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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02489526` - Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery	Phase 2
Terminated	`NCT05146453` - Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology	Phase 4
Completed	`NCT05635916` - Trial of Liposomal Bupivacaine for TKA	Phase 4
Recruiting	`NCT06028126` - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial	N/A
Not yet recruiting	`NCT03591172` - Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization	N/A
Completed	`NCT01686802` - Post-operative Oral Morphine Versus Ibuprofen	Phase 2
Completed	`NCT01667445` - Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty	Phase 4
Completed	`NCT01444924` - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery	Phase 2
Completed	`NCT00830089` - Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery	N/A
Completed	`NCT00968955` - Effect of Local Infiltration Analgesia in Total Hip Arthroplasty	Phase 4
Terminated	`NCT00875862` - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks	Phase 4
Completed	`NCT00847093` - LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery	Phase 4
Completed	`NCT00390312` - Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction	Phase 2
Recruiting	`NCT05278494` - Dextromethorphan for Treatment of Postoperative Pain	N/A
Recruiting	`NCT05973045` - Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy	N/A
Not yet recruiting	`NCT04999670` - Fascial Closure and Post-caesarean Pain	N/A
Enrolling by invitation	`NCT04346407` - Dronabinol for Post-operative Pain After Lumbar Fusion	Phase 4
Completed	`NCT03635515` - Occurrence of Post-op Pain Following Gentlewave	N/A
Terminated	`NCT03201809` - Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial	N/A
Completed	`NCT03254056` - Fascial Closure Techniques Post-Operative Pain Laparoscopy	N/A