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

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00849537
• Other study ID #: 8711
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 23, 2009
• Last updated: February 23, 2009
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: February 2009
• Source: hahid Beheshti University of Medical Sciences
• Contact: Siamak Moradian, MD
• Phone: 00982122592200
• Email: Moradian33195[@]yahoo.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Triamcinolone
Injection of intravitreal Triamcinolone

Locations

Country	Name	City	State
Iran, Islamic Republic of	Ophthalmic Research Centre	Tehran
Iran, Islamic Republic of	Siamak Moradian,MD	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macula diameter		6th week, 3, 6 months	Yes
Secondary	Diabetic retinopathy		6th weeks, 3 and 6 months later	Yes