The Management of Dry Eye Disease: Proceedings of Italian Dry Eye Consensus Group Using the Delphi Method

Aragona, Pasquale; Giannaccare, Giuseppe; Mencucci, Rita; Rubino, Pierangela; Cantera, Emilia; Finocchiaro, Claudia Yvonne; Vaccaro, Sabrina; Aiello, Francesco; Antoniazzi, Elena; Barabino, Stefano; Bombardieri, Stefano; Carlini, Gianpaolo; Chierego, Chiara; Gisoldi, Rossella Anna Maria Colabelli; Zazzo, Antonio Di; Fasciani, Romina; Franch, Antonella; Gabbriellini, Gianluca; Gagliano, Caterina; Leonardi, Andrea; Macrı́, Angelo; Mosca, L.; Orfeo, Vincenzo; Pinna, Antonio; Pocobelli, Augusto; Protti, Romolo; Rama, Paolo; Rania, Laura; Rechichi, Miguel; Russo, Andrea M.; Scorcia, Vincenzo; Spadea, Leopoldo; Trentadue, M.; Troisi, S.; Versura, Piera; Rolando, Maurizio

doi:10.3390/jcm11216437

Cited by 4 publications

(3 citation statements)

References 38 publications

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“…Dry eye disease (DED) is one of the most common ocular diseases, affecting 5-35% of the world's population [1][2][3]. DED is considered a disorder of the ocular surface, characterized by tear film instability accompanied by possibly independent features such as clinical signs, symptoms, and visual disturbances.…”

Section: Introductionmentioning

confidence: 99%

“…In particular, inflammation plays a critical role in the pathophysiology of DED, and the expression of IL-1, TNF-α, and IL-6 is key to the inflammatory response that activates adaptive immunity and leads to chronic DED and ocular surface impairment [1,[4][5][6][7][8]. Therefore, anti-inflammatory therapy, including high-dose corticosteroids, is essential for the treatment of severe DED [1,[8][9][10][11][12][13][14]. However, chronic therapy with corticosteroids is associated with side effects such as increased intraocular pressure (IOP), lens opacification, and ocular surface infections [15][16][17][18][19].…”

Section: Introductionmentioning

confidence: 99%

“…Moreover, dysregulation of neural feedback mechanisms can contribute to the syndrome by impairing reflex tearing and goblet cell function, thereby worsening the condition. A deeper understanding of these mechanisms is critical for developing targeted therapies [1,5,8].…”

Section: Introductionmentioning

confidence: 99%

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Dry Eye Para-Inflammation Treatment: Evaluation of a Novel Tear Substitute Containing Hyaluronic Acid and Low-Dose Hydrocortisone

Borroni,

Mazzotta,

Rocha-de-Lossada

et al. 2023

Biomedicines

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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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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Dry Eye Para-Inflammation Treatment: Evaluation of a Novel Tear Substitute Containing Hyaluronic Acid and Low-Dose Hydrocortisone

Borroni,

Mazzotta,

Rocha-de-Lossada

et al. 2023

Biomedicines

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Utilising Narrative Medicine to Identify Key Factors Affecting Quality of Life in Dry Eye Disease: An Italian Multicentre Study

Aragona,

Barabino,

Akbas

et al. 2024

Ophthalmol Ther

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Introduction Despite an improved understanding of its pathogenesis, dry eye disease (DED) remains relatively underestimated and its treatment challenging. A better alignment between the clinical evaluation and the patient self-assessment also requires capturing the whole patient experience of DED. This project aimed to unveil this experience through narrative medicine (NM). Methods The project involved 38 expert centres in Italy and one in San Marino, targeting adult patients with DED, their informal caregivers and their treating ophthalmologists. Written narratives and sociodemographic and quality of life (QoL)-related data were anonymously collected through the project’s webpage. Narratives were analysed through MAXQDA (VERBI Software, Berlin, Germany), NM classifications and content analysis. Results A total of 171 patients with DED, 37 informal caregivers and 81 ophthalmologists participated in the research. DED was defined as a disabling condition by 19% of patients and 35% of caregivers; 70% of patients reported that a therapeutic alliance is an integral part of DED treatment and 32% hope for more effective therapies. Forty-four per cent of patients assessed their own QoL as good; however, DED emerged as importantly impacting work performance and social events. DED physical, emotional and economic burden and the cruciality of a trusting care relationship represent the main themes that emerged across all narratives, while empathy and effective treatment are among the factors favouring coping with DED. Conclusion This project marked a pioneering initiative investigating the lived experience of patients with DED through NM, simultaneously involving all viewpoints involved in the care pathway. NM enabled the unveiling of factors favouring the ability to cope with DED and its associated QoL implications and provided valuable insights to improve the therapeutic alliance. Supplementary Information The online version contains supplementary material available at 10.1007/s40123-024-01033-7.

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Efficacy and Safety of Useul for Dry Eye Disease: Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel, Phase 2 Clinical Trial

Lyu,

Kwon,

Park

et al. 2024

Healthcare

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Introduction: Dry eye disease (DED) is a very frequently encountered ocular disease, making it a growing public health burden. However, current treatments for DED present unmet medical needs owing to their side effects or ineffectiveness. Therefore, an effective and safe therapeutic agent to manage DED is needed. Method and Analysis: We planned a phase 2, dose-finding, double-blind, randomized placebo-controlled trial to evaluate the efficacy and safety of two different doses of USL (Useul), the extract of Achyranthis Radix, compared with placebo, for DED. USL has been found to protect against DED by inducing tear secretion and improving corneal irregularity via anti-inflammatory effects, which will provide new therapeutic options. One hundred and twenty participants will be enrolled, after assessing the inclusion/exclusion criteria, at Daejeon University Daejeon Korean Medicine Hospital. Enrolled participants will be allocated to standard-dose USL, high-dose USL, or placebo groups in a 1:1:1 ratio and will be required to administer the trial medication twice a day for 12 weeks and visit the clinic five times. For efficacy outcomes, objective endpoints of fluorescein corneal staining score, tear break-up time, Schirmer’s test, and meibomian test and subjective endpoints of Ocular Surface Disease Index, visual analog scale, Standard Patient Evaluation for Eye Dryness-II, and biomarkers will be assessed throughout the trial. Safety will be assessed based on adverse events, vital signs, laboratory tests, visual acuity, and intraocular pressure. Discussion: Our study results are expected to provide clinical evidence for the use of DED as an effective and safe agent for DED.

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The Management of Dry Eye Disease: Proceedings of Italian Dry Eye Consensus Group Using the Delphi Method

Abstract: Dry eye disease (DED) is a highly prevalent, chronic and progressive condition that affects 5–33% of the world’s adult population [...]

Cited by 4 publications

References 38 publications

Dry Eye Para-Inflammation Treatment: Evaluation of a Novel Tear Substitute Containing Hyaluronic Acid and Low-Dose Hydrocortisone

Dry Eye Para-Inflammation Treatment: Evaluation of a Novel Tear Substitute Containing Hyaluronic Acid and Low-Dose Hydrocortisone

Utilising Narrative Medicine to Identify Key Factors Affecting Quality of Life in Dry Eye Disease: An Italian Multicentre Study

Efficacy and Safety of Useul for Dry Eye Disease: Protocol for a Randomized, Double-Blind, Placebo-Controlled, Parallel, Phase 2 Clinical Trial

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