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Purpose: To investigate whether higher blood pressure and greater arterial stiffness are associated with the presence of macular cysts and whether this association is already present in the absence of micro-aneurysms in individuals with and without type 2 diabetes., Methods: Using spectral domain optical coherence tomography (OCT), we performed a macular volume scan in 2647 individuals (mean age 60 ± 8 years, 50% men, 27% type 2 diabetes). The association between macular cysts and 24-hour systolic and diastolic blood pressure, pulse pressure, mean arterial blood pressure, carotid-femoral pulse wave velocity and carotid distensibility was assessed by use of logistic regression., Results: Twenty-four hours systolic blood pressure was associated with the presence of macular cysts [OR = 1.03 (95% CI 1.00-1.05) per 1 mmHg, p = 0.03]. 24 hr pulse pressure [OR = 1.61 (95% CI 1.11-2.34) per 10 mmHg, p = 0.01] and carotid-femoral pulse wave velocity [OR = 1.16 (95% CI 1.02-1.32) per 1 m/s, p = 0.02] were associated with macular cysts, while carotid distensibility was not [OR = 1.03 (95% CI 0.96-1.11) per 1.0*10 -3 /kPa, p = 0.45]. Associations were similar in individuals with and without type 2 diabetes and were already present in the absence of micro-aneurysms., Conclusion: Twenty-four hours systolic blood pressure, 24 hr pulse pressure and carotid-femoral pulse wave velocity are associated with the presence of OCT-detected macular cysts in individuals with and without type 2 diabetes, even in the absence of micro-aneurysms. Therefore, blood pressure and aortic stiffness are potential factors contributing to macular cysts., (© 2020 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To evaluate the long-term efficacy and safety of two minimally invasive glaucoma surgery implants with a subconjunctival drainage approach: the XEN45 Gel Stent ® (Xen) implant and the PRESERFLO™ MicroShunt (MicroShunt)., Methods: Retrospective comparative case series of primary open-angle glaucoma (POAG) patients with at least 6 months of follow-up after a MicroShunt or Xen implantation augmented with mitomycin C., Results: Forty-one eyes of 31 patients underwent Xen implantation, and 41 eyes of 33 patients, MicroShunt implantation. Baseline characteristics were similar, except for more combined surgeries with phacoemulsification in the Xen group (37% vs. 2%). Mean baseline IOP ± standard deviation dropped from 19.2 ± 4.4 to 13.8 ± 3.8 mmHg (n = 26) in the Xen group and from 20.1 ± 5.0 to 12.1 ± 3.5 (n = 14) in the MicroShunt group at 24 months of follow-up (p = 0.19, t-test). The number of IOP-lowering medications dropped from 2.5 ± 1.4 to 0.9 ± 1.2 in the Xen group and from 2.3 ± 1.5 to 0.7 ± 1.1 in the MicroShunt group. The probability of qualified success was 73% and 79% at 24 months of follow-up for the Xen and MicroShunt groups, respectively. Postoperative complications were usually mild and self-limiting. The number of bleb needling and secondary glaucoma surgery procedures was similar in both groups; however, in the Xen group more additional MicroPulse ® transscleral cyclophotocoagulation procedures were performed., Conclusion: Xen Gel Stent and PreserFlo MicroShunt implantations achieved comparable results in POAG eyes in terms of IOP-lowering and surgical success, with a similar high safety profile., (© 2020 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Purpose: In individuals with diabetes, injury to the corneal nerve fibres predisposes to delayed corneal epithelial healing, reduced corneal sensitivity and corneal erosion. We investigated to what extent a reduction in corneal nerve fibre length (CNFL) is present in individuals with prediabetes or type 2 diabetes (DM2) compared with individuals with normal glucose metabolism (NGM)., Methods: Using composite images acquired by corneal confocal microscopy, we assessed total CNFL per mm 2 in the subbasal nerve plexus of the cornea in 134 participants (mean age 59 ± 8 years, 49% men, 87 NGM, 20 prediabetes, 27 DM2). Multivariable linear regression was used to assess the association between CNFL and glucose metabolism status, adjusted for age and sex., Results: In individuals with type 2 diabetes, the mean CNFL was significantly reduced [β = -1.86 mm/mm 2 (95% CI -3.64 to -0.08), p = 0.04], as compared with individuals with normal glucose metabolism after adjustment for age and sex. Part of the reduction was present in individuals with prediabetes [β = -0.96 mm/mm 2 (95% CI -2.91 to 0.99), p = 0.34], with a linear trend of corneal nerve fibre reduction with severity of glucose metabolism status (p trend = 0.04)., Conclusions: A significant reduction in CNFL was found in individuals with DM2 compared with individuals with NGM. A trend of reduction in CNFL was observed between individuals with NGM and prediabetes. The reduction in corneal nerve fibre length could contribute to a delayed corneal healing and an increased risk for corneal complications after surgery., (© 2020 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Purpose: Performing bioinformatics analyses using trabecular meshwork (TM) gene expression data in order to further elucidate the molecular pathogenesis of primary open-angle glaucoma (POAG), and to identify candidate target genes., Methods: A systematic search in Gene Expression Omnibus and ArrayExpress was conducted, and quality control and preprocessing of the data was performed with ArrayAnalysis.org. Molecular pathway overrepresentation analysis was performed with PathVisio using pathway content from three pathway databases: WikiPathways, KEGG and Reactome. In addition, Gene Ontology (GO) analysis was performed on the gene expression data. The significantly changed pathways were clustered into functional categories which were combined into a network of connected genes., Results: Ninety-two significantly changed pathways were clustered into five functional categories: extracellular matrix (ECM), inflammation, complement activation, senescence and Rho GTPase signalling. ECM included pathways involved in collagen, actin and cell-matrix interactions. Inflammation included pathways entailing NF-κB and arachidonic acid. The network analysis showed that several genes overlap between the inflammation cluster on the one hand, and the ECM, complement activation and senescence clusters on the other hand. GO analysis, identified additional clusters, related to development and corticosteroids., Conclusion: This study provides an overview of the processes involved in the molecular pathogenesis of POAG in the TM. The results show good face validity and confirm findings from histological, biochemical, genome-wide association and transcriptomics studies. The identification of known points of action for drugs, such as Rho GTPase, arachidonic acid, NF-κB, prostaglandins and corticosteroid clusters, supports the value of this approach to identify potential drug targets., (© 2019 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Purpose: To study the retinal vascular oxygen saturation in amblyopic eyes and compare them to unaffected fellow eyes and eyes of normal subjects., Methods: A total of 32 amblyopic, 24 normal and 13 fellow eyes of patients below age of 18 were enrolled in this prospective observation study. Retinal oximetry was performed using the Oxymap T1 retinal oximeter. Retinal vascular oxygen saturations and diameters were compared between amblyopic eyes, normal eyes and unaffected fellow eyes., Results: The average age was 8.6 years in the amblyopia group (M:F 16:16) and 10.9 years in the normal group (M:F 7:5; p = 0.024). Median corrected distance visual acuity in the amblyopia group was 20/50; it was 20/20 in the other groups (p < 0.001). The average arteriolar and venous saturation in the amblyopia, normal and fellow group was 84.5% (95% CI: 82.6-86.4), 83.2% (95% CI: 80.7-85.6) and 80.8% (95% CI: 78.6-82.9) and 51.9% (95% CI: 50.4-53.4), 50.8% (95% CI: 48.2-53.4) and 49.3% (95% CI: 45.7-52.9). There was no statistically significant difference between the saturation values of the amblyopia group and the controls, however, significantly higher values were found in the amblyopia group compared to the fellow group for arteriolar and venous saturations (p = 0.013; p = 0.005). Arteriolar and venous diameters showed no significant difference between groups., Conclusion: Amblyopic eyes showed higher mean oxygen saturations than the fellow eyes. This observation could be due to altered neuronal activity or could be due to a measurement artefact due to alterations in retinal reflectivity., (© 2019 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: Ophthalmologists increasingly depend on new drugs to advance their treatment options. These options are limited by restraints on reimbursements for new and expensive drugs. These restraints are put in place through health policy decisions based on cost-effectiveness analyses (CEA). Cost-effectiveness analyses need to be valid and of good quality to support correct decisions to create new treatment opportunities. In this study, we report the quality, validity and usefulness of CEAs for therapies for nAMD., Methods: A systematic review in PubMed, EMBASE and Cochrane was performed to include CEAs. Quality and validity assessment was based on current general quality criteria and on elements that are specific to the field of ophthalmology., Results: Forty-eight CEAs were included in the review. Forty-four CEAs did not meet four basic model quality and validity criteria specific to CEAs in the field of ophthalmology (both eyes analysed instead of one; a time horizon extending beyond 4 years; extrapolating VA and treatment intervals beyond trial data realistically; and including the costs of low-vision). Four CEAs aligned with the quality and validity criteria. In two of these CEAs bevacizumab as-needed (PRN) was more cost-effective than bevacizumab monthly; aflibercept (VIEW); or ranibizumab monthly or PRN. In two CEAs, ranibizumab (PRN or treat and extent) was dominant over aflibercept. In two other CEAs, aflibercept was either more cost-effective or dominant over ranibizumab monthly or PRN., Conclusion: Two of the CEAs of sufficient quality and validity show that bevacizumab PRN is the most cost-effective treatment. Comparing ranibizumab and aflibercept, either treatment can be more cost-effective depending on the assumptions used for drug prices and treatment frequencies. The majority of the published CEAs are of insufficient quality and validity. They wrongly inform decision-makers at the cost of opportunities for ophthalmologists to treat patients. As such, they may negatively influence overall patient outcomes and societal costs. For future ophthalmic treatments, CEAs need to be improved and only published when they are of sufficient quality and validity., (© 2018 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To calculate the prevalence of all vitreomacular interface (VMI) disorders and stratify according to age, sex and (pre)diabetes status., Methods: The presence of VMI disorders was assessed in 2660 participants aged between 40 and 75 years from The Maastricht Study who had a gradable macular spectral-domain optical coherence tomography (SD-OCT) volume scan in at least one eye [mean 59.7 ± 8.2 years, 50.2% men, 1531 normal glucose metabolism (NGM), 401 prediabetes, 728 type 2 diabetes (DM2, oversampled)]. A stratified and multivariable logistic regression analysis was used., Results: The prevalence of the different VMI disorders for individuals with NGM, prediabetes and DM2 was, respectively, 5.7%, 6% and 6.7% for epiretinal membranes; 6%, 9.6% and 6.8% for vitreomacular traction; 1.1%, 0.7% and 0.3% for lamellar macular holes; 0.1%, 0% and 0% for pseudoholes; 1.1%, 1.9% and 5.5% for macular cysts. None of the participants was diagnosed with a macular hole. The prevalence of epiretinal membranes, vitreomacular traction and macular cysts was higher with age (p < 0.001). Vitreomacular traction and lamellar macular holes were more frequent in women (p < 0.01). DM2 is positively associated [OR = 3.9 (95% CI 2.11-7.22, p < 0.001)] with macular cysts and negatively associated with lamellar macular holes [OR = 0.2 (95% CI 0.04-0.9, p = 0.036)] after adjustment for age and sex. The calculated prevalence of VMI disorders was 15.9%., Conclusions: The calculated prevalence of VMI disorders in individuals aged between 40 and 75 years is 15.9%. The prevalence depends on age, sex and glucose metabolism status for several types of VMI disorders., (© 2018 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.)

Purpose: To assess macular thinning in individuals with prediabetes or type 2 diabetes without diabetic retinopathy (DM2 w/o DR) compared with individuals with normal glucose metabolism (NGM)., Methods: Using spectral domain optical coherence tomography (SD-OCT), we measured macular thickness in six subfields as defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) in 1838 participants from The Maastricht Study, a population-based cohort study (mean age 59 ± 8 years, 49% men, 1087 NGM, 279 prediabetes, 472 DM2 w/o DR). Multivariable linear regression was used to assess the association between macular thickness and glucose metabolism status., Results: After adjustment for age, sex and spherical equivalent, individuals with prediabetes showed a significant decrease in pericentral superior macular thickness [β = -2.14 μm (95% confidence interval (CI): -4.24 to -0.03), p < 0.05] compared with individuals with NGM. In individuals with DM2 w/o DR, the fovea [β = -4.05 μm (95% CI: -6.30 to -1.79), p < 0.001] and the four pericentral quadrants (range: β = -4.64 to -5.29 μm, p < 0.001) were significantly thinner compared with individuals with NGM. There was a significant linear trend of macular thinning with severity of glucose metabolism status in five subfields (p < 0.001)., Conclusion: Macular thickness is reduced in prediabetes and a greater reduction occurs in DM2, even before DR is clinically present. About half of the thinning observed in DM2 w/o DR was already found in prediabetes. Generalized thinning of the macula could be related to thinning of the temporal side of the optic nerve head through the connecting papillo-macular bundle., (© 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.)

Purpose: To study the effect of patient education and the TravAlert(®) -Eyot(®) drop guider on intraocular pressure (IOP) and adherence in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) monitored with the TravAlert(®) dosing aid., Methods: Multicentre, randomized, controlled clinical trial among 18 Dutch hospitals. Patients were randomized to one of the four study arms: (1) use of the dosing aid, (2) use of the dosing aid with the drop guider, (3) use of the dosing aid together with patient education or (4) use of the dosing aid and drop guider together with patient education. IOP was recorded at baseline and after 3 and 6 months. Data on adherence generated by the dosing aid were collected and studied at the end of the study., Results: Mean IOP dropped from 20.3 ± 5.7 mmHg at baseline to 16.3 ± 4.0 mmHg (right eye) after 6 months and from 20.2 ± 5.9 mmHg to 16.4 ± 4.1 mmHg (left eye). The mean adherence rate was 0.91 ± 0.1. IOP and adherence rate were not statistically different between the study arms. Patients with 'drug holidays' had a significantly higher mean IOP after 6 months. Patients who used the drop guider were less adherent. A lower adherence level was also associated with new patients with glaucoma and patients with a lower level of knowledge on glaucoma., Conclusion: Patient education is especially useful for new patients with glaucoma. The use of a drop guider does not improve adherence. Especially patients with 'drug holidays' are at risk for developing uncontrolled IOP levels., (Copyright © 2012 Acta Ophthalmologica Scandinavica Foundation.)

Purpose: To determine the cost-effectiveness of ocular hypertension (OH) treatment initiated with latanoprost compared to timolol., Methods: Two strategies for OH therapy are modelled, (1) 'starting with timolol' and (2) 'starting with latanoprost'. Therapy can be maintained or changed dependent on the achieved intraocular pressure (IOP) and side-effects. Adjustments of therapy to reach a target pressure involve monotherapy, combination therapy and laser. Four drugs are used: latanoprost, timolol, brimonidine and dorzolamide. Once the adjustments of therapy are completed, lifelong follow-up with IOP-dependent conversion to glaucoma and progression to blindness are modelled. Direct medical costs are assigned. The IOP-lowering effect of drugs is based on meta-analyses and applied by Monte Carlo simulation to a hypothetical cohort of patients with OH. The characteristics of the cohort, including the initial IOP distribution, are based on data of 1000 patients., Results: The IOP decreased from 25,4 mm Hg (mean) to 16.7 (±0.017) mm Hg (strategy 1) and to 16.5 (±0.013) mm Hg (strategy 2). Costs per patient within 15 months of therapy were € 367 and € 469, respectively. Lifetime blindness and costs were 0.0334 years and € 3,514 (strategy 1) and 0.0318 years and € 4,397 (strategy 2). Incremental costs per year of vision saved for strategy (2) in comparison with strategy (1) amount to, given the uncertainties in the model, approximately € 537,000., Conclusion: For saving 1 year of vision, high costs are needed when OH therapy is initiated with latanoprost compared to timolol, when the cost price of latanoprost remains high., (© 2010 The Authors. Acta Ophthalmologica © 2010 Acta Ophthalmologica Scandinavica Foundation.)