UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040322 |
|---|---|
| Receipt number | R000046010 |
| Scientific Title | Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/05/07 18:01:49 |
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Basic information
Public title
Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Acronym
Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Scientific Title
Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Scientific Title:Acronym
Clinical Outcomes of Customized Corneal Cross-linking According to Cone Shape
Region
| Japan |
Condition
Condition
Keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Customized CXL for advanced keratoconus was performed in 57 cases, 80 eyes by Cone shape (24 nipple type, 28 oval type,
globus type 28 eyes), and changes in visual acuity, refraction, corneal refractive power, and satisfaction (VAS) in each group were examined before and after 3 months after surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in visual acuity, refraction, corneal refractive power, and satisfaction (VAS) in each group 3 months before and after surgery
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Progression keratoconus
Key exclusion criteria
none
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shouji |
| Middle name | |
| Last name | Nobuyuki |
Organization
Kitasato Univ.
Division name
Ophthalmology
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
0427788111
masatakahashi-ktz@umin.ac.jp
Public contact
Name of contact person
| 1st name | masahide |
| Middle name | |
| Last name | takahasi |
Organization
Kitasato Univ.
Division name
Ophthalmology
Zip code
2520374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
TEL
0427788111
Homepage URL
masatakahashi-ktz@umin.ac.jp
Sponsor or person
Institute
Kitasato Univ.
Institute
Department
Personal name
Funding Source
Organization
Kitasato Univ.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine
Address
1-15-1 Kitasato, Minami-ku, Sagamihara-shi, Kanagawa
Tel
0427788111
masatakahashi-ktz@umin.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
| 2020 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046010
| Research Plan | |
|---|---|
| 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 |
