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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031829
Receipt No. R000035873
Scientific Title Efficacy and Safety of minimally invasive corneal cross linking: KeraVio study
Date of disclosure of the study information 2018/03/25
Last modified on 2020/01/06

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Basic information
Public title Efficacy and Safety of minimally invasive corneal cross linking: KeraVio study
Acronym KeraVio study
Scientific Title Efficacy and Safety of minimally invasive corneal cross linking: KeraVio study
Scientific Title:Acronym KeraVio study
Region
Japan

Condition
Condition Keratoconus and other corneal ectasia
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of novel technique of corneal cross-linking: KeraVio for prevention of progression in corneal ectasia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Kmax, thinnest corneal thickness
2. Axial length
3. Best corrected visual acuity
4. Uncorrected visual acuity
5. Manifest refractive spherical equivalent
6. Manifest cylinder refraction

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Violet light glass
Interventions/Control_2 Riboflavin drops
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
1 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria We defined the progression of corneal ectasia over the preceding 12 months as the following criteria.

1. an increase of at least 1.00 diopter (D) in the steepest keratometry
2. an increase of at least 1.00 D in the manifest refraction and manifest refractive spherical equivalent
- a degradation
3. an decrease of at least 0.1 mm in base curve of hard contact lens
Key exclusion criteria 1. Thinnest corneal thickness < 300 micron
2. Present medication of Psoralen
3. History of photodermatosis
4. History of epilepsy
5. History of fluorescein induced allergy
6. Cases with possibly undergoing keratoplasty during the observation period
7. Cases considered as inappropriate by physicians
8. Cases offering the stop of the treatment
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hidenaga
Middle name
Last name Kobashi
Organization Minamiaoyama Eye Clinic
Division name Department of Ophthalmology
Zip code 1070061
Address 3-3-11 Kitaaoyama, Minato, Tokyo, Japan
TEL 03-5772-1451
Email himon@hotmail.co.jp

Public contact
Name of contact person
1st name Hidenaga
Middle name
Last name Kobashi
Organization Minamiaoyama Eye Clinic
Division name Department of Ophthalmology
Zip code 1070061
Address 3-3-11 Kitaaoyama, Minato, Tokyo, Japan
TEL 03-5772-1451
Homepage URL
Email himon@hotmail.co.jp

Sponsor
Institute Minamiaoyama Eye Clinic
Institute
Department

Funding Source
Organization n/a
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Certified Review Board of Keio
Address 35 Shinanomachi, Shinjuku ku, Tokyo
Tel 03 5363 3503
Email med nintei jimu@adst.keio.ac.jp

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
2018 Year 03 Month 25 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 20
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
2018 Year 03 Month 03 Day
Date of IRB
2019 Year 03 Month 06 Day
Anticipated trial start date
2018 Year 03 Month 21 Day
Last follow-up date
2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 03 Month 21 Day
Last modified on
2020 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035873

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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