UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014719 |
|---|---|
| Receipt number | R000017109 |
| Scientific Title | Efficacy and safety of corneal crosslinking using KXL for keratoconic eyes |
| Date of disclosure of the study information | 2014/08/01 |
| Last modified on | 2018/02/01 14:49:26 |
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Basic information
Public title
Efficacy and safety of corneal crosslinking using KXL for keratoconic eyes
Acronym
Corneal crosslinking using KXL
Scientific Title
Efficacy and safety of corneal crosslinking using KXL for keratoconic eyes
Scientific Title:Acronym
Corneal crosslinking using KXL
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 corneal crosslinking using a new protocol (ultraviolet irradiation; 18 mW/cm2 x 5 minutes) with the KXL(R)(Avedro, Inc) for progressing keratoconic eyes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of visual acuity, manifest refraction, keratometric value, and corneal topography
Key secondary outcomes
Decrease of best corrected visual acuity, decrease of endothelial cell counts, and frequency of complications
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
Corneal crosslinking
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
Those who reveal all of following factors;
1. Keratoconus or keartectasia pattern by corneal topography/tomography
2. Thinnest corneal thickness is 400 um or more.
3. Progression of keratoconus in recent 2 years by corneal topography/tomography and/or manifest refraction. Progression of keratectasia after corneal refractive surgery.
4. Age 40 year-old or more.
Key exclusion criteria
Those who reveal one or more of following factors;
1. Thinnest corneal thickness is less than 400 um.
2. Corneal stromal opacity
3. Those who implanted artificial cardiac pacemaker or similar devices.
4. Ocular diseases, such as scar, herpetic infection, or nystagmus.
5. Infectious corneal disorders with unkonwn causes.
6. General diseases that can affect the corneal wound healing
7. Nallow angle, pregnancy, breast feeding
8. Occupation that is not allowed performing corneal refractive surgeries
9. Age less than 14 year-old
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Shimazaki |
Organization
Ichikawa General Hospital, Tokyo Dental College
Division name
Department of 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 | Jun Shimazaki |
Organization
Ichikawa General Hospital, Tokyo Dental College
Division name
Department of Ophthalmology
Zip code
Address
5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL
047-322-0151
Homepage URL
jun@eyebank.or.jp
Sponsor or person
Institute
Department of Ophthalmology, Ichikawa General Hospital, Tokyo Dental College
Institute
Department
Personal name
Funding Source
Organization
Tokyo Dental College
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
| 2014 | Year | 08 | Month | 01 | 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
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 31 | Day |
Last modified on
| 2018 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017109
| 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 |
