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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028187
Receipt No. R000032242
Scientific Title evaluation of intravitreal autologous blood to remove posterior cortical vitreous in vitrectomy
Date of disclosure of the study information 2017/08/01
Last modified on 2018/07/12

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Basic information
Public title evaluation of intravitreal autologous blood to remove posterior cortical vitreous in vitrectomy
Acronym intravitreal autologous blood to remove posterior cortical vitreous
Scientific Title evaluation of intravitreal autologous blood to remove posterior cortical vitreous in vitrectomy
Scientific Title:Acronym intravitreal autologous blood to remove posterior cortical vitreous
Region
Japan

Condition
Condition epiretinal membrane, macular hole, retinal detachment, diabetic retinopathy, retinal vein occlusion, retinoschisis
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate using vitreous autologous blood to remove the posterior cortical vitreous for patients undergoing vitrectomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time to remove posterior cortical vitreous
Key secondary outcomes Refraction, visual acuity, intraocular pressure, fundus examination, fundus photography, optical coherence tomography, axial length measurement

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 use of vitreous autologous blood
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 1 Inpatient only
2 Patients undergoing vitrectomy
3 After receiving sufficient explanation for participation in this study, patients who obtained written agreement by the patient's free will with sufficient understanding.
Key exclusion criteria 1 If the patient's consent was not obtained
2 Patients already have vitreous hemorrhage
3 Patients judged unsuitable as research subjects by research managers
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kitaoka
Organization Graduate School of Biomedical Sciences, Nagasaki University
Division name Department of Ophthalmology and Visual Sciences
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7345
Email tkitaoka@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihisa Yamada
Organization Nagasaki University Hospital
Division name Ophthalmology
Zip code
Address 1-7-1 Sakamoto, Nagasaki 852-8501, Japan
TEL 095-819-7345
Homepage URL
Email y-yoshi@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University
Institute
Department

Funding Source
Organization self funding
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 長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 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 07 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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

Management information
Registered date
2017 Year 07 Month 11 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032242

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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