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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012822
Receipt No. R000014979
Scientific Title Intraoperative evaluation of the retina and intraocular tissue in the treatment of vitreoretinal surgery
Date of disclosure of the study information 2014/01/14
Last modified on 2019/03/15

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Basic information
Public title Intraoperative evaluation of the retina and intraocular tissue in the treatment of vitreoretinal surgery
Acronym Intraoperative evaluation of the retina and intraocular tissue in the treatment of vitreoretinal surgery
Scientific Title Intraoperative evaluation of the retina and intraocular tissue in the treatment of vitreoretinal surgery
Scientific Title:Acronym Intraoperative evaluation of the retina and intraocular tissue in the treatment of vitreoretinal surgery
Region
Japan

Condition
Condition Vitreo-retinal disease
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the status of the retina by taking cross-sectional images of the retina using fiber-optic optical coherence tomography intra-operatively
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Status of the tissue observed during surgery
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Fiber-optic optical coherence tomography
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 undergo surgery for the vitreoretinal diseases, such as macular hole, pre-retinal membrane, vireo-retinal traction syndrome, macular edema, proliferative vitreoretinopathy, retinal detachment and diabetic retinopathy in our clinic
Key exclusion criteria None
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroko Terasaki
Organization Nagoya University Hospital
Division name Ophthalmology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-741-2111
Email terasaki@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunsuke Yasuda
Organization Nagoya University Hospital
Division name Ophthalmology
Zip code
Address 65 Tsuruma-cho, Showa-ku, Nagoya
TEL 052-741-2111
Homepage URL
Email s.yasuda@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 名古屋大学医学部付属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 14 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
2014 Year 01 Month 14 Day
Date of IRB
2014 Year 01 Month 27 Day
Anticipated trial start date
2014 Year 01 Month 28 Day
Last follow-up date
2019 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
2014 Year 01 Month 11 Day
Last modified on
2019 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014979

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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