UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005372 |
|---|---|
| Receipt number | 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 20:59:09 |
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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
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
yasukawa@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006372
