UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000433 |
|---|---|
| Receipt number | R000000525 |
| Scientific Title | Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion |
| Date of disclosure of the study information | 2006/06/30 |
| Last modified on | 2015/05/11 08:36:34 |
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Basic information
Public title
Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Acronym
Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Scientific Title
Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Scientific Title:Acronym
Randamized clinical trial of pars plana vitrectomy for macular edema from branch retinal vein occlusion
Region
| Japan |
Condition
Condition
Patients with macular edema from branch retinal vein occlusion
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Randamized clinical trial of pars plana vitrectomy and grid laser photocoagulation for patients with macular edema from branch retinal vein occlusion. Improvement of the visual outcome and foveal retinal thickness for the patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
12 months distant visual acuity
12 months foveal retinal thickness
Key secondary outcomes
Course of distant visual acuity over treatment period
Course of foveal retinal thickness over treatment period
Ischemic maculopathy at 12 months
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group1: grid laser photocoagulation
Interventions/Control_2
Group2: pars plana vitrectomy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants must have center-involved macular edema secondary to branch retinal vein occlusion documented for at least 2 months and not longer 18 months
Visual acuity greater than or equal to 0.1 (logMAR1.0) and less than or equal to 0.5 (logMAR0.3)
Foveal retinal thickness greater than or equal to 250 microns of the optical coherence tomography (mean of 2 measurements).
Key exclusion criteria
Ischemic maculopathy and macular degeneration
Presence of hemorrhage directly in the fovea
Additional ocular disease reducing the visual acuity
Sitting systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg at the screening visit
History of systemic corticosteroids within 4 months prior to randomization
History of laser photocoaguration for macular edema
History of major ocular surgery within 6 months prior to randomization
History of peribulbar or retrobulbar or intravitreal corticosteroid use
History of pars plana vitrectomy
Aphakia
Pregnancy
History of allergy to fluorescein
uncontrollable systemic disease
participation in another trial
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL
099-275-5402
tsakamot@m3.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima JAPAN
TEL
099-275-5402
Homepage URL
tsakamot@m3.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2006 | Year | 03 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 06 | Month | 20 | Day |
Last modified on
| 2015 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000525
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