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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011544
Receipt No. R000013501
Scientific Title Comparison of intraocular pressure measurements after penetrating keratoplasty(PKP) and Descemet's stripping automated endothelial keratoplasty(DSAEK)
Date of disclosure of the study information 2013/08/21
Last modified on 2013/08/21

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Basic information
Public title Comparison of intraocular pressure measurements after penetrating keratoplasty(PKP) and Descemet's stripping automated endothelial keratoplasty(DSAEK)
Acronym Comparison of intraocular pressure after PKP and DSAEK
Scientific Title Comparison of intraocular pressure measurements after penetrating keratoplasty(PKP) and Descemet's stripping automated endothelial keratoplasty(DSAEK)
Scientific Title:Acronym Comparison of intraocular pressure after PKP and DSAEK
Region
Japan

Condition
Condition Patients after PKP and DSAEK
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate intraocular pressure in PKP or DSAEK patients using five tonometers
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes intraocular pressure
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1.patients after PKP or DSAEK
2.Subjects who sign informed consent forms
Key exclusion criteria Subjects who don't sign informed consent forms
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitake Kato
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address AboshikuWaku68-1, Himeji city
TEL +81-79-272-8555
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitake Kato
Organization Saneikai Tsukazaki Hospital
Division name Ophthalmology
Zip code
Address AboshikuWaku68-1, Himeji city
TEL +81-79-272-8555
Homepage URL
Email y.kato@tsukazaki-eye.net

Sponsor
Institute Saneikai Tsukazaki Hospital
Institute
Department

Funding Source
Organization Saneikai Tsukazaki Hospital
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
2013 Year 08 Month 21 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
2013 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Intraocular pressure is measured by five tonometer devices.

Management information
Registered date
2013 Year 08 Month 21 Day
Last modified on
2013 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013501

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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