UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027544 |
|---|---|
| Receipt number | 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 21:31:39 |
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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
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
aihara-tky@umin.ac.jp
Public contact
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
reisakata-tky@umin.ac.jp
Sponsor or person
Institute
The Chinese University of Hong Kong
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031571
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