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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011492
Receipt No. 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

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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
Email 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
Email fwic7788@mb.infoweb.ne.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013447

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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