UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041287 |
|---|---|
| Receipt number | R000046187 |
| Scientific Title | Comparison of Phakic Intraocular Lens Vault Using Conventional Nomogram and Predicting Formulas |
| Date of disclosure of the study information | 2020/09/10 |
| Last modified on | 2021/02/04 08:34:36 |
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Basic information
Public title
Comparison of Phakic Intraocular Lens Vault Using Conventional Nomogram and Predicting Formulas
Acronym
Comparison of Phakic Intraocular Lens Vault Using Conventional Nomogram and Predicting Formulas
Scientific Title
Comparison of Phakic Intraocular Lens Vault Using Conventional Nomogram and Predicting Formulas
Scientific Title:Acronym
Comparison of Phakic Intraocular Lens Vault Using Conventional Nomogram and Predicting Formulas
Region
| Japan |
Condition
Condition
refractive error
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the achieved vault using the manufacturer's nomogram,and the predicted vault using the currently available predicting formulas,after posterior chamber phakic intraocular lens (Visian ICL) implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At 3 months postoperatively, we quantitatively measured the actual vault, and compared it with the predicted vault at NK and KS formulas.
Key secondary outcomes
We examine the matching rate of the optimal size of OCOS,Nk formula,KS formula.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases without ophthalmological diseases other than refractive error
Key exclusion criteria
Cases with ophthalmological diseases other than refractive error
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | kazutaka |
| Middle name | |
| Last name | kamiya |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
2520375
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
042-778-8111
kamiyak-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | wakako |
| Middle name | |
| Last name | ando |
Organization
Kitasato University Hospital
Division name
Ophthalmology
Zip code
2520375
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
wakako@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University 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
Kitasato University Hospital
Address
1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
Tel
042-778-8273
rinrib@med.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 | 09 | Month | 10 | 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
100
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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study (case-control study).
The subject was a patient who underwent ICL insertion surgery at our hospital from October 1, 2017 to April 30, 2020.
Evaluation items are ophthalmological examination values (vault value, visual acuity, subjective refractive power, intraocular pressure) and medical information.
Management information
Registered date
| 2020 | Year | 08 | Month | 03 | Day |
Last modified on
| 2021 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046187
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
