UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046187