The Effect of Intravitreal Ozurdex on DME After Cataract Surgery
The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME).
Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4).
BCVA, IOP and SD-OCT will be performed at each visit.
|Diabetic Macular Edema||Drug: dexamethasone intravitreal implant (OZURDEX)||Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery|
- The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery. [ Time Frame: 3 months ]
|Study Start Date:||December 2012|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.
Drug: dexamethasone intravitreal implant (OZURDEX)
Other Name: OZURDEX
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748487
|UHN, Toronto Western Hospital|
|Toronto, Ontario, Canada, M5T2S8|
|Principal Investigator:||Michael H Brent, MD||UHN_Toronto Western Hospital|