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The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Shahid Beheshti Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00849537
First received: February 23, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Drug: Triamcinolone
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:
  • Macula diameter [ Time Frame: 6th week, 3, 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Diabetic retinopathy [ Time Frame: 6th weeks, 3 and 6 months later ] [ Designated as safety issue: Yes ]

Study Start Date: April 2008
Estimated Study Completion Date: April 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Triamcinolone
Injection of intravitreal Triamcinolone
Drug: Triamcinolone
Injection of intravitreal Triamcinolone

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00849537

Contacts
Contact: Siamak Moradian, MD 00982122592200 Moradian33195@yahoo.com

Locations
Iran, Islamic Republic of
Recruiting
Tehran, Iran, Islamic Republic of
Ophthalmic Research Centre Active, not recruiting
Tehran, Iran, Islamic Republic of, 1666663111
Siamak Moradian,MD Active, not recruiting
Tehran, Iran, Islamic Republic of, 166666
Sponsors and Collaborators
Shahid Beheshti Medical University
Investigators
Principal Investigator: Dr. Siamak Moradian, MD Shaheed Beheshti University Of Medical Science
  More Information

No publications provided

Responsible Party: Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier: NCT00849537     History of Changes
Other Study ID Numbers: 8711
Study First Received: February 23, 2009
Last Updated: February 23, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
Triamcinolon
Cataract
Diabetic retinopathy
non-proliferative retinopathy

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014