UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040323 |
|---|---|
| Receipt number | R000046011 |
| Scientific Title | Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction. |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/11/06 09:08:10 |
* 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
Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Acronym
Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Scientific Title
Evaluation of Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Scientific Title:Acronym
Cause and Prognosis in Eyes Requiring Implantable Collamer Lens Extraction.
Region
| Japan |
Condition
Condition
myopia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of Implantable Collamer Lens Extraction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative visual acuity, refraction, endothelium, satisfaction
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
| 28 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A case of ICL extraction surgery at Kitasato University Hospital
Key exclusion criteria
nothing
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Syoji |
| Middle name | |
| Last name | Nobuyuki |
Organization
Kitasato Univ Hospital
Division name
opthalmology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
m09088w@st.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Hayakawa |
Organization
Kitasato Univ Hospital
Division name
opthalmology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
0427788464
Homepage URL
m09088w@st.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato Univ Hospital
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
Kitasato Univ Hospital
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
0427788464
m09088w@st.kitasato-u.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
| 2020 | Year | 10 | Month | 15 | 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
7
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
Main results already published
Date of protocol fixation
| 2020 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2020 | Year | 05 | Month | 07 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046011
