Browsing by Author "Rocha-de-Lossada, Carlos"

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    Autologous versus allogeneic versus umbilical cord sera for the treatment of severe dry eye disease : a double-blind randomized clinical trial
    (2022-03) Rodríguez Calvo-de-Mora, Marina; Domínguez-Ruiz, Cayetano; Barrero-Sojo, Francisco; Rodríguez-Moreno, Gustavo; Antúnez Rodríguez, Cristina; Ponce Verdugo, Laura; Hernández Lamas, María del Carmen; Hernández-Guijarro, Luisa; Villalvilla Castillo, Jacinto; Fernández-Baca Casares, Idefonso; Prat Arrojo, Isidro; Borroni, Davide; Alba-Linero, Carmen; Zamorano-Martín, Francisco; Moreno-Guerrero, Antonio; Rocha-de-Lossada, Carlos; Department of Doctoral Studies
    Purpose: To measure the effects of Autologous serum (AS), Allogeneic Serum (HS) and Umbilical Cord serum (CS) eye drops in severe dry eye disease (DES), as well as to characterize and quantify several molecules in the three sera (albumin, fibronectin; Vitamin A and E; IgG, IgA and IgM; Transforming growth factor β; Epithelial growth factor). Methods: Randomized, double-blind, single-centre, three-arm (AS, HS and CS) clinical trial. Sixty-three subjects were included with severe DES, 21 in each arm of the study. Visual acuity, Schirmer test, Breakup time (BUT), lissamine green, fluorescein staining measurements and a questionnaire were performed prior to treatment, and after one-month and three-month follow-up. Results: There was a significant main effect of time on visual acuities, Schirmer and BUT tests and fluorescein and lissamine green staining measurements and questionnaire scores (p = 0.015, p = 0.002, p < 0.001, p < 0.001, p = 0.031 and p < 0.001, respectively), although there was no significant interaction between time and serum type, nor between serum type and the test performed. Regarding the concentration of molecules, in our study AS contained significantly higher concentrations of IgA, IgG and fibronectin whereas HS contained significantly higher concentration of IgM, vitamins A and E, TGF and albumin. Contrary to previous reports, CS did not show higher concentration of any of the molecules analysed. Conclusions and relevance: The three sera were effective in the treatment of severe DES. CS did not contain a higher proportion of molecules compared to AS/HS. More research is needed to assess the effect of AS in patients with DES and autoimmune diseases.
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    A Comparative Analysis of the Ocular Microbiome : Insights into Healthy Eyes and Anophthalmic Sockets
    (2024-11) Zamorano-Martín, Francisco; Chumaceiro, Guillermo; Navarro-Torres, Pablo; Borroni, Davide; Urbinati, Facundo; Molina, Ángel; Paytuví-Gallart, Andreu; Rocha-de-Lossada, Carlos; Department of Ophthalmology
    The purpose of this study is to characterize the ocular surface microbiota of patients with an anophthalmic cavity. An eNAT with 1 mL of Liquid Amies Medium was used to collect samples. Microbial DNA from anophthalmic socket and healthy fellow control eye samples was isolated and sequenced. Raw reads were analyzed with GAIA (v 2.02). The richness and Shannon alpha diversity metrics, as well as Bray–Curtis beta diversity and Wilcoxon signed-rank test values, were computed with R packages such as phyloseq, mia, or DESeq2 to allow for microbiome analysis. Principal coordinate analysis (PCoA) was performed using the function plotReducedDim from the R package scater. The different taxonomic profiles were described under the concept of eye community state type (ECST). The microbiomes of both eyes from 25 patients with an anophthalmic cavity were analyzed in this study. While the microbial communities of paired eyes from the same patients showed notable dissimilarity, no consistent patterns emerged when comparing healthy eyes to anophthalmic sockets. Alpha diversity values did not significantly differ between healthy eyes and anophthalmic socket samples, though there was considerable variability within each group. Notably, anophthalmic socket samples generally exhibited lower abundances of genera such as Staphylococcus, Enterococcus, Paenibacillus, and Sediminibacterium compared to their healthy counterparts. Microbial variability between healthy eyes and anophthalmic sockets may be due to anatomical differences. Further research is needed to determine whether patients without anophthalmic sockets exhibit similar microbiome patterns in both eyes.
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    Dry Eye Para-Inflammation Treatment : Evaluation of a Novel Tear Substitute Containing Hyaluronic Acid and Low-Dose Hydrocortisone
    (2023-12) Borroni, Davide; Mazzotta, Cosimo; Rocha-de-Lossada, Carlos; Sánchez-González, José María; Ballesteros-Sanchez, Antonio; García-Lorente, María; Zamorano-Martín, Francisco; Spinelli, Antonio; Schiano-Lomoriello, Domenico; Tedesco, Giovanni Roberto
    Purpose: The purpose of this study was to check the efficacy and safety of a novel tear substitute containing hyaluronic acid and low-dose hydrocortisone in the treatment of moderate dry eye disease. Methods: In this prospective randomized study, 38 patients with moderate dry eye disease were divided into two treatment groups: Group 1 received one drop of 0.2% sodium hyaluronate and 0.001% hydrocortisone four times daily for 3 months, while Group 2 received 0.15% sodium hyaluronate and 3% trehalose at the same dosage. OSDI and SANDE questionnaires, Non-Invasive Break-Up time (NIBUT), Tear Meniscus Height (TMH), meibography, Lipid Layer Thickness (LLT), Tear Break-Up Time (TBUT), Corneal Staining Score (CFS), and Intraocular Pressure (IOP) were evaluated at baseline and after 1, 2, and 3 months of treatment. Results: During the treatment period, Group 1 showed statistically significant improvement in OSDI score (p = 0.002), SANDE score (p = 0.01), NIBUT (p < 0.0001), LLT (p < 0.0001), TBUT (p = 0.01), and CFS (p = 0.02). In Group 2, significant improvement was observed only in the TBUT score (p < 0.05). Comparison of the two groups showed that NIBUT and LLT were significantly different at the end of treatment (p = 0.001 for both comparisons), with more favorable results for sodium hyaluronate and hydrocortisone than for sodium hyaluronate and trehalose. No significant variations in intraocular pressure were observed in either group during the treatment period (p > 0.05). Conclusions: The study confirms that a 3-months treatment with hyaluronic acid 0.2% in combination with low-dose hydrocortisone 0.001% improves the signs and symptoms of moderate DED and that a low-dosage 0.001% hydrocortisone can be helpful in preventing the progression to chronic stages of DED.
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    Efficacy of bilateral OC-01 (varenicline solution) nasal spray in alleviating signs and symptoms of dry eye disease : A systematic review
    (2024-02) Ballesteros-Sánchez, Antonio; Borroni, Davide; De-Hita-Cantalejo, Concepción; Sánchez-González, María Carmen; Sanchez-Gomez, Serafin; Rocha-de-Lossada, Carlos; Sánchez-González, José María; Department of Doctoral Studies
    Purpose: To comprehensively review the efficacy and safety of OC-01 varenicline nasal spray versus vehicle nasal spray (VNS) in the treatment in dry eye disease (DED). Methods: A systematic review that included full-length randomized controlled studies (RCTs), as well as post hoc analyses of RCTs reporting new findings on OC-01 VNS treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included studies published between December 2021 and September 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected. Results: A total of 8 studies were included in this systematic review. OC-01 VNS treatment achieved higher improvement than vehicle in all reported variables. The mean differences between both groups were in favor of OC-01 VNS treatment and were as follow: eye dryness score base on a visual analogue scale (EDS-VAS) of −7.5 ± 2.2 points [-11.6 to −5.6], Schirmer test (ST) with anesthesia of 6.6 ± 2.3 mm [4.9 to 11.8] and total corneal fluorescein staining (tCFS) of −1.2 ± 0.01 points [-1.2 to −1.1]. Similar improvements were reported with OC-01 VNS 0.03 mg and 0.06 mg. Adverse events (AEs) were 15.5 ± 19.4 % [-13 to 80.5] higher in the OC-01 VNS group with an overall adherence > 93 %. Conclusions: OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies.
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    Evaluating GlicoPro Tear Substitute Derived from Helix aspersa Snail Mucus in Alleviating Severe Dry Eye Disease : A First-in-Human Study on Corneal Esthesiometry Recovery and Ocular Pain Relief
    (2024-03) Ballesteros-Sánchez, Antonio; Sánchez-González, José María; Tedesco, Giovanni Roberto; Rocha-de-Lossada, Carlos; Murano, Gianluca; Spinelli, Antonio; Mazzotta, Cosimo; Borroni, Davide; Department of Ophthalmology
    Background: To evaluate the effects of 10% GlicoPro tear substitute therapy in patients with severe dry eye disease (DED). Methods: In this prospective longitudinal study, 30 individuals receiving 10% GlicoPro four times daily for DED were evaluated. The ocular surface disease index (OSDI) questionnaire, average non-invasive break-up time (A-NIBUT), non-anesthetic and anesthetic corneal esthesiometry (CE), ocular pain, and the presence of conjunctivochalasis (CCH) were used as clinical endpoints. Treatment compliance using dosing diaries and AEs was assessed. Results: A significant improvement was observed in the clinical endpoints: the ΔOSDI questionnaire was −39.27 ± 13.22 [−65 to −15] points, ΔA-NIBUT was 3.10 ± 1.31 [1 to 5] s, Δnon-anesthetic CE was 14 ± 6.35 [5 to 25] mm, and Δanesthetic CE was 13 ± 5.35 [5 to 20] mm (p < 0.001 for all comparisons). Ocular pain was reduced in 92.5% of the patients at the end of the follow-up. However, there was no change in the presence of CCH. In addition, all the patients were fully compliant with the dosing and no AEs related to the use of the 10% GlicoPro tear substitute were reported. Conclusions: The 10% GlicoPro tear substitute has the potential to achieve beneficial effects in ocular surface treatments.
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    Ocular Surface Microbiota in Naïve Keratoconus : A Multicenter Validation Study
    (2023-10) Rocha-de-Lossada, Carlos; Mazzotta, Cosimo; Gabrielli, Federico; Papa, Filomena Tiziana; Gómez-Huertas, Carmen; García-López, Celia; Urbinati, Facundo; Rachwani-Anil, Rahul; García-Lorente, María; Sánchez-González, José María; Rechichi, Miguel; Rubegni, Giovanni; Borroni, Davide
    In the field of Ophthalmology, the mNGS 16S rRNA sequencing method of studying the microbiota and ocular microbiome is gaining more and more weight in the scientific community. This study aims to characterize the ocular microbiota of patients diagnosed with keratoconus who have not undergone any prior surgical treatment using the mNGS 16S rRNA sequencing method. Samples of naïve keratoconus patients were collected with an eNAT with 1 mL of Liquid Amies Medium (Copan Brescia, Italy), and DNA was extracted and analyzed with 16S NGS. The microbiota analysis showed a relative abundance of microorganisms at the phylum level in each sample collected from 38 patients with KC and 167 healthy controls. A comparison between healthy control and keratoconus samples identified two genera unique to keratoconus, Pelomonas and Ralstonia. Our findings suggest that alterations in the microbiota may play a role in the complex scenario of KC development.
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    Plasma Rich in Growth Factors (PRGF) in Transepithelial Photorefractive Keratectomy (TPRK)
    (2021-05) Sanchez-Gonzalez, Jose-Maria; Alonso-Aliste, Federico; Borroni, Davide; Amian-Cordero, Jonatan; De-Hita-Cantalejo, Concepcion; Capote-Puente, Raul; Bautista-Llamas, Maria-Jose; Sanchez-Gonzalez, Maria Carmen; Rodriguez-Calvo-de-Mora, Marina; Rocha-de-Lossada, Carlos; Department of Doctoral Studies
    To evaluate the usage of plasma rich in growth factor (PRGF) in transepithelial photorefractive keratectomy (TPRK) in low and moderate myopia, patients who underwent myopic and astigmatism TPRK with PRGF were involved in this retrospective, observational study. Subjects underwent a surgical procedure between February 2019 and June 2019. A three-month follow-up was recorded. Pain score was assessed with a visual analogue scale (0–10) and re-epithelialization time recorded. A total of 48 eyes from 24 patients were recruited. Mean uncorrected distance visual acuity (UDVA) was 20/20.31 (0.00 ± 0.02 LogMAR). A total of 98% of eyes did not change corrected distance visual acuity (CDVA) lines. Two percent of eyes lost one line of CDVA. Preoperative spherical equivalent was −2.67 ± 1.37 D and after three months changed to −0.21 ± 0.34 D, and 2% of eyes changed 0.50 D or more between one and three months. Pain score was 3.29 ± 0.61 (3 to 6) score points at day one and 0.08 ± 0.27 score points at day seven. Finally, re-epithelialization time was 2.50 ± 1.20 days. PRGF addition to conventional refractive treatment such as TPRK seems to alleviate immediate postoperative pain and positively contribute to corneal re-epithelization time.
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    Prophylactic Corneal Cross-Linking in Myopic Femtosecond Laser-Assisted In Situ Keratomileusis : Long-Term Visual and Refractive Outcomes
    (2021-03) Alonso-Aliste, Federico; Amián-Cordero, Jonatan; Rachwani-Anil, Rahul; De-Hita-Cantalejo, Concepción; Borroni, Davide; Rocha-de-Lossada, Carlos; Sánchez-González, José María; Department of Doctoral Studies
    The purpose of our study was to evaluate the safety, effectiveness, predictability, and stability of myopic and astigmatic laser-assisted in situ keratomileusis (LASIK) with simultaneous prophylactic corneal cross-linking (CXL) in thin corneas. In total, 100 eyes from 50 patients who were subjected to myopic and astigmatism femtosecond LASIK with simultaneous prophylactic CXL were included. The design of the study was retrospective, longitudinal, and observational. All patients had a 48-month follow-up. The MEL 80 excimer laser was utilized with the Aberration Smart Ablation platform. CXL treatment was applied when the predicted stromal thickness was less than 330 µm. Patients’ mean age was 30.22 ± 5.97 years. Previous mean spherical equivalent was −5.50 ± 1.65 (−9.50 to −1.13) diopters (D). Postoperative mean spherical equivalent was −0.24 ± 0.29 (−0.85 to +0.50) D. Visual acuity (VA) of 20/20 or better was observed in 87% of the eyes and no eyes experienced VA loss. Spherical equivalent within ±0.50 D was observed in 93% of eyes, and 4% of eyes varied by 0.50 D or more between 3 and 48 months. Prophylactic corneal cross-linking with simultaneous femtosecond laser-assisted in situ keratomileusis in thin corneas proved to be effective, safe, and predictable. The results remained stable after 48 months of follow-up.
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    Pseudopterygium : An Algorithm Approach Based on the Current Evidence
    (2022-08) Urbinati, Facundo; Borroni, Davide; Rodríguez-Calvo-de-Mora, Marina; Sánchez-González, José María; García-Lorente, María; Zamorano-Martín, Francisco; Rachwani-Anil, Rahul; Ortiz-Pérez, Santiago; Romano, Vito; Rocha-de-Lossada, Carlos; Department of Doctoral Studies
    Pseudopterygium is a non-progressive conjunctival adhesion to the peripheral cornea secondary to a corneal-limbus damage. According to the literature, the main etiology is a previous eye trauma. Nevertheless, this could be biased by the existence of other underdiagnosed causes of pseudopterygium, some of which may have severe consequences for the integrity of the eye and patient’s life. This comprehensive literature review was performed based on a search on the PubMed and Google Scholar databases of relevant pseudopterygium published papers according to our current knowledge and seeks to gather the existing evidence about its diverse etiologies and clinical features, as well as to propose a diagnostic algorithm to simplify its correct approach.
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    The role of matrix metalloproteinases in infectious corneal ulcers
    (2023-09-01) García-López, Celia; Rodríguez-Calvo-de-Mora, Marina; Borroni, Davide; Sánchez-González, José María; Romano, Vito; Rocha-de-Lossada, Carlos; Department of Doctoral Studies
    During infectious keratitis, the production of collagenolytic and inflammatory substances, along with increased corneal matrix metalloproteinase (MMP) activity, induces the degradation of corneal collagen and may cause postkeratitis complications, such as opacity, thinning, and corneal perforation. MMPs, especially MMP-2 and MMP-9, are overexpressed in infectious keratitis and sustained over time by inflammatory and nonmicrobial mechanisms. The high MMP levels are correlated with excessive corneal destruction in bacterial, herpetic, fungal, and acanthamoeba infections. Nonspecific treatments, such as tetracyclines, particularly doxycycline, or corticosteroids, are used as adjuvants to antimicrobials to alleviate the disproportionate degradation and inflammation of the corneal layers caused by corneal MMPs and decrease the recruitment and infiltration of inflammatory cells. Treatments showing inhibition of specific MMPs (Galardin, ZHAWOC7726), interfering with pro-MMP activation (EDTA, ascorbic acid), or showing anticytokine effect (epigallocatechin-2-gallate, TRAM-34) have been reported. Other treatments show a direct action over corneal collagen structure such as corneal cross-linking or have been associated with reduction of MMP levels such as amniotic membrane grafting. Although the use of these drugs has been shown in studies to be effective in controlling inflammation, especially in experimental ones, robust studies are still needed based on randomized and randomized clinical trials to demonstrate their potential effect as adjuvants in the management of infectious keratitis.