Post Vitrectomy StateNCT00300014
Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
A study testing Intravitreal triamcinolone injection and Air-fluid exchange in people with Post Vitrectomy State and Recurrent Diabetic Vitreous Hemorrhage, run by Asan Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Post Vitrectomy State, Recurrent Diabetic Vitreous Hemorrhage
- What is being tested?
- Intravitreal triamcinolone injection and Air-fluid exchange
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2006to May 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Previous vitrectomy due to proliferative diabetic retinopathy
- Recurrent diabetic vitreous hemorrhage
Who cannot join
- Monocular vision
- Uncontrollable intraocular pressure
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, 138-736
Sun Young Lee, MD, 82-2-3010-3970, sunylee@amc.seoul.kr
June-Gone Kim, MD, 82-3010-3673, dropkim@dreamwiz.com
About this study
Official title: Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
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.
Read the detailed description
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.
- Being tested
- Intravitreal triamcinolone injection, Air-fluid exchange
- Keywords
- Post vitrectomy, Recurrent diabetic vitreous hemorrhage, Intravitreal triamcinolone injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal triamcinolone injectionProcedure or surgery
Air-fluid exchangeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
day 1 : intraocular pressure, biomicroscope exam, fundus exam
day 7 : intraocular pressure, biomicroscope exam, fundus exam
2 weeks : intraocular pressure, biomicroscope exam, fundus exam
4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography
2 months : intraocular pressure, biomicroscope exam, fundus exam
3months : intraocular pressure, biomicroscope exam, fundus exam
6 months : intraocular pressure, biomicroscope exam, fundus exam
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2006 (estimated)
- Study startJan 2006
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Vitrectomy StateStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sun Young Lee, MD, Principal investigator, Asan Medical CenterHe Won Chung, MD, Principal investigator, Asan Medical CenterYoung Hee Yoon, MD, Principal investigator, Asan Medical CenterJune-Gone Kim, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00300014
- Sponsor's protocol ID
- IVT in vitreous hemorrhage
- Status last verified
- Jun 2007
- First submitted
- 7 Mar 2006
- Last updated
- 13 Jun 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
- ClinicalTrials.gov ID
- NCT00300014
- Acronym / sponsor ID
- IVT in vitreous hemorrhage
- Keywords
- Post vitrectomy, Recurrent diabetic vitreous hemorrhage, Intravitreal triamcinolone injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- May 2007
- First posted
- 8 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Previous vitrectomy due to proliferative diabetic retinopathy
- Recurrent diabetic vitreous hemorrhage
Key exclusion criteria (2 listed)
- Monocular vision
- Uncontrollable intraocular pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravitreal triamcinolone injection | Procedure or surgery | – |
| Air-fluid exchange | Procedure or surgery | – |
Primary outcome
day 1 : intraocular pressure, biomicroscope exam, fundus exam
day 7 : intraocular pressure, biomicroscope exam, fundus exam
2 weeks : intraocular pressure, biomicroscope exam, fundus exam
4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography
2 months : intraocular pressure, biomicroscope exam, fundus exam
3months : intraocular pressure, biomicroscope exam, fundus exam
6 months : intraocular pressure, biomicroscope exam, fundus exam
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2007.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sun Young Lee, MD principal investigator
Asan Medical Center
He Won Chung, MD principal investigator
Asan Medical Center
Young Hee Yoon, MD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal triamcinolone injection and Air-fluid exchange in people with Post Vitrectomy State and Recurrent Diabetic Vitreous Hemorrhage, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sun Young Lee, MD (82-2-3010-3970, sunylee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
day 1 : intraocular pressure, biomicroscope exam, fundus exam. The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2007.