UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000886 |
|---|---|
| Receipt number | R000001069 |
| Scientific Title | Evaluation of efficacy and safety of conductive keratoplasty for keratoconus |
| Date of disclosure of the study information | 2007/12/01 |
| Last modified on | 2009/12/28 11:24:47 |
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Basic information
Public title
Evaluation of efficacy and safety of conductive keratoplasty for keratoconus
Acronym
Efficacy and safety of CK for keratoconus
Scientific Title
Evaluation of efficacy and safety of conductive keratoplasty for keratoconus
Scientific Title:Acronym
Efficacy and safety of CK for keratoconus
Region
| Japan |
Condition
Condition
Keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess efficacy and safety of conductive keratoplasty on keratoconuc cornea.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy will be evaluated by visual acuity, refraction, corneal curvature, and corneal topography. Safety will be evaluated by assessing corneal endothelial cell count and frequency of other ocular complications.
Key secondary outcomes
Base
Study type
Interventional
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
Improvement of corneal shape by collagen shrinkage of corneal stroma using radio-wave
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed as keratoconus, which requires keratoplasty
Key exclusion criteria
Those who implanted medical instruments, such as pacemaker
Those who have ocular diseases, such as infection, corneal scar, herpetic keratitis, and/or nystagmus
Those who have systemic diseases affecting corneal wound healing
Those who have eyes with narrow angle
Pregnant or breast-feeding women
Occupation, by which refractive surgery is not arrowed.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuko Toda |
Organization
Minamiaoyama Eye Clinic
Division name
Ophthalmology
Zip code
Address
Minamiaoyama 2-27-25, Minato-ku, Tokyo
TEL
03-5772-1440
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Minamiaoyama Eye Clinic
Division name
Data analysis
Zip code
Address
Minamiaoyama 2-27-25, Minato-ku, Tokyo
TEL
03-5772-1440
Homepage URL
Sponsor or person
Institute
Minamiaoyama Eye Clinic
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Ophthalmology, Keio University, School of Medicine
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
| 2007 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2007 | Year | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 13 | Day |
Last modified on
| 2009 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001069
