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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016217
Receipt No. R000016959
Scientific Title Clinical trial of Descemet's membrane removal in Fuchs corneal endothelial dystrophy
Date of disclosure of the study information 2015/01/15
Last modified on 2015/01/15

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Basic information
Public title Clinical trial of Descemet's membrane removal in Fuchs corneal endothelial dystrophy
Acronym Descemet's membrane removal in Fuchs corneal endothelial dystrophy
Scientific Title Clinical trial of Descemet's membrane removal in Fuchs corneal endothelial dystrophy
Scientific Title:Acronym Descemet's membrane removal in Fuchs corneal endothelial dystrophy
Region
Japan

Condition
Condition Fuchs corneal endothelial dystrophy
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In eyes of Fuchs corneal endothelial dystrophy with central corneal edema and opacity, we evaluate postoperative visual acuity and corneal opacity/edema after central Descemet membrane removal.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Corrected visual acuity
Key secondary outcomes corneal thickness, corneal endothelial cell density, intraocular pressure, corneal stromal opacity

Base
Study type

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 Removal of Descemet membrane
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) Patients diagnosed as Fuchs corneal endothelial dystrophy
2) Corneal opacity and edema limited to corneal central area
3) Less than 500mm2 or uncountable corneal endothelial density
4) Corrected visual acuity is equal to or less than 16/20
5) Intra-ocular pressure is equal to or 21mmHg
Key exclusion criteria 1) Inappropriate patient based on screening tests
2) Uncontrolable dry eye
3) Corneas or conjunctivae with active bacterial, fungal or virus infection
4) Corneas with corneal epithelial or stromal diseases
5) Glaucomatous eyes treated with anti-glaucoma eye drops
6) Eyes with cataract affecting visual acuity
7) Patients within 1 month after cataract surgery
8) Eyes with macular disease
9) Patients with hypersensitivity to antibiotics and corticosteroid hormone
10) Patients with expecting mother or possible pregnancy
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoru Yamagami
Organization Tokyo University Hospital
Division name Corneal transplantation section
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL 03-5800-5109
Email syamagami-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoru Yamagami
Organization Tokyo University Hospital
Division name Corneal transplantation section
Zip code
Address Hongo 7-3-1, Bunkyo-ku, Tokyo
TEL 03-5800-5109
Homepage URL
Email syamagami-tky@umin.ac.jp

Sponsor
Institute Tokyo University Hospital
Institute
Department

Funding Source
Organization Corneal transplantation section
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Ophthalmology, Tokyo University Hospital
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 東京大学医学部附属病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 01 Month 15 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 Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 31 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 09 Month 30 Day
Date trial data considered complete
2019 Year 09 Month 30 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 01 Month 15 Day
Last modified on
2015 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016959

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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