UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038849 |
|---|---|
| Receipt number | R000044196 |
| Scientific Title | Raman spectroscopy spectra study using aqueous humor metabolites of cataract surgery patients |
| Date of disclosure of the study information | 2019/12/11 |
| Last modified on | 2021/12/12 09:46:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Raman spectroscopy study using aqueous humor of patients with cataract surgery
Acronym
Raman spectroscopy study using human aqueous humor
Scientific Title
Raman spectroscopy spectra study using aqueous humor metabolites of cataract surgery patients
Scientific Title:Acronym
Raman spectroscopy study using human aqueous humor metabolites
Region
| Japan |
Condition
Condition
Cataract
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, the aqueous humor will be collected after placing a scalpel in the eyeball at the start of surgery for a cataract patient, and the Raman spectrum of the aqueous humor will be obtained with the aqueous humor Raman spectrometer. It aims at making it the comparison object of the data obtained by "invasive aqueous humor Raman spectroscopy" in the future.
Basic objectives2
Others
Basic objectives -Others
The greatest significance of this study is to know the contents of true human aqueous humor.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Raman spectroscopic spectral shape after obtaining aqueous humor metabolites and characteristics of individual aqueous humor
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All Seven patients undergo cataract surgery (collecting aqueous humor at the time of cataract surgery), regardless of gender. Age is over 20 years old.
Key exclusion criteria
(1) Patients who have performed eye surgery within the past 6 months.
(2) Patients who need a substitute or agent to consent to participate in this study.
Target sample size
7
Research contact person
Name of lead principal investigator
| 1st name | Toshihide |
| Middle name | |
| Last name | Kurihara |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-5315-4132
kurihara@z8.keio.jp
Public contact
Name of contact person
| 1st name | Ari |
| Middle name | |
| Last name | Shinojima |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku
TEL
03-5315-4132
Homepage URL
ari.shinojima@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
SEED CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
7
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
| 2019 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Spectrum data and safety confirmation data will be organized and stored at Keio University School of Medicine, Department of Ophthalmology, Research Park Building 4N6.
Data analysis is performed at Keio University School of Medicine, Department of Ophthalmology, General Medical Science Research Building 4N6, and Seed Co., Ltd. does not perform data analysis.
Management information
Registered date
| 2019 | Year | 12 | Month | 11 | Day |
Last modified on
| 2021 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044196
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
