UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016217 |
|---|---|
| Receipt number | 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 15:51:21 |
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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
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
syamagami-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016959
