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

NCT ID: NCT00849537

Last Updated: 2009-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Triamcinolone

Injection of intravitreal Triamcinolone

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

Injection of intravitreal Triamcinolone

Interventions

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Triamcinolone

Injection of intravitreal Triamcinolone

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shaheed Beheshti Medical University

Principal Investigators

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Dr. Siamak Moradian, MD

Role: PRINCIPAL_INVESTIGATOR

Shaheed Beheshti University Of Medical Science

Locations

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Ophthalmic Research Centre

Tehran, Tehran Province, Iran

Site Status ACTIVE_NOT_RECRUITING

Siamak Moradian,MD

Tehran, Tehran Province, Iran

Site Status ACTIVE_NOT_RECRUITING

Tehran, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Siamak Moradian, MD

Role: CONTACT

00982122592200

Other Identifiers

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8711

Identifier Type: -

Identifier Source: org_study_id

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