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

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT01030601
Collaborator
(none)
48
1
2
12
4

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone sodium phosphate
Phase 2

Study Design

Study Type:
Interventional
Anticipated 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 :
Jan 1, 2010
Actual Primary Completion Date :
Jan 1, 2011
Actual Study Completion Date :
Jan 1, 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Central Retinal Thickness [within 3 months after cataract surgery]

Secondary Outcome Measures

  1. Best corrected visual acuity and incidence of laser treatments [within 3 months after cataract surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Toronto Western Hospital Toronto Ontario Canada M5T 2S8

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Michael H Brent, MD, FRCSC, University Health Network, Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01030601
Other Study ID Numbers:
  • IDDMECS
First Posted:
Dec 11, 2009
Last Update Posted:
Jan 11, 2011
Last Verified:
Jan 1, 2011

Study Results

No Results Posted as of Jan 11, 2011