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.

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.

Comparison of Vision Correction and Corneal Thickness at 180-Day Follow-Up After Femtosecond Laser-Assisted In-Situ Keratomileusis (FS-LASIK), Photorefractive Keratectomy (PRK), and Small Incision Lenticule Extraction (SMILE): A Study from a Single Center in Poland of 120 Patients with Myopia.

BACKGROUND This study from a single center in Poland included 120 patients with myopia, and the aim was to compare vision correction and corneal thickness at the 180-day follow-up after femtosecond laser-assisted in-situ keratomileusis (FS-LASIK), photorefractive keratectomy (PRK), or small incision lenticule extraction (SMILE). MATERIAL AND METHODS The effectiveness and safety of laser vision correction (LVC) procedures were evaluated by determining pre- and post-procedure uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) values on the Snell chart. Twenty patients with diagnosed mild myopia (sphere maximum -3.0 diopters D; cylinder maximum 0.5 D) were qualified for PRK surgery. Fifty patients with diagnosed intolerance (sphere maximum -6.0 D; cylinder maximum 5.0 D) were eligible for the FS-LASIK procedure. Fifty patients with diagnosed myopia (sphere maximum -6.0 D cylinder 3.5 D) were qualified for the SMILE procedure. RESULTS Regardless of which procedure was performed, both UDVA and CDVA improved significantly postoperatively (P<0.05). In addition, the UDVA and CDVA values were similar in the postoperative period (P>0.05). For each procedure, the EI was no less than 0.94. Regardless of which type of LVC procedure was performed, CET at the center and 1.5 mm from the center in 4 meridians thickened, and this change was not statistically significant over the observation period (P>0.05). CONCLUSIONS Our analysis demonstrated similar effectiveness of the 3 methods - PRK, FS-LASIK, and SMILE - in patients with mild and moderate myopia.

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.

Level of Secretion and the Role of the Nerve Growth Factor in Patients with Keratoconus before and after Collagen Fibre Cross-Linking Surgery.

BACKGROUND: The aim of this study was to analyse the concentration of the nerve growth factor (NGF-ß) in patients with keratoconus (KC) who are undergoing collagen fibre cross-linking (CXL) surgery in order to better understand the pathogenesis of this disease and observe the molecular changes occurring after the procedure. Among many cytokines, ß-NGF seems to play an important role in the healing processes of corneal damage. Therefore, its role in the regenerative process after CXL treatment may affect the course of treatment and its final results. Tear samples from 52 patients were collected in this prospective study. Additionally, the patients also had a number of tests performed, including corneal topography using optical coherence tomography. Flat (K 1), steep (K 2), cylindrical (CYL), and central corneal thickness (CCT) keratometry were assessed. The tear samples were collected, and other tests were performed before the CXL procedure and afterwards, during the 12-month follow-up period. The NGF concentration was measured using the Bio-Plex Magnetic Luminex Assay. Lower levels of NGF-ß were detected in the KC patients than in the control group (p < 0.001). The day after the procedure, the NGF-ß level was significantly lower (on average by 2.3 pg/mL) (p = 0.037) than before the procedure, after which, the level of the reagent increases, but only in the group with the advanced cone, one month after CXL it was significantly higher (p = 0.047). Regarding the correlation of NGF with topographic measurements, the following were found: NGF-ß correlates significantly (p < 0.05) and positively (r > 0) with K1 before the CXL procedure; NGF-ß correlates significantly (p < 0.05) and positively (r > 0) with K1 one month after CXL; NGF-ß correlates significantly (p < 0.05) and positively (r > 0) with CYL nine months after CXL; and, after twelve months, NGF-ß correlates significantly (p < 0.05) and positively (r > 0) with K2 and K1. Corneal sensitivity did not statistically and significantly correlate with the level of NGF-ß secretion. Our study suggests that NGF may be crucial in the development and progression of KC as well as in the repair mechanisms after CXL surgery. Further research is needed on the role of NGF and other inflammatory biomarkers for rapid diagnosis and selection of targeted therapy in patients with keratoconus.

Preventing the Progression of Myopia in Children-A Review of the Past Decade.

The growing incidence of myopia worldwide justifies the search for efficient methods of myopia prevention. Numerous pharmacological, optical, and lifestyle measures have already been utilized, but there remains a need to explore more practical and predictable methods for myopia control. This paper presents a review of the most recent studies on the prevention of myopia progression using defocus-incorporated multiple-segment spectacle lenses (DIMSsl), repeated low-level red-light (RLRL) therapy, and a combination of low-dose atropine (0.01%) with orthokeratology lenses.

Detailed corneal and genetic characteristics of a pediatric patient with macular corneal dystrophy - case report.

BACKGROUND: Corneal dystrophies are a group of rare, inherited disorders that are usually bilateral, symmetric, slowly progressive, and not related to environmental or systemic factors. The majority of publications present the advanced form of the disease with a typical clinical demonstration. The initial signs and symptoms of different epithelial and stromal corneal dystrophies are not specific; therefore, it is very important to establish the early characteristic corneal features of these disorders that could guide the diagnostic process. CASE PRESENTATION: The main purpose of this study was to report the differential diagnosis of a pediatric patient with bilateral anterior corneal involvement suspected of corneal dystrophy. An 8-year-old male patient presented with asymptomatic, persistent, superficial, bilateral, diffuse, anterior corneal opacities. Slit lamp examination results were not specific. Despite the lack of visible stromal involvement on the slit lamp examination, corneal analysis based on confocal microscopy and optical coherence tomography revealed characteristic features of macular corneal dystrophy (MCD). The diagnosis of MCD was confirmed by CHST6 gene sequencing. The early corneal characteristic features of MCD, established based on the findings of this case report, include corneal astigmatism (not specific), diffuse corneal thinning without a pattern of corneal ectasia (specific), and characteristic features on confocal microscopy (specific), including multiple, dark, oriented striae at different corneal depths. CONCLUSIONS: The clinical examination should be complemented with corneal imaging techniques, such as confocal microscopy and optical coherence tomography. In patients suspected of corneal dystrophy, genetic testing plays an important role in establishing the final diagnosis.

Metabolomic Signature Discriminates Normal Human Cornea from Keratoconus-A Pilot GC/MS Study.

The molecular etiology of keratoconus (KC), a pathological condition of the human cornea, remains unclear. The aim of this work was to perform profiling of metabolites and identification of features discriminating this pathology from the normal cornea. The combination of gas chromatography and mass spectrometry (GC/MS) techniques has been applied for profiling and identification of metabolites in corneal buttons from 6 healthy controls and 7 KC patients. An untargeted GC/MS-based approach allowed the detection of 377 compounds, including 46 identified unique metabolites, whose levels enabled the separation of compared groups of samples in unsupervised hierarchical cluster analysis. There were 13 identified metabolites whose levels differentiated between groups of samples. Downregulation of several carboxylic acids, fatty acids, and steroids was observed in KC when compared to the normal cornea. Metabolic pathways associated with compounds that discriminated both groups were involved in energy production, lipid metabolism, and amino acid metabolism. An observed signature may reflect cellular processes involved in the development of KC pathology, including oxidative stress and inflammation.

Macular corneal dystrophy: in vivo confocal and structural data.

OBJECTIVE: To demonstrate the corneal morphologic aspects obtained with in vivo confocal microscopy (CM) and light and electron microscopy of specimens obtained from the same patients with macular corneal dystrophy (MCD). DESIGN: Case series. PARTICIPANTS: Five consecutive patients affected by MCD undergoing penetrating keratoplasty (PK) in 1 eye. METHODS: The patients were examined with the slit-lamp, optical pachymetry, and CM before undergoing PK. The corneal buttons were processed for light, transmission, and scanning electron microscopy. MAIN OUTCOME MEASURES: Corneal in vivo CM, corneal light, and electron microscopy. RESULTS: Confocal microscopy showed areas of altered reflectivity in basal epithelial cells, which appeared hyperreflective or completely white. In the anterior stroma, rectilinear hyperreflective areas were shown. The stroma was characterized by a granular appearance of both keratocytes and extracellular matrix. Dark striae of different length and orientation were present in the middle and posterior stroma. The corneal endothelium showed polymegethism and cells containing bright granules in their cytoplasm. The histopathologic study demonstrated areas of thickened Bowman's layer covered by an epithelium reduced in height. The Bowman's layer thickenings were due to the accumulation of free or vesiculated material of different electron density. The keratocytes showed intracytoplasmatic vesicles, whereas the extracellular matrix presented a large quantity of intercellular electron-lucent material and parallel lamellae with an undulated course. Occasional macrophages, filled with vesicles of granular-filamentous material and evident podosomes, were observed. Descemet's membrane was formed by a normal anterior banded zone and a posterior nonbanded zone of honeycombed aspect. The endothelial cells showed a large number of intracytoplasmic vesicles. CONCLUSIONS: The structural changes observed with the histopathologic methods give an account and provide an explanation for the pathologic changes demonstrated by CM in the course of MCD. This may contribute to the understanding of in vivo imaging, allowing a better, noninvasive study of the disease evolution.

Selected parameters of the corneal deformation in the Corvis tonometer.

INTRODUCTION: Contemporary ophthalmology knows many methods of measuring intraocular pressure, namely the methods of non-contact and impression applanation tonometry. In non-contact applanation tonometers, e.g. the Corvis, the corneal flattening is caused by an air puff. Image registration of the corneal deflection performed by a tonometer enables to determine other interesting biomechanical parameters of the eye, which are not available in the tonometer. The measurement of new selected parameters is presented in this paper. MATERIAL AND METHOD: Images with an M × N × I resolution of 200 × 576 × 140 pixels were acquired from the Corvis device in the source recording format *.cst. A total of 13'400 2D images of patients examined routinely in the Clinical Department of Ophthalmology, in District Railway Hospital in Katowice, Poland, were analysed in accordance with the Declaration of Helsinki. A new method has been proposed for the analysis of corneal deflection images in the Corvis tonometer with the use of the Canny edge detection method, mathematical morphology methods and context-free operations. RESULTS: The resulting image analysis tool allows determination of the response of the cornea and the entire eyeball to an air puff. The paper presents the method that enables the measurement of the amplitude of curvature changes in the frequency range from 150 to 500 Hz and automatic designation of the eyeball movement direction. The analysis of these data resulted in 3 new features of dynamics of the eye reaction to an air puff. Classification of these features enabled to propose 4 classes of deformation. The proposed algorithm allows to obtain reproducible results fully automatically at a time of 5 s per patient using the Core i5 CPU M460 @ 2.5GHz 4GB of RAM. CONCLUSIONS: The paper presents the possibility of using a profiled algorithm of image analysis, proposed by the authors, to measure additional cornea deformation parameters. The new tool enables automatic measurement of the additional new parameters when using the Corvis tonometer. A detailed clinical examination based on this method will be presented in subsequent papers.

NMR spectroscopy of human eye tissues: a new insight into ocular biochemistry.

BACKGROUND: The human eye is a complex organ whose anatomy and functions has been described very well to date. Unfortunately, the knowledge of the biochemistry and metabolic properties of eye tissues varies. Our objective was to reveal the biochemical differences between main tissue components of human eyes. METHODS: Corneas, irises, ciliary bodies, lenses, and retinas were obtained from cadaver globes 0-1/2 hours postmortem of 6 male donors (age: 44-61 years). The metabolic profile of tissues was investigated with HR MAS 1H NMR spectroscopy. RESULTS: A total of 29 metabolites were assigned in the NMR spectra of the eye tissues. Significant differences between tissues were revealed in contents of the most distant eye-tissues, while irises and ciliary bodies showed minimal biochemical differences. ATP, acetate, choline, glutamate, lactate, myoinositol, and taurine were identified as the primary biochemical compounds responsible for differentiation of the eye tissues. CONCLUSIONS: In this study we showed for the first time the results of the analysis of the main human eye tissues with NMR spectroscopy. The biochemical contents of the selected tissues seemed to correspond to their primary anatomical and functional attributes, the way of the delivery of the nutrients, and the location of the tissues in the eye.

[Neovascular form of age-related macular degeneration --current management in Poland and in Europe]. / Postac neowaskularna zwyrodnienia plamki zwiazanego z wiekiem--aktualne metody post powania w Polsce i w Europie.

Currently in Poland neovascular form of age-related macular degeneration (AMD) is treated with vascular endothelial growth factor (VEGF) inhibitors--ranibizumab, aflibercept and bevacizumab. Photodynamic therapy is still refunded, although it is very rarely used. It can be estimated that only small minority (about 5-10%) of cases are properly treated due to mainly refunding restrictions in Poland. In countries with wider access to treatment 50% reduction in AMD-related blindness incidence was noted. Low-cost off-label anti-VEGF agent bevacizumab is almost inaccessible in Polish public health system because of law regulations. In order to increase availability of anti-VEGF injections vials of all mentioned drugs are divided which raises safety concerns. Despite new potent drug in the market aflibercept, cost of treatment remains very high. The optimal treatment regimen includes three monthly injections, after which is usually used pro re nata therapy based primarily on the outcome of macular optical coherence tomography. Routinely recommended antibiotic prophylaxis of injection-related endophthalmitis probably has no meaning apart from the generation of resistance.

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.

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.

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.

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.

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.

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.