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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OZURDEX | Experimental | 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intravitreal implant (OZURDEX) | Drug | intravitreal implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery. | 3 months |
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Inclusion Criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Brent, MD | UHN_Toronto Western Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UHN, Toronto Western Hospital | Toronto | Ontario | M5T2S8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28196056 | Derived | Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552. |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |