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Clinical evaluation of high resolution retinal ganglion cell imaging

Clinical evaluation of high resolution retinal ganglion cell imaging - Clinical evaluation of high resolution retinal ganglion cell imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000045092
Enrollment
80
Registered
2021-08-08
Start date
2021-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

glaucoma, retinal diseases, optic nerve associated diseases

Interventions

Visual acuity test, intraocular pressure test, visual field test, fundus photography, optical coherence tomography, adaptive optics optical coherence tomography system, etc.

Sponsors

Kyoto University Graduate School of Medicine,Department of Ophthalmology & Visual Sciences
Lead Sponsor
CANON INC.,Santen
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactShogo Numa

Kyoto University Graduate School of Medicine Ophthalmology & Visual Sciences

numa1988@kuhp.kyoto-u.ac.jp075-751-3250

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026