UMIN-CTR Clinical Trial

Basic information
Public title	Association of macular pigment optical density and eye condition
Acronym	MPOD and eye codition
Scientific Title	Association of macular pigment optical density and eye condition
Scientific Title:Acronym	MPOD and eye codition
Region	Japan

Condition
Condition	patients with eye diseases and healthy cases
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the association of MPOD, visual function, eye and systemic condition
Basic objectives2	Others
Basic objectives -Others	cross-sectional
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MPOD, visual function, eye exam and blood exam
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with eye diseases and healthy cases
Key exclusion criteria	Those who cannot undergo the examinations
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Yoko Middle name Last name Ozawa
Organization	Keio University
Division name	Department of Ophthalmology, School of Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL	03-3353-1211
Email	ozawa@a5.keio.jp

Public contact
Name of contact person	1st name Yoko Middle name Last name Ozawa
Organization	Keio University
Division name	Department of Ophthalmology, School of Medicine
Zip code	1608582
Address	35 Shinanomachi, Shinjukuku, Tokyo, Japan
TEL	03-3353-1211
Homepage URL
Email	ozawa@a5.keio.jp

Sponsor
Institute	Keio University
Institute
Department

Funding Source
Organization	Keio University
Organization
Division
Category of Funding Organization	Other
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 Shinjukuku Tokyo
Tel	0333531211
Email	ozawa@a5.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	2015 Year 11 Month 25 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	Enrolling by invitation
Date of protocol fixation	2015 Year 11 Month 25 Day
Date of IRB	2011 Year 03 Month 28 Day
Anticipated trial start date	2015 Year 11 Month 26 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry	2025 Year 03 Month 31 Day
Date trial data considered complete	2027 Year 03 Month 31 Day
Date analysis concluded	2027 Year 03 Month 31 Day

Other
Other related information	Case control study. Patients who visited Keio University Hospital after the registration starting date or healthy volunteears, who agreed to join the study are included. They receive MPOD, visual function, eye and blood exams.

Management information
Registered date	2015 Year 11 Month 25 Day
Last modified on	2020 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023001