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


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 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


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

Value
https://center6.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