$A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)$
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A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)

Jacob Larsen,1 Travis Whitt,2 Briana Parker,1 Russell Swan3,4 1Clinical Research, Vance Thompson Vision, Bozeman, MT, USA; 2Department of Optometry, Vance Thompson Vision, Bozeman, MT, USA; 3Department of Ophthalmology, Vance Thompson Vision, Bozeman, MT, USA; 4Ophthalmology Moran Eye Center, Univer...

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Autores principales:	Larsen J, Whitt T, Parker B, Swan R
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2021
Materias:	punctal plug steroid visual acuity cystoid macular edema patient preference Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/39800f6b473242658e080e99fcfe3ac0
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spelling	oai:doaj.org-article:39800f6b473242658e080e99fcfe3ac02021-12-02T15:55:04ZA Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)1177-5483https://doaj.org/article/39800f6b473242658e080e99fcfe3ac02021-05-01T00:00:00Zhttps://www.dovepress.com/a-randomized-controlled-prospective-study-of-the-effectiveness-and-saf-peer-reviewed-fulltext-article-OPTHhttps://doaj.org/toc/1177-5483Jacob Larsen,1 Travis Whitt,2 Briana Parker,1 Russell Swan3,4 1Clinical Research, Vance Thompson Vision, Bozeman, MT, USA; 2Department of Optometry, Vance Thompson Vision, Bozeman, MT, USA; 3Department of Ophthalmology, Vance Thompson Vision, Bozeman, MT, USA; 4Ophthalmology Moran Eye Center, University of Utah, Salt Lake City, UT, USACorrespondence: Jacob LarsenClinical Research, Vance Thompson Vision, Bozeman, MT, USATel +1 406-544-2140Fax +1 406-624-6560Email Jacob.larsen2020@outlook.comPurpose: To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4 mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral RLE surgery.Methods: This is a prospective, open-label, interventional, randomized, controlled study in 20 subjects who underwent bilateral RLE. Each patient served as their own control with one eye randomized to the intracanalicular insert (Group A) placed at the time of surgery and the contralateral randomized to topical corticosteroid drops (Group B). All eyes received intracameral moxifloxacin at the time of surgery, and post-operatively, topical moxifloxacin QID for one week and topical NSAID daily for four weeks. Post-operative evaluations were performed on Day 1, Week 1, and Week 4– 8.Results: Twenty patients participated. At 4– 8 weeks post-operation, 90% of patients evaluated with the COMTOL questionnaire preferred the intracanalicular insert while 10% preferred the topical steroid. Comparative analysis using the visual analog scale showed no difference in pain between the study and control group. No statistical difference was shown in post-operative corneal staining, anterior chamber cell count, anterior chamber flare or intraocular pressure. Mean LogMAR UCVA at 4– 8 weeks post-operation was 0.06 (± 0.230) in the study group and 0.065 (± 0.241) in the control group, which was not statistically or clinically different (p > 0.05).Conclusion: Patients undergoing bilateral RLE expressed a strong preference towards the use of an intracanalicular insert over a topical steroid for post-operative steroid treatment. There was no clinically or statistically significant difference in outcomes, including rate of cystoid macular edema, visual acuity and elevation of intraocular pressure.National Clinical Trial Number: 04549935.Keywords: punctal plug, steroid, visual acuity, cystoid macular edema, patient preferenceLarsen JWhitt TParker BSwan RDove Medical Pressarticlepunctal plugsteroidvisual acuitycystoid macular edemapatient preferenceOphthalmologyRE1-994ENClinical Ophthalmology, Vol Volume 15, Pp 2211-2217 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	punctal plug steroid visual acuity cystoid macular edema patient preference Ophthalmology RE1-994
spellingShingle	punctal plug steroid visual acuity cystoid macular edema patient preference Ophthalmology RE1-994 Larsen J Whitt T Parker B Swan R A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)
description	Jacob Larsen,1 Travis Whitt,2 Briana Parker,1 Russell Swan3,4 1Clinical Research, Vance Thompson Vision, Bozeman, MT, USA; 2Department of Optometry, Vance Thompson Vision, Bozeman, MT, USA; 3Department of Ophthalmology, Vance Thompson Vision, Bozeman, MT, USA; 4Ophthalmology Moran Eye Center, University of Utah, Salt Lake City, UT, USACorrespondence: Jacob LarsenClinical Research, Vance Thompson Vision, Bozeman, MT, USATel +1 406-544-2140Fax +1 406-624-6560Email Jacob.larsen2020@outlook.comPurpose: To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4 mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral RLE surgery.Methods: This is a prospective, open-label, interventional, randomized, controlled study in 20 subjects who underwent bilateral RLE. Each patient served as their own control with one eye randomized to the intracanalicular insert (Group A) placed at the time of surgery and the contralateral randomized to topical corticosteroid drops (Group B). All eyes received intracameral moxifloxacin at the time of surgery, and post-operatively, topical moxifloxacin QID for one week and topical NSAID daily for four weeks. Post-operative evaluations were performed on Day 1, Week 1, and Week 4– 8.Results: Twenty patients participated. At 4– 8 weeks post-operation, 90% of patients evaluated with the COMTOL questionnaire preferred the intracanalicular insert while 10% preferred the topical steroid. Comparative analysis using the visual analog scale showed no difference in pain between the study and control group. No statistical difference was shown in post-operative corneal staining, anterior chamber cell count, anterior chamber flare or intraocular pressure. Mean LogMAR UCVA at 4– 8 weeks post-operation was 0.06 (± 0.230) in the study group and 0.065 (± 0.241) in the control group, which was not statistically or clinically different (p > 0.05).Conclusion: Patients undergoing bilateral RLE expressed a strong preference towards the use of an intracanalicular insert over a topical steroid for post-operative steroid treatment. There was no clinically or statistically significant difference in outcomes, including rate of cystoid macular edema, visual acuity and elevation of intraocular pressure.National Clinical Trial Number: 04549935.Keywords: punctal plug, steroid, visual acuity, cystoid macular edema, patient preference
format	article
author	Larsen J Whitt T Parker B Swan R
author_facet	Larsen J Whitt T Parker B Swan R
author_sort	Larsen J
title	A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)
title_short	A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)
title_full	A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)
title_fullStr	A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)
title_full_unstemmed	A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)
title_sort	randomized, controlled, prospective study of the effectiveness and safety of an intracanalicular dexamethasone ophthalmic insert (0.4 mg) for the treatment of post-operative inflammation in patients undergoing refractive lens exchange (rle)
publisher	Dove Medical Press
publishDate	2021
url	https://doaj.org/article/39800f6b473242658e080e99fcfe3ac0
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A Randomized, Controlled, Prospective Study of the Effectiveness and Safety of an Intracanalicular Dexamethasone Ophthalmic Insert (0.4 Mg) for the Treatment of Post-Operative Inflammation in Patients Undergoing Refractive Lens Exchange (RLE)

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