Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:41 PM
Study NCT ID:
NCT04501367
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2020-07-30
Brief Title:
Assessing the Efficacy and Safety fo DEXTENZA Sustained Release Dexamethasone 04 mg Inserts 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
Sponsor:
Kovach Eye Institute
Organization:
Kovach Eye Institute
Study Overview
Official Title:
Assessing the Efficacy and Safety fo DEXTENZA Sustained Release Dexamethasone 04 mg Inserts When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi 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
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Assessing the efficacy and safety of DEXTENZA sustained release dexamethasone 04 mg inserts following 27 gauge vitrectomy with internal limiting membrane peel
Detailed Description:
Assessing the efficacy and safety of DEXTENZA sustained release dexamethasone 04 mg inserts when placed within the lower eye lid canaliculus or both the upper and lower canaliculi 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None