presence of intraretinal microcystic oedema or neurosensory detachment. The mean initial VA was 0.23, and the final mean VA after performing PDT was 0.38 (all the VA were measured in decimal scale). It should be noted that patients needed a mean of 1.69 PDT sessions. Three of the patients needed rescue treatment with trans-pupillary thermotherapy, intravitreal injection of anti-vascular endothelial growth factor (ranibizumab, aflibercept) or a dexamethasone intravitreal implant (Ozurdex®). The indication for a change of treatment was the persistence of intraretinal microcystic oedema and/or neurosensory detachment (or incomplete resolution) after 3 PDT sessions. As overall results, 62.5% of patients evolved into anatomical and functional (increase in AV or stability) resolution. CONCLUSIONS: PDT is a straight forward and fast procedure, with a good anatomical and functional response, causing minimal damage to adjacent vessels.

[New treatment protocols and follow-up in patients with exudative age-related macular degeneration]. / Nuevas pautas de tratamiento y seguimiento en pacientes con degeneración macular asociada a la edad exudativa.

Intravitreal ranibizumab (Lucentis®) injections are the treatment of choice in patients with exudative macular degeneration. In the last few years, several treatment and follow-up strategies have been evaluated with the aim of optimizing the safety and efficacy of this drug. In routine clinical practice, the Pro Re Nata (PRN) and treat-and-extend protocols or variants of the FUSION regimen have been used. PRN protocols are based on regular patient follow-up and on retreatment when there is evidence of reactivation of the lesion, basically determined by loss of visual acuity and persistent or recurrent macular fluid on optical coherence tomography. Treat-and-extend or FUSION protocols are based on early retreatment of the lesion before reactivation occurs with the aim of avoiding the irreversible visual loss that can occur in disease recurrences. There is no ideal treatment and follow-up protocol that could be used as an alternative to the monthly regimen and be applied and reproduced in all patients. Consequently, intravitreal ranibizumab therapy should be individualized in each patient.

[Guidelines of clinical practice of the SERV: treatment of exudative age-related macular degeneration (AMD)]. / Guías de práctica clínica de la SERV: tratamiento de la degeneración macular asociada a la edad (DMAE) exudativa.

OBJECTIVE: Age related macular degeneration (ARMD) in its neovascular form is a serious disease which produces legal blindness in many patients with poor prognosis if left untreated. We intend to establish a clinical guide with the different therapeutic options that exist nowadays, which may help the ophthalmologists in their clinical practice. METHODS: A group of medical retina experts selected by SERV have evaluated the results of different published studies with the drugs currently available, obtaining an evidence-based consensus. Some recommendations have been established for diagnosis, treatment and monitoring of patients with neovascular ARMD. RESULTS: The intravitreal injection of ranibizumab at a dosage of 0.5 mg produces significant improvement of visual acuity in subfoveal lesions, according to data obtained from studies with the highest level of evidence. It should be considered as a first choice drug. The use of bevacizumab, a drug with not approved indication for intraocular use, nor for the treatment of neovascular ARMD can reach a result which is closer to the ones obtained with ranibizumab than to those obtained with photodynamic therapy (PDT) and pegaptanib. The use of intravitreal pegaptanib sodium in intravitreal injection at a dosage of 0.3 mg as a treatment for subfoveal lesions can obtain similar results to the TFD, but with a wider range of injuries. CONCLUSION: The results of the evidence-based studies are a good guide for the treatment of this disease.

[Multifocal electroretinogram and age-related macular degeneration]. / Electrorretinograma multifocal y degeneración macular asociada a la edad.

PURPOSE: To assess the value of multifocal electroretinogram (mfERG) in clinical evaluation of the response of patients with choroidal neovascularization (CNV), secondary to age-related macular degeneration, to photodynamic therapy (PDT). METHODS: We designed a prospective non-comparative case series and enrolled 23 eyes of 22 patients with predominantly classic CNV. The initial evaluation included clinical examination with measurement of visual acuity (Colenbrander), biomicroscopic evaluation (BMC), retinography, fluorescein angiography (FA), Humphrey 24-2 visual field examination and mfERG. All patients were treated with PDT. Clinical follow-up was performed two and six months after treatment with visual acuity evaluation, BMC, visual field assessment and mfERG. FA was repeated after an interval of between four and six months in all patients. RESULTS: Visual acuity remained stable or improved in all patients included in the study. Visual field examination gave erratic and unreliable results because of patients' unstable fixation. N1 and P1 wave peak amplitudes in the central rings did not change significantly after treatment but they improved in rings 3 (p=0.000), 4 and 5 (p=0.008). CONCLUSIONS: Multifocal ERG is a useful tool for the clinical follow-up of CNV. It offers interesting non-subjective data of retinal sensitivity of patients with macular diseases treated with PDT. In addition we obtained a central retinal sensitivity map where we were able to evaluate the extent and depth of retinal damage.