دورية أكاديمية
Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial.
| العنوان: | Dexamethasone Intracanalicular Insert for Clinically Significant Aqueous-Deficient Dry Eye: A Randomized Controlled Trial. |
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| المؤلفون: | Lin MX; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; University of Maryland School of Medicine, Baltimore, Maryland., Guo L; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland., Saldanha IJ; Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland., VanCourt S; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland., Zeng J; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Stritch School of Medicine, Loyola University, Chicago, Illinois., Karakus S; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland., Hessen M; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland., Li G; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland; Icahn School of Medicine at Mount Sinai, New York, New York., Akpek EK; The Ocular Surface Disease Clinic, The Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland. Electronic address: esakpek@jhmi.edu. |
| المصدر: | Ophthalmology [Ophthalmology] 2024 Sep; Vol. 131 (9), pp. 1033-1044. Date of Electronic Publication: 2024 Mar 15. |
| نوع المنشور: | Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: United States NLM ID: 7802443 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-4713 (Electronic) Linking ISSN: 01616420 NLM ISO Abbreviation: Ophthalmology Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2000- : New York : Elsevier Original Publication: Rochester, Minn., American Academy of Ophthalmology. |
| مواضيع طبية MeSH: | Dexamethasone*/administration & dosage , Dry Eye Syndromes*/drug therapy , Dry Eye Syndromes*/diagnosis , Dry Eye Syndromes*/physiopathology , Glucocorticoids*/administration & dosage , Intraocular Pressure*/physiology , Intraocular Pressure*/drug effects, Humans ; Female ; Double-Blind Method ; Male ; Middle Aged ; Aged ; Drug Implants ; Adult ; Ophthalmic Solutions/administration & dosage ; Tears/physiology ; Tears/metabolism ; Treatment Outcome |
| مستخلص: | Purpose: To evaluate a commercially available dexamethasone intracanalicular insert to treat dry eye. Design: Single-center, double-masked randomized controlled trial. Participants: Patients with clinically significant aqueous-deficient dry eye (combined ocular surface staining score, ≥ 3 [0-12]; corneal fluorescein staining score, ≥ 2 [0-6]; and Schirmer's wetting, < 10 mm at 5 minutes in both eyes) with symptoms (dryness, eye discomfort, or visual fatigue, ≥ 30 [0-100]) despite treatment with at least 1 prescription drop and deemed candidates for topical steroid therapy. Methods: Seventy-five adult patients were enrolled. A 1:1 randomization sequence was used to determine which eye of each patient would receive the treatment (dexamethasone 0.4-mg intracanalicular insert with 30-day elution time) or sham (collagen plug). The fellow eye received the opposite treatment. Patients were masked to treatment assignment. Follow-up visits (at weeks 2, 4, and 6) were performed by a masked investigator. Main Outcome Measures: Dry eye parameters and patient symptoms were used for efficacy, and intraocular pressure (IOP) was used for safety assessment. Results: The severity of dry eye was comparable between the treatment arms (fellow eyes) at baseline. Eyes that received the dexamethasone insert showed significantly less corneal staining at week 4 (mean difference [MD], -0.55; 95% confidence interval [CI], -0.91 to -0.19) and conjunctival staining at week 4 (MD, -0.68; 95% CI, -1.05 to -0.30) and week 6 (MD, -0.34; 95% CI, -0.65 to -0.02). Schirmer's wetting was comparable between the two treatment arms. Although the patients reported less dryness in eyes that received the insert at week 4 (MD, -5.5; 95% CI, -11.4 to 0.4), no statistically significant differences were found in any patient-reported symptoms. At week 4, dexamethasone-treated eyes were more likely to show an IOP increase (by 5-10 mmHg; 9 eyes vs. 1 eye; relative risk, 9.00; 95% CI, 1.14-71.0). All cases of increased IOP were managed with short-term topical β-blockers and subsided. Conclusions: The dexamethasone intracanalicular insert may be considered a dropless dual treatment for clinically significant aqueous-deficient dry eye when topical steroid treatment is deemed appropriate. Financial Disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article. (Copyright © 2024 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Clinical trial; Dry eye; Treatment |
| المشرفين على المادة: | 7S5I7G3JQL (Dexamethasone) 0 (Glucocorticoids) 0 (Drug Implants) 0 (Ophthalmic Solutions) |
| تواريخ الأحداث: | Date Created: 20240316 Date Completed: 20240822 Latest Revision: 20240822 |
| رمز التحديث: | 20240823 |
| DOI: | 10.1016/j.ophtha.2024.03.010 |
| PMID: | 38492864 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1549-4713 |
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| DOI: | 10.1016/j.ophtha.2024.03.010 |