UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of macular microcircular alteration induced by glaucoma topical drugs using high resolution scannning LASER ophthalmoscope (SLO)
Title of the study (Brief title)	Evaluation of macular microcircular alteration induced by glaucoma topical drugs using high resolution scannning LASER ophthalmoscope (SLO)
Region	Japan

Condition
Condition	patients with: glaucoma ocular hypertension
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy of high resolution scannning LASER ophthalmoscope (SLO) in detecting macular blood flow alteration induced by glaucoma topical drugs. To assess the correlation among retinal blood flow parameters determined by high resolution SLO, laser speckle flowgraphy (LSFG), and optical coherence tomography (OCT).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood flow rate in macular capillaries before and at 7days, 1 and 3months after starting topical anti-glaucoma medications
Key secondary outcomes	Diameter of macular capillaries before and at 7days, 1 and 3months after starting topical anti-glaucoma medications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
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 take images of the human ocular fundus using scannning LASER ophthalmoscope (SLO), laser speckle flowgraphy (LSFG), and optical coherence tomography (OCT) before and at 7days, 1 and 3months after starting topical anti-glaucoma medications.
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 1) Male or female older than 20 years-old 2) patients with glaucoma or ocular hypertension 3) Subjects who sign an informed consent form to participate in the clinical study
Key exclusion criteria	1) Having any side-effects (hypersensitivity, rised intraocular pressure etc.) against mydriatics 2) Revealed narrow angle by slit-lamp examination 3) When a doctor accepted the middle-class above-mentioned cataract 4) Subjects who a doctor in attendance declares ineligible for any reason
Target sample size	160

Research contact person
Name of lead principal investigator	Nagahisa Yoshimura
Organization	Kyoto University Graduate School of Medicine
Division name	Ophthalmology & Visual Sciences
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL	+81-75-751-3248
Email	eye@med.kyoto-u.ac.jp

Public contact
Name of contact person	Hideo Nakanishi
Organization	Kyoto University Graduate School of Medicine
Division name	Ophthalmology & Visual Sciences
Address	54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL	+81-75-751-3248
Homepage URL
Email	eye@med.kyoto-u.ac.jp

Sponsor
Institute	Department of Ophthalmology & Visual Sciences, Kyoto University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	CANON INC.
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

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 09 Month 25 Day
Anticipated trial start date	2014 Year 10 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2016 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 25 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017450