UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014242
Receipt number R000016591
Scientific Title Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy
Date of disclosure of the study information 2014/06/12
Last modified on 2016/06/12 13:48:13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy

Acronym

Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy

Scientific Title

Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy

Scientific Title:Acronym

Clinical study of Descemet membrane endothelial keratoplasty (DMEK) for patients with bullous keratopathy

Region

Japan


Condition

Condition

Bullous keratopathy

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 (DMEK) for patients with bullous keratopathy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

corneal thickness after surgery

Key secondary outcomes

visual acuity, survival of the graft, corneal endothelial cell density, success in DMEK graft preparation, success in the graft transplantation, complication


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Descemet membrane endothelial keratoplasty

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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Bullous keratopathy patients who are indicated for Endothelial Keratoplasty in Osaka University Hospital
2)Aged 20 years old and over
3)Written informed consent

Key exclusion criteria

1)Bullous keratopathy patients who are not indicated for Endothelial Keratoplasty
2)Those who have been decided not appropriate for enrollment by the principal investigator.
3)Patients of less than 6 months follow-up period.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kohji Nishida

Organization

Osaka University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3451

Email

knishida@ophthal.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Soma

Organization

Osaka University Graduate School of Medicine

Division name

Department of Ophthalmology

Zip code


Address

2-2 Yamadaoka, Suita, Osaka 565-0871, Japan

TEL

06-6879-3456

Homepage URL


Email

soma@ophthal.med.osaka-u.ac.jp


Sponsor or person

Institute

Department of Ophthalmology, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


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

大阪大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2014 Year 06 Month 12 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

2014 Year 06 Month 09 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 06 Month 12 Day

Last modified on

2016 Year 06 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016591


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name