The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

Phase 3

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: dexamethasone intravitreal implant (OZURDEX)

• Registration Number: NCT01748487
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2012-12-10
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OZURDEX	dexamethasone intravitreal implant (OZURDEX)	24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UHN, Toronto Western Hospital; 🇨🇦 Toronto, Ontario, Canada