UMIN-CTR Clinical Trial

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
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	03-5315-4132
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	03-3353-1211
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044196