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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000938
Receipt No. 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

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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
Email

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
Email tueda@med.showa-u.ac.jp

Sponsor
Institute Showa University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001123

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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