Dextenza in the Post-op Management of Vitreoretinal Surgeries

Status Enrolling by invitation

Clinical Trial Summary

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Clinical Trial Description

Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days. The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04371445
Study type	Interventional
Source	The Cleveland Clinic
Contact
Status	Enrolling by invitation
Phase	Phase 4
Start date	December 1, 2020
Completion date	June 1, 2024

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