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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005372
Receipt No. R000006372
Scientific Title Study on the effects of supplements containing lutein on spontaneous resolution in eyes with chronic central serous chorioretinopathy
Date of disclosure of the study information 2011/04/16
Last modified on 2015/10/24

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Basic information
Public title Study on the effects of supplements containing lutein on spontaneous resolution in eyes with chronic central serous chorioretinopathy
Acronym Study on the effects of supplements containing lutein on chronic central serous chorioretinopathy
Scientific Title Study on the effects of supplements containing lutein on spontaneous resolution in eyes with chronic central serous chorioretinopathy
Scientific Title:Acronym Study on the effects of supplements containing lutein on chronic central serous chorioretinopathy
Region
Japan

Condition
Condition chronic central serous chorioretinopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of uptake of supplements containing lutein or placebo on spontaneous resolution in eyes with chronic central serous chorioretinopathy. The impacts of stop-smoking in current smokers will also be evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) Rate of spontaneous resolution of central serous chorioretinopathy
(2) Changes in macular volume measured by optical coherence tomography
Key secondary outcomes Best-corrected visual acuity

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 multivitamins, minerals, and luten
Interventions/Control_2 placebo
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. serous retinal detachment detectable on optical coherence tomography (OCT) with diagnosis of central serous chorioretinopathy (CSC) on the basis of fluorescein angiography
2. chronic CSC with a + any of b, c, d
a. not diagnosed as polypoidal choroidal vasculopathy (PCV) on fluorescein angigraphy
b. visual acuity loss due to persistent serous retinal detachment
c. durations of symptoms over 3 months
d. hyperautofluorescence in the area with serous retinal detachment
3. age over 40 years, obtainable for informed consent
4. Japanese patients
5. patients considered as eligible for study by the investigator
Key exclusion criteria 1. presence of hard exudate or subretinal hemorrhage in or around serous retinal detachment
2. past history of photocoagulation or photodynamic therapy
3. presence of other macular diseases
4. presence of uveitis
5. myopia with -8D or higher
6. past history of vitrectomy
7. hazy media causing difficulties in fundus examinations
8. active exudative age-related macular degeneration in a fellow eye
9. allergic to lutein, anti-oxidants, and minerals
10. daily take of lutein, anti-oxidants, or other supplements
11. pregnant or planned for pregnancy
12. undergone intraocular surgeries within the previous 6 months
13. judged by the investigator to be ineligible for other reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Yasukawa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL 052-853-8251
Email yasukawa@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Yasukawa
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Ophthalmology and Visual Science
Zip code
Address Kawasumi 1, Mizuho-cho, Mizuho-ku, Nagoya, Aich 467-8601, JAPAN
TEL 052-853-8251
Homepage URL
Email yasukawa@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Santen Pharmacuetical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 大阪大学病院(大阪府)、九州大学病院(福岡県)、駿河台日本大学病院(東京)、名古屋市立大学病院(名古屋)、福島県立医科大学(福島県)
Osaka University Hospital, Osaka; Kyushu University Hospital, Fukuoka; Surugadai Nihon University Hospital, Tokyo; Nagoya City University Hospital, Nagoya; Fukushima Prefectural University, Fukushima

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 16 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 Completed
Date of protocol fixation
2010 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2014 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 05 Month 31 Day
Date trial data considered complete
2014 Year 06 Month 30 Day
Date analysis concluded
2014 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 04 Day
Last modified on
2015 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006372

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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