UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030005 |
|---|---|
| Receipt number | 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 09:09:30 |
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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
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
kamiyak-tky@umin.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034266
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
