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

Primary Purpose

Diabetic Retinopathy

Status
Unknown status
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Triamcinolone
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring Triamcinolon, Cataract, Diabetic retinopathy, non-proliferative retinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ophthalmic Research Centre
  • Siamak Moradian,MD
  • Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Triamcinolone

Arm Description

Injection of intravitreal Triamcinolone

Outcomes

Primary Outcome Measures

Macula diameter

Secondary Outcome Measures

Diabetic retinopathy

Full Information

First Posted
February 23, 2009
Last Updated
February 23, 2009
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00849537
Brief Title
The Effect of Intravitral Injection of Triamcinolone Combined With Cataract Surgery (Phacoemulsification) on Diabetic Macular Edema and Diabetic Retinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Anticipated)
Study Completion Date
April 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
Keywords
Triamcinolon, Cataract, Diabetic retinopathy, non-proliferative retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone
Arm Type
Experimental
Arm Description
Injection of intravitreal Triamcinolone
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Intervention Description
Injection of intravitreal Triamcinolone
Primary Outcome Measure Information:
Title
Macula diameter
Time Frame
6th week, 3, 6 months
Secondary Outcome Measure Information:
Title
Diabetic retinopathy
Time Frame
6th weeks, 3 and 6 months later

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Siamak Moradian, MD
Phone
00982122592200
Email
Moradian33195@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Siamak Moradian, MD
Organizational Affiliation
Shaheed Beheshti University Of Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmic Research Centre
City
Tehran
ZIP/Postal Code
1666663111
Country
Iran, Islamic Republic of
Individual Site Status
Active, not recruiting
Facility Name
Siamak Moradian,MD
City
Tehran
ZIP/Postal Code
166666
Country
Iran, Islamic Republic of
Individual Site Status
Active, not recruiting
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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