The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy
1 other identifier
interventional
N/A
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2008
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 23, 2009
CompletedFirst Posted
Study publicly available on registry
February 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedFebruary 24, 2009
February 1, 2009
1 year
February 23, 2009
February 23, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Macula diameter
6th week, 3, 6 months
Secondary Outcomes (1)
Diabetic retinopathy
6th weeks, 3 and 6 months later
Study Arms (1)
Triamcinolone
EXPERIMENTALInjection of intravitreal Triamcinolone
Interventions
Eligibility Criteria
You may qualify if:
- Diabetic patients with non-proliferative diabetic retinopathy and regressed PDR
You may not qualify if:
- Uncontrolled HTN
- History of glaucoma
- Active PDR
- NVI
- TRD
- Any ophthalmic operation
- Renal problem(cr\>3)
- CVA
- Uveitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ophthalmic Research Centre
Tehran, Tehran Province, 1666663111, Iran
Siamak Moradian,MD
Tehran, Tehran Province, 166666, Iran
Unknown Facility
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Siamak Moradian, MD
Shaheed Beheshti University Of Medical Science
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 23, 2009
First Posted
February 24, 2009
Study Start
April 1, 2008
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
February 24, 2009
Record last verified: 2009-02