UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036230 |
|---|---|
| Receipt number | R000015485 |
| Scientific Title | Regional Differences in Corneal Endothelial Abnormalities |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/03/17 13:30:21 |
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Basic information
Public title
Regional Differences in Corneal Endothelial Abnormalities
Acronym
Regional Differences in Corneal Endothelial Abnormalities
Scientific Title
Regional Differences in Corneal Endothelial Abnormalities
Scientific Title:Acronym
Regional Differences in Corneal Endothelial Abnormalities
Region
| Japan |
Condition
Condition
corneal endotherial disease
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitate the regional corneal differences in an endothelial abnormality in corneal endotherial disease at multiple sites, including the intermediate zone.
Basic objectives2
Others
Basic objectives -Others
retrospective study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
regional corneal differences in an endothelial abnormality
Key secondary outcomes
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
| 39 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fuchs' endothelial corneal dystrophy
Key exclusion criteria
a history of intraocular surgery, contact lens wear, or other corneal diseases.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka University
Division name
Ophthalmology
Zip code
565-0871
Address
Suita Yamadaoka 2-2, Osaka
TEL
06-6879-3456
hisataka.fujimoto@ophthal.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisataka |
| Middle name | |
| Last name | Fujimoto |
Organization
Osaka University
Division name
Ophthalmology
Zip code
565-0871
Address
Suita Yamadaoka 2-2, Osaka
TEL
06-6879-3456
Homepage URL
hisataka.fujimoto@ophthal.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University
Address
Suita Yamadaoka 2-2, Osaka
Tel
06-6879-3456
hisataka.fujimoto@ophthal.med.osaka-u.ac.jp
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
| 2019 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://iovs.arvojournals.org/article.aspx?articleid=2128997
Publication of results
Published
Result
URL related to results and publications
https://iovs.arvojournals.org/article.aspx?articleid=2128997
Number of participants that the trial has enrolled
23
Results
The percentages of the images covered by the abnormal areas were 71% 36% in the center, 68% 35% in the paracentral zone, and 33% 36% in the peripheral zone. The values in the peripheral zone were significantly (P < 0.001) smaller than in the center and paracentral zones.
Results date posted
| 2019 | Year | 03 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Forty-one eyes of 23 patients with Fuchs' endothelial corneal dystrophy
Participant flow
Forty-one eyes of 23 patients with Fuchs' endothelial corneal dystrophy
Adverse events
none
Outcome measures
noncontact specular microscope in the central cornea, the paracentral zone 0.6 mm from the center, and the peripheral zone 3.7 mm peripheral to the center
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Invest Ophthalmol Vis Sci. 2014 Jul 24;55(8):5090-8. doi: 10.1167/iovs.14-14249.
Management information
Registered date
| 2019 | Year | 03 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015485
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
