- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00849537
The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy
February 23, 2009 updated by: Shahid Beheshti University of Medical Sciences
In this study, regressed proliferative diabetic retinopathy, very severe, severe and moderate non-prolifrative diabetic retinopathy patients who were going to have a cataract surgery, underwent a complete eye examination, OCT, FAG and color photography 2 weeks prior to their operation.
All patients divided in two: 1) control group (Phyco,PCIOL), 2) triamcinolone treatment group (Phaco with PCIOL+IVT).
One month after surgery a complete eye examination will be done especially; IOP and endophthalmitis.
A 6 month follow-up will be done for these two groups and diabetic retinopathy progression will be checked.
Study Overview
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Siamak Moradian, MD
- Phone Number: 00982122592200
- Email: Moradian33195@yahoo.com
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Recruiting
-
Tehran, Iran, Islamic Republic of, 1666663111
- Active, not recruiting
- Ophthalmic Research Centre
-
Tehran, Iran, Islamic Republic of, 166666
- Active, not recruiting
- Siamak Moradian,MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diabetic patients with non-proliferative diabetic retinopathy and regressed PDR
Exclusion Criteria:
- Uncontrolled HTN
- History of glaucoma
- Active PDR
- NVI
- TRD
- Any ophthalmic operation
- Renal problem(cr>3)
- CVA
- Uveitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Triamcinolone
Injection of intravitreal Triamcinolone
|
Injection of intravitreal Triamcinolone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Macula diameter
Time Frame: 6th week, 3, 6 months
|
6th week, 3, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diabetic retinopathy
Time Frame: 6th weeks, 3 and 6 months later
|
6th weeks, 3 and 6 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Dr. Siamak Moradian, MD, Shaheed Beheshti University Of Medical Science
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Anticipated)
April 1, 2009
Study Completion (Anticipated)
April 1, 2009
Study Registration Dates
First Submitted
February 23, 2009
First Submitted That Met QC Criteria
February 23, 2009
First Posted (Estimate)
February 24, 2009
Study Record Updates
Last Update Posted (Estimate)
February 24, 2009
Last Update Submitted That Met QC Criteria
February 23, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Diabetes Complications
- Diabetes Mellitus
- Retinal Diseases
- Diabetic Retinopathy
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
Other Study ID Numbers
- 8711
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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