UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045092 |
|---|---|
| Receipt number | R000051510 |
| Scientific Title | Clinical evaluation of high resolution retinal ganglion cell imaging |
| Date of disclosure of the study information | 2021/08/08 |
| Last modified on | 2021/09/10 19:41:07 |
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Basic information
Public title
Clinical evaluation of high resolution retinal ganglion cell imaging
Acronym
Clinical evaluation of high resolution retinal ganglion cell imaging
Scientific Title
Clinical evaluation of high resolution retinal ganglion cell imaging
Scientific Title:Acronym
Clinical evaluation of high resolution retinal ganglion cell imaging
Region
| Japan |
Condition
Condition
glaucoma, retinal diseases, optic nerve associated diseases
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A clinical research prototype of the Adaptive Optics-Scanning Laser Ophthalmoscope (AO-SLO), spectral-domain optical coherence tomography (SS-OCT), was used to image human eyes. The purpose of this study is to compare glaucomatous eyes with normal eyes and to evaluate the clinical usefulness of the acquired high-resolution fundus images of intraretinal cells, including retinal ganglion cells, and vascular indices.
Basic objectives2
Others
Basic objectives -Others
To search and evaluate novel index.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Each of the following items will be evaluated, as well as the correlation between each item.
1) Items to examine the difference between healthy and pathological eyes
Various parameters of cells in the retina, including retinal ganglion cells (number of cells at each position in the retina, cell density, cell arrangement, etc.)
2) Items to be examined for differences between the test device and other ophthalmic devices (OCT, etc.) Findings based on images and measurement data
3) Items to examine the differences in physical findings
Translated with www.DeepL.com/Translator (free version)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Visual acuity test, intraocular pressure test, visual field test, fundus photography, optical coherence tomography, adaptive optics optical coherence tomography system, etc.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Glaucoma group (Glaucomatous eyes)
1) Able to undergo regular ophthalmologic examinations at the Department of Ophthalmology, Kyoto University Hospital by ophthalmologist 2) Aged 40 years or older at the time of case registration 3) Any gender 4) Having eyes diagnosed as primary open-angle glaucoma (broad sense) by ophthalmologist 5) Without a history of severe or uncontrolled systemic disease 6) Written consent for participation in the study has been obtained from the subject himself/herself. Control group (healthy eyes) 1) Able to undergo multiple ophthalmologic examinations at the Department of Ophthalmology, Kyoto University Hospital. 2) Aged 40 years or older at the time of case enrollment. 3) Any gender. 4) Without a history of severe or uncontrolled systemic disease, and without retinal disease (including suspected glaucoma and anterior segment glaucoma) in at least one eye. 5) Written consent for participation in the study has been obtained from the subject.
Key exclusion criteria
Glaucoma group (glaucomatous eyes) 1) History of retinal disease (macular edema, retinal detachment, diabetic retinopathy, pathological myopia, etc.) or optic neuropathy other than glaucoma 2) Severe glaucoma (MD below -12 dB, etc.) 3) History of adverse reaction (hypersensitivity, increased intraocular pressure, etc.) to mydriatic agent 4) Narrow angle is observed in a slit-lamp examination, and mydriasis is considered to have a high risk of inducing an acute glaucoma attack. 5) Inability to perform appropriate fundus observation using AO-OCT due to lens opacity caused by cataract. 6) Lack of corrected visual acuity to perform visual field testing appropriately. 7) History of corneal refractive surgery or severe ocular trauma. 8) Corneal or conjunctival abnormality that prevents appropriate measurement of intraocular pressure using a tonometer 9) Other cases that the principal investigator or the physician in charge deems inappropriate for the safe conduct of this study Control group (healthy eyes) In addition to 3) to 9) of "Glaucoma eyes," the following will be included. 1) Suspected glaucoma, anterior segment glaucoma, retinal disease (macular edema, retinal detachment, diabetic retinopathy, pathological myopia, etc.), or a history of optic neuropathy other than glaucoma
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Akitaka |
| Middle name | |
| Last name | Tujikawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3250
tujikawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Shogo |
| Middle name | |
| Last name | Numa |
Organization
Kyoto University Graduate School of Medicine
Division name
Ophthalmology & Visual Sciences
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, JAPAN
TEL
075-751-3250
Homepage URL
numa1988@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine,Department of Ophthalmology & Visual Sciences
Institute
Department
Personal name
Funding Source
Organization
Santen
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
CANON INC.,Santen
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2021 | Year | 08 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 07 | Day |
Last modified on
| 2021 | Year | 09 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051510
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
