UMIN-CTR Clinical Trial

Basic information
Public title	A prospective observational study of structure and visual field progression in open-angle glaucoma
Acronym	A prospective observational study of structure and visual field progression in open-angle glaucoma
Scientific Title	A prospective observational study of structure and visual field progression in open-angle glaucoma
Scientific Title:Acronym	A prospective observational study of structure and visual field progression in open-angle glaucoma
Region	Japan

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

Objectives
Narrative objectives1	To investigate progression and correlation of structure and visual field in glaucoma patients
Basic objectives2	Others
Basic objectives -Others	Structure and visual field progression
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	MD Retinal nerve fiber layer
Key secondary outcomes

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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Subject who is willing to follow instruction, and has provided a written informed consent Diagnosis of open-angle glaucoma with glaucomatous visual field disorder in at least one eye In both eyes, gonioscopy grading of 3 or 4 in Shaffer classification
Key exclusion criteria	Subject who has a disease which considered inappropriate from safety perspective(severe cardiovascular/ respiratory/ hepatobiliary/ digestive/ urinary/ renal/ hematological/ endocrine/ immune disease, malignant tumor, etc.) The investigator, subinvestigator determined that the person is ineligible as study subject
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Hidenobu Middle name Last name Tanihara
Organization	Faculty of Life Science, Kumamoto University
Division name	Department of Ophthalmology
Zip code	860-8556
Address	1-1-1, Honjo Chuo-ku Kumamoto Japan
TEL	096-373-5247
Email	tanihara@pearl.ocn.ne.jp

Public contact
Name of contact person	1st name Hisashi Middle name Last name Kawata
Organization	Santen Pharmaceutical CO., LTD.
Division name	Clinical Development Group
Zip code	530-8552
Address	4-20, Ofukacho Kita-ku Osaka Japan
TEL	06-4802-9338
Homepage URL
Email	clinical@santen.co.jp

Sponsor
Institute	Santen Pharmaceutical CO., LTD.
Institute
Department

Funding Source
Organization	Santen Pharmaceutical CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kumamoto University CCR Review Board
Address	1-1-1, Honjo Chuo-ku Kumamoto Japan
Tel	096-373-5965
Email	byi-senshin@jimu.kumamoto-u.ac.jp

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	2013 Year 11 Month 29 Day

Related information
URL releasing protocol	Not applicable
Publication of results	Published

Result
URL related to results and publications	Not applicable
Number of participants that the trial has enrolled	119
Results	The analysis included 195 eyes of 115 patients [41 eyes in POAG (narrow) and 154 eyes in normal tension glaucoma (NTG)], 32 eyes in DH group, 10 eyes in migraine group, and 19 eyes in diabetic group. The mean IOP and mean MD of all groups at baseline were 13.3 plus or minus 2.2 mmHg and -6.4 plus or minus4.0 dB, respectively; the DH group had a greater proportion of NTG than the group without risk factors, but there was no significant difference in the degree of visual field impairment.
Results date posted	2022 Year 03 Month 10 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Not applicable due to observational study
Participant flow	Not applicable due to observational study
Adverse events	Not applicable due to observational study
Outcome measures	Not applicable due to observational study
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 02 Month 03 Day
Date of IRB	2010 Year 03 Month 24 Day
Anticipated trial start date	2010 Year 07 Month 01 Day
Last follow-up date	2015 Year 06 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	A prospective observational study

Management information
Registered date	2013 Year 11 Month 27 Day
Last modified on	2022 Year 03 Month 10 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014465