UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043630
Receipt number R000049820
Scientific Title Evaluation of visual function after Descemet membrane endothelial keratoplasty
Date of disclosure of the study information 2021/03/16
Last modified on 2021/03/16 16:59:28

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Basic information

Public title

Evaluation of visual function after Descemet membrane endothelial keratoplasty

Acronym

Evaluation of visual function after Descemet membrane endothelial keratoplasty

Scientific Title

Evaluation of visual function after Descemet membrane endothelial keratoplasty

Scientific Title:Acronym

Evaluation of visual function after Descemet membrane endothelial keratoplasty

Region

Japan


Condition

Condition

corneal endothelial cell dysfunction

Classification by specialty

Ophthalmology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of Descemet membrane endothelial keratoplasty

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Corneal endothelial cell count

Key secondary outcomes

visual acuity, corneal topography


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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cases after Descemet membrane endothelial keratoplasty

Key exclusion criteria

glaucome, retinal disease, systemic disease

Target sample size

2


Research contact person

Name of lead principal investigator

1st name Kenichiro
Middle name
Last name Yamazaki

Organization

Omiya Nanasato Eye Institute

Division name

Department of Ophthalmology

Zip code

3370017

Address

678-1, Futtono, Minuma Ward, Saitama City, Saitama Prefecture

TEL

0486867000

Email

karamawari@msn.com


Public contact

Name of contact person

1st name Kenichiro
Middle name
Last name Yamazaki

Organization

Omiya Nanasato Eye Institute

Division name

Department of Ophthalmology

Zip code

3370017

Address

678-1, Futtono, Minuma Ward, Saitama City, Saitama Prefecture

TEL

0486867000

Homepage URL


Email

karamawari@msn.com


Sponsor or person

Institute

Omiya Nanasato Eye Institute

Institute

Department

Personal name



Funding Source

Organization

Omiya Nanasato Eye Institute

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

Omiya Nanasato Eye Institute

Address

678-1, Futtono, Minuma Ward, Saitama City, Saitama Prefecture

Tel

0486867000

Email

karamawari@msn.com


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

2021 Year 03 Month 16 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

1

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

No longer recruiting

Date of protocol fixation

2019 Year 12 Month 02 Day

Date of IRB

2019 Year 12 Month 15 Day

Anticipated trial start date

2020 Year 01 Month 20 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observation of visual funstion and complication after Descemet membrane endothelial keratoplasty


Management information

Registered date

2021 Year 03 Month 16 Day

Last modified on

2021 Year 03 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049820


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name