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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036230
Receipt No. 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

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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
Email 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
Email hisataka.fujimoto@ophthal.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015485

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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