Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Summary

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Timeline

Start

2023-06-01

Primary completion

2025-02-05

Completion

2025-02-05

Publications

• Background ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. II. THE EFFECT OF DEXAMETHASONE IN THE GLAUCOMATOUS EYE. Arch Ophthalmol. 1963 Oct;70:492-9. doi: 10.1001/archopht.1963.00960050494011. No abstract available.
• Background Patel SB, Reddy NK, He YG. TOXIC POSTERIOR SEGMENT SYNDROME AFTER DROPLESS CATARACT SURGERY WITH COMPOUNDED TRIAMCINOLONE-MOXIFLOXACIN. Retina. 2020 Mar;40(3):446-455. doi: 10.1097/IAE.0000000000002450.
• Background Freire FS, Lang R, Abalem MF, Johnson MW. RETINAL DEPOSITS OF TRIAMCINOLONE-MOXIFLOXACIN AFTER DROPLESS CATARACT SURGERY. Retin Cases Brief Rep. 2023 Sep 1;17(5):577-580. doi: 10.1097/ICB.0000000000001243.
• Background Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
• Background Ibach MJ, Zimprich L, Wallin DD, Olevson C, Puls-Boever K, Thompson V. In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study. Clin Ophthalmol. 2022 Aug 13;16:2609-2615. doi: 10.2147/OPTH.S374405. eCollection 2022.
• Background Ibach MJ, Shafer BM, Wallin DD, Puls-Boever KR, Thompson VM, Berdahl JP. The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial. J Refract Surg. 2021 Sep;37(9):590-594. doi: 10.3928/1081597X-20210610-05. Epub 2021 Sep 1.
• Background Alsetri H, Fram N, Shiler O. Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. Clin Ophthalmol. 2024 Jul 16;18:2083-2091. doi: 10.2147/OPTH.S466118. eCollection 2024.
• Background Fram N, Alsetri H, Shiler O, Paterno PJ, Cabang J. Retrospective Study of a Sustained-Release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation After Cataract and Corneal Surgery. Clin Ophthalmol. 2022 Dec 10;16:4065-4074. doi: 10.2147/OPTH.S386702. eCollection 2022.
• Background Shapiro JN, Armenti ST, Levine H, Hood CT, Mian SI. Dexamethasone Intracanalicular Insert versus Standard Topical Steroids for the Prophylaxis of Inflammation after Cataract Surgery. Am J Ophthalmol. 2024 Dec;268:174-180. doi: 10.1016/j.ajo.2024.07.030. Epub 2024 Jul 31.
• Background Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24.
• Background Walters T, Endl M, Elmer TR, Levenson J, Majmudar P, Masket S. Sustained-release dexamethasone for the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2015 Oct;41(10):2049-59. doi: 10.1016/j.jcrs.2015.11.005.
• Background Donnenfeld ED, Hovanesian JA, Malik AG, Wong A. A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery. Clin Ophthalmol. 2023 Aug 15;17:2349-2356. doi: 10.2147/OPTH.S422502. eCollection 2023.
• Background Nassiri S, Hwang FS, Kim J, LeClair B, Yoon E, Pham M, Rauser ME. Comparative analysis of intravitreal triamcinolone acetonide-moxifloxacin versus standard perioperative eyedrops in cataract surgery. J Cataract Refract Surg. 2019 Jun;45(6):760-765. doi: 10.1016/j.jcrs.2018.12.019. Epub 2019 Mar 6.
• Background Chang DT, Herceg MC, Bilonick RA, Camejo L, Schuman JS, Noecker RJ. Intracameral dexamethasone reduces inflammation on the first postoperative day after cataract surgery in eyes with and without glaucoma. Clin Ophthalmol. 2009;3:345-55. doi: 10.2147/opth.s5730. Epub 2009 Jun 2.
• Background Kuriakose RK, Cho S, Nassiri S, Hwang FS. Comparative Outcomes of Standard Perioperative Eye Drops, Intravitreal Triamcinolone Acetonide-Moxifloxacin, and Intracameral Dexamethasone-Moxifloxacin-Ketorolac in Cataract Surgery. J Ophthalmol. 2022 Jul 19;2022:4857696. doi: 10.1155/2022/4857696. eCollection 2022.
• Background Miura M, Inomata T, Nakamura M, Sung J, Nagino K, Midorikawa-Inomata A, Zhu J, Fujimoto K, Okumura Y, Fujio K, Hirosawa K, Akasaki Y, Kuwahara M, Eguchi A, Shokirova H, Murakami A. Prevalence and Characteristics of Dry Eye Disease After Cataract Surgery: A Systematic Review and Meta-Analysis. Ophthalmol Ther. 2022 Aug;11(4):1309-1332. doi: 10.1007/s40123-022-00513-y. Epub 2022 May 9.
• Background Quintana NE, Allocco AR, Ponce JA, Magurno MG. Non steroidal anti-inflammatory drugs in the prevention of cystoid macular edema after uneventful cataract surgery. Clin Ophthalmol. 2014 Jun 25;8:1209-12. doi: 10.2147/OPTH.S61604. eCollection 2014.
• Background Belair ML, Kim SJ, Thorne JE, Dunn JP, Kedhar SR, Brown DM, Jabs DA. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol. 2009 Jul;148(1):128-35.e2. doi: 10.1016/j.ajo.2009.02.029. Epub 2009 Apr 29.
• Background Pande MV, Spalton DJ, Kerr-Muir MG, Marshall J. Postoperative inflammatory response to phacoemulsification and extracapsular cataract surgery: aqueous flare and cells. J Cataract Refract Surg. 1996;22 Suppl 1:770-4. doi: 10.1016/s0886-3350(96)80160-x.
• Background An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22.

Drugs

Indications