Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Following 27 Gauge Vitrectomy With Internal Limiting Membrane Peel for the Treatment of Retinal Edema Associated With Macular Pucker.

PHASE4UnknownINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 27, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
VitrectomyMacular PuckerRetinal Edema
Interventions
DRUG

Dexamethasone Intracanalicular Insert, 0.4 mg

To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery

DRUG

Dexamethasone Intracanalicular Insert, 0.4 mg

To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery

DRUG

Prednisone acetate 1%

To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery

Trial Locations (1)

60126

RECRUITING

Kovach Eye Institute, Elmhurst

Sponsors
All Listed Sponsors
lead

Kovach Eye Institute

INDUSTRY