VitrectomyNCT00685490
Vitrectomy for Branch Retinal Vein Occlusion
An observational study of Vitrectomy, run by Shinjo Ophthalmologic Institute at 1 site in Japan.
Trial summary
To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (BRVO). Read more about this study
- Who is it for?
- Ages 45 to 86 years
- Conditions the study is for
- Vitrectomy
- What is being tested?
- Vitrectomy w/o ILM peeling for macular edema with BRVO
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 70 participants
- Where
- 1 siteJapan
- Study dates
- Jul 1995to Nov 2006
- Phase
- Observational
- 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 45 to 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 70 consecutive patients who underwent PPV, with and without OLM peeling, for persistent macular edema associted with BRVO
Who may be able to join
- duration of symptoms lasting 27 weeks
Who cannot join
- vitreous hemorrhage
- severe cataract
- biomicroscopic vitreomacular traction and epiretinal membrane
- previous vitreoretinal surgery
- other ocular diseases that could contribute to visual loss.
- patients with macular branch vein occlusion
- patients with a history of previous grid laser photocoagulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion
To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (BRVO).
Results suggest the following hypothesis:
- PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent macular edema due to BRVO
- Effectiveness is maintained long term
- ILM peeling does not significantly affect postoperative best corrected visual acuity (BCVA)
- Conditions
- Vitrectomy
- Being tested
- Vitrectomy w/o ILM peeling for macular edema with BRVO
- Keywords
- branch retinal vein occlusion, internal limiting membrane, macular edema, vitrectomy
- Medical subject headings
- Retinal Vein Occlusion, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitrectomy w/o ILM peeling for macular edema with BRVOProcedure or surgery
Concurrent phacoemulsification and intraocular lens insertion in the capsular bag was performed, followed by PPV with separation of the posterior hyaloid from the optic disk and posterior retina with a posterior vitreous detachment was not present. Indocyanine green (ICG)-assisted peeling was performed in all consecutive patients between April 2000 and June 2003. 0.1% ICG solution was injected over the macular region. Immediately after application, the dye was washed out using a vitreous cutter. Repeated injection of ICG was not required. Triamcinolone acetonide (TA)-assisted ILM peeling was performed in all consecutive patients from July 2003 to November 2006.
| Study group | Role | What they receive |
|---|---|---|
| Surgical | Retrospective chart review of 70 eyes of 70 consecutive patients who underwent PPV, with and without ILM peeling, for persistent macular edema associated with BRVO Receives: Procedure: Vitrectomy w/o ILM peeling for macular edema with BRVO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reporting of the long term outcomes of PPV, with and without ILM peeling, in eyes with persistent macular edema secondary to BRVO
Measured: 11 years
Secondary outcomes (1)
Elevate the effectiveness of ILM peeling
Measured: 11 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJul 1995
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VitrectomyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shinjo Ophthalmologic Institute
- Sponsor type
- University, hospital or other
- Investigators
- Kazuyuki Kumagai, MD, Principal investigator, Shinjo Ophthalmologic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685490
- Sponsor's protocol ID
- KK-R-207-430R1
- Other IDs
- Kumagai BRVO
- Status last verified
- May 2008
- First submitted
- 22 May 2008
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitrectomy for Persistent Macular Edema in Branch Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00685490
- Acronym / sponsor ID
- KK-R-207-430R1
- Conditions
- Vitrectomy
- Keywords
- branch retinal vein occlusion, internal limiting membrane, macular edema, vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Shinjo Ophthalmologic InstituteUniversity, hospital or other
- Study start
- Jul 1995
- Study completion
- Nov 2006 (actual)
- First posted
- 28 May 2008 (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.
To evaluate the long term outcomes of pars plana vitrectomy (PPV), with and without internal limiting membrane (ILM) peeling, in eyes with persistent macular edema secondary to branch retinal vein occlusion (BRVO).
Results suggest the following hypothesis:
- PPV, with and without ILM peeling, appears to be beneficial in eyes with persistent macular edema due to BRVO
- Effectiveness is maintained long term
- ILM peeling does not significantly affect postoperative best corrected visual acuity (BCVA)
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical | – | Procedure: Vitrectomy w/o ILM peeling for macular edema with BRVORetrospective chart review of 70 eyes of 70 consecutive patients who underwent PPV, with and without ILM peeling, for persistent macular edema associated with BRVO |
Who may qualify
- Ages
- 45 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 70 consecutive patients who underwent PPV, with and without OLM peeling, for persistent macular edema associted with BRVO
Key inclusion criteria (1 listed)
- duration of symptoms lasting 27 weeks
Key exclusion criteria (7 listed)
- vitreous hemorrhage
- severe cataract
- biomicroscopic vitreomacular traction and epiretinal membrane
- previous vitreoretinal surgery
- other ocular diseases that could contribute to visual loss.
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 |
|---|---|---|
| Vitrectomy w/o ILM peeling for macular edema with BRVOConcurrent phacoemulsification and intraocular lens insertion in the capsular bag was performed, followed by PPV with separation of the posterior hyaloid from the optic disk and posterior retina with a posterior vitreous detachment was not present. Indocyanine green (ICG)-assisted peeling was performed in all consecutive patients between April 2000 and June 2003. 0.1% ICG solution was injected over the macular region. Immediately after application, the dye was washed out using a vitreous cutter. Repeated injection of ICG was not required. Triamcinolone acetonide (TA)-assisted ILM peeling was performed in all consecutive patients from July 2003 to November 2006. | Procedure or surgery | Surgical |
Primary outcome
Reporting of the long term outcomes of PPV, with and without ILM peeling, in eyes with persistent macular edema secondary to BRVO
Time frame: 11 years
1 secondary outcome
Elevate the effectiveness of ILM peeling
Time frame: 11 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
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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.
Kazuyuki Kumagai, MD principal investigator
Shinjo Ophthalmologic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vitrectomy, run by Shinjo Ophthalmologic Institute at 1 site in Japan.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 28 May 2008. 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 Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reporting of the long term outcomes of PPV, with and without ILM peeling, in eyes with persistent macular edema secondary to BRVO (time frame: 11 years). 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 28 May 2008.