UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045886 |
|---|---|
| Receipt number | R000052384 |
| Scientific Title | Examination of postoperative visual function and satisfaction by age for customized corneal cross-linking for progressive keratoconus |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2023/03/31 14:23:44 |
* 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
Examination of postoperative visual function and satisfaction by age for customized corneal cross-linking for progressive keratoconus
Acronym
Examination of postoperative visual function and satisfaction by age for customized corneal cross-linking for progressive keratoconus
Scientific Title
Examination of postoperative visual function and satisfaction by age for customized corneal cross-linking for progressive keratoconus
Scientific Title:Acronym
Examination of postoperative visual function and satisfaction by age for customized corneal cross-linking for progressive keratoconus
Region
| Japan |
Condition
Condition
progressive keratoconus
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
PiXL is performed on keratoconus cases using the Mosaic System, and a comparison is made between the group treated under 20 years old and the group treated over 20 years old
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Corneal power
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 12 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases between the ages of 12 and 50
Cases of corneal astigmatism 1.25D or more
Distance correction Cases in which it can be predicted that visual acuity will be corrected to 1.0 or higher in both eyes.
Key exclusion criteria
History of corneal transplantation, glaucoma surgery, retinal detachment surgery, etc.
There is a systemic disease (a disease that affects the healing of corneal wounds)
During pregnancy and lactation
In addition, when the doctor in charge judges that it is inappropriate
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Gotoda |
Organization
kitasato university hospital
Division name
Ophthalmology
Zip code
252-0329
Address
1-15-1,Kitasato,Minami-ku,Sagamihara-city,Kanagawa prefecture
TEL
0427788111
snothingventurednothinggained@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Gotoda |
Organization
kitasato university hospital
Division name
Ophthalmology
Zip code
252-0329
Address
1-15-1,Kitasato,Minami-ku,Sagamihara-city,Kanagawa prefecture
TEL
0427788111
Homepage URL
snothingventurednothinggained@gmail.com
Sponsor or person
Institute
kitasato university
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Kitasatouniversityhospital
Address
1-15-1,Kitasato,Minami-ku,Sagamihara-city,Kanagawa prefecture
Tel
0427788111
snothingventurednothinggained@gmail.com
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
| 2021 | Year | 11 | 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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052384
