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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033372
Receipt No. R000038044
Official scientific title of the study Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Date of disclosure of the study information 2018/07/12
Last modified on 2018/07/12

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Basic information
Official scientific title of the study Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Title of the study (Brief title) Prediction of spectacle-corrected visual acuity of keratoconus eye using anterior eye OCT
Region
Japan

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

Objectives
Narrative objectives1 To predict potential spectacle-corrected visual acuity of keratoconus patient's corneal shape.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual acuity of keratoconus eye will be predicted by the anterior eye OCT(optical coherence tomography, OCT)parameter. Multiple regression analysis will be used for statistical analysis method, spectacle-corrected visual acuity is for dependent variable, anterior eye OCT parameter is for explanatory variable to analyze. Prediction accuracy will be assessed in other group.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patient with anterior OCT test result and diagnosed as keratoconus by corneal specialist.
Key exclusion criteria Patient with other eye disease which may affect visual acuity (cataract, glaucoma, diabetic retinopathy, etc.), or patient with weak eyesight.
Target sample size 200

Research contact person
Name of lead principal investigator Yuri Esaka
Organization JCHO Chukyo Hospital
Division name Opthalmology
Address 1-1-10 Sanjo Minami-ku, Nagoya, Aichi
TEL 0120-758-0490
Email esaka@chukyogroup.jp

Public contact
Name of contact person Kazuo Ichikawa
Organization Chukyo Eye Clinic
Division name Color Vision Research Institute
Address 12-22 Sanbonmatsu, Atsuta-ku, Nagoya-shi, Aichi
TEL 052-884-7976
Homepage URL
Email ichikawa@chukyogroup.jp

Sponsor
Institute Chukyo Eye Clinic
Institute
Department

Funding Source
Organization non
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 岐阜赤十字病院(岐阜県)、名古屋アイクリニック(愛知県)

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 12 Day

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 10 Month 01 Day
Anticipated trial start date
2016 Year 11 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 Partially published
URL releasing results
Results
Other related information Visual acuity of keratoconus eye will be predicted by the anterior eye OCT(optical coherence tomography, OCT)parameter. Multiple regression analysis will be used for statistical analysis method, spectacle-corrected visual acuity is for dependent variable, anterior eye OCT parameter is for explanatory variable to analyze. Prediction accuracy will be assessed in other group.

Management information
Registered date
2018 Year 07 Month 12 Day
Last modified on
2018 Year 07 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038044

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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