UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010586
Receipt No. R000012369
Scientific Title Studies on the clinical usefulness of high-resolution optical coherence tomography
Date of disclosure of the study information 2013/04/24
Last modified on 2014/01/07

* 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 Studies on the clinical usefulness of high-resolution optical coherence tomography
Acronym high-resolution optical coherence tomography
Scientific Title Studies on the clinical usefulness of high-resolution optical coherence tomography
Scientific Title:Acronym high-resolution optical coherence tomography
Region
Japan

Condition
Condition patients with retinal disease or glaucoma
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate clinical usefulness of newly developed high-resolution optical coherence tomography in patients with retinal disease and glaucoma
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To measure the resolution of retinal or optic nerve lesions
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 To test a newly developed high-resolution optical coherence tomography in 50 patients
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 patients with retinal disease or glaucoma
Key exclusion criteria patients of age younger than 20 years
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, Mie
TEL 059-231-5027
Email mineo@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mineo Kondo
Organization Mie University Hospital
Division name Ophthalmology
Zip code
Address 2-174 Edobashi, Tsu, Mie, Japan
TEL 059-231-5027
Homepage URL
Email mineo@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Mie University Graduate School of Medicine
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 三重大学病院(三重県)

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 24 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
2013 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 17 Day
Last follow-up date
2013 Year 06 Month 15 Day
Date of closure to data entry
2013 Year 06 Month 15 Day
Date trial data considered complete
2013 Year 06 Month 30 Day
Date analysis concluded
2013 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 04 Month 24 Day
Last modified on
2014 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012369

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.