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      A Randomized Fellow-Eye Clinical Trial to Evaluate Patient Preference for Dexamethasone Intracanalicular Insert or Topical Prednisolone Acetate for Control of Postoperative Symptoms Following Bilateral Femtosecond Laser in Site Keratomileusis (LASIK)

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          Abstract

          Purpose

          To determine the preference of patients undergoing bilateral LASIK for either the dexamethasone intracanalicular insert or topical prednisolone acetate for control of postoperative symptoms and ocular surface signs.

          Methods

          In this randomized clinical trial, one eye was randomized to receive the dexamethasone insert or topical prednisolone acetate 1% four times daily for one week and 2 times daily for a second week; the fellow eye received the alternate therapy. One month postoperatively, patient preference for these two therapies was assessed using an adapted COMTOL questionnaire. Ocular comfort was assessed using the SPEED questionnaire. Corneal staining and uncorrected distance visual acuity (UDVA) were also assessed.

          Results

          Twenty patients participated. At Month 1, 80% of patients preferred the dexamethasone insert, 10% preferred prednisolone acetate, and 10% expressed no preference (p<0.001). SPEED scores measuring ocular comfort/discomfort related to dry eye symptoms were similar between groups (p=0.72), and both the incidence of patient-reported ocular dryness and the corneal staining scores were similar between groups. Both groups attained the same final UDVA.

          Conclusion

          Patients undergoing elective bilateral femtosecond LASIK surgery overwhelmingly (by an 8-to-1 margin) preferred the dexamethasone insert to topical prednisolone acetate for postoperative treatment. The insert produced comparable ocular comfort, corneal staining, and visual acuity outcomes to topical prednisolone. The insert is an appropriate means of postoperative symptom control in this quality of life-conscious population.

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          Most cited references17

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          Psychometric properties and validation of the Standard Patient Evaluation of Eye Dryness questionnaire.

          To characterize the psychometric properties of the standard patient evaluation of eye dryness (SPEED) questionnaire and to validate and compare its performance with 4 existing dry eye questionnaires.
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            Evaluation of eyedrop administration by inexperienced patients after cataract surgery.

            To evaluate efficacy and safety of eyedrop administration after cataract surgery and to identify predictors of better technique in patients without previous eyedrop experience.
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              Extended release of dexamethasone from silicone-hydrogel contact lenses containing vitamin E.

              Ophthalmic drug delivery by contact lenses is expected to be more efficient due to continuous extended release of drug and increased residence time in the tear film. However, commercial contact lenses release ophthalmic drugs for a short period of about an hour and are thus not suitable for extended delivery use. Here we explore a novel approach of increasing the release duration of dexamethasone (DX) from commercial contact lenses by loading Vitamin E into the lenses. The Vitamin E was loaded into the lenses by soaking the lenses in Vitamin E-ethanol solution followed by ethanol removal through evaporation. The results show that with about 30% of Vitamin E loading in the contact lens, the DX release time can be increased to 7 to 9 days for ACUVUE(®) OASYS™, NIGHT&DAY™, and O(2)OPTIX™, which is a 9 to 16 fold increase compared to the DX release duration by pure contact lens without Vitamin E loading. The DX delivery by contact lens can be viewed as a one-dimensional transport by a flat thin film, and a mathematical model based on the drug diffusivity difference between Vitamin E and silicone hydrogel was also proposed to explain the DX release time increase by Vitamin E loaded contact lens. Copyright © 2010 Elsevier B.V. All rights reserved.
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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
                06 August 2020
                2020
                : 14
                : 2223-2228
                Affiliations
                [1 ]Vance Thompson Vision , West Fargo, ND, USA
                [2 ]Ektropia Solutions LLC , Laguna Beach, CA, USA
                [3 ]Vance Thompson Vision , Sioux Falls, SD, USA
                Author notes
                Correspondence: Michael D Greenwood Vance Thompson Vision , 505 32nd Ave E, Suite B, West Fargo, ND58078, USATel +1 701-566-5390Fax +1 701-639-7199 Email Michael.Greenwood@VanceThompsonVision.com
                Author information
                http://orcid.org/0000-0001-8912-7005
                Article
                265311
                10.2147/OPTH.S265311
                7418164
                32821083
                859362e0-8ade-49f6-bcb0-80c1a614f31d
                © 2020 Greenwood 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 June 2020
                : 28 July 2020
                Page count
                Figures: 3, References: 21, Pages: 6
                Funding
                Funded by: Ocular Therapeutix;
                Supported by Ocular Therapeutix.
                Categories
                Original Research

                Ophthalmology & Optometry
                dexamethasone,dextenza,lasik,randomized trial,patient preference,ocular surface symptoms

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