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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003829
Receipt No. R000004618
Scientific Title Efficacy and safety of long-term use of topical corticosteroids following corneal transplantation
Date of disclosure of the study information 2010/07/01
Last modified on 2012/06/27

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Basic information
Public title Efficacy and safety of long-term use of topical corticosteroids following corneal transplantation
Acronym Long-term use of topical steroids following corneal transplantation
Scientific Title Efficacy and safety of long-term use of topical corticosteroids following corneal transplantation
Scientific Title:Acronym Long-term use of topical steroids following corneal transplantation
Region
Japan

Condition
Condition Following penetrating keratoplasty
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study efficacy and safety of long-term use of low dose topical corticosteroids following penetrating keratoplasty
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Development of immunological rejection during the study period
Key secondary outcomes Development of local complications associated with the use of topical corticosteroids

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 Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 use of topical low-dose corticosteroids (0.1% fluoromethorone) three times a day
Interventions/Control_2 discontinuation of topical corticosteroids
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Eyes that had penetrating keratoplasty for more than 1 years ago, and the grafts remain clear with the use of topical corticosteroids
Key exclusion criteria active ocular infection
eyes that need topical corticosteroids for uveitis or ocular allergy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Shimazaki
Organization Tokyo Dental College, Ichikawa General Hospital
Division name Ophthalmology
Zip code
Address 5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL 0473-22-0151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Jun Shimazaki
Organization Tokyo Dental College, Ichikawa General Hospital
Division name Ophthalmology
Zip code
Address 5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL 0473-22-0151
Homepage URL http://www.tdc-eyecom
Email jun@eyebank.or.jp

Sponsor
Institute Department of Ophthalmology, Tokyo Dental College, Ichikawa General Hospital
Institute
Department

Funding Source
Organization Department of Ophthalmology, Tokyo Dental College, Ichikawa General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 東京歯科大学市川総合病院(千葉)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Prolonged use of 0.1% fluorometholone was beneficial for the prevention of rejection after penetrating keratoplasty. Because no adverse consequences were noted, we recommend continuing use of the low-dose corticosteroids, even in non.high-risk cases
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
2010 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 06 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2012 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 06 Month 27 Day
Last modified on
2012 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004618

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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