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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041287
Receipt No. 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 2020/08/03

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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
Email 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
Email wakako@kitasato-u.ac.jp

Sponsor
Institute Kitasato University Hospital
Institute
Department

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
Email 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 No longer recruiting
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
2020 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046187

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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