Autologous Serum Eye Drops Research Articles (Page 1)

Severe dry eye disease is a commonly diagnosed condition that can be treated with serum eye drops (SEDs). SEDs are manufactured from the serum obtained from whole-blood donation. Patient information provided with SEDs has not been evaluated so far. This study aims to understand patients' views on SED materials and identify possible improvements. The study period was between 1 November 2021 and 30 June 2022. Eligible patients were supplied with either autologous SED (AutoSED) or patient-tailored (allogeneic) SED (PT SED) manufactured by Australian Red Cross Lifeblood. Patients were invited to participate via email or post and completed an online survey or participated in a semi-structured telephone interview. A total of 64 patients supplied with AutoSED and 18 with PT SED completed the survey, of whom 10 and 8, respectively, were interviewed. More AutoSED (89.1%) than PT SED (58.8%) patients reported that the instructions on the carton were helpful. More AutoSED patients (78.1%) than PT SED (55.6%) reported receiving the SED brochure and that the information was easy to understand. Information on how to dispose the eye drops and the risk of treatment was easy to understand. Sixteen patients reported accessing the quick-responsecode to view the SED video and indicated that it was easy to understand. Patient views on the materials provided with SEDs were generally positive. Suggested improvements included changing the location of sealing stickers on the carton, providing further detailed information on shelf-life after power supply challenges and natural disasters and storage and handling during travel.

Corneal ulceration is a frequent ophthalmic disorder in domestic cats that can cause ocular discomfort, visual impairment, and serious complications if left untreated. Conventional medical management often provides limited support for epithelial regeneration, leading to the need for alternative therapeutic options. This case study reports the clinical outcome of using autologous serum eye drops (ASEDs) in the treatment of corneal ulceration in a domestic cat. A cat presented with severe epiphora, conjunctival hyperemia, and a centrally located corneal ulcer confirmed by fluorescein staining. Autologous serum was prepared by weekly collection of 6 mL of blood from the dorsalis antebrachii vein, followed by centrifugation and aliquoting into sterile eye drop bottles stored at 4 °C. The serum was applied topically twice daily, accompanied by supportive therapy consisting of vitamin A supplementation, multivitamin injections, and an Elizabethan collar to prevent self-trauma. Clinical scoring (0–3) was used to monitor epiphora, conjunctival hyperemia, and corneal opacity over the treatment period. Marked improvement was observed within 14 days: epiphora and conjunctival hyperemia resolved completely, while corneal opacity improved from moderate to mild, with fluorescein staining becoming negative, indicating complete epithelial closure. No adverse effects were recorded during therapy. This case highlights the potential of autologous serum eye drops as a safe and effective adjunct treatment for feline corneal ulceration, warranting further investigation in larger cohorts to establish standardized protocols for veterinary ophthalmology

This study evaluates the efficacy and safety of autologous serum eye drops (ASEDs) combined with sodium hyaluronate in treating dry eye disease (DED) after phacoemulsification cataract surgery. This retrospective cohort study included patients diagnosed with DED within 1 week to 1 month after cataract surgery at our hospital (August 2022-July 2023). Patients were divided into a combined group (ASEDs + sodium hyaluronate, n = 48) and a monotherapy group (sodium hyaluronate only, n = 63). Propensity score matching was used to balance baseline characteristics, resulting in 48 patients in each group. Both groups were treated for at least 4 weeks. Clinical indicators, including Ocular Surface Disease Index (OSDI), Schirmer I test (SIT), tear breakup time (BUT), fluorescein staining, conjunctival hyperemia, and conjunctival impression cytology, were assessed before and after treatment. After propensity score matching, baseline characteristics were comparable (P > .05). The mean age was 43.83 ± 8.84 years in the combined group and 43.93 ± 8.84 years in the monotherapy group (P = .865), with male proportions of 47.9% and 45.8%, respectively (P = .779). Other variables, including body mass index, disease duration, OSDI, SIT, and BUT, also showed no significant differences. After 4 weeks, the combined group showed significantly greater improvements. OSDI scores decreased to 14.09 ± 4.22 versus 21.50 ± 4.82 (P < .001); SIT increased to 10.23 ± 2.00 mm versus 8.50 ± 1.50 mm (P < .001); BUT extended to 8.18 ± 0.96 seconds versus 6.00 ± 1.00 seconds (P < .001). Fluorescein staining scores reduced to 0.56 ± 0.22 versus 1.86 ± 0.76 (P < .001), with conjunctival hyperemia and conjunctival impression cytology scores also significantly improved in the combined group (P < .001). ASEDs combined with sodium hyaluronate significantly improve both symptoms and ocular surface parameters in post-cataract DED patients, showing superior efficacy over monotherapy and promising clinical value.

Severe corneal manifestations of graft-versus-host disease: Experience of a tertiary referral center.

According to the European Pharmacopoeia, multidose containers for eye drops must either contain antimicrobial agents, preservatives, or be fitted with filters or non-return valves to prevent microbial contamination after opening. Vials for single-day use do not have filters or non-return valves. The aim of this study is to demonstrate the safety of reclosable vials (ophtioles) containing unpreserved autologous serum eye drops (ASEDs) by evaluating their sterility during single-day use. Two types of reclosable ophtioles were evaluated, one with a screw cap (Meise System, Heinz Meise GmbH, Schalksmühle, Germany) and the other one with a plug cap (COL System, BIOMED DEVICE S. R. L., Modena, Italy). Drop application over 12 hours was simulated in the laboratory following the manufacturer's instructions. For the Meise System, drops were applied at 2-hour intervals, while for the COL System, drops were applied at 1-hour intervals. Each application involved inoculating a chocolate-agar PolyViteX plate (PolyViteX, bioMérieux SA, Marcy-l'Étoile, France) with two drops spaced apart on the same plate and then incubating the plate. After 24 hours, a final inoculation was performed to check for sterility, and the plates were scored after 24 and 48 hours of incubation. In the Meise System test series, 12 vials were tested, providing 192 measurements over 12 hours with a 2-hour application interval. With the COL System, 16 vials were tested, resulting in 448 measurements with a 1-hour application interval over 12 hours. Neither the Meise nor the COL System showed contamination of any application after 24 hours of incubation. After 48 hours of incubation, two vials of the Meise System showed a contamination in one measurement, but subsequent applications were sterile again. In the COL System, nine measurements in seven vials were positive. In three of these vials, the last application at 24 hours showed contamination after 48 hours of incubation, where no further drops were applied. The study confirms the sterility of ASEDs in two reclosable types of ophtiole systems during single-day use in laboratory-simulated conditions within 12 hours of application and 24 hours of incubation time. This is consistent with our several years of clinical experience of the absence of ocular infections caused by the use of ASEDs in the described ophtioles.

Objective: This case report highlights the challenges and innovative treatment approaches for managing trauma-induced anterior necrotizing scleritis (ANS), particularly in high-risk occupational settings, such as welding.Methods: We present the case of a 44-year-old male welder who suffered a metal particle injury in his right eye, leading to ANS. Initial treatments included removal of the foreign body, suturing of the conjunctival tear, and administration of antibiotics and hydrating eye drops. Subsequent treatments for the ensuing ANS included systemic and topical steroids, cyclosporine drops, oral prednisone, vitamin C supplements, dura and amniotic membrane grafting, and autologous serum eye drops. Following the failure of these interventions, a temporary tarsorrhaphy surgery was performed.Results: Despite the application of various conventional therapies, the patient’s condition did not improve significantly until temporary tarsorrhaphy was performed. This intervention, along with an intensive therapeutic regimen, led to the complete healing of the sclera and improved visual acuity.Conclusion: This case underscores the complexity of treating ANS, especially in cases resistant to standard treatment modalities. The successful use of temporary tarsorrhaphy in conjunction with other treatments highlights the need for an individualized approach to manage such conditions. This case contributes to the growing body of evidence suggesting the potential benefits of revisiting traditional surgical interventions for treating refractory cases of ANS.

Topical biological agents represent a significant advancement in the treatment of ocular surface diseases, offering a regenerative and therapeutic approach beyond conventional therapies. These agents are derived from serum (autologous or allogeneic), platelets, amniotic membrane, and pooled intravenous immunoglobulin. Their efficacy stems from their rich composition of growth factors, cytokines, and anti-inflammatory molecules that promote tissue healing, reduce inflammation, and enhance corneal regeneration. Autologous serum eye drops, closely mimicking natural tears, have been widely utilized for conditions such as dry eye disease, neurotrophic keratopathy, and persistent epithelial defects. Similarly, platelet derivatives, including platelet-rich plasma (PRP) and platelet lysate (PL), have demonstrated accelerated wound healing and nerve regeneration benefits. Amniotic membrane extracts and human amniotic fluid eye drops share the anti-inflammatory and regenerative properties of the human amniotic membrane. Recent advancements have introduced the use of topical IVIG, which modulates immune responses in severe inflammatory dry eye conditions, such as ocular graft-versus-host disease. Despite these promising applications, challenges such as variability in preparation, storage limitations, and cost remain. Nevertheless, the future of topical biological agents is promising, with emerging recombinant therapies and personalized treatment approaches shaping modern ophthalmologic care. As research continues to expand, these agents are poised to become integral components in managing ocular surface disorders, improving patient outcomes, and reducing dependence on traditional therapies.

For specific samples, there are different methods and requirements for testing sterility. Blood and blood products are analyzed using automated blood culture methods, while pharmacopeial sterility is assessed using membrane filtration or direct inoculation according to the European Pharmacopoeia (Ph. Eur. 2.6.1.) to detect microbial growth. As autologous serum eye drops (ASEDs) may be viewed as both a blood product and a classical drug, the Swiss legislator has classified these as non-standardizable drugs, and thus, the pharmacopeial requirements apply. This study investigates ASED preparations with respect to the performance of a common automated blood culture system, BD BACTEC, in detecting aerobic and anaerobic bacteria and fungi in ASED preparations, with pharmacopeial sterility testing using agar plate cultures. Based on the European Pharmacopoeia, we inoculated sterile filtered blood serum with BioBalls of the six reference strains at a low concentration of three colony-forming units per milliliter (CFU/mL). A test battery of three different BD BACTEC culture media (hereafter referred to as Trio-BACTEC : BD BACTEC Plus Aerobic/F-Medium, BD BACTEC Lytic/10 Anaerobic/F-Medium, BD BACTEC Mycosis IC/F-Medium) and three agar plates [Tryptic Soy Agar (TSA), Chocolate Blood Agar, Sabouraud's Dextrose Agar] were inoculated per strain. We incubated the Trio- BACTEC in the BD BACTEC Blood Culture System at 35 °C for 5 days, the TSA and Chocolate plates at 35 °C for 5 days, and the Sabouraud plates at 25 °C for 7 days. We confirmed positive growth signals by microscopy or MALDI-ToF mass spectrometry and included negative controls. We detected all reference strains using BACTEC and agar plates. No growth was observed in the negative controls. Overall, growth detection by BACTEC and agar plates was comparable, except for Aspergillus brasiliensis and Candida albicans, which was detected after 1 day on solid media and after 2 days on BACTEC. This study demonstrates the comparability of sensitivity and detection speed using the automated blood culture method and agar plates for sterility validation of ASED, even at low bacterial and fungal contamination levels.

Study of quality of life in patients treated with autologous serum eye drops

Autologous serum eye drops in the management of ocular surface disorders: a systematic review

Aims/Purpose: To present a case series of patients with persistent epithelial defects (PED) of different etiologies treated with topical insulin after failure of conventional treatments and evaluate its efficacy.Methods: We reviewed the clinical history of 17 patients with PED that were treated with topical insulin since 2020, refractory to conventional treatments.Results: Of the 17 patients with PED that we reviewed, 16 of them achieved reepithelization with topical insulin after failure of conventional treatment. Reepithelization mean time was 29 days (range 6‐60 days). Recurrence of the epithelial defect was observed in 2 patients. None of the patients that achieved epithelization needed extra treatment after topical insulin in order to solve the PED. No adverse effects were reported with the use of topical insuline and it was well tolerated.Conclusions: Topical insulin is a very effective treatment for reepithelization of refractory persistent epithelial defects with good tolerance, no adverse effects, and good availability and cost‐effectiveness in comparison to other treatments.References Aynsley TR. THE USE OF INSULIN IN THE TREATMENT OF CORNEAL ULCERS. Br J Ophthalmol. 1945 Jul;29(7):361‐3. doi: 10.1136/bjo.29.7.361. PMID: 18170130; PMCID: PMC513802. Zagon IS et al. Use of topical insulin to normalize corneal epithelial healing in diabetes mellitus. Arch Ophthalmol. 2007 Aug;125(8):1082‐8. doi: 10.1001/archopht.125.8.1082. PMID: 17698755. Diaz‐Valle D et al. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280‐2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21. PMID: 32951459. Diaz‐Valle Det al. Comparison of the efficacy of topical insulin with autologous serum eye drops in persistent epithelial defects of the cornea. Acta Ophthalmol. 2022 Jun;100(4):e912‐e919. doi: 10.1111/aos.14997. Epub 2021 Aug 18. PMID: 34407296. Wang AL et al. Use of Topical Insulin to Treat Refractory Neurotrophic Corneal Ulcers. Cornea. PMID: 28742619; PMCID: PMC5633504. NaPier E et al. Neurotrophic keratopathy/ current challenges and future prospects. Ann Med.. PMID/ 35243932; PMCID/ PMC8903790.

The purpose of this study was to compare the growth factor concentrations in undiluted autologous platelet-rich plasma (APRP) and autologous serum (AS) eye drops. This was a single-center, prospective trial conducted in a tertiary university hospital in Bangkok, Thailand. Ninety-six patients with moderate-to-severe dry eye disease, who were randomly assigned to receive either 100% APRP or 100% AS, were enrolled in the study. Primary outcome measures were the concentrations of epitheliotrophic factors, including epithelial growth factor (EGF), basic fibroblast growth factor (bFGF), hepatocyte growth factor (HGF), β-nerve growth factor (β-NGF), platelet-derived growth factor (PDGF)-AA, PDGF-BB, transforming growth factor (TGF)-α, TGF-β1, and vascular endothelial growth factor (VEGF) in 100% APRP and 100% AS. Secondary outcome measures were the correlations between baseline patient characteristics and each growth factor concentration. Undiluted APRP contained more EGF, bFGF, and β-NGF than undiluted AS (P < 0.001, P < 0.001, P = 0.018, respectively). Meanwhile, undiluted AS yielded higher concentrations of HGF, PDGF-AA, PDGF-BB, and VEGF compared with undiluted APRP (P < 0.001 all). There were no significant differences in TGF-α and TGF-β1 concentrations between the two groups. In the 100% APRP group, the platelet concentrations had positive correlations with the concentrations of EGF (P = 0.028) and VEGF (P = 0.020). In the 100% AS group, Sjögren's syndrome negatively correlated with the concentrations of PDGF-BB (P = 0.028) and VEGF (P = 0.023). Diabetes mellitus (DM) showed negative correlations with the concentrations of HGF (P = 0.001), TGF-α (P = 0.001), and VEGF (P = 0.002). With our simple preparation protocols, 100% APRP contains higher concentrations of EGF, bFGF, and β-NGF, whereas 100% AS contains higher concentrations of HGF, PDGF-AA, PDGF-BB, and VEGF. This could allow ophthalmologists to tailor treatments to individual patients by targeting growth factor supply based on their underlying pathophysiology. ClinicalTrials.gov identifier, NCT04683796.

ABSTRACT Purpose While substantial research has focused on systemic immunomodulatory therapy for ocular cicatricial pemphigoid (OCP), limited data exist on managing associated ocular surface disease (OSD). This study evaluates treatments for OCP-related OSD at our institution. Methods We conducted a retrospective analysis of patients diagnosed with cicatrizing conjunctivitis at the University of Colorado Hospital from January 1, 2013, to October 31, 2023. Patients with cicatrizing conjunctivitis due to non-OCP conditions were excluded, and disease severity was classified using the Foster Staging System. Results Our review included 30 patients with OCP, all with at least six months of follow-up. The mean age of symptom onset (n = 19) was 62.2 years (SD = 16.4), while the mean age at diagnosis (n = 28) was 65.1 years (SD = 12.7). The most common OSD treatments at the last visit were preservative-free artificial tears (87%), topical corticosteroids (43%), autologous serum eye drops (40%), topical antibiotics (30%), and topical immunomodulators (23%). All patients used at least one treatment, with 83.3% on prescription therapies. Patients averaged 3.33 (SD: 1.4) treatments, with 1.7 (SD: 1.2) being prescriptions. Topical immunomodulators had the highest discontinuation rate at 73.1% (n = 19/26). Autologous serum eye drops and topical corticosteroids were the least discontinued treatments. Number of total treatments, prescriptions, and procedures sharply increased at stage three OCP. Conclusions The number of treatments and procedures increased with OCP severity, indicating that advanced OCP often necessitated more intensive OSD management.

To investigate the effect of adding autologous serum eye drops to the postoperative regime after amniotic membrane transplantation for severe persistent corneal ulcers. Forty eyes of 40 patients with persistent corneal ulcers were randomly assigned to artificial tears (sodium hyaluronate 0.2%, ATs group, n=20) or autologous serum eye drops (ASEDs, n=20) following treatment with amniotic membrane transplantation. Digital slit lamp images were acquired from all patients before and 30d post treatment. The area with fibrovascular tissue was calculated using Image J. Central corneal sensitivity was assessed by Cochet-Bonnet aesthesiometry before and one month after treatment. Scar tissue transparency was assessed with a novel optical densitometry. Mean age of patients was 61.65±16.47y and 57.3±19.11y in the ATs group and ASEDs group, respectively. Twenty-two male and 18 female patients were included in the study. The improvement in visual acuity was significantly greater in the ASEDs group (0.14±0.04) than the ATs (0.08±0.04; P=0.00046). Cochet-Bonnet aesthesiometry improved significantly after treatment with a similar rate between groups. There were no statistically significant differences in the area of postoperative fibrovascular tissue between the two groups (P=0.082). The success rate in the two groups was similar. The difference in densitometry between the ATs and ASEDs group was statistically significant (P=0.042) with greater reduction from baseline in the ASEDS group. Autologous serum eye drops can lead to better visual acuity, more stable results and improved densitometry and should be considered in the postoperative care following amniotic membrane transplantation.

Dry eye disease (DED) is highly prevalent worldwide, leading to increased medical costs, economic burdens on families and society, and a diminished quality of life for patients. The utilization of autologous serum eye drops (ASEDs) for the treatment of DED is progressively rising. To further evaluate the efficacy and safety of ASEDs in the treatment of DED. A thorough search for randomized controlled trials (RCTs) was conducted across eight databases, including PubMed, EMBASE, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, Wanfang, SinoMed, and VIP. This search encompassed the inception of each database up to April 1, 2024, with a specific focus on identifying RCTs evaluating the efficacy and safety of ASEDs for the treatment of DED. Data analysis was conducted utilizing Stata 15.0 software and the Cochrane Risk of Bias Assessment Tool was utilized to appraise the literature's quality. The study encompassed 12 RCTs. In comparison to the use of artificial tears (AT), patients diagnosed with DED who utilized ASEDs displayed elevated the Schirmer test (ST) scores [WMD = 2.35, 95% CI (1.45, 3.24), p < 0.001] and tear-film breakup time (TBUT) scores [WMD = 2.83, 95% CI (2.27, 3.39), p < 0.001], decreased Corneal fluorescence staining (CFS) scores [SMD = -2.11, 95% CI (-3.07, -1.15), p < 0.001] and the Ocular Surface Disease Index (OSDI) scores [WMD = -10.54, 95% CI (-13.31, -7.77), p < 0.001], and experienced a reduced frequency of adverse events [RR = 0.36, 95% CI (0.13, 0.99), p = 0.048]. In this study, ASEDs had been shown to enhance tear secretion, extend tear film break-up time, mitigate corneal epithelial damage, ameliorate OSDI scores, and exhibit greater safety compared to AT.

Allogeneic serum-based eye drops may give better results than autologous drops in Sjögren's syndrome dry eye

Introduction: The purpose of the study was to evaluate the frequency of topical immunomodulatory and immunosuppressive therapies in patients with ocular chronic graft-versus-host disease (cGVHD) in consideration of inflammatory activity and systemic immunosuppressive therapies in a tertiary care university hospital setting. Methods: We included 95 adult patients (48 male, 47 female) with ocular chronic graft-versus-host disease (cGVHD) after alloHSCT (median age 49.5 years). Clinical ophthalmological findings and the grade of ocular cGVHD according to the NIH eye score and the German-Austrian-Swiss Consensus (GAS) Grading were analyzed. Systemic GVHD manifestations as well as the prevalence of topical and systemic (immunomodulatory) therapies were assessed. Results: A total of 74 of 95 patients (77.8%) had manifestations of systemic chronic graft-versus-host disease other than ocular GVHD. 68.42% (65/95) of patients were under systemic immunosuppressive therapy with at least one immunosuppressive medication. All patients (95/95) received lid-margin hygiene and phosphate- and preservative-free lubricating eye drops. Twenty-five percent of the cohort (24/95) were treated with autologous serum eye drops (ASEDs). In total, 80% (76/95) of patients required topical steroid therapy to treat acute exacerbation of inflammation at least once; continuous topical steroid therapy was only necessary for a minor part (12%) with refractory chronic inflammation. A total of 92.63% (88/95) were primarily treated with ciclosporin A 0.1% as Ikervis®, of whom at least one third did not continue the therapy because of intolerable side effects during follow-up and received alternative topical formulations. Conclusions: Our data show that patients with ocular cGVHD mostly need topical therapy including anti-inflammatory agents despite systemic immunosuppressive therapy. In our cohort, 80% of patients received topical steroids, and more than 90% received topical ciclosporin A eye drops, which were tolerated by only two thirds of patients due to side effects.

Purpose The purpose of this study was to assess in-vitro efficacy of a suffusion of autologous serum withcyclosporine 0.05% (CsA) and sodium hyaluronate 0.1% (SH). Methods The expression of proinflammatory markers interleukin 6 (IL-6) and TNF-Alpha (TNF-α) in limbal epithelial cells was evaluated. Also, assessment of the stability of epithelial growth factor and transforming growth factor-beta (EGF, TGF-β) in the 50% combinations with autologous serum (AS) was done. The characteristics (pH, density, osmolality) of the two combinations were also evaluated. Additionally, cytotoxicity effect of given test compounds was evaluated on human limbal epithelial cells (LEpiC). Results The percentage of cells expressing IL-6 subjected to AS + SH and AS + CsA were 6.23% and 5.69% respectively. There was no significant difference in percentage of cells expressing TNF-α between the formulations (5.87%, 5.83% respectively). The growth factors; EGF and TGF-β remained stable forone month duration (on 2 and 4 weeks) at 4 °C without significant difference between the time intervals tested. The results of MTT assay suggested that limbal epithelial cells treated with AS + CsA and AS + SH combinations showed minimal toxicity however it was not significant statistically (p ≤ 0.05). Conclusion Two test combinations (AS + CsA, AS + SH) showed stable growth factors (EGF, TGF-β) and good anti-inflammatory property against pro-inflammatory markers. Also, the 2 combinations were found safe on cultured limbal epithelial cells. The novel combination of autologous serum in CsA may provide added benefit in dry eye disease (DED) through their combined anti-inflammatory and epitheliotropic effects.

Dry eye syndrome is a common ophthalmic condition caused by a deficiency in the tear film, leading to discomfort and damage to the ocular surface. Dry eye syndrome is divided into three main categories: ADDE (aqueous deficient dry eye), EDE (evaporative dry eye), and a mixed form. Diagnosis involves assessing clinical symptoms, laboratory tests, and patient history. Treatment depends on the cause and severity of symptoms, including artificial tears, anti-inflammatory medications, autologous serum eye drops, and innovative lipid microemulsion eye drops. These modern drops stabilize the tear film, protect the ocular surface, and support regenerative processes, providing patients with relief and improved quality of life.

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