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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01030601
Recruitment Status : Completed
First Posted : December 11, 2009
Last Update Posted : January 11, 2011
Information provided by:
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Diabetes Macular Edema Pseudophakia Drug: Dexamethasone sodium phosphate Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)
Study Start Date : January 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Edema

Arm Intervention/treatment
No Intervention: Control
Diabetics undergoing routine cataract surgery
Experimental: Treatment
Diabetics undergoing cataract surgery with injection of 0.5mg in 0.05cc of dexamethasone at the end of surgery
Drug: Dexamethasone sodium phosphate
0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial

Primary Outcome Measures :
  1. Central Retinal Thickness [ Time Frame: within 3 months after cataract surgery ]

Secondary Outcome Measures :
  1. Best corrected visual acuity and incidence of laser treatments [ Time Frame: within 3 months after cataract surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01030601

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Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
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Principal Investigator: Michael H Brent, MD, FRCSC University Health Network, Toronto
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Responsible Party: Dr. Michael Brent, MD, FRCSC, Toronto Western Hospital Identifier: NCT01030601    
Other Study ID Numbers: IDDMECS
First Posted: December 11, 2009    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011
Keywords provided by University Health Network, Toronto:
Macular Edema
Cataract surgery
Additional relevant MeSH terms:
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Macular Edema
Capsule Opacification
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action