UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001165
Receipt number R000001424
Scientific Title The effect of the non-steroid anti-inflammatory drug, bromfenac sodium hydrate on the postoperative inflammation following a phakic intraocular lens implantation
Date of disclosure of the study information 2008/06/01
Last modified on 2011/06/15 14:47:11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effect of the non-steroid anti-inflammatory drug, bromfenac sodium hydrate on the postoperative inflammation following a phakic intraocular lens implantation

Acronym

The effect of the non-steroid anti-inflammatory drug, bromfenac sodium hydrate on the postoperative inflammation following a phakic intraocular lens implantation

Scientific Title

The effect of the non-steroid anti-inflammatory drug, bromfenac sodium hydrate on the postoperative inflammation following a phakic intraocular lens implantation

Scientific Title:Acronym

The effect of the non-steroid anti-inflammatory drug, bromfenac sodium hydrate on the postoperative inflammation following a phakic intraocular lens implantation

Region

Japan


Condition

Condition

refractive error(mainly high myopia)

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the anti-inflammatory effect of topical bromfenac with that of the topical steroid for the postoperative inflammation following the phakic intraocular lens implantation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

anterior chamber flare, corneal thickness, macular thickness

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Maneuver

Interventions/Control_1

phakic intraocular lens implantation

Interventions/Control_2

topical bromfenac or topical steroid

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

20 years-old <=

Age-upper limit

60 years-old >

Gender

Male and Female

Key inclusion criteria

Ptients who underwent phakic intraocular lens implantation without any intraoerative complications

Key exclusion criteria

ocular and systemic complications

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

35, Shinanomachi, Shinjuku-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuno Negishi

Organization

Keio University School of Medicine

Division name

Department of Ophthalmology

Zip code


Address


TEL


Homepage URL


Email

fwic7788@mb.infoweb.ne.jp


Sponsor or person

Institute

Keio university School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Ophthalmology, Keio university School of Medicine

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

2008 Year 06 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

2008 Year 04 Month 28 Day

Date of IRB


Anticipated trial start date

2008 Year 06 Month 01 Day

Last follow-up date

2010 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2008 Year 05 Month 26 Day

Last modified on

2011 Year 06 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001424


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name