UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000938 |
|---|---|
| Receipt number | R000001123 |
| Scientific Title | Preventive effect of lutein treatment on angiographic macula edema after cataract surgery |
| Date of disclosure of the study information | 2007/12/10 |
| Last modified on | 2007/12/14 21:04:44 |
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Basic information
Public title
Preventive effect of lutein treatment on angiographic macula edema after cataract surgery
Acronym
Preventive effect of lutein on macula edema after cataract surgery
Scientific Title
Preventive effect of lutein treatment on angiographic macula edema after cataract surgery
Scientific Title:Acronym
Preventive effect of lutein on macula edema after cataract surgery
Region
| Japan |
Condition
Condition
angiographic macula edema after cataract surgery
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lutein treatment on the incidence of angiographic macula edema
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The angiographic macula edema was detected by fluorescence angiography at 3 and 6 months after cataract surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
*Period: From 1 month before to 6 months after cataract surgery.
*Dose: 10 mg lutein
1 tablet/day
Interventions/Control_2
*Period: From 1 month before to 6 months after cataract surgery.
*Dose: placebo
1 tablet/day
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
| 48 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who receive cataract surgery
Key exclusion criteria
Patients have complications which related Ophthalmology.
Patients have hypertensive retinopathy, diabetic retinopathy, uveitis include past histroy, retinal detachment, glaucoma, lutein allergy.
Patients take antibiotics, steroids, supplements which containe carotenoids.
Cataract surgery takes over 30 minutes.
Pateints have complications by cataract surgery.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Ueda |
Organization
Showa University
Division name
Department of Ophthalmology, School of Medicine
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8553
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiko Ueda |
Organization
Showa University Hospital
Division name
Ophthalmology
Zip code
Address
1-5-8, Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8553
Homepage URL
http://www.showa-u.ac.jp
tueda@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Self funding
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
YES
Study ID_1
05502
Org. issuing International ID_1
Showa University Institutional Review board
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
At 3 months after the surgery, the macula leakage by FA was observed 14%(3/22) patients in the lutein group and 42% (11/26) in placebo group, respectivery. At 6 months, the macula leakage by FA decreased significantly from 36%(9/25) in the placebo group to 5%(1/22, P<0.05).
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
| 2005 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 12 | Month | 07 | Day |
Last modified on
| 2007 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001123
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
