UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Anterior Chamber Angle Measurement with Swept-source Optical Coherence Tomography - A Pilot Normative Database Collection Study
Title of the study (Brief title)	Anterior Chamber Angle Measurement with SS-OCT
Region	Japan Asia(except Japan) North America

Condition
Condition	healthy subjects, primary angle-closure suspect, primary angle-closure and primary angle-closure glaucoma
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Primary angle-closure glaucoma (PACG) is a leading cause of irreversible blindness in Asia. It has been estimated that there will be more than 15million people with PACG worldwide by 2020 among which 84.8% are in Asia. As glaucoma is by large asymptomatic, identifying and treating patients at risk of disease progression is fundamental to prevent glaucoma blindness. From primary angle-closure suspect (PACS) (i.e. appositional contact between the peripheral iris and posterior trabecular meshwork for >180 degrees), to primary angle-closure (PAC) (i.e. iridotrabecular contact for >180 degrees together with elevated intraocular pressure (IOP) and / or development of peripheral anterior synechiae(PAS)) and then PACG, primary angle closure diseases forma continuum of progressive disorders of the anterior chamber angle and the optic nerve that would lead to visual impairment and blindness if left undetected. Although the diagnosis of angle-closure has been based on gonioscopic evaluation of iridotrabecular contact, reliable quantification of the anterior chamber angle width is difficult with gonioscopy. With the availability of swept-source optical coherence tomography (SS-OCT), it is feasible to measure the anterior chamber angle dimensions with high reproducibility for 360 degrees. This study aims to collect anterior chamber angle measurements from normal subjects and patients with primary angle closure diseases using the SS-OCT, and develop a normative database for discrimination between primary angle closure eyes and eyes with open angle. The normative database will provide an important clinical tool for clinicians to detect primary angle closure diseases for prevention of disease progression and blindness.
Basic objectives2	Others
Basic objectives -Others	To collect anterior chamber angle measurements from normal subjects and patients with primary angle closure diseases using the SS-OCT.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The scan protocols comprise (1) custom 'Lens biometry' which includes 18 radial B-scans (800 A-scans/B-scan), each with 16 mm in length and 14 mm in depth and (2) 'Anterior segment' which includes 16 radial B-scans (800 A-scans/B-scan), each with 16 mm in length and 11 mm in depth. Eyes will be imaged in the dark (<1.0 lux) for three times with custom 'Lens Biometry' and once with 'Anterior segment'; and then in room light (needs to standardize the room light illumination) for three times with custom 'Lens Biometry' and once with 'Anterior segment'.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Japanese healthy subjects and/or patients with primary angle closure glaucoma (PACG) 1. over 40 years 2. eyes not performing cataract surgery 3. maximum visual acuity more than 0.5 4. spherical equivalent (refraction) more than -1.0 diopters Normal eyes always show normal intraocular pressure (from 10 to 21 mmHg), have an open angle, and have no glaucomatous optic neuropathy Glaucoma is an eye with characteristic morphological changes of the optic disc or retinal nerve fiber and corresponding visual field defects PACG is classified as follows according to angular examination and intraocular pressure .primary angle closure suspect(PACS) .primary angle closure (PAC) .primary angle closure glaucoma (PACG)
Key exclusion criteria	Those who do not meet inclusion criteria from 1 to 4 Secondary glaucoma, eyes after intraocular surgery including laser treatment, eyes with strong cataract, those who can not conduct reliable examination
Target sample size	90

Research contact person
Name of lead principal investigator	Makoto Aihara
Organization	The University of Tokyo hospital
Division name	Department of ophthalmology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Email	aihara-tky@umin.ac.jp

Public contact
Name of contact person	Rei Sakata
Organization	The University of Tokyo hospital
Division name	Department of ophthalmology
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL	03-3815-5411
Homepage URL
Email	reisakata-tky@umin.ac.jp

Sponsor
Institute	The Chinese University of Hong Kong
Institute
Department

Funding Source
Organization	Tomey Corporation Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	東京大学医学部附属病院（東京都）

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 30 Day
Anticipated trial start date	2017 Year 06 Month 05 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study

Management information
Registered date	2017 Year 05 Month 30 Day
Last modified on	2018 Year 11 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031571