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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027586
Receipt No. R000031619
Scientific Title A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK)
Date of disclosure of the study information 2017/06/01
Last modified on 2018/12/02

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Basic information
Public title A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK)
Acronym A prospective study of Descemet membrane endothelial keratoplasty (DMEK)
Scientific Title A prospective study of the outcomes of Descemet membrane endothelial keratoplasty (DMEK)
Scientific Title:Acronym A prospective study of Descemet membrane endothelial keratoplasty (DMEK)
Region
Japan

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

Objectives
Narrative objectives1 Descemet membrane endothelial keratoplasty
(DMEK) involving transplantation of only one layer of the endothelium and the thin Descemet membrane, results in quick and excellent improvement in postoperative visual acuity due to less irregularity on the anterior and posterior surfaces of the cornea, and to the very low incidence of post-operative graft rejection. Many ophthalmologists in Europe and the United States have started to perform DMEK in patients with Fuchs corneal endothelial dystrophy. However, it is thought to be a difficult procedure for Asian eyes, which tend to have a shorter axial length, narrower anterior chamber, darkly colored iris, and more advanced corneal edema resulting from various etiologies of bullous keratopathy, compared to Caucasian eyes. A prospective study of the efficacy of DMEK in Asian eye is necessary. BBG 250 (BBG; Sigma-Aldrich, St. Louis, MO, USA) was dissolved in balanced saline solution (BSS or BSS-plus; Alcon, Osaka, Japan) to 0.1% (w/v). All grafts were peeled as described previously. BBG (0.1%, w/v) was used to stain the graft edges during peeling. The donor membrane graft stained with 0.1% (w/v) BBG (1.0 mg/ml) was placed into an intraocular lens injector (model WJ-60M 1 or 2; Santen Pharmaceuticals, Osaka, Japan) and inserted into the anterior chamber. After the donor graft disc was loaded on an intraocular lens inserter (WJ-60M;Santen) with a small amount of OVD(Opegan; Santen) between the graft and the tip of the plunger
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Visual acuity(logMAR),Endothelial Cell Density(ECD), Central Corneal Thickness(CCT),High-order Abberattions(HOAs), and VFQ-25 were assessed preoperatively, and at1,3, 6 months, 1, 2, 3, 4, and 5 years postoperatively.
Key secondary outcomes Central retinal thickness, Cystoid macula edema(CME), posteior synechia, iris abnormality, operative time, graft unfolding timewere assessed preoperatively, and at1,3, 6 months, 1, 2, 3, 4, and 5 years postoperatively.

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 Bullous keratopathy, Fuchs endothelial dystrophy, pseudo-exfoliation syndrome, birth injury, corneal endothelitis, eye with low corneal endothelial cell density, because of unknown factors
Key exclusion criteria patient who dont agree with the research
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takahiko Hayashi
Organization Yokohama Minami Kyosai Hospital
Division name Department of Ophthalmology
Zip code
Address 1-21-1 Mutuurahigashi, kanazawa-ku, Yokohama, kanagawa, Japan
TEL +81457872101
Email htakahiko-aikou@unim.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takahiko Hayashi
Organization Yokohama Minami Kyosai Hospital
Division name Department of Ophthalmology
Zip code
Address 1-21-1 Mutuurahigashi, kanazawa-ku, Yokohama, kanagawa, Japan
TEL 81457872101
Homepage URL
Email htakahiko-aikou@umin.ac.jp

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

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications https://journals.lww.com/corneajrnl/Abstract/2018/09000/Double_Bubble_Technique_in_Descemet_Membrane
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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 09 Month 30 Day

Other
Other related information Prospective, observatiol study

Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2018 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031619

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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