UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027136
Receipt No. R000031093
Scientific Title Measurement of cyclodeviation using SD-OCT
Date of disclosure of the study information 2017/06/01
Last modified on 2017/04/26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Measurement of cyclodeviation using SD-OCT
Acronym Measurement of cyclodeviation using SD-OCT
Scientific Title Measurement of cyclodeviation using SD-OCT
Scientific Title:Acronym Measurement of cyclodeviation using SD-OCT
Region
Japan

Condition
Condition Normal volunteers
Cyclotropia
Classification by specialty
Ophthalmology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy of OCT for measurement of
objective cyclodeviation in normal volunteer, patients with cataract and cyclotropia.
Basic objectives2 Others
Basic objectives -Others Changes of objective cyclodeviation before and after ophthalmologic procedures
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes objective cyclodeviation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Objective cyclodeviation is measured by OCT in
normal volunteers and patients with cataract and cyclotropia before and after procedures.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Normal volunteers
Patients with Cataract: best corrected visual acuity >0.6
Patients with cyclotropia: best corrected visual acuity >0.6
Key exclusion criteria Patients received any ophthalmological surgeries within 6 months before this study.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumi Gomi
Organization Hyogo College of Medicine
Division name Ophthalmology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL 0798-45-6462
Email fgomi@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroto Ishikawa
Organization Hyogo College of Medicine
Division name Ophthalmology
Zip code
Address 1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan 663-8501
TEL 0798-45-6462
Homepage URL
Email ohmyeye@hyo-med.ac.jp

Sponsor
Institute Department of Ophthalmology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization None
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 兵庫医科大学病院 眼科

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 06 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 04 Month 26 Day
Last modified on
2017 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.