UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023027 |
|---|---|
| Receipt number | R000026541 |
| Scientific Title | The clinical outcomes of the surgery for large macular holes: a multicenter retrospective study. |
| Date of disclosure of the study information | 2016/07/06 |
| Last modified on | 2019/01/07 17:08:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The clinical outcomes of the surgery for large macular holes: a multicenter retrospective study.
Acronym
The clinical outcomes of the surgery for large macular holes: a multicenter retrospective study.
Scientific Title
The clinical outcomes of the surgery for large macular holes: a multicenter retrospective study.
Scientific Title:Acronym
The clinical outcomes of the surgery for large macular holes: a multicenter retrospective study.
Region
| Japan |
Condition
Condition
large macular hole
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate about the clinical outcomes of the surgery for large macular holes and to assess the efficacy and safety of inverted internal limiting membrane flap technique.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Closure rate of macular holes
Key secondary outcomes
Best corrected visual acuity, the diameter of macular hole and foveal structure.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Vitrectomy for large macular holes and investigating clinical outcome with or without Inverted ILM Flap Technique.
Interventions/Control_2
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient receiving surgery for idiopatihc large macular holes from February 1, 2011 to January 31, 2016.
Key exclusion criteria
highly myopic eye (-6.0 diopter or less)
those with an apparent retinal or choroidal diseases including diabetic retinoparhy, age-related macular degeneration, retinal vein occlusion and others
those with a history of retinal surgery
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiji Sakamoto |
Organization
Kagoshima University
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 | Toshifumi Yamashita |
Organization
Kagoshima University
Division name
Ophthalmology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-5402
Homepage URL
http://www.kufm.kagoshima-u.ac.jp/~op/clinical_research_info.php?no=15
yyamatos@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Ophthalmology, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
A grant from the Ministry of Health, Labor and Welfare, and by a Aid for Scientric Research from the Ministry of Education, Science, and Culture of the Japanese Government
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
鹿児島大学病院、徳島大学病院、筑波大学病院、奈良医科大学病院、福井大学病院、名古屋市立大学病院、兵庫医科大学病院、市立札幌病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2016 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2019 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
