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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006671
Receipt No. R000007879
Scientific Title Priventive effect of nepafenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Date of disclosure of the study information 2011/11/04
Last modified on 2011/11/04

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Basic information
Public title Priventive effect of nepafenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Acronym Priventive effect of nepafenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Scientific Title Priventive effect of nepafenac ophtalmic solution for changing of foveal thickness after cataract surgery.
Scientific Title:Acronym Priventive effect of nepafenac 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 nepafenac 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 Not applicable

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
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Period,Dose:Nepafenac was administrated three times per day from operation day to 6week after cataract surgery.
Interventions/Control_2 Period.Dose:Nepafenac was administrated three times per day from operation day to 6week after cataract surgery.
Steroidal ophtalmic sorution was administrated 3 times per day form after cataract surgery 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 nepafenac 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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kitano Shigehiko
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 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Endo Naoko
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 03-3353-8111
Homepage URL
Email

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
2011 Year 11 Month 04 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 Open public recruiting
Date of protocol fixation
2011 Year 05 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 04 Day
Last modified on
2011 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007879

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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