UMIN-CTR Clinical Trial

Basic information
Public title	Observation study on measurement macular pigment optical density using resonance raman spectroscopy
Acronym	Measurement macular pigment optical density using resonance raman spectroscopy
Scientific Title	Observation study on measurement macular pigment optical density using resonance raman spectroscopy
Scientific Title:Acronym	Measurement macular pigment optical density using resonance raman spectroscopy
Region	Japan

Condition
Condition	age-related macular degeneration
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate macular pigment density in patients with age-related macular degeneration
Basic objectives2	Others
Basic objectives -Others	Observation study
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Macular pigment optical density
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Eyes with age-related macular degeneration (2)Judged by the investigator to be eligible as a subject on the basis of screening tests (3)Aged 50 years or older at provision of informed consent, and has given consent in writing
Key exclusion criteria	(1)Presence of cataracts of a severity sufficient (2)Pupile size of less than 6.5 mm
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Obana
Organization	Seirei Hamamatsu General Hospital
Division name	Department of Ophthalmology
Zip code	430-8558
Address	Naka-ku
TEL	0534742222
Email	obana@sis.seirei.or.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Asano
Organization	Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name	Department of Ophthalmology
Zip code	430-8558
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, 430-8558, Japan
TEL	053-474-2222
Homepage URL
Email	asanoma@sis.seirei.or.jp

Sponsor
Institute	Seirei Hamamatsu Genaral Hospital (Shizuoka Prefecture)
Institute
Department

Funding Source
Organization	Otsuka Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Japan Ocular Carotenoids Study Group(JOCS)
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Seirei Hamamatsu General Hospital
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City
Tel	0534742222
Email	asanoma@sis.seirei.or.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	北海道大学大学院医学研究科医学専攻研究眼科学講座(北海道）、聖隷浜松病院眼科(静岡県）、神戸大学医学部眼科(兵庫県）、島根大学医学部眼科(島根県）

Other administrative information
Date of disclosure of the study information	2011 Year 01 Month 05 Day

Related information
URL releasing protocol	none
Publication of results	Unpublished

Result
URL related to results and publications	none
Number of participants that the trial has enrolled	37
Results	The Raman counts of the patients with age-related macular degeneration ranged from 737 to 3288. the mean was 2056, standard deviation was 973.
Results date posted	2021 Year 04 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	patients with exudative age-related macular degeneration
Participant flow	Macular pigment optical density was measuered.
Adverse events	None
Outcome measures	Macular pigment optical density
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 01 Month 27 Day
Date of IRB	2010 Year 02 Month 17 Day
Anticipated trial start date	2011 Year 01 Month 01 Day
Last follow-up date	2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study

Management information
Registered date	2011 Year 01 Month 05 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005739