UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024553 |
|---|---|
| Receipt number | R000011900 |
| Scientific Title | Collecting lens and vitreoretinal samples during surgeries from the patients with cataract and retinal diseases |
| Date of disclosure of the study information | 2016/10/25 |
| Last modified on | 2023/10/30 11:52:56 |
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Basic information
Public title
Collecting lens and vitreoretinal samples during
surgeries from the patients with cataract and retinal diseases
Acronym
Collecting lens and vitreoretinal samples during
surgeries from the patients with cataract and retinal diseases
Scientific Title
Collecting lens and vitreoretinal samples during
surgeries from the patients with cataract and retinal diseases
Scientific Title:Acronym
Collecting lens and vitreoretinal samples during
surgeries from the patients with cataract and retinal diseases
Region
| Japan |
Condition
Condition
cataract, retinal rdetachment, proliferative vitreoretinopathy, diabetic retinopathy, macular hole, epiretinal membrane, vitreous hemorrhage
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect lens and vitreoretinal samples during surgeries and examine the difference dependenton each diseases
Basic objectives2
Others
Basic objectives -Others
the efficacy for the diagnosis and treatment by analysing ocular pathology.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
pathological findings from the samples
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who receive cataract and vitreoretinal surgeries.
Key exclusion criteria
n/a
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-2277
h-kaneko@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Kaneko |
Organization
Nagoya University
Division name
Department of Ophthalmology
Zip code
466-8550
Address
65 Tsurumai, Showa-ku, Nagoya
TEL
052-744-2277
Homepage URL
h-kaneko@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Department of Ophthalmology, Nagoya University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Ophthalmology, Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2277
h-kaneko@med.nagoya-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
名古屋大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Vitreous fluid samples from retinal diseases associated with infection were analyzed for electrolytes, and iron levels were found to be significantly lower than in control diseases (e.g., macular hole).
Results date posted
| 2023 | Year | 10 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
No specific adverse events have occurred.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cross-sectional study
Management information
Registered date
| 2016 | Year | 10 | Month | 24 | Day |
Last modified on
| 2023 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011900
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
