A four-years retrospective study: Clinical outcomes of XEN45 in patients with glaucoma.

INTRODUCTION: To evaluate the long-term effectiveness and safety of XEN45 implant, either alone or in combination with cataract surgery, in patients with glaucoma. METHODS: Retrospective and single center study conducted on consecutive patients who underwent a XEN45 implant, either alone or in combination with cataract surgery, between November 2016 and October 2021. The primary endpoint was the mean IOP lowering from preoperative values. RESULTS: Among the 230 screened patients, 206 eyes (176 patients) were included. Fifty-three (25.7%) eyes had undergone XEN-alone and 153 (74.3%) eyes had undergone a combined procedure (XEN+Phacoemulsification). The mean preoperative intraocular pressure (IOP) was significantly higher in the XEN-alone (22.2±5.9 mmHg) than in the XEN+Phaco (19.8±4.5 mmHg) group (p=0.0035). In the overall study population, the mean preoperative IOP was significantly lowered from 20.5±5.0 mmHg to 15.8±4.4 at year-4, p<0.0001. The mean preoperative (95% CI) IOP was significantly lowered from 22.2 (20.6 to 23.8) mmHg and 19.8 (19.1 to 20.6) mmHg to 15.6 (12.2 to 16.9) mmHg and 15.9 (15.2 to 16.5) mmHg at year-4 in the XEN-alone and XEN+Phaco groups, respectively (p<0.0001 each, respectively). The number of ocular hypotensive medications was significant reduced from 2.6±1.0 drugs to 1.3±1.3 drugs, with no significant differences between XEN-alone and XEN+Phaco groups (p=0.1671). On the first postoperative day, 62 (30.1%) eyes presented some type of complication. Fifteen (7.3%) eyes underwent a needling procedure. CONCLUSION: XEN45, either alone or in combination with phacoemulsification, significantly lowered the IOP and reduce the need of ocular hypotensive medication in the long-term.

Influence of inflammatory plasma biomarkers on choroidal thickness in type 2 diabetes mellitus.

PURPOSE: To assess the influence of inflammatory plasma biomarkers on choroidal thickness (CT) in patients with type 2 diabetes (T2D). METHODS: Cross-sectional study enrolling T2D patients and age-matched healthy controls (>55 years of age, Caucasian, axial length <26 mm, no macular edema, and naïve). Patients were examined with swept-source OCT Triton, obtaining automatic measurements. CT was analyzed using the ETDRS grid and the recently proposed choroidal division. A blood analysis was commanded: general biochemical profile, liver status, T2D status, thyroid and parathyroid activity, coagulation, general immunological profile, and inflammatory biomarkers. RESULTS: 124 eyes of 124 patients with a mean age between 66 and 68 years were examined. The new choroidal division showed differences between groups (p < 0.05) in more sectors than the ETDRS grid, and more biomarkers influenced these new sectors. T2D patients had higher levels of IL-8, TNF-α, MCP1, adiponectin and L-selectin. CT was influenced by TNF-α, IL-17, leukocytes and erythrocyte sedimentation rate, as well as by HDL cholesterol, albumin, liver function biomarkers, and TSH. HbA1c showed little influence on CT. CONCLUSIONS: T2D patients present increased plasma inflammatory biomarkers, exhibiting an influence on CT. IL-17 is related to a thicker choroid but TNF-α is related to a thinner choroid. HbA1c has little influence on CT. The recently proposed choroidal division is more sensitive to CT changes than the ETDRS grid. Some sectors are more sensitive to plasma biomarkers.

Macro and microangiopathy related to retinopathy and choroidopathy in type 2 diabetes.

PURPOSE: To describe the relationship between diabetic retinopathy (DR) and choroidal thickness (CT), and systemic macro and microangiopathy in patients with type 2 diabetes (T2D). METHODS: Cross-sectional study enrolling 200 eyes (100 T2D naïve patients) without macular edema. DR was graded and swept-source optical coherence tomography Triton DRI (Topcon) was used to measure CT, which gave automatic measurements in ETDRS grid. An endocrinologist examined all the patients and searched in their medical records for data about macro and microangiopathy: ischemic cardiopathy (IC), cerebrovascular accident (CVA), peripheral artery disease (PAD), nephropathy, and peripheral polyneuropathy (PPN). RESULTS: Mean age was 67.38 ± 8.15 years, mean axial length was 23.26 ± 0.09 mm, and mean IOP was 16.75 ± 3.06 mmHg. Sixty eyes had no DR, 46 had mild, 64 had moderate, 20 had severe, and 10 had proliferative DR. IC was correlated with horizontal choroidal zones (p < 0.05 and η between 0.16 and 0.21) but not with DR (p = 0.16). CVA was neither correlated with CT (p > 0.05) nor with DR (p = 0.39). PAD was not correlated with CT (p > 0.05) but it was with DR (p = 0.03). The type of nephropathy was correlated both with CT in vertical sectors (p < 0.05 and η between 0.15 and 0.27) and DR (p = 0.01, τ = 0.24). PPN was not correlated with CT (p > 0.05) but it was with DR (p = 0.03). CONCLUSIONS: DR is correlated with microangiopathy (nephropathy and PPN) but not with macroangiopathy (IC, CVA, and PAD). CT is mildly correlated with nephropathy and IC. Some choroidal regions are more sensitive than others to each diabetic macro and microvascular manifestation.

Mapping of choriocapillaris vascular density in young and aged healthy subjects.

PURPOSE: To compare macular vascular density (VD) of the choriocapillaris (CC) between young and aged healthy individuals. METHODS: A cross-sectional study was performed enrolling young and senior healthy individuals of Caucasian race and an axial length (AL) lower than 26 mm, and without systemic or ophthalmological diseases. CC VD was imaged with DRI Triton OCTA using a 6 × 6 mm macular analysis. Internal software delimited CC boundaries and gave colour pictures, which were analysed and codified into numbers, and a grid of 30 × 30 VD values was obtained. Two-dimension (2D) and three-dimension (3D) representations were created. RESULTS: 53 eyes of 53 young healthy individuals and 30 eyes of 30 senior healthy individuals were enrolled. Mean age was 27.17 ± 3.90 years, and 67.00 ± 7.41 years, respectively (p < 0.001). There were no differences in intraocular pressure (IOP) or AL (23.73 ± 0.79 mm, 23.18 ± 0.80 mm, respectively, p = 0.24). There were differences in foveal VD and in temporal perifoveal macula, but not in nasal perifoveal macula. Foveal VD was the highest in both groups. CONCLUSIONS: Foveal CC VD has been found to be considerably high with this method, and it is the area which most decreases with age. Nasal perifoveal VD is not reduced in older individuals. These outcomes are opposite to other studies using different methods but they are in line with previous histological findings.

Relationship between vascular densities of choriocapillaris and the whole choroid using OCTA.

PURPOSE: To study the vascular density (VD) of choriocapillaris and the whole choroid using optical coherence tomography-angiography (OCTA). METHODS: Cross-sectional study enrolling healthy individuals between 18 and 35 years old and with an axial length (AL) lower than 26 mm, who were examined with swept-source OCTA Triton DRI (Topcon). Color pictures of both VD were obtained from a fovea-centered 6 × 6 mm macular exam, which were divided into 900 squares and codified into numbers. RESULTS: A total of 50 patients (100 eyes) with a mean age of 27.29 ± 3.90 years and a mean AL of 23.67 ± 0.74 mm were analyzed. The highest choroidal VD was found in juxtapapillary macula, being followed by the most temporal macula and fovea. The lowest was found in superior and inferior perifoveal areas. The highest VD in choriocapillaris was in the fovea. VD in this layer was uniform, with a decrease from temporal toward nasal. Both VD differed and but correlated, especially in the fovea and in inferior-temporal macula. CONCLUSION: VD of choriocapillaris and the whole choroid are not similar. The former is maximal in the fovea, and the latter is maximal in the juxtapapillary macula. In general lines, choroidal VD is higher than that of choriocapillaris. Both VD are directly correlated.

Clinical Comparison of the Performance of Two Marketed Ophthalmic Viscoelastic Devices (OVDs): The Bacterially Derived Healon PRO OVD and Animal-Derived Healon OVD.

This clinical investigation compared the clinical performance of two marketed ophthalmic viscoelastic devices (OVDs): the bacterially derived Healon PRO OVD (test) and the animal-derived Healon OVD (control) under normal use conditions during cataract removal and lens implantation. This prospective, multicenter, randomized, parallel, participant/evaluator masked, postmarket investigation enrolled 139 subjects (170 eyes), 116 (143 eyes) of which were treated (73 test; 70 control group). Both test and control OVDs were used, at a minimum, to inflate the anterior chamber and protect the endothelium prior to cataract extraction according to the standard procedure. The surgeon completed a postsurgery OVD clinical performance questionnaire, and intraocular pressure (IOP) was measured before surgery and at the 1 day postoperative visit with Goldmann applanation tonometry. Any IOP measurement of 30 mmHg or higher was considered a "spike" and recorded as a study-specific, serious adverse event. The bacterially derived Healon PRO OVD was found to be statistically noninferior to the overall clinical performance of the animal-derived Healon OVD control; thus, the primary hypothesis was satisfied. There were no statistically significant differences between OVD groups for any of the additional endpoints relating to IOP changes or to safety, thus satisfying additional hypotheses. The Healon PRO OVD showed statistically significant improvements in surgeon ratings for ease of injectability, transparency/visibility, and ease of IOL placement. The safety profile was also similar between OVD groups with regards to serious and/or device-related adverse events, as well as medical and lens findings. The results of this clinical investigation support the safety and effectiveness of the bacterially derived, currently marketed Healon PRO OVD and indicate that the intraocular surgical performance was similar between the two OVDs.

Mapping choroidal thickness in patients with type 2 diabetes.

OBJECTIVE: To determine and compare topographic features of the choroidal thickness (CT) between patients with type 2 diabetes (T2D) and age-matched healthy controls based on swept source-optical coherence tomography (SS-OCT). DESIGN: Cross-sectional study. PARTICIPANTS: 96 T2D patients and 33 healthy individuals aged above 18 years and with an axial length (AL) lower than 26 mm were included. METHODS: A macular 6 × 6 mm cube, comprising 900 200 × 200 µm cubes, was scanned with SS-OCT. The choroid was automatically segmented using the segmentation algorithm. Three-dimensional maps were created to represent the choroid. The scanned area was divided into different zones based on CT, and equivalent zones were compared between groups. RESULTS: Mean age (standard deviation) in the control group was 66.83 (7.3) years, and that of the T2D group was 67.94 (7.9) years (p = 0.48). Both groups were similar regarding AL and spherical equivalent. Overall, CT was significantly thinner in the T2D group; it was 203.78 (53.40) in healthy individuals and 169.98 (63.22) in T2D patients (p = 0.01). Outside the fovea, the mean CT was thicker in the superior hemiretina and decreased inferiorly, temporally, and nasally, with minimum thickness in the most distant points from the fovea. CONCLUSIONS: Choroidal thickness follows an ellipsoid pattern in both nondiabetic and diabetic eyes, with diabetic eyes showing thinner measurements diffusely. Understanding these differences is important for future studies aimed at understanding the pathophysiological underpinnings of diabetic retinopathy.

Distribution of Choroidal Thinning in High Myopia, Diabetes Mellitus, and Aging: A Swept-Source OCT Study.

PURPOSE: To compare the macular choroidal thinning between young healthy, aged healthy, young high myopic, and aged type 2 diabetic (T2D) patients using the Early Treatment Diabetic Retinopathy Study (ETDRS) grid and three-dimensional (3D) maps. METHODS: A prospective study including 102 eyes of 51 healthy young subjects, 60 eyes of 30 healthy aged subjects, 24 eyes of 12 high myopic patients, and 110 eyes of 55 T2D patients. Choroidal thickness (CT) was examined with swept-source optical coherence tomography Triton DRI (Topcon Corporation, Tokyo, Japan). The choroid was automatically segmented using the software algorithm, and mean CT values of a 6 × 6 mm macular cube were exported. 3D maps were created to represent CT, and its values were compared using the ETDRS grid. RESULTS: Mean age was 27.31 ± 3.95, 66.41 ± 7.54, 27.69 ± 3.89, and 66.48 ± 7.59 years in young healthy, aged healthy, young high myopic, and T2D patients, respectively. CT was not shown to be uniform, as superior and central zones were thicker. All ETDRS sectors were always thicker (p < 0.05) in young healthy individuals than in the others. It was found that the choroidal sector which got thinner was inferior in case of age (103.28 µm decrease), inferior-nasal in high myopia (86.19 µm decrease), and temporal in T2D (55.57 µm decrease). In addition, the choroid got thinner in those regions where it was thicker in healthy subjects. CONCLUSIONS: 3D maps allow a further comprehension of choroidal changes. The choroidal pattern in young healthy individuals resembles a mountain range; with age, a mountain peak; in high myopia, an inverted gorge; and in aged T2D, gathered hills. Not all choroidal regions are affected in a similar way, as it depends on the pathology. The thicker the zone is in healthy subjects, the thinner it becomes with any pathology.