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      Efficacy of carbomer sodium hyaluronate trehalose vs hyaluronic acid to improve tear film instability and ocular surface discomfort after cataract surgery

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          Abstract

          Purpose

          To evaluate the effects of carbomer sodium hyaluronate trehalose (CHT) and sodium hyaluronate eye drops on tear film stability and ocular discomfort after cataract surgery.

          Setting

          Santa Maria della Misericordia Hospital, Rovigo, Italy.

          Design

          Prospective randomized case-control study.

          Patients and methods

          This study enrolled sixty patients scheduled for unilateral cataract surgery. After phacoemulsification, subjects received carbomer sodium hyaluronate trehalose (trehalose group) or sodium hyaluronate tears (HG group) substitute and were assessed through objective (break up time, corneal and conjunctival staining) and subjective (OSDI questionnaire) clinical evaluations after a two times a day topical administration. Outcome measures were collected preoperatively (baseline), one week (day 7) and 1 month (day 30) after surgery. Finally, each patient was asked to give his personal treatment satisfaction score.

          Results

          Trehalose group showed a steeper break up time (BUT) increase compared to patient treated with hyaluronic acid ( P<0.001). OSDI questionnaire presented a opposite trend, trehalose patients evidenced a significantly major improvement ( P<0.001), and in seven days mean values reduced by more than three times. Fluorescein staining reduction was documented with both treatments, although there was no statistically significant difference between groups. Finally CHT resulted in a significantly greater global satisfaction score ( P<0.001).

          Conclusions

          CHT was effective and well tolerated in reducing dry eye disease symptoms and improving the clinical outcome after cataract surgery. On some parameters (BUT, OSDI), this new formulation was more effective than commonly used sodium hyaluronate in treating ocular irritation and tear film alterations.

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          Most cited references24

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          Etiology, prevalence, and treatment of dry eye disease

          Purpose: This review article examines the prevalence, etiology, and current therapies of dry eye disease, with special focus on postmenopausal women. Method: A systematic literature search utilizing MEDLINE was conducted to identify peer-reviewed articles related to dry eye published prior to September 2008. The terms “dry eye” and “women” were searched in combination with one or more of the following words or phrases: prevalence, postmenopausal, etiology, risk factors, therapy, medications, surgery, tear film, and quality of life. Articles were selected based on their direct applicability to the subject matter. A manual search was also conducted based on citations in the published literature. Results: Epidemiologic studies identified prevalence rates ranging from 7% in the United States to 33% in Taiwan and Japan. Risk factors include advanced age, female sex, smoking, extreme heat or cold weather conditions, low relative humidity, use of video display terminals, refractive surgery, contact lens wear, and certain medications. Conclusion: The last decade has brought about a better understanding of the etiology of dry eye disease. New therapies that can alleviate the signs and symptoms of dry eye disease and, consequently, improve the quality of life of dry eye patients are available in the market.
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            Effect of trehalose on protein structure.

            Trehalose is a ubiquitous molecule that occurs in lower and higher life forms but not in mammals. Till about 40 years ago, trehalose was visualized as a storage molecule, aiding the release of glucose for carrying out cellular functions. This perception has now changed dramatically. The role of trehalose has expanded, and this molecule has now been implicated in a variety of situations. Trehalose is synthesized as a stress-responsive factor when cells are exposed to environmental stresses like heat, cold, oxidation, desiccation, and so forth. When unicellular organisms are exposed to stress, they adapt by synthesizing huge amounts of trehalose, which helps them in retaining cellular integrity. This is thought to occur by prevention of denaturation of proteins by trehalose, which would otherwise degrade under stress. This explanation may be rational, since recently, trehalose has been shown to slow down the rate of polyglutamine-mediated protein aggregation and the resultant pathogenesis by stabilizing an aggregation-prone model protein. In recent years, trehalose has also proved useful in the cryopreservation of sperm and stem cells and in the development of a highly reliable organ preservation solution. This review aims to highlight the changing perception of the role of trehalose over the last 10 years and to propose common mechanisms that may be involved in all the myriad ways in which trehalose stabilizes protein structures. These will take into account the structure of trehalose molecule and its interactions with its environment, and the explanations will focus on the role of trehalose in preventing protein denaturation.
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              An objective approach to dry eye disease severity.

              A prospective, multisite clinical study (10 sites in the European Union and the United States) evaluated the clinical utility of commonly used tests and tear osmolarity for assessing dry eye disease severity. Three hundred fourteen consecutive subjects between the ages of 18 and 82 years were recruited from the general patient population, 299 of which qualified with complete datasets. Osmolarity testing, Schirmer test without anesthesia, tear film breakup time (TBUT), corneal staining, meibomian dysfunction assessment, and conjunctival staining were performed bilaterally. A symptom questionnaire, the Ocular Surface Disease Index (OSDI), was also administered to each patient. Distributions of clinical signs and symptoms against a continuous composite severity index were evaluated. Osmolarity was found to have the highest correlation coefficient to disease severity (r(2) = 0.55), followed by conjunctival staining (r(2) = 0.47), corneal staining (r(2) = 0.43), OSDI (r(2) = 0.41), meibomian score (r(2) = 0.37), TBUT (r(2) = 0.30), and Schirmer result (r(2) = 0.17). A comparison of standard threshold-based classification with the composite severity index revealed significant overlap between the disease severities of prospectively defined normal and dry eye groups. Fully 63% of the subjects were found to be poorly classified by combinations of clinical thresholds. Tear film osmolarity was found to be the single best marker of disease severity across normal, mild/moderate, and severe categories. Other tests were found to be informative in the more severe forms of disease; thus, clinical judgment remains an important element in the clinical assessment of dry eye severity. The results also indicate that the initiation and progression of dry eye is multifactorial and supports the rationale for redefining severity on the basis of a continuum of clinical signs. (ClinicalTrials.gov number, NCT00848198.).
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                Author and article information

                Journal
                Clin Ophthalmol
                Clin Ophthalmol
                OPTH
                clinop
                Clinical Ophthalmology (Auckland, N.Z.)
                Dove
                1177-5467
                1177-5483
                09 July 2019
                2019
                : 13
                : 1157-1163
                Affiliations
                [1 ]Ophthalmology Unit, Santa Maria della Misericordia Hospital , Rovigo, Italy
                [2 ]Neurosciences Department, Ophthalmology Unit, University of Padua , Padua, Italy
                [3 ]Ophthalmology Unit, Dell’Angelo Hospital , Meste, Italy
                Author notes
                Correspondence: A La Gloria ValerioSanta Maria della Misericordia Hospital , 140, Tre Martiri Street, Rovigo, ItalyTel +39 042 539 3486Email alvise85.lagloria@ 123456gmail.com
                Article
                208256
                10.2147/OPTH.S208256
                6629019
                2079ff48-83f1-446e-9654-ec50c095d76b
                © 2019 Caretti et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 10 March 2019
                : 05 June 2019
                Page count
                Figures: 3, Tables: 3, References: 27, Pages: 7
                Categories
                Original Research

                Ophthalmology & Optometry
                cataract surgery,tear film instability,artificial tears,trehalose
                Ophthalmology & Optometry
                cataract surgery, tear film instability, artificial tears, trehalose

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