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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022734
Receipt No. R000026189
Scientific Title Analyses of intravitreal antioxidant potential and cytokine profiles of various vitreoretinal diseases
Date of disclosure of the study information 2016/12/01
Last modified on 2017/11/10

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Basic information
Public title Analyses of intravitreal antioxidant potential and cytokine profiles of various vitreoretinal diseases
Acronym Biochemical analyses of the vitreous with vitreoretinal diseases
Scientific Title Analyses of intravitreal antioxidant potential and cytokine profiles of various vitreoretinal diseases
Scientific Title:Acronym Biochemical analyses of the vitreous with vitreoretinal diseases
Region
Japan

Condition
Condition vitreoretinal diseases
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To understand mechanisms and pathogenesis of vitreoretinal diseases including macular hole, epiretinal membrane, proliferative diabetic retinopathy, rhegmatogenous retinal detachment and retinal vein occlusion, the vitreous fluid obtained by vitrectomy are biochemically analyzed, with specifically interests in the antioxidant potentials and cytokine profiles.
Basic objectives2 Others
Basic objectives -Others biochemical analyses
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Differences in the antioxidant potentials and cytokine profiles between various vitreoretinal diseases
Key secondary outcomes Characteristic patterns of the antioxidant potentials and cytokine profiles in each of various vitreoretinal diseases

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment No need to know

Intervention
No. of arms 5
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for rhegmatogenous retinal detachment.
Interventions/Control_2 Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for macular hole.
Interventions/Control_3 Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for epiretinal membrane.
Interventions/Control_4 Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for proliferative diabetic retinopathy.
Interventions/Control_5 Collection of 0.5ml of undiluted vitreous fluid before starting vitrectomy for retinal vein occlusion.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients with various vitreoretinal diseases which need to be treated by vitreous surgery.
Key exclusion criteria Patients who were previously undergone vitrectomy surgery.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuru Nakazawa
Organization Hirosaki University Graduate school of Medicine
Division name Department of Ophthalmology
Zip code
Address 5 Zaifu-cho, Hirosaki, 036-8562, Japan
TEL 0172-39-5094
Email mitsuru@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuru Nakazawa
Organization Hirosaki University Graduate school of Medicine
Division name Department of Ophthalmology
Zip code
Address 5 Zaifu-cho, Hirosaki, 036-8562, Japan
TEL 0172-39-5094
Homepage URL http://www.med.hirosaki-u.ac.jp/~ophthal/
Email mitsuru@hirosaki-u.ac.jp

Sponsor
Institute Department of Ophthalmology, Hirosaki University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.med.hirosaki-u.ac.jp/~ophthal/
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 Enrolling by invitation
Date of protocol fixation
2015 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 06 Month 14 Day
Date analysis concluded
2020 Year 12 Month 31 Day

Other
Other related information The data have been published in the following articles.

Maeno A, Suzuki Y, Adachi K, Takahashi S, Yokoi Y, Nakazawa M.
Characterization of biological antioxidant potential in the vitreous fluid from patients with rhegmatogenous retinal detachment. Acta Ophthalmol 94 (6), e515-516, 2016, doi: 10.1111/aos.13002.
Suzuki Y, Suzuki K, Kudo T, Metoki T, Nakazawa M.
Level of vascular endothelial growth factor in the vitreous fluid of proliferative diabetic retinopathy patients and postoperative complications of vitrectomy. Ophthalmologica 236, 133-138, 2016.
Takahashi S, Adachi K, Suzuki Y, Maeno A, Nakazawa M.
Profiles of inflammatory cytokines in the vitreous fluid from patients with rhegmatogenous retinal detachment and their correlations with clinical features. BioMed Res Int 2016, article ID 4256183, 9 pages, 2016. doi:10.1155/2016/4256183
Suzuki Y, Adachi K, Takahashi S, Maeno A, Nakazawa M.
Oxidative stress in the vitreous fluid with rhegmatogenous retinal detachment. J Clin Exp Ophthalmol 6: 682-686, 2017. Doi:10.4172/2155-9570.1000682

Management information
Registered date
2016 Year 06 Month 14 Day
Last modified on
2017 Year 11 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026189

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/12/16 Suzuki oxidative paper.pdf


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