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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027544
Receipt No. R000031571
Scientific Title Anterior Chamber Angle Measurement with Swept-source Optical Coherence Tomography - A Pilot Normative Database Collection Study
Date of disclosure of the study information 2017/06/01
Last modified on 2018/11/30

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Basic information
Public title Anterior Chamber Angle Measurement with Swept-source Optical Coherence Tomography - A Pilot Normative Database Collection Study
Acronym Anterior Chamber Angle Measurement with SS-OCT
Scientific Title Anterior Chamber Angle Measurement with Swept-source Optical Coherence Tomography - A Pilot Normative Database Collection Study
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Makoto Aihara
Organization The University of Tokyo hospital
Division name Department of ophthalmology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Email aihara-tky@umin.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Rei Sakata
Organization The University of Tokyo hospital
Division name Department of ophthalmology
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2017 Year 05 Month 30 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000031571

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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