UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective cohort study about visiual function before and after Endothelial Keratoplasty using NEI VFQ-25 subscale score
Title of the study (Brief title)	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	Takahiko Hayashi
Organization	Yokohama Minami Kyosai Hospital
Division name	Ophthalmology
Address	1-21-1, Mutsuura-Higashi, Kanazawa-ku, Yokohama, Kanagawa
TEL	045-782-2101
Email	takamed@gmail.com

Public contact
Name of contact person	Takahiko Hayashi
Organization	Yokohama Minami Kyosai Hospital
Division name	Opthalmology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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