Diabetic Macular Edema Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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