UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Acronym	Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Scientific Title	Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Scientific Title:Acronym	Comparison of ocular biometry measurements using ANTERION, IOLMaster 700, and CASIA2
Region	Japan

Condition
Condition	Patients before cataract surgery and patients before refraction correction
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Anterion, IOLMaster 700, and CASIA2 are measured for patients undergoing pre-cataract and pre-refraction surgery tests, and biometric values are compared.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	keratometry, corneal astigmatism, corneal thickness, axial length, anterior chamber depth, corneal thickness, and lens thickness, corneal diameter
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients before cataract surgery and patients before refraction correction
Key exclusion criteria	Eyes with any history of ocular surgery, ocular trauma, or other concomitant eye diseases, and eyes developing any intraoperative or postoperative complications
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Kazutaka Middle name Last name Kamiya
Organization	Kitasato university Hospital
Division name	Ophthalmology
Zip code	2520375
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788111
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	1st name Rina Middle name Last name Ogawa
Organization	Kitasato university Hospital
Division name	Ophthalmology
Zip code	2520375
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788429
Homepage URL
Email	rina-o@umin.ac.jp

Sponsor
Institute	Kitasato university Hospital
Institute
Department

Funding Source
Organization	Kitasato university Hospital
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	0427788111
Email	kamiyak-tky@umin.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	北里大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2021 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	200
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	2021 Year 09 Month 30 Day
Date of IRB	2021 Year 09 Month 29 Day
Anticipated trial start date	2021 Year 09 Month 30 Day
Last follow-up date	2021 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The average corneal refractive power, corneal astigmatism, corneal thickness, axial length, anterior chamber depth, lens thickness, and corneal diameter are measured and compared between models.

Management information
Registered date	2021 Year 09 Month 30 Day
Last modified on	2022 Year 04 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052073