UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011350 |
|---|---|
| Receipt number | R000013299 |
| Scientific Title | Efficaty and safety of corneal collagen cross-linking for keratoconus, keratectasia and infectious keratitis |
| Date of disclosure of the study information | 2013/08/02 |
| Last modified on | 2018/05/19 00:58:47 |
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Basic information
Public title
Efficaty and safety of corneal collagen cross-linking for keratoconus, keratectasia and infectious keratitis
Acronym
Efficacy and safety of CXL for keratoconus and other diseases.
Scientific Title
Efficaty and safety of corneal collagen cross-linking for keratoconus, keratectasia and infectious keratitis
Scientific Title:Acronym
Efficacy and safety of CXL for keratoconus and other diseases.
Region
| Japan |
Condition
Condition
keratoconus
keratectasia
infectious keratitis
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of corneal collagen cross-linking for keratoconus, keratectasia and infectious keratitis
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
visual acuity
refraction
spherical equivalent
endothelial cell density
complication
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
| Medicine | Device,equipment |
Interventions/Control_1
Observation period 1-2 years
Exposure of UVA 3mW/cm2 for 30 minutes
Adminisration of 0.1% ribofravin solution for 30 minutes before UVA exposure and 30 minutes during UVA exposure.
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
| 14 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Progressive keratoconus or keratectasia
Minimum corneal thickness 400 micrometers and more.
Infectious keratitis sized less than 5mm
Key exclusion criteria
Corneal thickness less than 400 micrometers
Unknown infectious keratitis
Other ocular diseases
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Shimazaki |
Organization
Tokyo Dental Collete Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
jun@eyebank.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Konomi |
Organization
Tokyo Dental College Ichikawa General Hospital
Division name
Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba
TEL
047-322-0151
Homepage URL
jzt02060@nifty.ne.jp
Sponsor or person
Institute
Tokyo Dental College Ichikawa General Hospital
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
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
| 2013 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 02 | Day |
Last modified on
| 2018 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013299
