UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031967 |
|---|---|
| Receipt number | R000036500 |
| Scientific Title | Investigation of usefulness of high speed crosslinking |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/02/25 13:57:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of usefulness of high speed crosslinking
Acronym
Investigation of usefulness of high speed crosslinking
Scientific Title
Investigation of usefulness of high speed crosslinking
Scientific Title:Acronym
Investigation of usefulness of high speed crosslinking
Region
| Japan |
Condition
Condition
Keratoconus, Percussive corneal degeneration, Keratectasia, Infective keratitis, Bullous keratopathy, Refractive abnormality
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effectiveness and safety of high speed crosslinking
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vision, intraocular pressure, corneal refractive power, corneal thickness, complications
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
Prevention of disease progression by collagen crosslinking to the cornea.
After instillation of Paracel 2 (0.22% riboflavin, physiological saline), Ultraviolet rays with a wavelength of 365 nm are irradiated.
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
Progressive keratoconus, Percussive corneal degeneration, Keratectasia, Infectious keratitis, Bullous keratopathy, Refractive abnormality
Key exclusion criteria
Those who satisfy at least one of the following conditions
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunori Miyata |
Organization
Miyata Eye Hospital
Division name
Ophthalmology Department
Zip code
Address
6-3 Kurahara-cho, Miyakonojo-shi, Miyazaki
TEL
0986221441
miyata@miyata-med.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosai Mori |
Organization
Miyata Eye Hospital
Division name
Ophthalmology Department
Zip code
Address
6-3 Kurahara-cho, Miyakonojo-shi, Miyazaki
TEL
0986221441
Homepage URL
mori@miyata-med.ne.jp
Sponsor or person
Institute
Miyata Eye Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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 | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036500
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
