UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000711 |
|---|---|
| Receipt number | 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 14:07:18 |
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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
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
endo@dmc.twmu.ac.jp
Sponsor or person
Institute
Tokyo women's medical university diabetic center opthalmology depertment
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000846
