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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036009
Receipt No. R000041014
Scientific Title The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Date of disclosure of the study information 2019/02/26
Last modified on 2019/02/26

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Basic information
Public title The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Acronym The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Scientific Title The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Scientific Title:Acronym The retinal and choroidal displacement after vitrectomy in eyes with macular hole
Region
Japan

Condition
Condition macular hole
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The macular displacement after vitrectomy in eyes with macular hole has been reported in previous studies. The aim of our study is to clarify the retinal and choroidal displacement after vitrectomy in eyes with macular hole using OCT (optical coherence tomography) and OCT angiography.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Sex,age,visual acuity,visual field,refraction,corneal curvature radius,corneal thickness,ocular axial length,fundus observation,optical coherence tomography,optical coherence tomography angiography,fundus photograph,fluorescence angiography,slit lamp microscopy,duration of disease,current medical history,past hisory,family history,medication used surgery content
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent macular hole surgery from 1 January 2016 to 31 March 2020
Key exclusion criteria nothing special
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Iwase
Organization Nagoya University School of Medicine
Division name Department of Opthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-744-2275
Email tiwase@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kensuke Goto
Organization Nagoya University School of Medicine
Division name Department of Opthalmology
Zip code
Address Tsurumai-cho 65, Showa-ku, Nagoya city, Aichi prefecture
TEL 052-744-2275
Homepage URL
Email kensuke.goto1214@gmail.com

Sponsor
Institute Nagoya University
Institute
Department

Funding Source
Organization Nagoya University
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
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 26 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 Open public recruiting
Date of protocol fixation
2016 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information nothing special

Management information
Registered date
2019 Year 02 Month 26 Day
Last modified on
2019 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041014

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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