UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022734 |
|---|---|
| Receipt number | 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 | 2021/07/02 11:16:58 |
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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 | Mitsuru |
| Middle name | |
| Last name | Nakazawa |
Organization
Hirosaki University Graduate school of Medicine
Division name
Department of Ophthalmology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, 036-8562, Japan
TEL
0172-39-5094
mitsuru@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Mitsuru |
| Middle name | |
| Last name | Nakazawa |
Organization
Hirosaki University Graduate school of Medicine
Division name
Department of Ophthalmology
Zip code
036-8562
Address
5 Zaifu-cho, Hirosaki, 036-8562, Japan
TEL
0172-39-5094
Homepage URL
http://www.med.hirosaki-u.ac.jp/~ophthal/
mitsuru@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
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
Committee of ethics in Hirosaki University Graduate School of Medicine
Address
5 Zaifu-cho, Hirosaki
Tel
0172-39-5094
mituru@hirosaki-u.ac.jp
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
弘前大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
http://www.med.hirosaki-u.ac.jp/~ophthal/
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
200
Results
The results indicated that the biological antioxidative potential was decreased in the vitreous gel with retinal detachment, and that inflammatory reactions are related to the pathobiochemistry in the vitreous with retinal detachment.
Results date posted
| 2021 | Year | 07 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who undergo vitreous surgery due to rhegmatogenous retinal detachment, macular hole or diabetic retinopathy.
Participant flow
an aliquot of the vitreous gel is preserved during surgery.
Adverse events
no
Outcome measures
biological antioxidant potential and inflammatory cytokines
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 17 | Day |
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
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026189
