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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038849
Receipt No. 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 2020/06/11

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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 three 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 3

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 03-5363-3204
Email 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 03-5363-3204
Homepage URL
Email ari.shinojima@keio.jp

Sponsor
Institute Keio University
Institute
Department

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 03-5363-3204
Email ari.shinojima@keio.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 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
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
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
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 4S7.
Data analysis is performed at Keio University School of Medicine, Department of Ophthalmology, General Medical Science Research Building 4S7, and Seed Co., Ltd. does not perform data analysis.

Management information
Registered date
2019 Year 12 Month 11 Day
Last modified on
2020 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.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


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