UMIN-CTR Clinical Trial

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