UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029740 |
|---|---|
| Receipt number | R000033936 |
| Scientific Title | Validation of implantable collamer Lens Sizing Method based on Anterior Segment Optical Coherence Tomography using CASIA2 |
| Date of disclosure of the study information | 2017/10/27 |
| Last modified on | 2017/10/27 15:44:52 |
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Basic information
Public title
Validation of implantable collamer Lens Sizing Method based on Anterior Segment Optical Coherence Tomography using CASIA2
Acronym
Validation of ICL Sizing Method based on AS-OCT CASIA2
Scientific Title
Validation of implantable collamer Lens Sizing Method based on Anterior Segment Optical Coherence Tomography using CASIA2
Scientific Title:Acronym
Validation of ICL Sizing Method based on AS-OCT CASIA2
Region
| Japan |
Condition
Condition
Refractive errors
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of a size determination formula using anterior segment optical coherence tomography (OCT) parameters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Vault
Key secondary outcomes
Lens size
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Sizing of ICL by using the parameters of CASIA2
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
Patients who follow the guidelines of the Japanese Ophthalmological Society and undergo this operation at a clinic certified for phakic intraocular lens implantation surgery
Key exclusion criteria
Patients who did not agree with this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Nakamura |
Organization
REC Medical Corporation
Division name
Nagoya Eye Clinic
Zip code
Address
3F, 25-1 Namiyose-cho, Atsuta-ku, Nagoya, 456-0003 Japan
TEL
052-872-0490
nic@bc5.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Nakamura |
Organization
REC Medical Corporation
Division name
Nagoya Eye Clinic
Zip code
Address
3F, 25-1 Namiyose-cho, Atsuta-ku, Nagoya, 456-0003 Japan
TEL
052-872-0490
Homepage URL
nic@bc5.so-net.ne.jp
Sponsor or person
Institute
Nagoya Eye Clinic
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 01 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study was approved by the Institutional Ethics Committee in January 2017. Although this study was started thereafter, it was not registered to UMIN-CTR.
Management information
Registered date
| 2017 | Year | 10 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033936
