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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027923
Receipt No. R000031981
Scientific Title A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score
Date of disclosure of the study information 2017/07/01
Last modified on 2018/06/03

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Basic information
Public title A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score
Acronym Change of NEI VFQ-25 subscale score after Endothelial Keratoplasty
Scientific Title A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score
Scientific Title:Acronym Change of NEI VFQ-25 subscale score after Endothelial Keratoplasty
Region
Japan

Condition
Condition bullous keratopathy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Endothelial keratoplasty, such as Descemet stripping automated endothelial keratoplasty (DSAEK), or Descemet membrane endothelial keratoplasty (DMEK), is expected to provide better visual function. However, the correlation between visual acuity and the quality of vision has not been well understood until now. We have to analyze the quality of life after endothelial keratoplasty using the NEI VFQ-25 subscale score.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes best-corrected visual acuity, corneal endothelial cell density, and central corneal thickness preoperatively and 6 months postoperatively vfq25 High-order aberrations
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 patients with bullous keratopathy, who are treated with DSAEK or DMEK under agreement with this study
Key exclusion criteria patients who disagree with this study
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiko Hayashi
Organization Yokohama Minami Kyosai Hospital
Division name Ophthalmology
Zip code
Address 1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL 045-782-2101
Email takamed@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Takahiko Hayashi
Organization Yokohama Minami Kyosai Hospital
Division name Opthalmology
Zip code
Address 1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL 0457872101
Homepage URL
Email takamed@gmail.com

Sponsor
Institute Department of Ophthalmology, Yokohama Minami Kyosai Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2017 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
2014 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information None

Management information
Registered date
2017 Year 06 Month 25 Day
Last modified on
2018 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031981

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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