Case report: Surgical management of vitreous obstruction following PreserFlo ® MicroShunt implantation.

Purpose: To describe a clinical case of lumen obstruction a few days after implantation of the PreserFlo® Microshunt which has been resolved by anterior vitrectomy. Observation: A 76-year-old patient with advanced and progressing primary open-angle glaucoma (POAG) presented ten days after PreserFlo® Microshunt implantation in his left eye with an intraocular pressure (IOP) of 24 mmHg because of vitreous obstruction. Anterior vitrectomy with 25 Gauge vitrector was performed to remove the vitreous using a bimanual technique with two corneal accesses. The surgery was successful in lowering uncontrolled IOP without device repositioning. A free lumen and a IOP in the low range of tens was observed during follow-up. Conclusions and importance: PreserFlo ® MicroShunt obstruction by vitreous in pseudophakic patient is a possible complication. Anterior vitrectomy without the need of tube repositioning was successful in lowering uncontrolled IOP.

Functional and anatomic changes between early postoperative recovery and long-term follow-up after combined epiretinal and internal limiting membrane peeling.

OBJECTIVE: To evaluate short- and long-term changes in best-corrected visual acuity (BCVA) and retinal layer thicknesses after combined epiretinal membrane (ERM) and internal limiting membrane (ILM) peeling for macular holes and symptomatic ERMs. DESIGN: Retrospective observational case series. PARTICIPANTS: Patients with ERMs or with macular holes and ERMs treated with combined ERM and ILM peeling. METHODS: Study eyes (n = 36) and healthy fellow eyes (n = 17) were evaluated using the automated segmentation of retinal layers performed by SPECTRALIS software that automatically calculated the average central retinal thickness and the average thickness in each of the individual retinal layers. The analysis was performed at 6-18 months after surgery and after 60 months. MAIN OUTCOME MEASURES: Changes in BCVA and retinal layer thicknesses determined by automated segmentation at the first and last follow-up visits. RESULTS: BCVA improved from a baseline 0.48 ± 0.25 logMAR (20/60 Snellen) to 0.18 ± 0.18 logMAR (20/30 Snellen) at the short-term postoperative examination (p < 0.0001). Between first and last follow-up visit, 5 eyes (14%) were classified as better, 28 (78%) as stable, and 3 (8%) as worse. BCVA of the control fellow eyes remained stable during the follow-up. The thicknesses of retinal layers decreased significantly (p < 0.009). At the last follow-up, the ganglion cell layer was thinner and the inner nuclear layer was thicker in the operated eyes compared with the healthy fellow eyes. CONCLUSION: Combined ERM and ILM peeling may improve BCVA in some patients. However, over a long follow-up period, it can be associated with progressive ganglion cell layer thinning that could affect BCVA stability.

MULTIMODAL IMAGING CHARACTERISTICS AND FUNCTIONAL CORRELATES IN RIP HEALING.

PURPOSE: To report the imaging and functional features of the repair tissue following retinal pigment epithelium (RPE) tears. METHODS: This cross-sectional observational study included patients with RPE tears secondary to neovascular age-related macular degeneration and at least 12 months of follow-up. The following variables were analyzed: best-corrected visual acuity; retinal sensitivity using microperimetry; outer retinal layers status and RPE resurfacing on optical coherence tomography; fibrosis; autofluorescence signal recovery using blue-light and near-infrared autofluorescence. RESULTS: Overall, 48 eyes were included (age: 82 ± 5 years) and 34 of them showed signs of healing. Retinal pigment epithelium resurfacing was noticed in 22 cases, whereas fibrosis appeared in 21 eyes. Autofluorescence improved in 17 cases using blue-light infrared autofluorescence and 7 eyes on near-infrared autofluorescence. Outer retinal layers were more frequently preserved when RPE resurfacing and autofluorescence improvement occurred ( P < 0.05). Although best-corrected visual acuity was higher for smaller RPE tears ( P = 0.01), retinal sensitivity of the healing tissue was positively affected by autofluorescence improvement ( P < 0.001) and by absence of fibrosis ( P = 0.03). CONCLUSION: Autofluorescence signal recovery after rip occurrence possibly reflects the underlying status of the RPE and is associated with better functional outcomes. Our findings highlight the importance of blue-light infrared autofluorescence and especially near-infrared autofluorescence assessment in the setting of rip healing.

Six Drivers to Face the XXI Century Challenges and Build the New Healthcare System: "La Salute in Movimento" Manifesto.

The aging of the population, the burden of chronic diseases, possible new pandemics are among the challenges for healthcare in the XXI century. To face them, technological innovations and the national recovery and resilience plan within the European Union can represent opportunities to implement changes and renovate the current healthcare system in Italy, in an effort to guarantee equal access to health services. Considering such scenario, a panel of Italian experts gathered in a multidisciplinary Think Tank to discuss possible design of concepts at the basis of a new healthcare system. These ideas were summarized in a manifesto with six drivers for change: vision, governance, competence, intelligence, humanity and relationship. Each driver was linked to an action to actively move toward a new healthcare system based on trust between science, citizens and institutions.

Clinical Evaluation of an Instrument-Integrated OCT-Based Distance Sensor for Robotic Vitreoretinal Surgery.

Purpose: To assess the efficacy of an instrument-integrated OCT (iiOCT)-based distance sensor during robotic vitreoretinal surgery using the Preceyes Surgical System (PSS; Preceyes B.V.). Design: Single-center interventional study. Participants: Patients requiring vitreoretinal surgery. Methods: Five patients were enrolled. Standard preoperative OCT images were obtained. After vitrectomy, a predefined set of actions was performed using the iiOCT-based sensor. Images then were processed to assess the signal-to-noise ratio (SNR) at various angles to the retina and at different distances between the instrument tip and the retinal surface. Preoperative and intraoperative OCT images were compared qualitatively and quantitatively. Main Outcomes Measures: The feasibility in performing surgical tasks using the iiOCT-based sensor during vitreoretinal surgery, the SNR when imaging the retina, differences among intraoperative and preoperative OCT images, and characteristics of intraoperative retinal movements detected with the iiOCT-based probe. Results: Surgeons were able to perform all the tasks but one. The PSS was able to maintain a fixed distance. The SNR of the iiOCT-based sensor signal was adequate to determine the distance to the retina and to control the PSS. Analysis of iiOCT-based sensor A-scans identified 3 clearly distinguishable retinal layers, including the inner retinal boundary and the interface at the retinal pigment epithelium-Bruch's membrane. Thickness values differed by less than 5% from that measured by preoperative OCT, indicating its accuracy. The Fourier analysis of iiOCT-based sensor recordings identified anteroposterior retinal movements attributed to heartbeat and respiration. Conclusions: This iiOCT-based sensor was tested successfully and promises reliable use during robot-assisted surgery. An iiOCT-based sensor is a promising step toward OCT-guided robotic retinal surgery.

Sutureless scleral fixation: comparison between 3-piece IOL and new single-piece foldable IOL.

PURPOSE: Comparing two different sutureless scleral fixation techniques. METHODS: A retrospective study of patients who underwent sutureless scleral fixation IOL from October 2013 to May 2018 at "Luigi Sacco Hospital", University of Milan. Comparison between two groups: Group 1 implanted with a 3-piece ALCON-MA60AC and group 2 implanted with a newly developed single-piece foldable IOL SOLEKO FIL-SSF. Patients underwent a complete preoperative ophthalmic assessment and post-operative evaluation at 1, 3, and 6 months. Vitrectomy was performed in all cases. The two groups were compared for age, axial length, and lens status at baseline. Visual acuity, refractive results, surgical time, and post-operative complications were recorded. RESULTS: Thirty-one eyes were included: group 1, 15 eyes of 15 patients, and group 2, 16 eyes of 14 patients. No difference was found in visual acuity. Mean refractive error was 1D in both groups (group 1 1.01D, group 2 1.09D), but spherical equivalent was more often moved toward negative values and induced astigmatism was greater in the 3-piece group (group 1 1.91D [SD ± 2.07], group 2 0.67D [SD ± 0.88] P = 0.04). Surgical procedure was faster in group 2 (mean time difference 21', P = 0.01*). New displacement occurred in 5 cases (33%) of group 1 and in no cases of group 2 (P = 0.01*). Post-operative bleeding was registered only in group 1 (20%), but the difference was not statistically significant. CONCLUSIONS: The group 2 IOL gives in our sample better results due to less post-operative astigmatism and reducing dislocation and bleeding during follow-up. Surgical technique appeared easier and faster: the specifically designed IOL seems to be a feasible solution for sutureless scleral fixation.

Evaluation of the ocular fluid dynamic effects on intraocular magnesium-based device: A comparison between CFD and FSI approaches.

Magnesium is an essential element for the ocular functions and used for the realization of medical devices due to its low corrosion resistance, bioresorbable nature and biocompatibility. Wet age-related macular degeneration is one of the main causes of blindness with patients treated by intravitreal injections of inhibitor drugs. According to the need to reduce the number of injections, the development of new drug delivery devices able to extend the therapeutical outcomes is mandatory and magnesium can be considered as a promising candidate. The aim of the work concerns the evaluation of the ocular fluid dynamic role on a magnesium-based device placed in the vitreous chamber. Particularly, the fluid-induced shear stress field on the surfaces in contact with the liquefied vitreous was studied. Both computational fluid dynamic and fluid-structure interaction approaches were proposed and then compared. Saccadic motion was implemented to recreate the vitreous fluid dynamics. High changes in terms of fluid-induced shear stress field varying the CFD and FSI numerical approaches and kinematic parameters of the saccadic function can be noticed. The comparison between CFD and FSI approaches showed minor significant differences and both implementations suggested the possibility to obtain a uniform and controlled corrosion of the device.

A drug delivery analysis of large molecules in ocular vitreous chamber: Dependency on saccadic movements after intravitreal injection.

The purpose of this study is to investigate the effect of vitreous sloshing induced by saccades on the intravitreal delivery of large molecule drugs. The vitreous body was considered in its age-related liquefaction condition. Fluid dynamics and large molecule distribution were described by the coupling of mass conservation's and Fick's laws with continuity and momentum equations for a Newtonian incompressible fluid in a 3D unsteady analysis. Two injection sites were analyzed, in both the mixing effect of a 50° periodic saccade leads to uniform drug distribution in 30 s of simulation, the initial bolus site being left after 3 s of simulation. In absence of saccadic movements, the dominant transport contribution is the diffusive one and large molecules hardly reach their uniform distribution inside the vitreous cavity. A model describing the intravitreal distribution of large molecules in presence of saccades was developed, improving the understanding of drug transport mechanism after an intravitreal injection and highlighting how advection contribution enhances its distribution in the vitreous chamber.

A Combined Approach for the Analysis of Ocular Fluid Dynamics in the Presence of Saccadic Movements.

One of the main ocular diseases is age-related macular degeneration, actually treated with antibodies injections into the eye. This problem has been faced by computational approaches, taking into account either the influence of the tissues surrounding the vitreous, or the saccades. The aim of this work is to propose a combined fluid dynamic model of the vitreous chamber that analyses the impact of the saccades on the fluid dynamic mechanisms. The ocular vitreous humor was modeled considering liquefaction occurring in presence of age-related macular degeneration. We identified two kinds of boundary conditions, one related to the physiological environment outside the chamber, and one related to the saccades. The scleral hydraulic conductivity was evaluated by means of experimental permeability tests. An exponential decay was used to describe the trend of the scleral hydraulic conductivity with the acting pressure drop. The streamline analysis shows two main stagnant regions on the equatorial plane and peculiar fluid dynamics in absence of saccades. This study demonstrates the major role played by the saccades in determining the fluid dynamic mechanisms inside the vitreous chamber of the eye and represents a powerful tool to investigate vitreous dynamics and its relation to clinical issues.

Imaging of tangential traction types in lamellar macular holes.

PURPOSE: To determine the best imaging procedure for the definition of tangential tractions generated by epiretinal membranes in lamellar macular holes. METHODS: Inclusion criteria were a diagnosis of lamellar macular hole with tractional epiretinal membranes based upon fundus autofluorescence (FAF), and spectral-domain optical coherence tomography (SD-OCT) imaging (HRA + OCT Spectralis, Heidelberg Engineering, Heidelberg, Germany). Tangential tractions were evaluated with infrared reflectance (IR; 820 nm) and OCT en face (193 B-scans, 30 × 20°pattern size, 31 µm between two consecutive B-scans). Three different categories of tangential traction were previously defined: 1) unidirectional, 2) pluridirectional, and 3) concentric. Two independent masked physicians evaluated the images in order to categorize the type of tangential traction either with IR and OCT (en face) for every single patient. Cohen's kappa statistic was used to evaluate inter-observer and inter-instrument agreement. RESULTS: Twenty eyes of 19 patients were included in the study. Inter-observer OCT test showed almost perfect agreement between examiners (κ = 0.86). Inter-observer IR test showed substantial agreement (κ = 0.7). Inter-instrument agreement was fair for both observers, respectively κ = 0.35 for observer 1 and κ = 0.22 for observer 2. Intra-observer agreement was almost perfect for OCT (κ = 0.93) and substantial for IR (κ = 0.78). CONCLUSION: Tangential traction associated with epiretinal membranes in lamellar macular holes can be successfully evaluated by OCT en face and IR reflectance. Inter-observer concordance is high for both instruments. However, high inter-instrument discordance is present. Therefore, the gold standard imaging technique for differentiating the different types of contraction in epiretinal membranes has still to be determined.

Long-term follow-up of fellow eye in patients with lamellar macular hole.

BACKGROUND: To evaluate macular changes in fellow eyes of patients diagnosed with lamellar macular hole (LMH) using spectral-domain optical coherence tomography (SD-OCT) and blue fundus autofluorescence (B-FAF). METHODS: Fellow eyes of patients diagnosed with a LMH were retrospectively evaluated on OCT. Best-corrected visual acuity (BCVA) and central foveal thickness (CFT) were recorded. Corresponding B-FAF images, vitreo-macular relations, and type of epiretinal membranes (ERMs) were also examined. RESULTS: Thirty-five patients were included. At baseline, six fellow eyes (17%) showed a normal foveal profile, 26 (74%) had a tractional ERM, and three cases (9%) revealed a bilateral LMH, one of them with a lamellar hole-associated epiretinal proliferation (LHEP). A posterior vitreous detachment (PVD) was present in 29 patients (83%), four (11%) had only a vitreo-papillary adhesion (VPA), and two (6%) had both vitreo-macular adhesion (VMA) and VPA. After a mean follow-up of 4.6 ± 1.9 years, one eye (3%) developed a vitreous detachment from the macula with persistent VPA, and one developed a PVD from a VPA with subsequent ERM formation. BCVA and mean CFT remained stable in 35 eyes (100%). Likewise, no B-FAF signal variations were detected. One patient developed a LMH during the 3rd year of follow-up. CONCLUSIONS: Our data suggest that the presence of a LMH in one eye does not increase significantly the risk of developing the same condition in the fellow eye after 4 years. Bilateral condition is uncommon, and an ERM is often detected in the fellow eye. LHEPs were not observed in fellow eyes with foveal integrity, and all LHEPs observed (in main and fellow eyes) were always associated with LMHs; this supports the hypothesis that LHEP is a consequence and not a causative factor for LMHs. The occurrence of a LMH in one fellow eye after 3 years follow-up may suggest that a higher incidence of bilateral disease could develop in a longer time span.

Dark Atrophy: An Optical Coherence Tomography Angiography Study.

PURPOSE: To assess the status of choriocapillaris in eyes with macular atrophy secondary to age-related macular degeneration (AMD) (geographic atrophy [GA]) and Stargardt disease (STGD) using optical coherence tomography angiography (OCTA). DESIGN: Prospective, observational case series. PARTICIPANTS: A total of 14 patients (20 eyes) affected by GA and 10 patients (20 eyes) affected by STGD. METHODS: Each patient underwent a complete ophthalmological examination including fundus autofluorescence (FAF), dynamic simultaneous fluorescein angiography (FA) and indocyanine green angiography (ICGA), enhanced-depth imaging optical coherence tomography (EDI-OCT) (HRA+OCT Spectralis, Heidelberg Engineering, Heidelberg, Germany), and OCTA using AngioVue technologies (Optovue Inc, Freemont, CA). MAIN OUTCOME MEASURES: An evaluation of the status of choriocapillaris in the 2 groups was performed. RESULTS: Patients' mean age was 75 years for subjects with GA (median, 76 years; range, 63-88 years) and 61 years for STGD (median, 62 years; range, 40-74 years). Atrophy was bilateral in 42% (n = 6) of subjects with GA and 100% (n = 10) of subjects with STGD. In the early frames, FA displayed hyperfluorescence in the atrophic area in 100% (n = 20) of eyes affected by GA and 20% (n = 4) of eyes affected by STGD; dark choroid was present in 0% of GA eyes and 65% of STGD eyes (n = 13). Atrophy in ICGA late frames was hypofluorescent in 20% (n = 4) of GA eyes and 100% (n = 20) of STGD eyes. A ring at atrophy margins was detected in both FA (90%, n = 18) and ICGA (100%, n = 20) in STGD eyes. Mean subfoveal choroidal thickness was 156 µm (147, 42-362 µm) for GA eyes and 168 µm (167, 55-320 µm) for STGD eyes (P = 0.59). At OCTA evaluation, GA eyes showed persisting, rarefied choriocapillaris in correspondence of retinal pigment epithelium (RPE) atrophy in 80% (n = 16) of cases, whereas eyes affected by STGD had disappearance of this tissue in 100% (n = 20; P < 0.0001). CONCLUSIONS: Analysis of macular atrophy by OCTA in patients with STGD revealed an extensive loss of choriocapillaris in the central area with persisting tissue at its margins, whereas in those with GA the area of RPE loss showed persistent but rarefied choriocapillaris.

Key drivers of visual acuity gains in neovascular age-related macular degeneration in real life: findings from the AURA study.

BACKGROUND/AIMS: To identify predictive markers for the outcomes of anti-vascular endothelial growth factor therapy for neovascular age-related macular degeneration (nAMD). METHODS: AURA was a retrospective, observational, multicentre study that monitored the 2-year outcomes following intravitreal ranibizumab treatment in patients with nAMD. Using stepwise regression analysis, we evaluated the association between visual acuity outcomes, baseline characteristics and resource utilisation in order to determine which variables are significantly linked to outcomes in AURA. We also examined the relationship between visual acuity outcomes and number of injections received. RESULTS: Analyses were performed using data from year 1 (n=1695) and year 2 completers (n=1184). Logistic analysis showed that baseline visual acuity score, age at start of therapy, number of ophthalmoscopies and optical coherence tomography (OCT) (combined) and number of injections (ranibizumab) were significant (p<0.05) prognostic factors for vision maintenance (loss <15 letters) or vision gain (≥15 letters). Patients who received >7 injections (in 1 year) or >14 injections (over 2 years) gained more letters and demonstrated greater vision maintenance (loss of <15 letters) than patients who received fewer injections. There was a significant (p<0.05) association between number of injections and national reimbursement schemes and OCT. CONCLUSIONS: A number of factors that are predictive of treatment outcomes in a real-life setting were identified. Notably, the decline of treatment benefits may be linked to number of injections and a failure to visit clinicians and receive OCT as required. These findings may be helpful in guiding ophthalmologist treatment decisions under limited time and financial constraints. TRIAL REGISTRATION NUMBER: NCT01447043.

Surgery for CNV and autologous choroidal RPE patch transplantation: exposing the submacular space.

BACKGROUND: To evaluate the feasibility of transplanting a full-thickness patch of choroid, choriocapillaries, Bruch's membrane and RPE (RPE-choroid FTAP) from the peripheral to the subfoveal area of the same eye, after performing a 180 degrees peripheral retinotomy and removing subfoveal choroidal neovascularization. Thereafter, to study the surgical complications, anatomical outcome and patch perfusion during follow-up. METHODS: A retrospective case series of 13 eyes of 13 consecutive patients with a follow-up of 4 to 20 months. All patients suffered from advanced subfoveal choroidal neovascularization and were non-responders to standard care. After performing a complete vitrectomy, a 180 degrees peripheral temporal retinotomy and the removal of subfoveal neovascularization, a FTAP of choroid, choriocapillaris, Bruch's membrane and the RPE were isolated from the mid periphery of the uveal bed, transpositioned under the fovea and covered with the retina. Patients received a complete ophthalmic examination, fluorescein angiography (FA), indocyanin green angiography (ICGA) and optical coherence tomography (OCT) during follow-up. RESULTS: An FTAP could be harvested in every eye and transplanted under the fovea. No intraoperative complications occurred. The FTAP was recognizable at FA, ICGA and OCT at each time point, up to 20 months postoperatively. Perfusion of the choroidal bed were observed into the FTAP during follow-up, from one week after surgery. CONCLUSION: The creation of an FTAP through a 180 degrees peripheral retinotomy is feasible and safe. The FTAP is vital and perfused. Further studies are needed to collect more data.