UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027923
Receipt number 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 12:01:18

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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 or person

Institute

Department of Ophthalmology, Yokohama Minami Kyosai Hospital

Institute

Department

Personal name



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

Value
https://center6.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