The Effect of Intravitreal Ozurdex on DME After Cataract Surgery
NCT01748487 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2015-12-02
Summary
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.
Conditions
Interventions
- DRUG
-
dexamethasone intravitreal implant (OZURDEX)
intravitreal implant
Sponsors & Collaborators
-
University Health Network, Toronto
lead OTHER
Principal Investigators
-
Michael H Brent, MD · UHN_Toronto Western Hospital
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- Canada
Study Locations
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