Ophthalmology and Therapy最新文献

Introduction: This study aims to evaluate the ocular and systemic safety profiles of intravitreal biosimilar ranibizumab Ranieyes (Lupin Pharmaceuticals, Mumbai, India) in real-world clinical settings across multiple chorioretinal vascular diseases, including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) in adults.

Methods: We conducted a retrospective, consecutive, interventional, uncontrolled multicenter study using data from three hospital networks in India. A total of 1401 eyes received 2194 injections of Ranieyes between June 2022 and November 2023. Patients were followed for a minimum of 6 months, and data on ocular and systemic adverse events (AEs) were collected and analyzed.

Results: The study population included 636 male patients and 533 female patients, with a mean age of 58.63 ± 11.54 years. The average number of injections per eye was 1.49 ± 0.23, with the highest frequency in the nAMD group (mean of 2.3 ± 0.23 injections per eye) over 6 months. Non-serious adverse events (nsAEs) were observed in 26.83% of injections, with mild ocular pain and transient blurring of vision being the most common. Serious ocular adverse events were rare, occurring in 0.85% of eyes, with retinal pigment epithelial tear (RPE TEAR) being the most frequent. Systemic adverse events were noted in 5.03% of patients, and all but one were non-serious. One patient developed non-fatal myocardial infarction, the causal relationship of which, however, was not established with the intravitreal agent used. No cases of endophthalmitis were observed.

Conclusions: This large-scale, real-world study demonstrates that Ranieyes is a safe intravitreal antivascular endothelial growth factor (anti-VEGF) agent across various chorioretinal vascular diseases. The safety profile of Ranieyes is consistent with that of the reference product, making it a viable option in resource-constrained settings.

Introduction: With technological advancements and the growing prevalence of smartphones, ophthalmology has opportunely harnessed medical technology for visual function assessment as a home monitoring tool for patients. Ophthalmology applications that offer these have likewise become more readily available in recent years, which may be used for early detection and monitoring of eye conditions. To date, no review has been done to evaluate and compare the utility of these apps. This review provides an updated overview of visual functions assessment using mobile applications available on the Apple App and Google Play Stores, enabling eye care professionals to make informed selections of their use in ophthalmology.

Methods: We reviewed 160 visual function applications available on Apple iTunes and the Google Play Stores. The parameters surveyed included types of visual function tests, the involvement of healthcare professionals in their development, cost, and download count.

Results: Visual tests, including visual acuity and color vision tests, were most common among apps surveyed, and they were comparable to traditional clinical methods. Certain applications were more widely used, some of which have had studies conducted to assess the reliability of test results. Limitations of these apps include the absence of healthcare professionals' involvement in their development, the lack of approval by regulatory authorities and minimal cloud-based features to communicate results to healthcare professionals.

Conclusions: The prevalence and easy access of visual function testing applications present opportunities to enhance teleophthalmology through early detection and monitoring of eye conditions. Future development to enhance the quality of the apps should involve regulatory bodies and medical professionals, followed up by research using larger samples with longer follow-up studies to review the reliability and validity of ophthalmology applications. This would potentially enable these applications to be incorporated into the comprehensive assessment and follow-up care of patients' eye health.

Introduction: Phototherapeutic keratectomy (PTK) is a treatment for recurrent corneal erosion syndrome (RCES). The aim of this study was to investigate whether deeper ablations yielded greater success rates.

Methods: Retrospective case notes review with prospective patient-reported outcome measures for all patients who had undergone PTK for RCES at a single tertiary referral unit. Patients received treatment with the Schwind Amaris^® 750 s excimer laser. The primary outcome measure was recurrence-free survival of patients with ablation depth ≥ 15 µm compared to < 15 µm.

Results: Seventy eyes of 63 patients were included for analysis, of whom 39 (56%) had preceding trauma and 20 (29%) had epithelial basement membrane dystrophy (EBMD), with the remaining 11 (15%) of unknown aetiology. Twenty eyes (29%) received an ablation ≥ 15 µm (mean ablation depth 16.85 ± 3.4 µm) and 50 (71%) received < 15 µm (mean ablation depth 9.26 ± 1.5 µm). Overall, 65 eyes (93%) reported a subjective improvement in symptoms, with 46 (66%) remaining completely symptom free at the last follow-up [mean follow-up 24 (range, 9-48) months]. Eighty-five per cent of eyes in the ≥ 15 µm group remained symptom free compared to 58% of those with < 15 µm (p = 0.036).

Conclusion: PTK is an effective treatment for RCES, with deeper ablations yielding longer symptom-free survival.

Introduction: To evaluate the anterior chamber (AC) inflammation in the early postoperative period after cataract surgery and before Descemet membrane endothelial keratoplasty (DMEK) by quantifying oxidative stress and inflammatory mediators in aqueous humor of patients with Fuchs' endothelial corneal dystrophy (FECD).

Methods: In this prospective single-center study, 15 patients with FECD underwent cataract surgery and DMEK in a two-stage procedure. Aqueous humor was collected from the AC at the beginning of cataract surgery and 3 months later at the beginning of DMEK. In the control group, which consisted of 15 age-matched phakic patients without FECD, aqueous humor was only collected at the beginning of cataract surgery. Mediators of postoperative inflammation including TNF-α, VEGF, IL-2, IL-1 β, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, GM-CSF, IFN-γ, CXCL5/ENA-78, FGF-basic, G-CSF, IL-1-α, IL-1-ra, IL-17, CCL2/MCP-1, CCL3/MIP-1a, CCL4/MIP-1b, TPO, TGF-β-1, TGF-β-2, and TGF-β-3 concentrations were measured using a Multiplex-Array-System.

Results: The concentration of TNF-α (p = 0.021), IL-6 (p = 0.005), IL-8 (p = 0.001), CXCL5/ENA78 (p = 0.002), CCL2/MCP-1 (p = 0.001) and CCL4/MIP-1b (p = 0.037) were significantly higher 3 months after cataract surgery at the beginning of DMEK compared to control group at beginning of cataract surgery. The levels of IL-2, IL-5, IL-8, IL-10, and IL-1-α were significantly higher in phakic eyes in the control group (p < 0.05) before cataract surgery.

Conclusions: The present study indicates significantly increased proinflammatory cytokines 3 months after cataract surgery in eyes with FECD. Our findings suggest postoperative inflammation in the AC up to 3 months after cataract surgery. Therefore, it may be reasonable to combine cataract surgery with DMEK in cataract patients with FECD.

Diabetic retinopathy (DR) is one of the leading causes of vision loss among people of working age. However, people with diabetes are often unaware of the importance of DR screening for preserving vision, highlighting the importance of patient education about DR and DR-related ocular and systemic comorbidities. In this podcast, three patients with different stages of DR and two ophthalmologists exchanged their views on diagnosis, treatment, and progression of DR and diabetic macular edema. The discussion revealed that DR affects not only the physical aspects of patients' lives but also their mental wellbeing. The challenges of a DR diagnosis can be compounded by communication gaps that exist between patients, physicians, and the pharmaceutical industry. Development of new therapies is currently informed mainly by physician perspectives. However, the large burden of current treatments calls for new therapeutic approaches that meet patients' needs better. The preferred method of treatment administration can differ from patient to patient and the choices between treatments that necessitate repeated visits, monitoring, and at-home care must be discussed. As such, going forward it is crucial to consider both the physician and patient perspectives in shaping the clinical landscape of DR.

Introduction: In contrast with patients receiving therapy for retinal disease during clinical trials, those treated in routine clinical practice experience various challenges (including administrative, clinic, social, and patient-related factors) that can often result in high patient and clinic burden, and contribute to suboptimal visual outcomes. The objective of this study was to understand the challenges associated with clinical management of diabetic macular edema from the perspectives of patients, healthcare providers, and clinic staff, and identify opportunities to improve eye care for people with diabetes.

Methods: We conducted a survey of patients with diabetic macular edema, providers, and clinic staff in 78 clinics across 24 countries on six continents, representing a diverse range of individuals, healthcare systems, settings, and reimbursement models. Surveys comprised a series of single- and multiple-response questions completed anonymously. Data gathered included patient personal characteristics, challenges with appointment attendance, treatment experiences, and opportunities to improve support. Provider and clinic staff surveys asked similar questions about their perspectives; and clinic characteristics were also captured.

Results: Overall, 5681 surveys were gathered: 3752 from patients with diabetic macular edema, 680 from providers, and 1249 from clinic staff. Too many appointments, too short treatment intervals, difficulties in traveling to the clinic or arranging adequate support to travel, out-of-pocket costs, office/parking fees, and long waiting times were noted by all as contributing to increase the burden on the patient and caregiver. Patients generally desired more in-depth discussions with their provider, which would help with information exchange and better expectation-setting.

Conclusions: The wealth of systematic data generated by this global survey highlights the breadth and scale of challenges associated with the clinical management of patients with diabetic macular edema. Addressing the opportunities for improvement raised by patients, providers, and clinic staff could increase patient adherence to treatment, reduce appointment burden, and improve clinic capacity.

Introduction: Dry eye disease (DED) is a multifactorial condition of the ocular surface, primarily treated with tear substitutes, which do not fully restore natural tear functions. In this pilot study, we tested the hypothesis that T-Lysyal (T-Lys) improves symptoms and signs in patients with DED. Additionally, we provide a literature overview on the effects of T-Lys in ophthalmology and non-ophthalmology conditions to elucidate its mechanisms of action.

Methods: A double-masked, randomized pilot study was conducted in patients with DED treated with T-Lys or hyaluronic acid (HA) 0.2% combined with tamarind seeds polysaccharide (control group) for 2 months. Inclusion criteria were a diagnosis of DED with symptoms lasting ≥ 6 months, Symptom Assessment in Dry Eye (SANDE) score ≥ 30, and at least one of the following: fluorescein staining of the cornea (score ≥ 3, NEI scale), conjunctival staining (Lissamine Green, score ≥ 3), or tear breakup time (T-BUT) ≤ 10 s. Data from the right eye were used for statistical analysis. A PubMed literature search of T-Lys studies was also performed without publication year restrictions.

Results: Twelve patients in the T-Lys group and 15 in the control group completed the study (mean age 67 ± 11 years). T-Lys treatment resulted in significant improvements from baseline (V0) to 2 months (V2) in symptoms assessed by visual analogue scale (T-Lys: 4.58 ± 2.57 mm at V0, 2.92 ± 1.38 mm at V2, p < 0.05; control: 5.13 ± 2.29 mm at V0, 5.3 ± 2.4 mm at V2), T-BUT (T-Lys: 2.58 ± 1.31 s at V0, 3.58 ± 1.37 s at V2, p < 0.05; control: 3.07 ± 1.43 s at V0, 3 ± 1.13 s at V2), and corneal staining (T-Lys: 2.16 ± 4.17 at V0, 1.41 ± 3.70 at V2, p < 0.05; control: 1.4 ± 2.19 at V0, 1.4 ± 2.16 at V2). No adverse events were reported. Literature findings supported T-Lys's efficacy in managing both ophthalmology and non-ophthalmology conditions.

Conclusion: This study provides the first clinical evidence of T-Lys efficacy in patients with DED, supporting preclinical data and highlighting its potential as a promising ocular surface modulator.

Trial registration: The study was registered in the ISRCTN registry for Clinical Studies with no. 13587929.

The glaucoma treatment paradigm is in evolution. The topical medications-first approach is limited by significant barriers such as high rates of nonadherence and side effects including ocular surface disease. The era of interventional glaucoma has seen the development of selective laser trabeculoplasty (SLT), procedural pharmaceuticals, and minimally invasive glaucoma surgeries (MIGS). New and emerging data support the use of these interventional treatment modalities early in the course of glaucoma rather than reserving them for advanced or treatment-recalcitrant cases. The various treatments available represent multiple mechanisms (e.g., trabecular outflow, uveoscleral outflow, aqueous suppression) and modalities (medications, laser, incisional surgery) by which intraocular pressure (IOP) is reduced. Many patients require more than one treatment to achieve adequate IOP reduction and glaucoma control. Comprehensive IOP control-reduction of both mean IOP and IOP fluctuation-can best be achieved by targeting multiple mechanisms of IOP reduction and taking advantage of the attributes of multiple treatment modalities.

Introduction: Neovascular age-related macular degeneration is a global public-health concern, associated with a considerable burden to individuals, healthcare systems, and society. The objective of this study was to understand different perspectives on the challenges associated with the clinical management of neovascular age-related macular degeneration, which could elucidate measures to comprehensively improve clinical care and outcomes.

Methods: A survey was carried out of patients with neovascular age-related macular degeneration, their providers, and clinic staff in 77 clinics across 24 countries on six continents, from a diverse range of healthcare systems, settings, and reimbursement models. Surveys comprised a series of single/multiple-response questions completed anonymously. Data gathered included patient personal characteristics, appointment attendance challenges, treatment experiences, and opportunities to improve support. Provider and clinic staff surveys asked similar questions about their perspectives; clinic characteristics were also captured.

Results: There were 6425 responses; 4558 patients with neovascular age-related macular degeneration, 659 providers, and 1208 clinic staff. Challenges identified included concern about patient burden to family/friends, high frequency of treatment, difficulties in traveling to appointments, long waiting times, and insufficient comprehension of neovascular age-related macular degeneration. Participants identified logistical (improved financial assistance with treatment and out-of-pocket costs, and appointment reminders), operational (addressing clinic set up to reduce waiting times and improving the amount of time providers spend with patients), and educational (improving quality and provision of patient information and expectation-setting) opportunities to improve care.

Conclusions: The wealth of data generated by this global survey highlights the breadth of challenges associated with clinical management of patients with neovascular age-related macular degeneration. Addressing the opportunities raised could improve patient adherence to treatment and potentially outcomes, reduce appointment burden, and increase clinic capacity.

Introduction: The needs of family caregivers providing care to relatives with visual impairment are often dismissed, leading to caregiver burden. The Zarit Burden Interview (ZBI) can measure the caregiver burden of caring for a family member with vision impairment. The purpose of this study is to validate the ZBI in Mexican family caregivers of patients with visual impairment.

Methods: The ZBI was applied to 137 family caregivers of patients with visual acuity ≤ 20/200 in the best eye for ≥ 6 months. The ZBI's reliability was determined using Cronbach's α and the factor structure using exploratory factor analysis (EFA, principal axis factoring with promax rotation). Items with loadings < 0.400 were eliminated. Retained factors were determined using the scree test and Horn's parallel analysis (95% CI). Associations between burden factors and other variables were evaluated with descriptive and inferential statistics.

Results: Mean ZBI score was 26.2 ± 13.1, and internal consistency was high (α = 0.871). EFA yielded four factors: (1) embarrassment and frustration, (2) self-efficacy expectations, (3) interference in personal relationships, and (4) personal strain. The α values ranged from 0.649 to 0.812. Spousal caregivers had significantly higher scores (factors 1, 2, and 4), whereas adult children had less scores (factor 3). There was a significant positive correlation between hours of daily caregiving and factors 2 (r = 0.350) and 3 (r = 0.388). A worse degree of visual impairment was associated with higher mean factor scores in all factors.

Conclusions: The ZBI is a valid instrument to detect burden in Mexican caregivers of patients with visual impairment. We identified a four-factor structure that improved our understanding of the ZBI's underlying constructs. Interventions targeting specific types of burden are warranted.