Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases.

INTRODUCTION: SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO). METHODS: This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product. RESULTS: A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study. CONCLUSIONS: This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.

Optimised, Broad NGS Panel for Inherited Eye Diseases to Diagnose 1000 Patients in Poland.

Advances in gene therapy and genome editing give hope that new treatments will soon be available for inherited eye diseases that together affect a significant proportion of the adult population. New solutions are needed to make genetic diagnosis fast and affordable. This is the first study of such a large group of patients with inherited retinal dystrophies (IRD) and inherited optic neuropathies (ION) in the Polish population. It is based on four years of diagnostic analysis using a broad, targeted NGS approach. The results include the most common pathogenic variants, as well as 91 novel causative variants, including frameshifts in the cumbersome RPGR ORF15 region. The high frequency of the ABCA4 complex haplotype p.(Leu541Pro;Ala1038Val) was confirmed. Additionally, a deletion of exons 22-24 in USH2A, probably specific to the Polish population, was uncovered as the most frequent copy number variation. The diagnostic yield of the broad NGS panel reached 64.3% and is comparable to the results reported for genetic studies of IRD and ION performed for other populations with more extensive WES or WGS methods. A combined approach to identify genetic causes of all known diseases manifesting in the posterior eye segment appears to be the optimal choice given the currently available treatment options and advanced clinical trials.

Superficial Keratectomy Alone versus in Combination with Amniotic Membrane Transplantation in Aniridia-Associated Keratopathy and a Short-Term Clinical Outcome.

Background/Objectives: Aniridia-associated keratopathy (AAK) is a potentially vision-threatening pathology in congenital aniridia, for which both the underlying etiopathogenesis and effective treatment remain unclear. Methods:This prospective study was conducted to assess and compare the short-term outcome after superficial keratectomy (SK) alone or in a combination with an amniotic membrane transplantation (AMT). Here, 76 eyes were enrolled in 76 patients with grade 4 AAK. In all eyes, in order to assess preoperatively the efficiency of the limbal epithelial stem cells (LESC), the presence of corneal epithelial cells in confocal microscopy was established. The analyses included: best corrected visual acuity (BCVA), the stage of AAK and the number of corneal quadrants involved in corneal neovascularization (CNV). Results: Six months after surgery, the mean BCVA was 0.05 and ranged from 0.002 up to 0.1 in both groups. Improvement in BCVA occurred in 94.29% patients when *SK alone* was performed, and in 92.68% when in combination with AMT. There were no statistically significant differences in the effect of therapy depending on the type of surgery, regarding BCVA, stage of AAK and the number of quadrants with CNV. Conclusions: SK alone is an effective procedure in short outcomes limited to six months for advanced AAK in association with LESC partial efficiency.

Postoperative Astigmatism after Keratoplasty: A Systematic Review Meta-Analysis Based on PRISMA.

Background: The number of corneal transplants is rising, with the aim to treat a spectrum of diseases ranging from dystrophies to corneal opacities caused by trauma or chemical burns. Refractive outcomes after this procedure are often impossible to predict and associated with high levels of astigmatism. However, there are many techniques that affect the reduction of astigmatism and improve the quality of life of patients. Objectives: The aim was to compare the improvement in postoperative visual acuity (logMAR) and amount of corneal astigmatism (Diopters) after corneal keratoplasty in patients who additionally underwent a surgical procedure, which affects the reduction in postoperative astigmatism, and to determine the most effective method. Search Methods and Selection Criteria: A thorough search was carried out across online electronic databases including PubMed, Embrase, Ovid MEDLINE, Scopus, and Web of Science, using combinations containing the following phrases: postoperative astigmatism, post-keratoplasty astigmatism, anterior lamellar keratoplasty (ALK), deep anterior lamellar keratoplasty (DALK), posterior lamellar keratoplasty, endothelial keratoplasty (EK), penetrating keratoplasty (PK), corneal transplant, keratoplasty, refractive surgery, kerato-refractive surgery, laser in situ keratomileusis (LASIK), and femtosecond LASIK. This was to determine all English-language publications that discuss refractive operations for postoperative or post-keratoplasty astigmatism. These bibliographies were searched for English-language publications published between 2010 and 2023. We proceeded to review each detected record's reference list. Data Extraction: Study characteristics such as study design, sample size, participant information, operations performed, and clinical outcomes were all extracted. Data Statistical Analyses: The Comprehensive Meta-Analysis software (version 3.3.070, 2014) was used to perform the analysis. The threshold of 0.05 for p-values was considered statistically significant. All effect sizes are reported as standardized differences (Std diff) in means with a 95% confidence interval (CI) and visualized graphically as forest plots. Publication bias is presented as a funnel plot of standard error by Std diff in means. Four methods were used to evaluate the heterogeneity among the studies: Q-value, I2, chi-square (χ2), and tau-squared. Main Results: We included 21 studies that randomized 1539 eyes that underwent corneal transplantation surgery either by PKP, DALK, or DSEAK techniques. The results showed the most significant improvement in the visual acuity and significant decrease in the corneal astigmatism after laser surgery procedures, like femtosecond-assisted keratotomy after DALK and PKP and LASIK after DSEAK.

Exploring the Potential of an Eye Tissue Donor Reporting App in Enhancing the Procurement of Corneal Donors: Mixed Methods Observational Study.

BACKGROUND: The availability of donated eye tissue saves and enhances vision in transplant recipients; however, the current demand for tissue surpasses the available supply. Corneal donor shortages lead to increased wait times, delayed surgeries, prolonged visual impairment, and increased inconvenience to patients requiring eye tissue transplantation. A web-based application was previously developed to facilitate easy and intuitive submission of potential donor information. OBJECTIVE: The primary objectives of this study were to assess health care professionals' attitudes toward the potential application and evaluate its effectiveness based on user feedback and donor registrations through the application. METHODS: Researchers used a mixed methods approach, commencing with a literature review to identify challenges associated with donor procurement. Stakeholder interviews were conducted to gauge health care professionals' perspectives regarding the application. User feedback was collected through questionnaires, surveys, and interviews to assess the application's usability and impact. An assessment of the reported potential donors and questionnaire responses were analyzed. RESULTS: The final version of the application successfully reported 24 real cornea donors. Among 64 health care providers who used the application to communicate about potential donors, 32 of them submitted trial entries exclusively for testing purposes. The remaining 8 health care professionals reported potential donors; however, these individuals did not meet the donor qualification criteria. The majority of participants found the application user-friendly and expressed their readiness to use it in the future. Positive ratings were assigned to the layout, appearance, purpose, and specific features of the application. Respondents highlighted the automatic sending of notifications via SMS text messages and the integration of all necessary documents for donor qualification and tissue collection as the most valuable functions of the application. CONCLUSIONS: The study indicates that donor reporting applications offer promising solutions to enhance tissue donor procurement. This application streamlined the reporting process, reduced paperwork, facilitated communication, and collected valuable data for analysis.

Selective Upregulation of Interleukin 1 Receptor Antagonist and Interleukin-8 in Fuchs' Endothelial Corneal Dystrophy with Accompanying Cataract.

(1) Background: Patients with Fuchs' endothelial corneal dystrophy (FECD) may have coexisting cataracts and, therefore, may require a cataract surgery, which poses challenges due to potential endothelial cell damage. FECD is a degenerative eye disease of unclear etiology, with inflammatory cytokines maybe playing an important role in its development and progression. The present study aimed to investigate the cytokine profile in the aqueous humor of FECD eyes with cataract. (2) Methods: Fifty-two patients were included in the study, 26 with FECD + cataract and 26 with cataract as a control group. Samples of the aqueous humor were analyzed for pro- and anti-inflammatory cytokines using a Bio-Plex 200 system. (3) Results: Interleukin 1 receptor antagonist (IL-1Ra) and interleukin IL-8 levels were significantly higher in the aqueous humor of FECD + cataract patients compared to the control/cataract group. Moreover, the levels of anti-inflammatory IL-10 showed a strong trend to be higher in the FECD + cataract group compared to the control group. In contrast, there were no statistically significant differences in IL-1ß, IL-6, IL-4, IL-10, IL-13, IL-17A, and tumor necrosis factor TNF-α between the groups. (4) Conclusions: Presented research contributes to a better understanding of FECD pathogenesis. Elevated levels of IL-1Ra and IL-8 may serve as a defense mechanism in people with FECD and coexisting cataract.

A deep learning approach to explore the association of age-related macular degeneration polygenic risk score with retinal optical coherence tomography: A preliminary study.

PURPOSE: Age-related macular degeneration (AMD) is a complex eye disorder affecting millions worldwide. This article uses deep learning techniques to investigate the relationship between AMD, genetics and optical coherence tomography (OCT) scans. METHODS: The cohort consisted of 332 patients, of which 235 were diagnosed with AMD and 97 were controls with no signs of AMD. The genome-wide association studies summary statistics utilized to establish the polygenic risk score (PRS) in relation to AMD were derived from the GERA European study. A PRS estimation based on OCT volumes for both eyes was performed using a proprietary convolutional neural network (CNN) model supported by machine learning models. The method's performance was assessed using numerical evaluation metrics, and the Grad-CAM technique was used to evaluate the results by visualizing the features learned by the model. RESULTS: The best results were obtained with the CNN and the Extra Tree regressor (MAE = 0.55, MSE = 0.49, RMSE = 0.70, R2 = 0.34). Extending the feature vector with additional information on AMD diagnosis, age and smoking history improved the results slightly, with mainly AMD diagnosis used by the model (MAE = 0.54, MSE = 0.44, RMSE = 0.66, R2 = 0.42). Grad-CAM heatmap evaluation showed that the model decisions rely on retinal morphology factors relevant to AMD diagnosis. CONCLUSION: The developed method allows an efficient PRS estimation from OCT images. A new technique for analysing the association of OCT images with PRS of AMD, using a deep learning approach, may provide an opportunity to discover new associations between genotype-based AMD risk and retinal morphology.

Assessment of Changes in Cap and Residual Stromal Thickness Values during a 6-Month Observation after Refractive Lenticule Extraction Small Incision Lenticule Extraction.

Background: In this study, the changes in corneal cap and residual stromal thickness (RST) values during a 180-day observation period after refractive lenticule extraction small incision lenticule extraction (ReLEx SMILE) were assessed. Methods: Fifty patients underwent ReLEx SMILE using the VisuMax 500 femtosecond laser, with corneal imaging conducted pre and post procedure via anterior segment optical coherence tomography (AS-OCT). Cap thickness in the center and 1.5 mm from the center in four meridians was measured at various intervals. Results: The results showed a significant decrease in cap thickness 180 days post procedure compared to earlier intervals (p < 0.05). Similarly, RST decreased gradually and significantly post procedure (p < 0.05). Notably, changes in cap thickness within the central 1.5 mm area were more dynamic than RST changes during the 6-month observation period following SMILE. Conclusions: The corneal cap thickness measured with swept-source AS-OCT within the central 1.5 mm area underwent more dynamic changes than the residual stromal thickness during the 6-month observation following SMILE.

Artificial-Intelligence-Enhanced Analysis of In Vivo Confocal Microscopy in Corneal Diseases: A Review.

Artificial intelligence (AI) has seen significant progress in medical diagnostics, particularly in image and video analysis. This review focuses on the application of AI in analyzing in vivo confocal microscopy (IVCM) images for corneal diseases. The cornea, as an exposed and delicate part of the body, necessitates the precise diagnoses of various conditions. Convolutional neural networks (CNNs), a key component of deep learning, are a powerful tool for image data analysis. This review highlights AI applications in diagnosing keratitis, dry eye disease, and diabetic corneal neuropathy. It discusses the potential of AI in detecting infectious agents, analyzing corneal nerve morphology, and identifying the subtle changes in nerve fiber characteristics in diabetic corneal neuropathy. However, challenges still remain, including limited datasets, overfitting, low-quality images, and unrepresentative training datasets. This review explores augmentation techniques and the importance of feature engineering to address these challenges. Despite the progress made, challenges are still present, such as the "black-box" nature of AI models and the need for explainable AI (XAI). Expanding datasets, fostering collaborative efforts, and developing user-friendly AI tools are crucial for enhancing the acceptance and integration of AI into clinical practice.

Association of Genetic Risk for Age-Related Macular Degeneration with Morphological Features of the Retinal Microvascular Network.

BACKGROUND: Age-related macular degeneration (AMD) is a multifactorial disease encompassing a complex interaction between aging, environmental risk factors, and genetic susceptibility. The study aimed to determine whether there is a relationship between the polygenic risk score (PRS) in patients with AMD and the characteristics of the retinal vascular network visualized by optical coherence tomography angiography (OCTA). METHODS: 235 patients with AMD and 97 healthy controls were included. We used data from a previous AMD PRS study with the same group. The vascular features from different retina layers were compared between the control group and the patients with AMD. The association between features and PRS was then analyzed using univariate and multivariate approaches. RESULTS: Significant differences between the control group and AMD patients were found in the vessel diameter distribution (variance: p = 0.0193, skewness: p = 0.0457) and fractal dimension distribution (mean: p = 0.0024, variance: p = 0.0123). Both univariate and multivariate analyses showed no direct and significant association between the characteristics of the vascular network and AMD PRS. CONCLUSIONS: The vascular features of the retina do not constitute a biomarker of the risk of AMD. We have not identified a genotype-phenotype relationship, and the expression of AMD-related genes is perhaps not associated with the characteristics of the retinal vascular network.

The level of cytokines in tears as a novel indicator of demyelinating diseases.

INTRODUCTION: A novel research objective is to identify new molecules in more readily accessible biological fluids that could be used in the diagnosis of multiple sclerosis (MS) and other demyelinating disorders. AIM: To compare the level of selected cytokines in tears between patients with MS or other demyelinating disorder and healthy controls. MATERIAL AND METHODS: 84 patients with diagnosed MS during remission or with other demyelinating disease of the CNS and 70 healthy controls were enrolled in the study. Tears were collected without any stimulation and stored till the day of assessment. The concentration of selected cytokines was measured by the Bio-Plex Pro Human cytokine screening panel 27 cytokines assay according to the manufacturer's instructions. Statistical analysis was performed with Statistica 13. RESULTS: IL-1b level was significantly lower in the study group compared to the control group [3,6 vs 8.71, p < 0.001]. The same pattern was observed for IL-6 [3,1 vs 5.26, p = 0.027] and IL-10 [1,7 vs 10.92, p < 0.001] (Table 1). In the study group, IL-1RA (p = 0.015), IL-5 (p = 0.04), IL-9 (p = 0.014), and IL-15 (p = 0.037) showed significant correlations with age. In the total sample, IL-1Ra (p = 0.016) and IFN-g (p = 0.041) were significantly correlated with age, while in the control group, IL-8 (p = 0.09), MIP-1a (p = 0.009), and RANTES (p = 0.031) showed significant correlations. CONCLUSIONS: Our results show that MS and other demyelination diseases lead to decrease in the overall level of cytokines in tears. Further research is needed to determine the role of tear fluid in the assessment of demyelinating disorders like MS.

Outcomes of Boston Keratoprosthesis Type I Implantation in Poland: A Retrospective Study on 118 Patients.

Background: Boston Keratoprosthesis Type I (BI-KPro I) is a synthetic cornea that can be used to restore vision in patients with corneal blindness. This retrospective study evaluated the outcomes of BI-KPro implantation in 118 patients. Material: The mean age of the patients was 56.76 ± 14.24 years. Indications for keratoprosthesis implantation were as follows: graft failure, 47 (39.83%); ocular burn, 38 (32.20%); neurotrophic keratopathy, 11 (9.32%), mucous membrane pemphigoid 9 (7.67%); autoimmune, 6 (5.08%); Stevens-Johnson syndrome, 4 (3.39%); and aniridia (2.54%). Methods: The surgeries were performed between March 2019 and June 2022 at a single clinical center in two locations. The postoperative visual acuity, complications, and need for additional surgical procedures were analyzed. Results: The Best Corrected Visual Acuity before surgery was 0.01 ± 0.006. After one year (V1), it was 0.30 ± 0.27; at two years (V2), it was 0.27 ± 0.26; and at three years (V3), it was 0.21 ± 0.23. The percentage of patients with visual acuity better than 0.1 on the Snellen chart was 37.29% after 1 year, 49.35% after 2 years, and 46.81% after 3 years of follow up. The most common complications were glaucoma (78 patients; 66.1%), corneal melting (22 patients; 18.6%), and retroprosthetic membranes (20 patients; 17.0%). Conclusions: The BI-KPro can significantly improve visual acuity. The worst long-term results were obtained in the group of patients with autoimmune diseases; therefore, careful consideration should be given to implanting BI-KPro in this group. The high incidence of de novo glaucoma or the progression of pre-existing glaucoma suggests the need for careful monitoring.

Fuch's Endothelial Corneal Dystrophy in Cataract Patients Is Associated with Elevated Levels of Inflammatory Chemokines, but Not Growth Factors, in the Aqueous Humor.

The study investigated a profile of chemokines and growth factors in the aqueous humor (AH) of eyes with Fuch's endothelial corneal dystrophy (FECD) and cataracts in comparison with cataract patients as a control group. A total of 52 AH samples (26 FECD + cataract and 26 cataract/control) were collected before cataract surgery. None of the patients had any clinically apparent inflammation at the time of AH collection. The AH levels of MCP-1 (CCL2), MIP-1α (CCL3), MIP-1ß(CCL4), RANTES (CCL5), eotaxin (CCL11), IP-10 (CXCL10), FGF basic, G-CSF, GM-CSF, PDGF-bb, and VEGF were compared between the groups. The analyses were performed using the Bio-Plex 200 System from Bio-Rad. Among the studied parameters, the AH levels of RANTES, eotaxin, and IP-10 significantly increased in the FECD + cataract eyes, compared with the cataract controls (p < 0.05). Elevated levels of the RANTES, Eotaxin, and IP-10 indicate more intense inflammation in the eyes of patients in the FECD + cataract group. Moreover, these factors exhibit potential as predictive biomarkers for early detection of FECD in cataract patients. The discovery of elevated concentrations of biochemical markers in a patient, who has not yet received a clinical diagnosis, may suggest the need for heightened observation of the other eye to monitor the potential development of FECD.

Endocyclophotocoagulation Combined with Phacoemulsification in Glaucoma Treatment: Five-Year Results.

BACKGROUND: this study aimed to assess the effectiveness and safety of phaco-endocyclophotocoagulation (phaco-ECP) in patients with glaucoma over five consecutive years. METHODS: Thirty-eight patients (38 eyes) with primary and secondary glaucoma were enrolled to undergo phaco-ECP (Endo Optiks URAM E2, Beaver-Visitec International, Waltham, MA, USA). The primary outcome measures were intraocular pressure (IOP) reduction, success rates, glaucoma medication use, and visual acuity after phaco-ECP. An IOP reduction of 20% compared to the baseline value without re-intervention was considered a successful treatment. Complete success was defined as a cessation of antiglaucoma medications. Secondary outcome measures included intraoperative and postoperative complications. Measurements were performed preoperatively and in the first week and 1, 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, and 60 months postoperatively. RESULTS: The mean ± SD values of IOP preoperatively, at 12, 24, 36, 48, and 60 months postoperatively were 22.6 ± 6.7 mmHg, 15.9 ± 3.9 mmHg (p < 0.001), 15.9 ± 2.9 mmHg (p < 0.001), 15.6 ± 2.7 mmHg (p < 0.001), 15.5 ± 3.8 mmHg (p < 0.001), and 15.2 ± 2.6 mmHg (p < 0.001), respectively. The mean IOP at the last follow-up was reduced by 32.7%. The decrease in the number of antiglaucoma medications was statistically significant at each follow-up visit compared to the baseline. The qualified success rate was 40.6%. All patients at the 60-month follow-up visit required the use of antiglaucoma medications-none of the patients achieved complete success. During the follow-up period, nine patients (28.3%) that required retreatment due to nonachievement of the target IOP were considered failures. Six patients (15.8%) were lost from the follow-up. A total of 23 patients were evaluated 60 months after their phaco-ECP. Complications directly associated with the procedure, such as corneal edema (25.6%), IOP spikes (20.5%), IOL dislocation (2.6%), and uveitis (12.8%), were observed in our patients. Hypotony was not observed in any of our patients. CONCLUSIONS: The phaco-ECP procedure was effective, well-tolerated, and safe for reducing IOP in glaucoma patients with cataracts over a long-term follow-up. Randomized, larger-scale studies are required to validate the results obtained.

Analysis of Cytokine and Chemokine Level in Tear Film in Keratoconus Patients before and after Corneal Cross-Linking (CXL) Treatment.

Keratoconus (KC) is a degenerative corneal disorder whose aetiology remains unknown. The aim of our study was to analyse the expressions of cytokines and chemokines in KC patients before and after specified time intervals after corneal cross-linking (CXL) treatment to better understand the molecular mechanisms occurring before and after CXL in KC patients process of corneal regeneration.; Tear samples were gathered from 52 participants immediately after the CXL procedure and during the 12-month follow-up period. All patients underwent a detailed ophthalmological examination and tear samples were collected before and after CXL at regular intervals: 1 day before and after the surgery, at the day 7 visit, and at 1, 3, 6, 9, and 12 months after CXL. The control group consisted of 20 healthy people. 10 patients were women (50%) and 10 were men (50%). The mean age was 30 ± 3 years of age. Tear analysis was performed using the Bio-Plex 3D Suspension Array System. Corneal topography parameters measured by Scheimpflug Camera included: keratometry values (Ks, Kf), PI-Apex, PI-Thinnest, Cylinder.; All the 12 months post-op values of the KC patients' topographic measurements were significantly lower than the pre-op. As for the tear cytokine levels comparison between the patient and control groups, cytokine levels of TNF-α, IL-6, and CXCL-10, among others, were detected in lower amounts in the KC group. The pre-op level of IL-6 exhibited a significant increase the day after CXL, whereas comparing the day after the procedure to 12 months after CXL, this showed a significant decrease. Both TNF-α and IL-1 showed a significant decrease compared to the day before and after CXL. We observed significantly higher levels of IL-1ß, IL-10, IFN-γ and TNF-α in moderate and severe keratoconus than in mild keratoconus (p < 0.05). We also demonstrated a statistically significant positive correlation between both pre-op and 12 months after CXL TNF-α, IFN-γ, IL-6 and Ks and Kf values (p < 0.05, r > 0); Alterations of inflammatory mediators in tear fluid after CXL link with topographic changes and may contribute to the development and progression of KC.

General Treatment and Ophthalmic Management of Peters' Anomaly.

Peters' anomaly (PA) is a manifestation of complex disorders in the development of the anterior segment of the eye. The most recognizable feature of the disease is a doughnut-shaped central corneal opacity and adhesions between the opacity and underlying iris. Glaucoma is observed in 30-70% of patients, with up to 50% of the patients showing concomitant vision-threatening disorders. Up to 60% of patients have systemic abnormalities or developmental delays. Being a rare malformation, PA is one of the most common congenital indications for corneal transplantation in infants. Penetrating keratoplasty is used as the primary method of treatment in cases with corneal opacification of a degree that forbids visual development in both eyes. The heterogeneity of co-occurring ophthalmic and systemic malformations in the spectrum of PA determines the wide range of success, defined by various endpoints: graft clarity or visual acuity. Although surgical advancement has made corneal grafting possible in younger children, it has a higher graft failure rate and worse visual prognosis than adult keratoplasty. Optical sector iridectomy, pupil dilation, or cornea rotation can alternatively be performed. Satisfying results of pediatric keratoprosthesis in particular cases of PA have been described. Postoperative treatment of PA aims to maintain a clear optical pathway and prevent amblyopia. This article therefore aims at reporting the ophthalmic treatment and need for multidisciplinary management of PA, including pharmacological and surgical treatment.

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial.

BACKGROUND/AIMS: To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD). DESIGN: Prospective, double-masked, randomised, phase 3 trial. METHODS: Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch's membrane). Additional endpoints included safety, PK and immunogenicity. RESULTS: Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (-2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were -119.2 µm and -132.4 µm for SB15/SB15 and -126.6 µm and -136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (-6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (-18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (-2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups. CONCLUSIONS: Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

Visual Acuity Examination Methodology in Keratoconus.

Visual acuity is one of the most important parameters for evaluating the vision of patients with keratoconus. This study reviewed 295 articles related to keratoconus published between 2017 and 2022 in which visual acuity was one of the parameters measured. The methodology of visual acuity testing in studies on keratoconus was thoroughly analyzed. The analysis showed that the most commonly indicated chart for testing visual acuity papers on keratoconus is the Snellen chart. It was shown that in 150 out of 295 articles, the authors do not describe the methodology for testing visual acuity. What is more, it was also shown that in 68 of the 295 articles which were analyzed, a procedure for converting visual acuity tested with a Snellen chart into a logMAR scale was used. In this review, we discuss the validity and reliability of such conversions. In particular, we show that insufficient description of visual acuity testing methodology and lack of information on the conversion of visual acuity results into the logMAR scale may contribute to the misinterpretation of visual acuity test results.

Efficacy of Continuous-Wave Transscleral Cyclophotocoagulation Post-Pars Plana Vitrectomy in Glaucoma Patients: A Retrospective Study from Poland.

BACKGROUND Glaucoma, a vision-threatening condition, results from optic nerve damage and affects millions of people worldwide. Often asymptomatic, it is hereditary, with risk factors like hypertension, diabetes, and steroid use. Despite its link with intraocular pressure (IOP), not everyone with high IOP develops glaucoma. After pars plana vitrectomy (PPV), patients face increased IOP risks. Traditional treatment includes pharmacotherapy, and, when ineffective, surgical interventions. Continuous-wave transscleral cyclophotocoagulation (CW-TSCPC) is an alternative for refractory glaucoma but can have complications. Our study compares the efficacy and safety of CW-TSCPC after PPV. MATERIAL AND METHODS The study group consisted of 18 patients diagnosed with glaucoma who underwent the CW-TSCP procedure as the first-choice therapy after conservative treatment of glaucoma proved ineffective. The comparison group consisted of 12 patients who underwent the CW-TSCP procedure after conservative drug treatment and in whom surgical treatment of glaucoma had been unsuccessful. All patients had inadequate control of IOP after PPV. RESULTS Study and comparison group patients showed a decrease in IOP during the follow-up, independent of the type of endotamponade used (P<0.05). When the indication for PPV was retinal detachment hemorrhage into the vitreous chamber, a significant decrease in IOP between 0 days and 180 days was only found in the study group (P<0.05). In contrast, when the indication for PPV was the state after uveitis or proliferative diabetic retinopathy, a significant decrease in IOP was found at 180 days in the study and comparison groups (P<0.05). CONCLUSIONS The analysis showed that the CW-TSCPC procedure can be recommended as the first-choice invasive treatment in patients with increased IOP after PPV.