UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017847 |
|---|---|
| Receipt number | R000020676 |
| Scientific Title | Comparative study of 27-gauge versus 25-gauge vitrectomy for epiretinal membrane |
| Date of disclosure of the study information | 2015/06/09 |
| Last modified on | 2017/04/09 10:41:32 |
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Basic information
Public title
Comparative study of 27-gauge versus 25-gauge vitrectomy for epiretinal membrane
Acronym
Comparative study of 27-gauge versus 25-gauge vitrectomy
Scientific Title
Comparative study of 27-gauge versus 25-gauge vitrectomy for epiretinal membrane
Scientific Title:Acronym
Comparative study of 27-gauge versus 25-gauge vitrectomy
Region
| Japan |
Condition
Condition
epiretinal membrane
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare 27-gauge with 25-gauge microincision vitrectomy in patients with epiretinal membrane
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operation time, postoperative inflammation, intraocular pressure (IOP), time for scleral wound closure, rate of hypotony, surgically induced astigmatism (SIA), and best-corrected visual acuity (BCVA) at 6 months postoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
microincision vitrectomy surgery (MIVS) with 27-gauge
Interventions/Control_2
microincision vitrectomy surgery (MIVS) with 25-gauge
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)patients with an epiretinal membrane indicated in vitrectomy
2)Written imformed consent
Key exclusion criteria
1)patients had a history of prior scleral buckling and pars plana vitrectomy, high myopia with a refractive error of greater than -8.00 diopters (D), and severe cataract of higher than grade 3.
2)A case of the patient do not consent that participate in this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jiro Kogo |
Organization
St. Marianna University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
kogo@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jiro Kogo |
Organization
St. Marianna University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
kogo@marianna-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology
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
YES
Study ID_1
2341
Org. issuing International ID_1
St. Marianna University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
聖マリアンナ医科大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 09 | Day |
Last modified on
| 2017 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020676
