UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of Simulated Keratometry and Total Refractive Power for Keratoconus According to the Stage of Amsler-Krumeich Classification.
Title of the study (Brief title)	Comparison of Simulated Keratometry and Total Refractive Power for Keratoconus
Region	Japan

Condition
Condition	Keratoconus
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the simulated keratometry (Sim K) and the total corneal refractive power (TCRP) in eyes with keratoconus with respect to the Amsler-Krumeich classification.
Basic objectives2	Others
Basic objectives -Others	Correlation of Sim K with the differences between Sim K and TCRP
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the simulated keratometry (Sim K) and the total corneal refractive power (TCRP)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -but assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Corneal tomography
Interventions/Control_2	Corneal tomography
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Keratoconus was diagnosed by one experienced clinician (KK) with evident findings characteristic of keratoconus (e.g., corneal topography with asymmetric bow-tie pattern with or without skewed axes), and at least one keratoconus sign (e.g., stromal thinning, conical protrusion of the cornea at the apex, Fleischer ring, Vogt striae, or anterior stromal scar) on slit-lamp examination.
Key exclusion criteria	Eyes with pellucid marginal degeneration, other corneal diseases, and previous ocular trauma or surgery, were excluded from the study.
Target sample size	100

Research contact person
Name of lead principal investigator	Kazutaka Kamiya
Organization	Kitasato University
Division name	Dept of Opthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Email	kamiyak-tky@umin.ac.jp

Public contact
Name of contact person	Kazutaka Kamiya
Organization	Kitasato University
Division name	Dept of Opthalmology
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL	0427788464
Homepage URL
Email	kamiyak-tky@umin.ac.jp

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 11 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 01 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 11 Month 16 Day
Last modified on	2019 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034266