UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002484 |
|---|---|
| Receipt number | R000003046 |
| Scientific Title | New surgical treatment for keratoconus |
| Date of disclosure of the study information | 2009/09/15 |
| Last modified on | 2017/04/12 18:07:20 |
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Basic information
Public title
New surgical treatment for keratoconus
Acronym
New surgical treatment for keratoconus
Scientific Title
New surgical treatment for keratoconus
Scientific Title:Acronym
New surgical treatment for keratoconus
Region
| Japan |
Condition
Condition
keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
New surgical trial for keratoconus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
visual acuity of preoperative and postoperative
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
ICR
Interventions/Control_2
crossrincking
Interventions/Control_3
conduktive keratoplasty
thermal keratoplasty
Interventions/Control_4
PK
Interventions/Control_5
KP
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 9 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
keratoconus and keratoectasia
Key exclusion criteria
severe cornealn opacity, too thin cornea
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Kinoshita |
Organization
Kyoto prefectural Univ.of Med.
Division name
ophthalmology
Zip code
Address
Kamigyo-Ku 465 Kajii Cho, Kyoto
TEL
075-251-5111
shigeruk@koot.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Nakai |
Organization
Kyoto prefectural Univ.of Med.
Division name
ophthalmology
Zip code
Address
465 Kajii-cho, Nakagyouku Kyouto, JAPAN
TEL
0752515578
Homepage URL
yoshinak@koto.kpu-m.ac.jp
Sponsor or person
Institute
Ophthalmology of Kyoto prefectural Univ.of Med.
Institute
Department
Personal name
Funding Source
Organization
Kyoto prefectural Univ.of Med.
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
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | 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
Open public recruiting
Date of protocol fixation
| 2009 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 13 | Day |
Last modified on
| 2017 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003046
