UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023908 |
|---|---|
| Receipt number | R000027459 |
| Scientific Title | Femtosecond laser-assisted intracorneal ring segment implantation(Ferrara Ring) for correction of keratoconus. |
| Date of disclosure of the study information | 2016/09/02 |
| Last modified on | 2018/09/04 09:44:04 |
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Basic information
Public title
Femtosecond laser-assisted intracorneal ring segment implantation(Ferrara Ring) for correction of keratoconus.
Acronym
Femtosecond laser-assisted ICRS for correction of keratoconus.
Scientific Title
Femtosecond laser-assisted intracorneal ring segment implantation(Ferrara Ring) for correction of keratoconus.
Scientific Title:Acronym
Femtosecond laser-assisted ICRS for correction of keratoconus.
Region
| Japan |
Condition
Condition
Keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the effectiveness of the intracorneal ring segment implantation(Ferrara ring).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual acuity
Key secondary outcomes
Corneal topography
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
| Device,equipment |
Interventions/Control_1
We perform femtosecond laser-assisted intracorneal ring segment implantation(Ferrara Ring)to patients.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) The mild to moderate case that had a diagnosis of a conical cornea in Keio University Hospital
2) Case with more than 400 micro metre of penumbra cornea thickness (segment episode)
3) Age: 20 years old or older
4) The case that is available for follow-up after an operation more than one year
5) The patient that the document agreement was provided about the treatment using the cornea segment
Key exclusion criteria
A case not to meet the uptake standard mentioned above.
There is other ophthalmopathy (including cornea herpes, a cataract, the retina disease)
Under the pregnancy
The patient whom the explanation of mental abnormality or the doctor cannot understand
The special occupation that a refraction cure is not permitted
The patient who judged that the medical attendant was inappropriate
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Tsubota |
Organization
Keio university school of medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo-to, Japan
TEL
03-3353-1211
tsubota@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto Shimmura |
Organization
Keio university school of medicine
Division name
Department of Ophthalmology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo-to, Japan
TEL
03-3353-1211
Homepage URL
shige@z8.keio.jp
Sponsor or person
Institute
Keio university school of medicine Department of Ophthalmology
Institute
Department
Personal name
Funding Source
Organization
none
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
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 02 | 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
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 18 | 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
| 2016 | Year | 09 | Month | 02 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027459
