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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013744
Receipt No. R000016041
Scientific Title Corneal Crosslinking for keratoconus/keratectasia
Date of disclosure of the study information 2014/04/17
Last modified on 2017/10/19

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Basic information
Public title Corneal Crosslinking for keratoconus/keratectasia
Acronym Corneal Crosslinking for keratoconus
Scientific Title Corneal Crosslinking for keratoconus/keratectasia
Scientific Title:Acronym Corneal Crosslinking for keratoconus
Region
Japan

Condition
Condition Keratoconus/keratectasia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety for corneal crosslinking for keratoconus/keratectasia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual acuity, manifest refraction, keratometric readings, corneal thickness
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 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. Increase in Steepest K-value more than 1.0D
2. Increase in manifest cylinder more than 1.0D
3. Increase in manifest spherical equivalent more than 1.0D
4. Decrease of base curve of the back surface of best-fitted hard contact lens more than 1.0D
One of the above conditions was shown within recent 24 months

and
the thinnest corneal thickness is 400 um or more.
Key exclusion criteria The corneal thickness is less than 400 um
Those who is implanted cardiac pacemaker, or other medical devices
Non of the conditions below are observed;
1 Increase in Steepest K-value more than 1.0D
2 Increase in manifest cylinder more than 1.0D
3 Increase in manifest spherical equivalent more than 1.0D
4 Decrease of base curve of the back surface of best-fitted hard contact lens more than 1.0D
Those who have ocular disorders, such as infections, scars, ocular herpes, nystagmus etc.
those who have general diseases that can affect the corneal wound healing
Narrow angle
Those who is in pregnancy or breast-feeding
Occupations that are not allowed to undergo refractive surgeries
Age less than 14 year-old
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Kawakita
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Email keio.eye.research.sec@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoko Kato
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211
Homepage URL
Email nkato@ndmc.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Keio University School of Medicine
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
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
2014 Year 04 Month 17 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
2012 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 25 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 04 Month 17 Day
Last modified on
2017 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016041

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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