UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031829 |
|---|---|
| Receipt number | 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 10:41:51 |
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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
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
himon@hotmail.co.jp
Sponsor or person
Institute
Minamiaoyama Eye Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035873
