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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030005
Receipt No. R000034266
Scientific Title Comparison of Simulated Keratometry and Total Refractive Power for Keratoconus According to the Stage of Amsler-Krumeich Classification.
Date of disclosure of the study information 2017/11/16
Last modified on 2019/01/29

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Basic information
Public title Comparison of Simulated Keratometry and Total Refractive Power for Keratoconus According to the Stage of Amsler-Krumeich Classification.
Acronym Comparison of Simulated Keratometry and Total Refractive Power for Keratoconus
Scientific Title Comparison of Simulated Keratometry and Total Refractive Power for Keratoconus According to the Stage of Amsler-Krumeich Classification.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name Dept of Opthalmology
Zip code
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa
TEL 0427788464
Email kamiyak-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Kamiya
Organization Kitasato University
Division name Dept of Opthalmology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2016 Year 01 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000034266

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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