UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of visual function in glaucoma
Title of the study (Brief title)	Evaluation of visual function in glaucoma
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the influence that visual field loss gives to the daily visual function in glaucoma patients using functional visual acuity
Basic objectives2	Others
Basic objectives -Others	Evaluation of visual performance
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of visual acuity, functional visual acuity and perimetry
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with 20/20 vision or more 2) Patients conducted high reliable examination measured by the Humphrey Visual Field Testing Instrument
Key exclusion criteria	1) Patients with disorder affected functional visual acuity
Target sample size	45

Research contact person
Name of lead principal investigator	Yoshitaka Tasaka
Organization	Minami-matsuyama Hospital
Division name	Ophthalmology
Address	1-3-10 Asoda-cho, Matsuyama, Ehime
TEL	089-941-8255
Email	tasaka@m.ehime-u.ac.jp

Public contact
Name of contact person	Tomoyuki Kamao
Organization	Ehime University
Division name	Ophthalmology
Address	Shitsukawa, Ton-city, Ehime
TEL	089-960-5361
Homepage URL
Email	t-kamao@m.ehime-u.ac.jp

Sponsor
Institute	Department of Ophthalmology, Ehime University Graduate School of Medicine
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	None
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	南松山病院（愛媛県） Minami-matsuyama Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 30 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date	2015 Year 05 Month 31 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	case series All patients were examined who meet the selection criteria at Minami-matsuyama Hospital from February 2015 to March 2015. To compare visual acuity, functional visual acuity and perimetry of paracentral scotoma, non-paracentral scotoma and control group.

Management information
Registered date	2016 Year 05 Month 31 Day
Last modified on	2016 Year 05 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025997