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Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) (IDDMECS)

Primary Purpose

Diabetes, Macular Edema, Pseudophakia

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Dexamethasone sodium phosphate
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes focused on measuring Diabetic, Macular Edema, Pseudophakic, Dexamethasone, Intravitreal, Cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diabetic patients for Cataract Surgery with vision of ≤ 20/50 and > grade 3 any cataract type using the Lens Opacities Classification System III. Diabetics included must have at least one microaneurysm in the posterior pole (defined by the Superior and Inferior Arcade).

Exclusion Criteria:

  • Without any diabetic retinopathy and those with active uncontrolled proliferative disease
  • Retinal disease,other than Diabetes, that can affect macular edema
  • Uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma
  • Eyes with cataract precluding proper OCT measurement pre-operatively
  • Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns

Sites / Locations

  • Toronto Western Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Treatment

Arm Description

Diabetics undergoing routine cataract surgery

Diabetics undergoing cataract surgery with injection of 0.5mg in 0.05cc of dexamethasone at the end of surgery

Outcomes

Primary Outcome Measures

Central Retinal Thickness

Secondary Outcome Measures

Best corrected visual acuity and incidence of laser treatments

Full Information

First Posted
December 9, 2009
Last Updated
January 10, 2011
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01030601
Brief Title
Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)
Acronym
IDDMECS
Official Title
Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto

4. Oversight

5. Study Description

Brief Summary
Macular Edema (Swelling of a particular site of the retina) can become a significant problem for Diabetics undergoing Cataract surgery. And a significant number of people who undergo Cataract surgery each year are diabetics. And when you multiply these two factors together you are left with a significant number of people who do not gain as much vision as their peers. Diabetics who develop Macular Edema actually can loose some vision after surgery and when you follow them up, they don't gain as much vision. This Study aims to prevent such an event from happening and therefore allow Diabetics to gain as much vision as they can from cataract surgery. This study will use Dexamethasone injected intravitreally (into the gel of the eye) at the end of cataract extraction to control Macular edema brought about by surgery. The main outcome is the central retina thickness and retinal volume as measured by Optical Coherence Tomography. Secondary outcomes are BCVA and incidence of Laser Treatment. Other Drugs, life Bevacizumab and Pegaptanib, have been used for this purpose but they are expensive and have potential systemic side-effects due to anti-VEGF (vascular endothelial growth factor) actions. Dexamethasone has been used in the eye for decades and is short-lived, minimizing possible systemic effects. Moreover, this drug is at least 15x cheaper than the previously mentioned ones and therefore has tremendous benefit for developing countries. We seek an alternative drug that can reduce or prevent Macular edema at a less expensive and safer way.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Macular Edema, Pseudophakia
Keywords
Diabetic, Macular Edema, Pseudophakic, Dexamethasone, Intravitreal, Cataract surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Diabetics undergoing routine cataract surgery
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Diabetics undergoing cataract surgery with injection of 0.5mg in 0.05cc of dexamethasone at the end of surgery
Intervention Type
Drug
Intervention Name(s)
Dexamethasone sodium phosphate
Intervention Description
0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial
Primary Outcome Measure Information:
Title
Central Retinal Thickness
Time Frame
within 3 months after cataract surgery
Secondary Outcome Measure Information:
Title
Best corrected visual acuity and incidence of laser treatments
Time Frame
within 3 months after cataract surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetic patients for Cataract Surgery with vision of ≤ 20/50 and > grade 3 any cataract type using the Lens Opacities Classification System III. Diabetics included must have at least one microaneurysm in the posterior pole (defined by the Superior and Inferior Arcade). Exclusion Criteria: Without any diabetic retinopathy and those with active uncontrolled proliferative disease Retinal disease,other than Diabetes, that can affect macular edema Uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma Eyes with cataract precluding proper OCT measurement pre-operatively Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Brent, MD, FRCSC
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)

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