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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026747
Receipt No. R000030708
Scientific Title Effectiveness of retinal transplantation for intractable macular hole
Date of disclosure of the study information 2017/04/15
Last modified on 2017/03/28

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Basic information
Public title Effectiveness of retinal transplantation for intractable macular hole
Acronym Retinal transplantation for intractable macular hole
Scientific Title Effectiveness of retinal transplantation for intractable macular hole
Scientific Title:Acronym Retinal transplantation for intractable macular hole
Region
Japan

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

Objectives
Narrative objectives1 We will investigate the effectiveness and safety of retinal transplantation for refractory macular holes
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
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 fundus angiography, slit lamp microscopy, duration of disease, current medical history, past history, family history,
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Intervention by surgical 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients diagnosed as refractory macular hole between April 15, 2017 and December 15, 2020
Key exclusion criteria nothing special
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Kaneko
Organization Nagoya University Hospital
Division name Department of Ophthalmology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 0527442275
Email h-kaneko@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Kaneko
Organization Nagoya University Hospital
Division name Department of Ophthalmology
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 0527442275
Homepage URL
Email h-kaneko@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Self-procurement
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
2017 Year 04 Month 15 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
2017 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 03 Month 28 Day
Last modified on
2017 Year 03 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030708

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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