Fight Retinal Blindness SPAIN. Report 3: clinical outcomes of vascular endothelial growth factor inhibitors in low vision eyes with neovascular age-related macular degeneration. A national database study.

OBJECTIVES: To compare visual outcomes for low vision eyes (LVE) (<35 letters LogMAR or <20/200 Snellen) versus non-low vision eyes (NLVE) (>35 letters LogMAR or >20/200 Snellen) at the time of the first injection in a clinical practice setting. METHODS: Subgroup analysis of a multicenter national database of treatment- naïve eyes neovascular age related macular degeneration (nAMD) treated with anti-VEGF intravitreal injections divided into LVE and NLVE. Demographics, visual acuity (VA) at baseline and subsequent timepoints (12, 24, and 36 months), number of injections and visits data were collected using a validated web-based tool (Fight Retinal Blindness!). RESULTS: 3138 eyes were included, 705 LVE and 2433 NLVE. The LVE group had the greatest VA gain (p < 0.001), at 12, 24, and 36 months (+15, +15, and +13 letters respectively). The proportion of patients with VA loss (-5 letters) differed between groups at 12, 24, and 36 and was significantly greater (p < 0.001) in NLVE. The proportion of patients with VA gain (+5 letters) was significantly higher (p < 0.001) in LVE in all timeframes. The proportions of LVE that still had VA ≤ 35 letters at 12, 24, and 36 months were 54%, 54%, and 57%. Conversely, 8%, 9%, and 8% of LVE achieved VA ≥ 70 letters at 12, 24, and 36 months. LVE received fewer intravitreal injections than NLVE throughout follow-up (6, 9, 12 vs 7, 11, 15). CONCLUSION: Findings of this study support the need for ongoing therapy in patients with initial visual acuity less than 35 letters since sustained visual improvements can be achieved and maintained for the first 3 years of treatment.

Assessing the economic burden of vision loss and irreversible legal blindness in Spain (2021-2030): a societal perspective.

OBJECTIVE: To estimate the economic impact for the society, generated as a consequence of the onset of loss of vision and irreversible legal blindness, for the main ophthalmologic diseases in Spain: glaucoma, diabetic retinopathy (DR), diabetic macular edema (DME), age-related macular degeneration (AMD) and high myopia (HM). METHODS: A cost analysis model was developed to estimate the economic burden of glaucoma, DR, DME, AMD and HM over a 10-year time horizon (2021-2030), from a societal perspective in Spain. The epidemiological and economic parameters used in the model were obtained through a literature review. Prevalence, incidence, and progression stages were used to establish the epidemiological flows. Annual costs per patient from publications were included and classified into direct healthcare, direct non-healthcare and indirect costs. Costs from other countries were converted based on purchasing-power-parity (€EUR, PPP). Epidemiological parameters about population and cost results were validated by a panel of experts. All costs were adjusted to euros, 2021 (€, 2021), and using the Consumer Price Index (CPI) of the last 10 years, extrapolated to 2030 euros (€, 2030). RESULTS: It was estimated that the total population of patients with the main diseases pathologies (glaucoma, DR, DME, AMD and HM) will increase to 7.99 million patients by 2030, representing an increase of 103%. The total cost by 2030 of all pathologies would amount to 99.8 billion euros. Direct non-healthcare costs account for the largest item (44%), followed by loss of productivity costs (38%), and direct healthcare costs (18%). The pathologies with the highest cumulative costs will be glaucoma (€33.6 billion) and DME (€19.8 billion).The greatest increment costs compared to 2021 will likely be generated by pathologies related to diabetes mellitus, such as DR (703%) and DME (317%). CONCLUSIONS: Knowing the costs associated with the pathologies that generate loss of vision and irreversible legal blindness is essential to understand the socioeconomic impact associated with these pathologies. Furthermore, the high cost of treating these diseases makes necessary to coordinate efforts between administrations, together with the support of patient associations, to meet their needs.

Anterior Scleral Thickness and Anterior Segment Biometrics Measured with Swept Source Ocular Coherence Tomography in High Myopic Eyes with and without Glaucoma: A Comparative Study.

Background: To assess the anterior scleral thickness (AST), Schlemm's canal diameter (SCD), trabecular meshwork diameter (TMD) and conjunctiva tenon capsule thickness (CTT) in high myopic (HM) subjects and HM subjects with glaucoma (HMG) compared to control eyes. Methods: One hundred and twenty eyes were included, and AST at 0, 1, 2 and 3 mm from the scleral spur, SCD, TMD and CTT were measured. Results: Mean age was 64.2 ± 11.0 years, and the temporal SCD and temporal TMD were significantly longer in the HMG subjects compared to the controls (380.0 ± 62 µm vs. 316.7 ± 72 µm, p = 0.001) and (637.6 ± 113 µm vs. 512.1 ± 97 µm, p = 0.000), respectively. There were no significant differences between the HM and HMG subjects in SCD and TMD (all p > 0.025). Compared to the HM subjects, the temporal AST0 (432.5 ± 79 µm vs. 532.8 ± 99 µm, p = 0.000), temporal AST1 (383.9 ± 64 µm vs. 460.5 ± 80 µm, p = 0.000), temporal AST2 (404.0 ± 68 µm vs. 464.0 ± 88 µm, p = 0.006) and temporal AST3 (403.0 ± 80 µm vs. 458.1 ± 91 µm, p = 0.014) were significantly thinner in the HMG group. No differences were found between the CTT in the three groups (all p > 0.025). Conclusions: Our data indicate a thinner AST in HMG subjects and no differences in SCD and TMD between HM and HMG subjects.

Macular Neovascularization Type Influence on Anti-VEGF Intravitreal Therapy Outcomes in Age-Related Macular Degeneration.

PURPOSE: To evaluate the influence of macular neovascularization (MNV) lesion type on 12-month clinical outcomes in treatment-naive eyes with neovascular age-related macular degeneration (nAMD) treated with anti-VEGF drugs nationwide. DESIGN: Multicenter national nAMD database observational study. SUBJECTS: One thousand six hundred six treatment-naive nAMD eyes (1330 patients) undergoing anti-VEGF therapy for 12 months nationwide. METHODS: Demographics, visual acuity (VA) in logarithm of the minimum angle of resolution letters, number of injections and visits were was collected using a validated web-based tool. Neovascular lesion phenotype was classified as type 1 (T1, n = 711), type 2 (T2, n = 505), type 3 (T3, n = 315), and aneurysmal type 1 (A-T1, n = 75), according to the new proposed consensus classification. MAIN OUTCOME MEASURES: Mean VA change at 12 months, final VA at 12 months, number of injections, time to lesion inactivation. RESULTS: A total of 1606 treatment-naive nAMD eyes (1330 patients) received a median of 7 injections over 12 months. Mean (± standard deviation) baseline VA was significantly lower for T2 (49.4 ± 23.5 letters) compared with T1 (57.8 ± 20.8) and T3 (58.2 ± 19.4) (both P < 0.05) lesions. Mean VA change at 12 months was significantly greater for A-T1 (+9.5 letters) compared with T3 (+3.1 letters, P < 0.05). Patients with T3 lesions had fewer active visits (24.9%) than those with other lesion types (T1, 30.5%; T2, 32.6%; A-T1, 27.5%; all P < 0.05). Aflibercept was the most used drug in A-T1 lesions (70.1%) and ranibizumab in T1 (40.7%), T2 (57.7%), and T3 (47.6%) lesions. CONCLUSIONS: This study highlights the relevance of MNV type on clinical outcomes in nAMD and reports significant differences in baseline VA, VA change, and lesion activity at 12 months. This report provides data about lesion-specific clinical features, which may guide the management of nAMD cases and potentially support personalized clinical decision making for these patients. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

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.

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 µm 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 mm3 at baseline to 9.6 ± 2.9 mm3 (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. TRIAL REGISTRATION NUMBER: EudraCT identifier: 2016-001680-37.

Update on the Utility of Optical Coherence Tomography in the Analysis of the Optic Nerve Head in Highly Myopic Eyes with and without Glaucoma.

Glaucoma diagnosis in highly myopic subjects by optic nerve head (ONH) imaging is challenging as it is difficult to distinguish structural defects related to glaucoma from myopia-related defects in these subjects. Optical coherence tomography (OCT) has evolved to become a routine examination at present, providing key information in the assessment of glaucoma based on the study of the ONH. However, the correct segmentation and interpretation of the ONH data employing OCT is still a challenge in highly myopic patients. High-resolution OCT images can help qualitatively and quantitatively describe the structural characteristics and anatomical changes in highly myopic subjects with and without glaucoma. The ONH and peripapillary area can be analyzed to measure the myopic atrophic-related zone, the existence of intrachoroidal cavitation, staphyloma, and ONH pits by OCT. Similarly, the lamina cribosa observed in the OCT images may reveal anatomical changes that justify visual defects. Several quantitative parameters of the ONH obtained from OCT images were proposed to predict the progression of visual defects in glaucoma subjects. Additionally, OCT images help identify factors that may negatively influence the measurement of the retinal nerve fiber layer (RNFL) and provide better analysis using new parameters, such as Bruch's Membrane Opening-Minimum Rim Width, which serves as an alternative to RNFL measurements in highly myopic subjects due to its superior diagnostic ability.

Ten-year prevalence of rhegmatogenous retinal detachment in myopic eyes after posterior chamber phakic implantable collamer lens.

PURPOSE: To determine and compare the prevalence of rhegmatogenous retinal detachment (RRD) in myopic eyes operated of posterior chamber phakic implantable collamer lens (ICL) with a control group of nonoperated myopic eyes over 10 years of follow-up. SETTING: Clinica Baviera, Madrid, Spain. DESIGN: Retrospective cohort study. METHODS: There were 2 study cohorts: one with patients operated with ICL and a control group of nonoperated patients. The primary outcome of RRD was measured retrospectively, first through chart review of ICL-operated patients with at least 10 years of follow-up, then secondarily through telephone questionnaires and specialist verification for those with incomplete follow-up. Prevalence and incidence were calculated and compared, as well as their possible association with other risk factors. RESULTS: 58 operated patients completed follow-up in our clinic. A survey of 3849 more patients was conducted for a total of 252 operated with a mean spherical equivalent (SEQ) of -12.6 diopters (D) and 221 nonoperated with a mean SEQ of -10.5 D. 7 eyes developed an RRD in the operated vs 5 eyes among the nonoperated (prevalence 1.71% vs 1.25%, respectively, P = .773). The equivalence tests, the two one-sided test and the null hypothesis test between groups, were within the 0.02 limits, confirming the null hypothesis, and compared survival curves did not show significant differences ( P = .59). CONCLUSIONS: ICL implantation surgery for high myopia did not affect the prevalence of RRD in operated eyes compared with similar nonoperated eyes, in this long-term study.

Choroidal Thickness in a Hyperopic Pediatric Population.

Aims: To evaluate the choroidal thickness (CT) in hyperopic and emmetropic children using swept-source optical coherence tomography (SS-OCT). Methods: This was a prospective, cross-sectional comparative study. Macular choroidal thickness and axial length of 62 eyes from hyperopic pediatric patients were studied. CT was determined at nine different macular locations. The results were compared to 66 eyes of healthy pediatric patients. Results: Study groups were classified as a hyperopic group (SE ≥ 2D) and an emmetropic group (SE < 2D). The hyperopic group have shorter AL than the emmetropic group (p < 0.001). The mean CT is greater in the hyperopic group (p = 0.039), and there are no significant differences between CT and gender (p = 0.389). Study participants were also classified by age (2−5 years old and 6−18 years old), and we observe differences in CT, but these differences are only significant for the 6−18 years old group (p < 0.05). Conclusions: CT in hyperopic pediatric populations is statistically thicker than in healthy pediatric patients. AL and SE have statistically significant correlations with CT values, and those correlations are seen in children in the ocular slow-growing phase (6−18 years old), and not in the early years (2−5 years old).

Updates on the utility of anterior segment optical coherence tomography in the assessment of filtration blebs after glaucoma surgery.

The formation of filtration blebs is the main drainage mechanism for reducing intraocular pressure after traditional incisional glaucoma surgery such as trabeculectomy and non-penetrating deep sclerotomy. Early and short-lasting blebs may also occur after canaloplasty. Bleb formation also plays an important role after the implantation of glaucoma drainage devices, including Minimally Invasive Glaucoma Surgery devices. Anterior segment optical coherence tomography (AS-OCT) is a rapid and non-invasive high-resolution imaging technique that has evolved in recent years to become a routine examination. Anterior segment optical coherence tomography (AS-OCT) provides key information in the assessment and follow-up of glaucoma surgery, especially in the assessment of filtration blebs. Thus, bleb morphology can be qualitatively classified into diffuse, cystic, encapsulated and flattened, and AS-OCT imaging can also provide several quantitative parameters of the bleb, such as total bleb height, bleb fluid-filled cavity height, bleb wall thickness, number of microcysts and trabeculectomy opening size. These parameters could have an impact on clinical management during follow-up because they may predict the success or failure of the surgery in the early and late postoperative periods. Additionally, they may also guide the procedures used to increase filtration and reduce intraocular pressure, such as bleb needling and laser suture lysis.

Challenges in Diabetic Macular Edema Management: An Expert Consensus Report.

PURPOSE: This paper aimed to present daily-practice recommendations for the management of diabetic macular edema (DME) patients based on available scientific evidence and the clinical experience of the consensus panel. METHODS: A group of Spanish retina experts agreed to discuss different aspects related with the clinical management of DME patients. RESULTS: Panel was mainly focused on therapeutic objectives in DME management; definition terms; and role of biomarkers as prognostic and predictive factors to intravitreal treatment response. The panel recommends to start DME treatment as soon as possible in those eyes with a visual acuity less than 20/25 (always according to the retina unit capacity). Naïve patient was defined, in a strict manner, as a patient who, up to that moment, had never received any treatment. A refractory DME patient may be defined as the one who did not achieve a complete resolution of the disease, regardless of the treatment administered. Different optical coherence tomography biomarkers, such as disorganization of the retinal inner layers, hyperreflective dots, and cysts, have been identified as prognostic factors. CONCLUSION: This document has sought to lay down a set of recommendations and to identify key issues that may be useful for the daily management of DME patients.

Numerical model to predict and compare the hypotensive efficacy and safety of minimally invasive glaucoma surgery devices.

PURPOSE: To predict and compare the hypotensive efficacy of three minimally-invasive glaucoma surgery (MIGS) implants through a numerical model. METHODS: Post-implant hypotensive efficacy was evaluated by using a numerical model and a computational fluid dynamics simulation. Three different devices were compared: the XEN 45 stent (tube diameter, 45 µm), the XEN 63 stent (63 µm) and the PreserFlo microshunt (70 µm). The influence of the filtration bleb pressure (Bp) and tube diameter, length, and position within the anterior chamber (AC) on intraocular pressure (IOP) were evaluated. RESULTS: Using baseline IOPs of 25, 30 and 50 mmHg, respectively, the corresponding computed post-implant IOPs for each device were as follows: XEN 45: 17 mmHg (29% decrease), 19 mmHg (45%) and 20 mmHg (59%) respectively; XEN 63: 13 mmHg (48%), 13 mmHg (62%), and 13 mmHg (73%); PreserFlo: 12 mmHg (59%), 13 mmHg (73%) and 13 mmHg (73%). At a baseline IOP of 35 mmHg with an increase in the outflow resistance within the Bp from 5 to 17 mmHg, the hypotensive efficacy for each device was reduced as follows: XEN45: 54% to 37%; XEN 63: 74% to 46%; and PreserFlo: 75% to 47%. The length and the position of the tube in the AC had only a minimal (non-significant) effect on IOP (<0.1 mmHg). CONCLUSIONS: This hydrodynamic/numerical model showed that implant diameter and bleb pressure are the two most pertinent determinants of hypotensive efficacy. In distinction, tube length and position in the AC do not significantly influence IOP.

Genetic and environmental factors related to the development of myopic maculopathy in Spanish patients.

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.

Ciliary muscle dimensions measured by swept-source optical coherence tomography in eyes with primary open-angle glaucoma and healthy eyes.

PURPOSE: To compare in vivo swept-source optical coherence tomography (SS-OCT) measurements of the ciliary muscle (CM) in patients with primary open-angle glaucoma (POAG) and healthy subjects, and examine correlations between CM dimensions and several covariates. METHODS: This was a cross-sectional study of the right eyes of 181 subjects: 89 POAG patients and 92 healthy subjects. Using the Triton SS-OCT device (Topcon, Tokyo, Japan), CM length (CML), area (CMA) and thickness measured 1000 µm (CMT1), 2000 µm (CMT2) and 3000 µm (CMT3) from the scleral spur were determined in the temporal and nasal quadrants. POAG patients were subjected to visual field (VF) and peripapillary retinal nerve fiber layer (RNFL) assessment. CM dimensions were then assessed for correlation with VF mean defect (MD), mean RNFL thickness and intraocular pressure (IOP). RESULTS: Mean CMLs were 4325 ± 340 µm and 4195 ± 843 µm for the healthy subjects and POAG patients, respectively (p = 0.17). Mean CM thicknesses were CMT1 = 546 ± 56 µm, CMT2 = 326 ± 44 µm and CMT3 = 174 ± 16 µm in the healthy eyes versus CMT1 = 534 ± 108, CMT2 = 332 ± 99 and CMT3 = 183 ± 74 in the POAG eyes, with no significant differences detected (all p ≥ 0.25). In the temporal quadrant, mean CMA was 1.12 ± 0.29 mm2 and 1.15 ± 0.24 mm2 for the healthy and POAG subjects, respectively (p = 0.45). No correlations were observed between CM measurements and RNFL thickness (p ≥ 0.15), IOP or VF MD (p ≥ 0.14) in POAG subjects irrespective of glaucoma severity (p ≥ 0.19). CONCLUSIONS: While SS-OCT proved useful to measure CM dimensions in vivo, these dimensions did not differ between healthy individuals and POAG subjects. In the patients with POAG, no correlations were detected between CM dimensions and VF, RNFL or IOP.

Normative Database of Peripapillary Vessel Density Measured by Optical Coherence Tomography Angiography and Correlation Study.

Purpose: To provide a normative data set of swept-source optical coherence tomography angiography (SS-OCTA) peripapillary vessel density (VD) measurements and assess correlations with age, gender, disc area and axial length (AL). Material and Methods: This was an observational cross-sectional study conducted on 346 right eyes of healthy subjects. Peripapillary SS-OCTA VD measurements were obtained in the retinal superficial capillary plexus (SCP), deep capillary plexus (DCP), and choriocapillaris (CC) in all four quadrants using the Triton device (Topcon, Nagoya, Japan). AL measurements were made by optical biometry. Results: Mean participant age was 37.7 ± 19.8 years (range 5- 83), AL was 23.9 ± 1.3 mm (21-27), and 59% were women. Mean VDs for all quadrants were 57.2 ± 5.7% for SCP (52.4 ± 4.0% - 62.1 ± 4.2%), 46.3 ± 6.5% for DCP (41.9 ± 5.8% - 49.7 ± 4.8%) and 60.8 ± 7.4% for CC (53.4 ± 5.8% - 65.7 ± 5.5%). Negative correlation was detected between SCP VD and age (R = -0.264; P < .001), while correlation between DCP densities and age was positive (R = 0.202; P = .002). No associations were detected between peripapillary VD and gender (P ≥ 0.087) and negative correlation was found with AL and disc area only in the CC (P ≤ 0.004). In a subgroup analysis of 33 individuals, we noted no differences in VD between fellow eyes (P ≥ 0.139). Conclusion: Peripapillary VD showed wide individual variation when measured with the Triton SS-OCTA in the different retinal plexuses and CC. While correlations were observed with age, no relationships emerged with gender and only CC showed negative correlation with AL and disc area.

A Multiple Stakeholder Multicriteria Decision Analysis in Diabetic Macular Edema Management: The MULTIDEX-EMD Study.

BACKGROUND: The clinical and economic management of retinal diseases has become more complex following the introduction of new intravitreal treatments. Multicriteria decision analysis (MCDA) offers 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 defined all of the criteria that could influence DME treatment decision-making. These criteria were then screened using a discrete choice experiment (DCE) (phase B). Next, a multinomial logit model was fitted 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 defined (phase A) and grouped into 5 categories: efficacy/effectiveness, 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), effect 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 effect duration. It should also contribute to system sustainability by being affordable, it should have a positive impact on HRQoL, and it should prevent disability.

Use of intravitreal dexamethasone implants in the treatment of diabetic macular edema: Expert recommendations using a Delphi approach.

OBJECTIVE: The aim of this study is to develop guidance on the use of intravitreal dexamethasone implants in the treatment of diabetic macular edema. METHOD: The study was performed using the modified Delphi method to obtain a consensus among a panel of experts on management of patients with diabetic macular edema and use of intravitreal dexamethasone implants in clinical practice. Thirty-seven panel members, experts on retina, from different Spanish centers were invited to participate. Individual and anonymous opinions were asked by answering a 76-item questionnaire across 11 topic areas (two rounds were done). Level of agreement was assessed using a Likert-type scale of 9 points. RESULTS: Agreement on "consensus" was reached during the first round in 63 items. The 13 remaining items underwent a second round of voting. After the second round, agreement on "consensus" was reached on five items. Finally, eight items remained without consensus. CONCLUSION: Intravitreal dexamethasone implants are useful in the treatment of patients with diabetic macular edema with different profiles, for example, pseudophakic, poor-adherents, vitrectomized, candidates for cataract surgery, patients with high inflammatory component, and with a history of cardiovascular events. The use of intravitreal dexamethasone reduces the number of visits and facilitates compliance. Experts thought that the switch from anti-vascular endothelial growth factor therapy to intravitreal dexamethasone implants should be done preferably after three injections. Also, pro re nata treatment provides better results in diabetic macular edema patients as it helps to prevent undertreatment. Finally, experts concluded that clinical guidelines and treatment protocols for diabetic macular edema need to be updated.

Prognostic Tomographic Classification of Myopic Choroidal Neovascularization.

BACKGROUND AND OBJECTIVES: To investigate the prognostic value of the development of a hyperreflective envelopment of the neovascular tissue in myopic choroidal neovascularization (mCNV) after the first intravitreal ranibizumab injection and to establish a tomographic classification of mCNV depending on this healing process. PATIENTS AND METHODS: Twenty-five eyes of 25 patients with mCNV were retrospectively studied. Patients were classified into type A (presence of a hyperreflective coating of the neovascular tissue 1 month after first intravitreal ranibizumab) and type B (absence of or partial coating). Visual acuity (VA) and number of injections were recorded. Differences between both types were assessed at 6 and 12 months of follow-up. RESULTS: Fifteen patients (60%) were classified as type A and 10 as type B (40%). Type A showed better VA than type B. VA improvement was only significant for type A. No differences in the number of injections were observed; however, a trend to a larger amount in type B was observed. CONCLUSIONS: The proposed classification may have prognostic value, with type A mCNV showing better visual outcomes. Further studies are needed to confirm these findings. [Ophthalmic Surg Lasers Imaging Retina. 2018;49:775-779.].

Clinical Decision-Making when Treating Diabetic Macular Edema Patients with Dexamethasone Intravitreal Implants.

Diabetes mellitus (DM) is a metabolic disease frequently associated with comorbidities that include diabetic macular edema (DME). The current medical approach to treating DME involves intravitreal injections with either anti-vascular endothelial growth factors or steroids. However, the burden associated with intravitreal injections and DM-derived complications is high, underlining the need to find optimal treatment regimens. In this article we describe the considerations we apply when treating DME patients with dexamethasone intravitreal implants (Ozurdex®), particularly those that influence the clinical decision-making process during the follow-up period. These considerations are based both on the available medical literature and on our clinical experience following the use of these implants in this type of patient, the goal being to optimize the number of injections and the clinical outcome of this therapy. We also provide a general overview of the pathophysiology of DME, highlighting the inflammatory component as a rationale to use steroids in these patients.

Color Doppler imaging of the retrobulbar circulation and plasmatic biomarkers of vascular risk in age-related macular degeneration: A pilot study.

PURPOSE: To evaluate preliminarily and compare the level of plasmatic biomarkers of vascular risk in patients with and without exudative age-related macular degeneration (ARMD) and to relate it to vascular resistance alterations in the ophthalmic artery (OA), central retinal artery (CRA), posterior temporal ciliary artery (PTCA), and posterior nasal ciliary artery (PNCA). METHODS: Color Doppler imaging of the OA, CRA, PTCA, and PNCA was performed in 30 eyes of 30 cataract patients (control group) as well as in 30 eyes of 30 patients with naive exudative ARMD (study group), measuring the peak systolic velocity, end-diastolic velocity (EDV), and Pourcelot resistive index (RI). Likewise, in both groups, a blood test was performed to determine the plasmatic levels of homocysteine, C-reactive protein (CRP), B12 vitamin, and folic acid. RESULTS: A positive and significant correlation was found between the level of CRP and RI of the OA in the ARMD group (r = 0.498, P = 0.005), with an increased RI in all arteries compared to controls, although differences only reached statistical significance for the PTCA (P = 0.035). Likewise, a significantly lower EDV for the CRA was found in ARMD eyes compared to controls (P = 0.041). In the study group, significantly higher plasmatic levels of homocysteine (P = 0.042) and CRP (P = 0.046) were found. In contrast, no significant differences were found between groups in the levels of folic acid (P = 0.265) and B12 vitamin (P = 0.520). CONCLUSION: The decrease of the choroidal perfusion related to hyperhomocysteinemia, and increase in the CRP plasmatic levels may play an etiological role on the exudative ARMD. This should be investigated in future studies with larger samples of patients.

Update on Diagnosis and Treatment of Diabetic Retinopathy: A Consensus Guideline of the Working Group of Ocular Health (Spanish Society of Diabetes and Spanish Vitreous and Retina Society).

A group of members of the Spanish Retina and Vitreous Society (SERV) and of the Working Group of Ocular Health of the Spanish Society of Diabetes (SED) updated knowledge regarding the diagnosis and treatment of diabetic retinopathy (DR) based on recent evidence reported in the literature. A synthesis of this consensus forms the basis of the present review, which is intended to inform clinicians on current advances in the field of DR and their clinical applicability to patients with this disease. Aspects presented in this article include screening procedures of DR, new technologies in the early diagnosis of DR, control of risk factors in the different stages of the disease, indications of panretinal laser photocoagulation, efficacy of intravitreal antiangiogenic agents and steroids, and surgical options for treating DR-related complications. Practical information regarding periodicity of screening procedures in patients with type 1 and type 2 diabetes, ophthalmological controls according to the stage of retinopathy and complications, and criteria and degree of urgency for referral of a DR patient to the ophthalmologist are also presented.