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.

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.

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.

The Prevalence of Vitreomacular Interface Pathology in a Spanish Tertiary Hospital.

PURPOSE: To determine the prevalence of vitreomacular interface (VMI) pathology, using spectral-domain optical coherence tomography (SD-OCT). METHODS: VMI status was classified into macular posterior vitreous detachment (PVD), focal vitreomacular adhesion (VMA; ≤1,500 µm), broad VMA (>1,500 µm), focal vitreomacular traction (VMT; ≤1,500 µm), broad VMT (>1,500 µm), full-thickness macular hole (FTMH) with the presence of VMT, and FTMH without the presence of VMT. RESULTS: A total of 1,976 eyes were included. A nonpathologic VMI was observed in 1,875 eyes (94.8%), including 1,050 (53.1%) with PVD, 120 (6.1%) with focal VMA and 705 (35.6%) with broad VMA. A pathologic state of the VMI was diagnosed in 101 eyes (5.1%). Thirty-three eyes (1.7%) were classified as focal VMT, 29 (1.4%) as broad VMT, 39 (1.9%) as FTMH, resulting in 6 small, 12 medium and 21 large FTMHs, six eyes had VMT associated to FTMH. CONCLUSIONS: Even in a tertiary care, retinal referral practice, VMI pathology is a relatively rare condition. There was a higher prevalence in a tertiary hospital study compared to population-based studies.

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.

The p53 codon 72 polymorphism (rs1042522) is associated with proliferative vitreoretinopathy: the Retina 4 Project.

PURPOSE: To compare the distribution of a p53 gene polymorphism among European subjects undergoing primary retinal detachment (RD) surgery in relation to the development of proliferative vitreoretinopathy (PVR). DESIGN: Case-controlled gene association study conducted as a component of the Retina 4 Project (a European multicenter study). PARTICIPANTS AND CONTROLS: Five hundred fifty DNA samples, 134 with PVR secondary to primary RD and 416 with RD without PVR. METHODS: The p53 codon 72 polymorphism (rs1042522) was analyzed using allele-specific primer polymerase chain reaction. Proportions of genotypes and the proline (Pro-P) homozygote groups between subsamples from different countries were analyzed in 2 phases. In the first, subsamples from Spain and Portugal were analyzed. After significant results were found, samples from the United Kingdom (UK) and The Netherlands were analyzed (second phase). Genotypic and allelic frequencies were compared between cases and controls in the global sample. MAIN OUTCOME MEASURES: Single significant associations with PVR. RESULTS: A significant difference (P<0.05, Fisher exact test) was observed regarding the p53 genotype frequencies at codon 72 between the PVR cases and the non-PVR controls in Spain and Portugal (phase I), but not in the UK or The Netherlands (phase II). Analysis of Pro homozygote carriers between cases and controls revealed differences in Spain (29.01-42.18 and 2.29-10.20, respectively), Portugal (10.49-29.50 and 1.35-8.89, respectively), and The Netherlands (16.49-31.70 and 4.51-15.09, respectively), but no differences in the UK (7.68-18.1 and 4.85-13.94, respectively). The odds ratio of Pro carriers from Spain and Portugal together was 8.12 (95% confidence interval [CI], 3.72-17.69; P<0.05), whereas the odds ratio of Pro carriers from the UK and The Netherlands was 2.12 (95% CI, 0.96-4.68; P = 0.07). All control samples were in Hardy-Weinberg equilibrium. Considering the entire sample, significant differences were found in genotype frequencies between cases (RR, 30.59%; RP, 43.28%; PP, 26.11% [R = Arg; P = Pro]) and controls (RR, 39.66%; RP, 52.64%; PP, 7.69%) and in Pro homozygote carriers between controls (Pro homozygote 95% CI, 18.67-33.52) and cases (Pro homozygote 95% CI, 5.1-10.2). CONCLUSIONS: Results indicate that the Pro variant of p53 codon 72 polymorphism is associated with a higher risk of PVR developing after a primary RD. Further studies are necessary to understand the role of this polymorphism in the development of PVR.

External validation of existing formulas to predict the risk of developing proliferative vitreoretinopathy: the Retina 1 Project; report 5.

PURPOSE: To externally validate the accuracy of previously published formulas for predicting proliferative vitreoretinopathy development after retinal detachment surgery. METHODS: Clinical variables from consecutive retinal detachment patients (n = 1,047) were collected from the Retina 1 Project conducted in 17 Spanish and Portuguese centers. These data were used for external validation of four previously published formulas, F1 to F4. Receiver-operating characteristic curves were used to validate the quality of formulas, and measures of discrimination, precision, and calibration were calculated for each. Concordance among the formulas was determined by Cohen kappa index. RESULTS: The areas under the receiver-operating characteristic curves were as follows: F1, 0.5809; F2, 0.5398; F3, 0.5964; and F4, 0.4617. F1 had the highest accuracy, 74.21%. Almost 19% of proliferative vitreoretinopathy cases were correctly classified by F1 compared with 13%, 15%, and 10% for F2, F3, and F4, respectively. There was moderate concordance between F2 and F3 but little between the other formulas. CONCLUSION: After external validation, none of the formulas were accurate enough for routine clinical use. To increase its usefulness, other factors besides the clinical ones considered here should be incorporated into future formulas for predicting risk of developing proliferative vitreoretinopathy.

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.

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.

Restoration of macular structure as the determining factor for macular hole surgery outcome.

OBJECTIVE: The aim of this work is to evaluate the preoperative and postoperative spectral domain optical coherence tomography (SD-OCT) findings as predictors of visual acuity for macular hole (MH) surgery. METHODS: Fifty eyes of 46 patients diagnosed with MH and that had undergone 25-g vitrectomy with internal limiting membrane peeling were included in this retrospective study. A complete clinical examination and SD-OCT were performed before and after surgery. Three groups were considered on the basis of the postoperative integrity of photoreceptor inner and outer segment (IS-OS) junction and the external limiting membrane (ELM): group A (11 eyes, both lines disrupted), group B (ten eyes, disrupted IS/OS line and complete ELM), and group C (29 eyes, both lines restored). RESULTS: LogMAR BCVA improved significantly after surgery from an average 0.60 ± 0.29 to 0.19 ± 0.19 (p < 0.01). No significant differences had been detected preoperatively among these groups (p≥0.18). Postoperative BCVA was significantly better in group C compared to groups A and B (p ≤ 0.01). A significant correlation was found between ELM restoration and postoperative BCVA (r = -0.63, p < 0.01), as well as between IS/OS line restoration and postoperative BCVA (r = -0.55, p < 0.01). CONCLUSIONS: Outer retina restoration seems to be the best determining factor for a good visual rehabilitation after MH surgery.

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.

Prevalence and causes of bilateral blindness and visual impairment among institutionalized elderly people in Pamplona, Spain.

PURPOSE: To estimate the prevalence and causes of bilateral blindness and visual impairment in an urban institutionalized population aged 65 years and older. METHODS: A total of 392 nursing home residents completed a standardized eye examination, including measurement of visual acuity (VA), intraocular pressure, lens opacity grading, indirect ophthalmoscopy, and photography of the macular area. The major causes of vision loss identified for all participants were blindness and visual impairment. RESULTS: The average subject age was 82 years (65-97); women outnumbered men 263 to 129. The prevalence of bilateral blindness (VA > or =1.0 logarithm of the minimum angle of resolution [logMAR]) was 14.9% (43/288); the prevalence of visual impairment (VA > or =0.5 and 1.0 logMAR) was 31.9% (92/288). Blindness and visual impairment increased significantly with age (p<0.05), odds ratio (OR) 1.047 and 1.088, respectively. Cataract was the most common cause of bilateral blindness and visual impairment (27.9% and 44.6%, respectively) followed by pathologic myopia (23.3%) and age-related macular degeneration (AMD) (20.9%) for blindness, and by AMD (27.2%) and pathologic myopia (12%) for visual impairment. Fifty percent of subjects with visual loss had the potential for improved vision with medical or surgical intervention. CONCLUSIONS: Although the prevalences were high, these data are important since it is difficult for epidemiologic studies to include aged, institutionalized individuals, although their numbers are increasing. Recognition of the predominant causes of visual loss dependent on age is fundamental for early diagnosis and treatment of ocular diseases. Many cases of low vision can be treated with appropriate ophthalmologic care.

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.

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.

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.

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.

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.