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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023027
Receipt No. 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

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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
Email 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
Email yyamatos@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Ophthalmology, Kagoshima University
Institute
Department

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
Email

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
URL(English) https://upload.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


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