A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748487
|Contact: Michael Brent, MDfirstname.lastname@example.org|
|UHN, Toronto Western Hospital||Recruiting|
|Toronto, Ontario, Canada, M5T2S8|
|Contact: Michael Brent, MD +14163007503 email@example.com|