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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027660
Receipt No. R000031686
Scientific Title Evaluation of ocular circulation after vitreous surgery for macular diseases.
Date of disclosure of the study information 2017/06/07
Last modified on 2018/06/07

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Basic information
Public title Evaluation of ocular circulation after vitreous surgery for macular diseases.
Acronym Ocular circulation after macular surgery.
Scientific Title Evaluation of ocular circulation after vitreous surgery for macular diseases.
Scientific Title:Acronym Ocular circulation after macular surgery.
Region
Japan

Condition
Condition Macular hoe, Epi-retinal membrane, Macular edema
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate changes in ocular circulation pre and after vitreous surgery for macular diseases using laser speckle flowgraphy (LSFG).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate the optic nerve head circulation using LSFG at pre, 1 month and 3month after vitreous surgery for macular disease.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Comparison of surgical times by multiple surgions.
Interventions/Control_2 Comparison of concentration of adrenaline in vitreous reflux fluid (0.3 ml, 0.5 ml, 1.0 ml) during vitreous surgery.
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
50 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria In patients with mauclar hole, epi-retinal membrane, macular edema.
Key exclusion criteria In patients with severe cataract, history of any vitreous surgery, and arrhythmia.
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomoaki Shiba
Organization School of Medicine, Toho University
Division name Ophthalmology
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3761-4151
Email tomoaki-s@med.toho-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomoaki Shiba
Organization School of Medicine, Toho University
Division name Ophthalmology
Zip code
Address 6-11-1 Omori-Nishi, Ota-ku, Tokyo 143-8541, Japan
TEL 03-3761-4151
Homepage URL
Email tomoaki-s@med.toho-u.ac.jp

Sponsor
Institute School of Medicine, Toho University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 06 Month 07 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
2017 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 07 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 06 Month 06 Day
Last modified on
2018 Year 06 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031686

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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