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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000711
Receipt No. R000000846
Scientific Title Priventive effect of Bromfenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Date of disclosure of the study information 2007/07/01
Last modified on 2007/12/04

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Basic information
Public title Priventive effect of Bromfenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Acronym Priventive effect of Bromfenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Scientific Title Priventive effect of Bromfenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Scientific Title:Acronym Priventive effect of Bromfenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Region
Japan

Condition
Condition macular edema after cataract surgery
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare a bromfenac sodium to a steroidal ophtalmic solution in priventing cystoid macular edema after cataract surgery in diabetic patients using optical coherence tomography3.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Best corrected visual acuity, slit lamp microscopy, amount of anterior chamber flare and cells mesured laser flare cell photometry. Retinal thickness and foveal volum ware mesured by OCT3
recorded each visit,preoperatively, 1day, 1week,2weeks, 4weeks, 6weeks after cataract surgery.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bromfenac sodium was administrated to eye after cataract surgery two times per day for 1day to 6weeks.
Interventions/Control_2 Steroidal ophtalmic sorution was administrated to eye after cataract surgery four times per day for 1day to 6weeks.
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
35 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients of performede cataract surgery.Retinal thickness is less than 250 micrio meter.
Key exclusion criteria Eyes of sever diabetic retinopathy, eyes allergic to bromfenac or steroid, eyes previously and post operatively underwent intraocular surgery of auy type, history of uveitis or presence of any retinal choloidal disease other than diabeties, patient with severe cardiac incompetence or cereberovascular disorder and patient undergo hemo dialysis.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shigehiko kitano
Organization Tokyo women's medical university diabetic center opthalmology depertment
Division name Tokyo women's medical university diabetic center opthalmology depertment
Zip code
Address shinjukuku kawadacho 8-1
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo women's medical university diabetic center opthalmology depertment
Division name Tokyo women's medical university diabetic center opthalmology depertment
Zip code
Address
TEL
Homepage URL
Email endo@dmc.twmu.ac.jp

Sponsor
Institute Tokyo women's medical university diabetic center opthalmology depertment
Institute
Department

Funding Source
Organization Tokyo women's medical university diabetic center opthalmology depertment
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2007 Year 07 Month 01 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
2005 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2006 Year 03 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 12 Month 01 Day
Date trial data considered complete
2007 Year 12 Month 01 Day
Date analysis concluded
2007 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 05 Month 08 Day
Last modified on
2007 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000846

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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