POLYPOIDAL LESIONS ASSOCIATED WITH CHOROIDAL NEVI.

PURPOSE: To investigate eyes with polypoidal lesions associated with choroidal nevi, their multimodal imaging characteristics, and long clinical follow-up. METHODS: Multicenter, retrospective case series study of patients with polypoidal lesions overlying choroidal nevi. Demographic and clinical information were recorded. Multimodal imaging including color fundus photography, optical coherence tomography, optical coherence tomography angiography, fundus fluorescein angiography, indocyanine angiography, and A- and B-scan ultrasonography were analyzed for nevus and polypoidal lesion characteristics. RESULTS: Fourteen eyes (14 patients; mean age: 70.3 ± 6.7 years) with polypoidal lesions overlying choroidal nevi were included. The mean follow-up duration was 50.0 ± 27.9 months (range 12-108). All nevi were pigmented on color fundus photography, flat on ultrasonography with a mean basal diameter of 3.8 ± 0.4 mm. In all but one eye, optical coherence tomography showed a shallow irregular pigment epithelium detachment overlying the nevus. A total of 11/14 eyes (78.6%) had exudative activity, 9 eyes received intravitreal anti-vascular endothelial growth factor injections, and one eye required intravitreal anti-vascular endothelial growth factor combined with photodynamic therapy. Mean visual acuity was 20/32 at baseline and 20/50 at final visit. CONCLUSION: We present the largest known cohort of eyes with polypoidal lesions associated with choroidal nevi with up to 9 years follow-up. The exudative degree of the polypoidal lesion in this condition is variable and treatment decisions should be taken on an individual basis. We hypothesize that choroidal ischemia because of altered choroidal vasculature rather than Haller layer hyperpermeability plays a role in the formation of polypoidal lesions overlying nevi.

[LOWER EYELID BLEPHAROPLASTY].

INTRODUCTION: Eyelid blepharoplasty, including lower eyelid blepharoplasty, are among the most common aesthetic surgeries recently performed. In contrast to upper eyelid blepharoplasty, lower eyelid blepharoplasty is a surgery with mostly an aesthetic indication, in which patients bear all associated costs, and their expectations rise accordingly. Nevertheless, the complexity of the anatomy, the differences in the aging processes of the face and eyelids between patients, the diversity of surgical methods, and the expectations gap make the surgery more challenging in comparison to upper eyelid blepharoplasty. A comprehensive understanding of the eyelid anatomy and the surrounding tissues, as well as matching expectations alongside with thorough preoperative evaluation, are all essential for providing a more personal adjustment of the surgical method and avoiding complications and mental distress for both patients and surgeons. This article briefly reviews the anatomy and aging processes of the lower eyelids, the main surgical approaches, and their common complications. Moreover, we present a framework for how such complications can be avoided.

[OPHTHALMOLOGY - ON THE TIP OF THE SPEAR].

INTRODUCTION: Ophthalmology is a broad branch of medicine, which includes an extensive range of sub-specialties on one hand, and interfaces with other fields of medicine on the other. This issue contains papers from different sub-specialties of ophthalmology, that together cover several of the most important issues in this field. These papers present the topics in a manner compatible with the wide readership of the journal, and touch upon the most current updates and innovations. The original articles in this issue deal with treatments for the prevention of myopia progression in children, treatment of complicated cases of retinal detachment in children, ocular manifestations of vascular abnormalities in patients with coronavirus, and a series of patients with corneal damage due to ultraviolet-C (UVC) lamps intended to clear the air of this virus. The review papers describe glaucoma and the current change in its treatment paradigm, which focuses on earlier intervention, ocular manifestations of systemic autoimmune diseases, and the possibilities for artificial corneal implantation. We hope that this special issue will be of interest and clinical value to its readers.

Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials.

BACKGROUND: To reduce treatment burden and optimise patient outcomes in diabetic macular oedema, we present 1-year results from two phase 3 trials of faricimab, a novel angiopoietin-2 and vascular endothelial growth factor-A bispecific antibody. METHODS: YOSEMITE and RHINE were randomised, double-masked, non-inferiority trials across 353 sites worldwide. Adults with vision loss due to centre-involving diabetic macular oedema were randomly assigned (1:1:1) to intravitreal faricimab 6·0 mg every 8 weeks, faricimab 6·0 mg per personalised treatment interval (PTI), or aflibercept 2·0 mg every 8 weeks up to week 100. PTI dosing intervals were extended, maintained, or reduced (every 4 weeks up to every 16 weeks) based on disease activity at active dosing visits. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Efficacy analyses included the intention-to-treat population (non-inferiority margin 4 Early Treatment Diabetic Retinopathy Study [ETDRS] letters); safety analyses included patients with at least one dose of study treatment. These trials are registered with ClinicalTrials.gov (YOSEMITE NCT03622580 and RHINE NCT03622593). FINDINGS: 3247 patients were screened for eligibility in YOSEMITE (n=1532) and RHINE (n=1715). After exclusions, 940 patients were enrolled into YOSEMITE between Sept 5, 2018, and Sept 19, 2019, and 951 patients were enrolled into RHINE between Oct 9, 2018, and Sept 20, 2019. These 1891 patients were randomly assigned to faricimab every 8 weeks (YOSEMITE n=315, RHINE n=317), faricimab PTI (n=313, n=319), or aflibercept every 8 weeks (n=312, n=315). Non-inferiority for the primary endpoint was achieved with faricimab every 8 weeks (adjusted mean vs aflibercept every 8 weeks in YOSEMITE 10·7 ETDRS letters [97·52% CI 9·4 to 12·0] vs 10·9 ETDRS letters [9·6 to 12·2], difference -0·2 ETDRS letters [-2·0 to 1·6]; RHINE 11·8 ETDRS letters [10·6 to 13·0] vs 10·3 ETDRS letters [9·1 to 11·4] letters, difference 1·5 ETDRS letters [-0·1 to 3·2]) and faricimab PTI (YOSEMITE 11·6 ETDRS letters [10·3 to 12·9], difference 0·7 ETDRS letters [-1·1 to 2·5]; RHINE 10·8 ETDRS letters [9·6 to 11·9], difference 0·5 ETDRS letters [-1·1 to 2·1]). Incidence of ocular adverse events was comparable between faricimab every 8 weeks (YOSEMITE n=98 [31%], RHINE n=137 [43%]), faricimab PTI (n=106 [34%], n=119 [37%]), and aflibercept every 8 weeks (n=102 [33%], n=113 [36%]). INTERPRETATION: Robust vision gains and anatomical improvements with faricimab were achieved with adjustable dosing up to every 16 weeks, demonstrating the potential for faricimab to extend the durability of treatment for patients with diabetic macular oedema. FUNDING: F Hoffmann-La Roche.

Artificial intelligence for home monitoring devices.

PURPOSE OF REVIEW: Home monitoring in ophthalmology is appropriate for disease stages requiring frequent monitoring or rapid intervention, for example, neovascular age-related macular degeneration (AMD) and glaucoma, where the balance between frequent hospital attendance versus risk of late detection is a constant challenge. Artificial intelligence approaches are well suited to address some challenges of home monitoring. RECENT FINDINGS: Ophthalmic data collected at home have included functional (e.g. perimetry), biometric (e.g. intraocular pressure), and imaging [e.g. optical coherence tomography (OCT)] data. Potential advantages include early detection/intervention, convenience, cost, and visual outcomes. Artificial intelligence can assist with home monitoring workflows by handling large data volumes from frequent testing, compensating for test quality, and extracting useful metrics from complex data. Important use cases include machine learning applied to hyperacuity self-testing for detecting neovascular AMD and deep learning applied to OCT data for quantifying retinal fluid. SUMMARY: Home monitoring of health conditions is useful for chronic diseases requiring rapid intervention or frequent data sampling to decrease risk of irreversible vision loss. Artificial intelligence may facilitate accurate, frequent, large-scale home monitoring, if algorithms are integrated safely into workflows. Clinical trials and economic evaluations are important to demonstrate the value of artificial intelligence-based home monitoring, towards improved visual outcomes.

The impact of artificial intelligence on retinal disease management: Vision Academy retinal expert consensus.

PURPOSE OF REVIEW: The aim of this review is to define the "state-of-the-art" in artificial intelligence (AI)-enabled devices that support the management of retinal conditions and to provide Vision Academy recommendations on the topic. RECENT FINDINGS: Most of the AI models described in the literature have not been approved for disease management purposes by regulatory authorities. These new technologies are promising as they may be able to provide personalized treatments as well as a personalized risk score for various retinal diseases. However, several issues still need to be addressed, such as the lack of a common regulatory pathway and a lack of clarity regarding the applicability of AI-enabled medical devices in different populations. SUMMARY: It is likely that current clinical practice will need to change following the application of AI-enabled medical devices. These devices are likely to have an impact on the management of retinal disease. However, a consensus needs to be reached to ensure they are safe and effective for the overall population.

Current status and practical considerations of artificial intelligence use in screening and diagnosing retinal diseases: Vision Academy retinal expert consensus.

PURPOSE OF REVIEW: The application of artificial intelligence (AI) technologies in screening and diagnosing retinal diseases may play an important role in telemedicine and has potential to shape modern healthcare ecosystems, including within ophthalmology. RECENT FINDINGS: In this article, we examine the latest publications relevant to AI in retinal disease and discuss the currently available algorithms. We summarize four key requirements underlining the successful application of AI algorithms in real-world practice: processing massive data; practicability of an AI model in ophthalmology; policy compliance and the regulatory environment; and balancing profit and cost when developing and maintaining AI models. SUMMARY: The Vision Academy recognizes the advantages and disadvantages of AI-based technologies and gives insightful recommendations for future directions.

Future perspectives for treating patients with geographic atrophy.

PURPOSE: Geographic atrophy (GA) is a late-stage form of age-related macular degeneration (AMD) characterized by the expansion of atrophic lesions in the outer retina. There are currently no approved pharmacological treatments to prevent or slow the progression of GA. This review describes the progression and assessment of GA, predictive imaging features, and complement-targeting investigational drugs for GA. METHODS: A literature search on GA was conducted. RESULTS: Expansion of atrophic lesions in patients with GA is associated with a decline in several measures of visual function. GA lesion size has been moderately associated with measures obtained through microperimetry, whereas GA lesion size in the 1-mm diameter area centered on the fovea has been associated with visual acuity. Optical coherence tomography (OCT) can provide 3-dimensional quantitative assessment of atrophy and is useful for identifying early atrophy in GA. Features that have been found to predict the development of GA include certain drusen characteristics and pigmentary abnormalities. Specific OCT features, including hyper-reflective foci and OCT-reflective drusen substructures, have been associated with AMD disease progression. Lesion characteristics, including focality, regularity of shape, location, and perilesional fundus autofluorescence patterns, have been identified as predictors of faster GA lesion growth. Certain investigational complement-targeting drugs have shown efficacy in slowing the progression of GA. CONCLUSION: GA is a progressive disease associated with irreversible vision loss. Therefore, the lack of treatment options presents a significant unmet need. OCT and drugs under investigation for GA are promising future tools for disease management.

The ideal intravitreal injection setting: office, ambulatory surgery room or operating theatre? A narrative review and international survey.

PURPOSE: This study reviews evidence and provides recommendations for the ideal setting of intravitreal injection (IVI) administration of vascular endothelial growth factor (VEGF) inhibitors. METHODS: A multi-step approach was employed, including content analysis of regulations and guidelines, a systematic literature review, and an international survey assessing perioperative complications and endophthalmitis incidence in relation to injection settings. The literature review searched PubMed and Cochrane databases from 2006 to 2022, focusing on studies reporting correlations between complications and treatment settings. The survey utilized a web-based questionnaire distributed to clinical sites and the international ophthalmic community, with data managed using electronic capture tools. RESULTS: We reviewed regulations and guidelines from 23 countries across five continents, finding significant variation in IVI administration settings. In most countries, IVI is primarily administered in outpatient clean rooms (96%) or offices (39%), while in others, it is restricted to ambulatory surgery rooms or hospital-based operating theatres (4%). The literature review found that endophthalmitis risk after IVI is generally low (0.01% to 0.26% per procedure), with no significant difference between office-based and operating room settings. The international survey (20 centers, 96,624 anti-VEGF injections) found low overall incidences of severe perioperative systemic adverse events and endophthalmitis, independent of injection settings. CONCLUSION: No significant differences in perioperative complications were observed among various settings, including operating theatres, ambulatory surgery rooms, offices, hospitals, or extra-hospital environments. Choosing the appropriate clinical setting can optimize patient management, potentially increasing effectiveness, quality, productivity, and capacity.

Postponed care due to COVID-19 lockdown impact on visual acuity of retinal vein occlusion patients: a large cohort.

PURPOSE: To evaluate the impact of postponed care attributed to coronavirus disease (COVID-19) pandemic lockdowns on visual acuity and the number of anti-VEGF injections in patients with retinal vein occlusion (RVO). METHODS: A multicenter, retrospective study of consecutive RVO patients previously treated with anti-VEGF injections, which compared data from pre- (2019) and during (2020) COVID-19 lockdown period. RESULTS: A total of 814 RVO patients with a mean age of 72.8 years met the inclusion criteria. Of them, 439 patients were assessed in 2019 and 375 in 2020. There was no significant difference between the COVID-19 and pre-COVID-19 period in terms of baseline and final BCVA (p = 0.7 and 0.9 respectively), but there was a significantly reduced mean number of anti-VEGF injections during the COVID-19 period (5.0 and. 5.9 respectively, p < 0.01), with a constant lower ratio of injections per patient. A noticeable decline was found during March-May (p < 0.01) in 2020. Baseline BCVA (0.69, p < 0.01) and the number of injections (- 0.01, p = 0.01) were predictors of final BCVA. CONCLUSIONS: In a large cohort of RVO patients, during 2020 lockdowns imposed due to the COVID-19 pandemic, a significant reduction in the annual number of anti-VEGF injections was noted. The postponed care did not result in a significant impact on the final BCVA. Baseline BCVA and the number of annual injections serve as predictors for final BCVA in RVO patients.

Functional and anatomical outcomes of fovea on, fovea off and fovea-splitting rhegmatogenous retinal detachment.

PURPOSE: To compare the anatomical and functional outcomes of fovea-on, fovea-off, and fovea-split rhegmatogenous retinal detachment (RRD). METHODS: Retrospective case series of consecutive patients diagnosed with RRD and treated with only pars plana vitrectomy (PPV). Preoperative and postoperative optical coherence tomography (OCT) and functional outcomes were obtained prior to and 6 months after surgery. RRD extending to the edge of the fovea on OCT was termed fovea-split RRD. RESULTS: A total of 152 eyes were included, out of which 89 eyes presented with a fovea-off, 36 with a fovea-on, and 27 with a fovea-split RRD. The mean visual acuity (VA) preoperatively was 1.32 ± 0.58 logMAR (20/400 equivalent on Snellen chart), 0.19 ± 0.20 (20/30), and 0.71 ± 0.56 (20/100) for the fovea-off, fovea-on, and fovea-split groups, respectively (p < 0.001). The mean VA at 6 months of follow-up significantly improved for the fovea-split and fovea-off groups to 0.54 ± 0.79 (20/70) (p < 0.001) and 0.45 ± 0.29 (20/50) (p = 0.01), respectively, and remained stable for the fovea-on group 0.24 ± 0.20 (20/30) (p = 0.25). Differences in alterations of the outer retinal layers (p < 0.001) and in the in-segment/outer-segment ratio (p < 0.001) were found between the groups. CONCLUSION: Eyes with fovea-split RRD had both a preoperative and a final postoperative VA between those of fovea-on and fovea-off eyes and different anatomical changes on OCT. This new entity warrants different patient expectations for postoperative outcomes.

COVID-19 Pandemic Lockdowns' Impact on Visual Acuity of Diabetic Macular Edema: A Large Cohort.

INTRODUCTION: The objective of this study was to evaluate the impact of unplanned treatment gap, secondary to COVID-19 pandemic lockdowns, on visual acuity in previously treated diabetic macular edema (DME) patients. METHODS: A multicenter, retrospective study of DME patients, previously treated with anti-VEGF injections, who were followed up during COVID-19 pandemic (2020) compared to pre-CO-VID-19 period (2019). RESULTS: A total of 634 DME patients with a mean age of 68.4 years met the inclusion criteria, 385 were assessed in 2019 (pre-COVID-19) and 239 patients assessed in 2020 (COVID-19). Baseline best corrected visual acuity (BCVA) among patients in 2019 and 2020 was 0.52 ± 0.44, 0.45 ± 0.43 (logarithm of the minimal angle of resolution, respectively). There was no significant difference between the years 2020 and 2019 in baseline BCVA (p = 0.07). Mean number of anti-VEGF injections was significantly lower (5 vs. 6, p < 0.01), with a major lower ratio of injections per patient in the COVID-19 first lockdown period (March-June 2020) in the COVID-19 group. Baseline BCVA (p < 0.01) was the only significant predictor of final BCVA. Number of injections, age, gender, and the year were not found as predictors of final BCVA. CONCLUSIONS: In a large cohort of DME patients, an unplanned delay in treatment with anti-VEGF injections for 2-3 months, due to COVID-19 pandemic lockdown, had no significance impact on visual acuity. For most patients, returning to routine treatment regimen was sufficient for maintaining BCVA.

From Data to Deployment: The Collaborative Community on Ophthalmic Imaging Roadmap for Artificial Intelligence in Age-Related Macular Degeneration.

OBJECTIVE: Health care systems worldwide are challenged to provide adequate care for the 200 million individuals with age-related macular degeneration (AMD). Artificial intelligence (AI) has the potential to make a significant, positive impact on the diagnosis and management of patients with AMD; however, the development of effective AI devices for clinical care faces numerous considerations and challenges, a fact evidenced by a current absence of Food and Drug Administration (FDA)-approved AI devices for AMD. PURPOSE: To delineate the state of AI for AMD, including current data, standards, achievements, and challenges. METHODS: Members of the Collaborative Community on Ophthalmic Imaging Working Group for AI in AMD attended an inaugural meeting on September 7, 2020, to discuss the topic. Subsequently, they undertook a comprehensive review of the medical literature relevant to the topic. Members engaged in meetings and discussion through December 2021 to synthesize the information and arrive at a consensus. RESULTS: Existing infrastructure for robust AI development for AMD includes several large, labeled data sets of color fundus photography and OCT images; however, image data often do not contain the metadata necessary for the development of reliable, valid, and generalizable models. Data sharing for AMD model development is made difficult by restrictions on data privacy and security, although potential solutions are under investigation. Computing resources may be adequate for current applications, but knowledge of machine learning development may be scarce in many clinical ophthalmology settings. Despite these challenges, researchers have produced promising AI models for AMD for screening, diagnosis, prediction, and monitoring. Future goals include defining benchmarks to facilitate regulatory authorization and subsequent clinical setting generalization. CONCLUSIONS: Delivering an FDA-authorized, AI-based device for clinical care in AMD involves numerous considerations, including the identification of an appropriate clinical application; acquisition and development of a large, high-quality data set; development of the AI architecture; training and validation of the model; and functional interactions between the model output and clinical end user. The research efforts undertaken to date represent starting points for the medical devices that eventually will benefit providers, health care systems, and patients.

ACQUIRED VITELLIFORM LESIONS: A Novel Finding in Eyes with Peripapillary Pachychoroid Syndrome.

PURPOSE: To describe a novel finding of acquired vitelliform lesions in eyes with peripapillary pachychoroid syndrome. METHODS: A retrospective, multicenter, observational case series including seven patients with peripapillary pachychoroid syndrome and concomitant acquired vitelliform lesions. Medical records and multimodal imaging findings were comprehensively reviewed. RESULTS: Six of seven patients were men, with a mean age of 72.6 years. Mean baseline best-corrected visual acuity was 0.11 ± 0.07 (Snellen equivalent 20/25), and all patients presented with baseline best-corrected visual acuity of 20/30 or better. Mean follow-up time was 24.4 months (range 1-54 months). At last follow-up, best-corrected visual acuity was stable in 13/14 eyes, and deteriorated in one eye because of subfoveal atrophy.Fundus examination revealed peripapillary retinal pigment epithelium alterations and pigment migration in all eyes. Fundus autofluorescence showed mottled hyperautofluorescence and hypoautofluorescence in the peripapillary region, and hypoautofluorescent lesions corresponding to the pigmentary changes. Optical coherence tomography showed nasal choroidal thickening and pachyvessels with overlying retinal pigment epithelium irregularity. All eyes presented with peripapillary intraretinal fluid. Subretinal fluid was present in five eyes of three patients. Acquired vitelliform lesions were present in 11 eyes. CONCLUSION: The novel association between peripapillary pachychoroid syndrome and acquired vitelliform lesions is characterized by the classic findings of both entities, and visual prognosis is accordingly good.

IMPACT OF COVID-19 PANDEMIC LOCKDOWNS ON VISUAL ACUITY OF PATIENTS WITH NEOVASCULAR AMD: A Large Cohort.

PURPOSE: Evaluating the impact of delayed care, secondary to coronavirus disease 2019 (COVID-19) pandemic lockdowns, on visual acuity in previously treated neovascular age-related macular degeneration (nAMD) patients. METHODS: This was a multicenter, retrospective, study of patients with nAMD previously treated with anti-VEGF injections who were followed up during 2019 (pre-COVID-19) and compared with patients with nAMD during 2020 (COVID-19). RESULTS: A total of 1,192 patients with nAMD with a mean age of 81.5 years met the inclusion criteria. Of these, 850 patients were assessed in 2019 (pre-COVID-19) and 630 patients were assessed in 2020 (COVID-19). Three hundred eight patients were assessed through both 2019 and 2020 and thus were included in both cohorts. There was no significant difference between 2020 and 2019 in baseline and change in best-corrected visual acuity (BCVA; P = 0.342 and P = 0.911, respectively). The mean number of anti-VEGF injections was significantly lower (5.55 vs. 6.13, P < 0.01), with constant lower ratio of injections per patient in the COVID-19 period. Baseline BCVA (0.859, P < 0.01), number of injections (-0.006, P = 0.01), and age (0.003, P < 0.01) were predictors of final BCVA. CONCLUSION: In patients with nAMD, delayed care secondary to COVID-19 pandemic lockdowns has no statistically significant impact on BCVA. Best-corrected visual acuity, older age, and lower number of yearly anti-VEGF injections are predictors for decrease BCVA.

FLUID-BASED VISUAL PROGNOSTICATION IN TYPE 3 MACULAR NEOVASCULARIZATION-FLIP-3 STUDY.

PURPOSE: To analyze the effect of fluid on visual acuity in cases of Type 3 macular neovascularization. METHODS: This multicentric, retrospective cohort study included eyes with treatment-naïve Type 3 macular neovascularization. Analysis of fluid in different compartments was performed. Group A included eyes with isolated intraretinal fluid, whereas Group B included eyes with intraretinal fluid in conjunction with subretinal fluid and/or sub retinal pigment epithelial fluid. RESULTS: Eyes in Group A (31, 55.3%) had better best-corrected visual acuity of 20/50 snellen equivalent (0.42 ± 0.31 logarithm of the minimum angle of resolution) at baseline and 20/50 snellen equivalent (0.40 ± 0.28 logarithm of the minimum angle of resolution) at complete resolution compared with Group B with visual acuity of 20/80 snellen equivalent (0.64 ± 0.35 logarithm of the minimum angle of resolution) (P = 0.0181) at baseline and 20/100 snellen equivalent (0.70 ± 0.40 logarithm of the minimum angle of resolution) (P = 0.0021) at complete resolution. Subfoveal atrophy was more in Group B (82.6% 19/23) at complete resolution in comparison to Group A (16/31, 51.6%). Eyes in Group B needed more anti-vascular endothelial growth factor injections (10.3 ± 9.0) for complete resolution compared with Group A (5.7 ± 4.8). CONCLUSION: Intraretinal fluid may be associated with good visual acuity in Type 3 macular neovascularization in contrast to other forms of neovascular age related macular degeneration. Furthermore, intraretinal fluid in isolation may need fewer injections and could probably be associated with less subfoveal atrophy.

Evaluation of a self-imaging SD-OCT system designed for remote home monitoring.

PURPOSE: To compare identification rates of retinal fluid of the Notal Vision Home Optical Coherence Tomography (OCT) device (NVHO) when used by people with age-related macular degeneration (AMD) to those captured by a commercial OCT. METHODS: Prospective, cross-sectional study where patients underwent commercial OCT imaging followed by self-imaging with either the NVHO 2.5 or the NVHO 3 in clinic setting. Outcomes included patients' ability to acquire analyzable OCT images with the NVHO and to compare those with commercial images. RESULTS: Successful images were acquired with the NVHO 2.5 in 469/531 eyes (88%) in 264/290 subjects (91%) with the mean (SD) age of 78.8 (8.8); 153 (58%) were female with median visual acuity (VA) of 20/40. In the NVHO 3 cohort, 69 eyes of 45 subjects (93%) completed the self-imaging. Higher rates of successful imaging were found in eyes with VA ≥ 20/320. Positive percent agreement/negative percent agreement for detecting the presence of subretinal and/or intraretinal fluid when reviewing for fluid in three repeated volume scans were 97%/95%, respectively for the NVHO v3. CONCLUSION: Self-testing with the NVHO can produce high quality images suitable for fluid identification by human graders, suggesting the device may be able to complement standard-of-care clinical assessments and treatments.

Is There a Dose-Response Relationship? Real-World Outcomes of Anti-Vascular Endothelial Growth Factor Treatment in Neovascular Age-Related Macular Degeneration.

PURPOSE: The aim of study was to explore the dose-response relationship of anti-vascular endothelial growth factor (VEGF) agents, with bevacizumab as 1st-line treatment, on the visual-acuity (VA) outcome during the first year of treatment in neovascular AMD (nAMD) patients in real-life conditions. METHODS: This was a retrospective, observational, single-center study at the Ophthalmology Division, Tel Aviv Medical Center. Inclusion criterion was naive AMD patients treated with anti-VEGF injections between the years 2017-2020. Electronic medical records were scanned using the MDClone software, and data from time of diagnosis, containing baseline VA, final VA, number of injections, and the injected agent, were gathered. Subjects were divided into three groups based on their baseline VA ("good," "middle," and "low"). RESULTS: A total of 672 patients were included. The cohort demonstrated a statistically nonsignificant correlation with a positive trend between the log transformation of the number of annual injections and the change in VA (p = 0.145). However, a significant correlation was established within the "low-VA" group (p = 0.015). The "good-" and "middle-VA" groups did not reach statistical significance. Baseline VA was the single significant predictor for VA gain within patients with baseline VA of 6/12 or less. CONCLUSIONS: A dose-response relationship between anti-VEGF injections and the VA outcome was found only for patients with low baseline VA. Individual patient characteristics might need to be taken into account to customize treatment regimen and improve visual outcome.

Additive Value of a Face-to-Face Visit to Virtual Remote Decision in Patients with Neovascular Age-Related Macular Degeneration.

INTRODUCTION: The increasing high prevalence of neovascular age-related macular degeneration (nvAMD) in the aging population combined with the need for frequent monitoring and treatment for many years, especially in the COVID-19 era, raises the need to establish an effective, reliable, and safe follow-up and treatment model. This study evaluates the difference in treatment decisions comparing between the gold standard face-to-face clinical examination and virtual evaluation approach based only on visual acuity (VA) and optical coherence tomography (OCT) scans without clinical fundoscopic examination in nvAMD patients. METHODS: A single-center retrospective cohort study was conducted that compared an original "face-to-face" visit treatment decision regarding the need for anti-vascular endothelial growth factor drug, interval, and treatment regimen based on routine VA, spectral domain OCT imaging, and dilated fundus examination to two "virtual" treatment decisions based on evaluation of OCT scans and previous medical records before and after revealing VA data on the same nvAMD patients eyes. RESULTS: About 169 eyes of 114 patients were included in the study. Forty-nine patients (43%) suffered from bilateral nvAMD and had both eyes included in the study. Agreement between the "face-to-face visit treatment decision" and "virtual treatment decision" was noted in 74.6% and 71.6% eyes before and after revealing the patient's VA in the study visit, respectively. CONCLUSIONS: Virtual evaluation results in similar treatment decisions for nvAMD patients compared to standard face-to-face clinical examination.

Epiretinal Membrane in Patients with Diabetic Macular Edema.

PURPOSE: The aim of the study was to compare anatomical and functional outcomes of pars plana vitrectomy (PPV) with epiretinal membrane (ERM) peeling in diabetes retinopathy patients with and without diabetic macular edema (DME). METHODS: A retrospective interventional case series of consecutive patients who underwent PPV with ERM peeling. Patients were divided into two groups: those with and without preoperative DME. Visual acuity (VA) and optical coherence tomography parameters were evaluated before surgery and during 12 months of follow-up. RESULTS: A total of 354 patients underwent PPV with ERM peeling, of which 51 met the inclusion criteria. Twenty-three were diagnosed with DME and were younger (66.3 ± 9.6 vs. 73.1 ± 8.2 years, p = 0.001), had longer diabetes mellitus (DM) duration (18.9 ± 7.1 vs. 14.3 ± 10.9 years, p = 0.04) and higher HbA1C% (7.6 ± 1.4 vs. 7.1 ± 1.3, p = 0.04). VA improved from 20/105 to 20/60 Snellen (p = 0.004) and central macular thickness decreased from 469.3 ± 64.9 µm to 331.1 ± 92.2 µm (p < 0.001) in the DME group and from 20/87 to 20/44 Snellen (p < 0.001) and from 463.1 ± 53.5 µm to 341.3 ± 49.5 µm (p = 0.01) in the non-DME group. Yearly intravitreal injection rate decreased from 5.9 ± 2.5 to 2.9 ± 3.0 (p < 0.001) injections in the DME group. CONCLUSIONS: DME patients with ERM experience significant improvement in VA, macular thickness, and yearly intravitreal injections after PPV with ERM peeling. DME patients are younger, with longer duration of DM and higher HbA1C% levels at presentation in comparison to diabetic ERM patients without DME.