UMIN-CTR Clinical Trial

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

Recruitment status Terminated
Unique ID issued by UMIN UMIN000014796
Receipt No. R000016155
Scientific Title Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Date of disclosure of the study information 2014/08/08
Last modified on 2019/02/15

* 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 Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Acronym Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Scientific Title Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Scientific Title:Acronym Retrospective study using Ocular Response Analyzer(ORA) to clarify patient's condition of glaucoma
Region
Japan

Condition
Condition Glaucoma, Glaucoma suspect, Cataract
Classification by specialty
Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine corneal biomechanical properties by Ocular Response Analyzer (ORA), and investigate the relationship between intraocular pressure, retinal nerve fiber layer and visual field in glaucoma patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes ・Age
・Gender
・Distant Visual Acuity
・Spherical equivalent(Refractive value)
・Corneal Topography(Corneal radius, Corneal refraction, Corneal astigmatism)
・Intraocular Pressure
・Visual field: Humphrey Field Analyzer
・Thickness of retinal nerve fiber layer
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・Normal eye
・Cataract eye
・Glaucoma eye
・Glaucoma suspect eye
Key exclusion criteria Those patients who underwent ophthalmic operation
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuya Morita
Organization Faculty of Medicine, Kitasato University
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa Japan
TEL 042-778-8464
Email tamosace@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tetsuya Morita
Organization Kitasato University Hospital
Division name Department of Ophthalmology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa Japan
TEL 042-778-8464
Homepage URL
Email tamosace@gmail.com

Sponsor
Institute Department of Ophthalmology,
Kitasato University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kitasato University
Organization
Division
Category of Funding Organization Self funding
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 北里大学病院(神奈川県) Kitasato University Hospital(Kanagawa)

Other administrative information
Date of disclosure of the study information
2014 Year 08 Month 08 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 Terminated
Date of protocol fixation
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cancellation

Management information
Registered date
2014 Year 08 Month 08 Day
Last modified on
2019 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016155


Contact us.