UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011492 |
|---|---|
| Receipt number | R000013447 |
| Scientific Title | Safety and efficacy of accelerated corneal crosslinking for progressive keratoconus |
| Date of disclosure of the study information | 2013/08/15 |
| Last modified on | 2016/02/21 19:54:10 |
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Basic information
Public title
Safety and efficacy of accelerated corneal crosslinking for progressive keratoconus
Acronym
Accelerated corneal crosslinking for keratoconus
Scientific Title
Safety and efficacy of accelerated corneal crosslinking for progressive keratoconus
Scientific Title:Acronym
Accelerated corneal crosslinking for keratoconus
Region
| Japan |
Condition
Condition
Keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of accelerated corneal crosslinking using KXL for progressing keratoconus
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity, manifest refraction, keratometric value, corneal endothelial cell number
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
Accelerated 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
1. Patients with keratoconus
2. Keratoconus is progressing within recent 2 years.
2. The thinnest corneal thickness must be more than 400 micrometer
Key exclusion criteria
1. Thinnest corneal thickness is less than 400 micrometer.
2. Those who are implanted cardiac pacemaker, or other medical devices.
3. Non-progressing keratoconus
4. Those who had other ophthalmic disorders.
5. Those who had general disorders that may impede corneal wound healing
6. In pregnancy, or presently breastfeeding
7. Occupation not allowed corneal refractive surgeries
8. Age less than 14 years-old
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-0149
fwic7788@mb.infoweb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuno Negishi |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
Address
Shinanomachi 25, Shinjuku-ku, Tokyo
TEL
03-3353-0149
Homepage URL
fwic7788@mb.infoweb.ne.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Atworking KK.
Organization
Division
Category of Funding Organization
Profit organization
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 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 21 | 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
| 2013 | Year | 08 | Month | 15 | Day |
Last modified on
| 2016 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013447
