MedDataX Logo

Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

NCT ID: NCT00300014

Last Updated: 2007-06-13

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. Despite measures to prevent and control this bleeding, it can lead to air-fluid exchange in the office or to additional surgery in the operating room. Air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. Vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. In contrast, IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position.

We believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Vitrectomy State Recurrent Diabetic Vitreous Hemorrhage

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravitreal triamcinolone injection

Intervention Type PROCEDURE

Air-fluid exchange

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Previous vitrectomy due to proliferative diabetic retinopathy
* Recurrent diabetic vitreous hemorrhage

Exclusion Criteria

* Monocular vision
* Uncontrollable intraocular pressure
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Asan Medical Center

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sun Young Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

He Won Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Young Hee Yoon, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

June-Gone Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Sun Young Lee, MD

Role: CONTACT

[email protected]
82-2-3010-3970

June-Gone Kim, MD

Role: CONTACT

[email protected]
82-2-3010-3673

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Sun Young Lee, MD

Role: primary

[email protected]
82-2-3010-3970

June-Gone Kim, MD

Role: backup

[email protected]
82-3010-3673

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IVT in vitreous hemorrhage

Identifier Type: -

Identifier Source: org_study_id