Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Macular Edema Pseudophakia |
Drug: Dexamethasone sodium phosphate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) |
- Central Retinal Thickness [ Time Frame: within 3 months after cataract surgery ] [ Designated as safety issue: No ]
- Best corrected visual acuity and incidence of laser treatments [ Time Frame: within 3 months after cataract surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Canada, Ontario | |
| Toronto Western Hospital | |
| Toronto, Ontario, Canada, M5T 2S8 | |
| Principal Investigator: | Michael H Brent, MD, FRCSC | University Health Network, Toronto |
More Information
No publications provided
| Responsible Party: | Dr. Michael Brent, MD, FRCSC, Toronto Western Hospital |
| ClinicalTrials.gov Identifier: | NCT01030601 History of Changes |
| Other Study ID Numbers: | IDDMECS |
| Study First Received: | December 9, 2009 |
| Last Updated: | January 10, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University Health Network, Toronto:
|
Diabetic Macular Edema Pseudophakic |
Dexamethasone Intravitreal Cataract surgery |
Additional relevant MeSH terms:
|
Edema Macular Edema Pseudophakia Cataract Signs and Symptoms Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Lens Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Sodium phosphate BB 1101 |
Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013