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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. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Shahid Beheshti University of Medical Sciences.
Recruitment status was:  Recruiting
Information provided by:
Shahid Beheshti University of Medical Sciences Identifier:
First received: February 23, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Macula diameter [ Time Frame: 6th week, 3, 6 months ]

Secondary Outcome Measures:
  • Diabetic retinopathy [ Time Frame: 6th weeks, 3 and 6 months later ]

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


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00849537

Contact: Siamak Moradian, MD 00982122592200

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
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Principal Investigator: Dr. Siamak Moradian, MD Shaheed Beheshti University Of Medical Science
  More Information

Responsible Party: Shaheed Beheshti Medical University Identifier: NCT00849537     History of Changes
Other Study ID Numbers: 8711
Study First Received: February 23, 2009
Last Updated: February 23, 2009

Keywords provided by Shahid Beheshti University of Medical Sciences:
Diabetic retinopathy
non-proliferative retinopathy

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017