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Exploratory clinical study for early detection of glaucoma using novel evaluation device. (Exploratory clinical study for early detection of glaucoma using novel evaluation device.)

Exploratory clinical study for early detection of glaucoma using novel evaluation device.

Akiba Ryutaro

Chiba University Hospital

1-8-1, Inohana, Chuo-Ku, Chiba City, Chiba

akiba@chiba-u.jp

Akiba Ryutaro

Chiba University Hospital

1-8-1, Inohana, Chuo-Ku, Chiba City, Chiba

+81-43-226-2124

akiba@chiba-u.jp

Recruiting

Oct. 26, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

[Healthy subject]
Subject meeting all of below conditions:
1. Age between 20 and 80 years.
2. Eyes with open angle
3. Eyes with best corrected decimal visual acuity of or above 0.5
4. Eyes with refractive error of less than -6 diopters (spherical) and -3 diopters (cylinder).
5. Subject must undergo through explanation of the study, then sign the written consent form upon subject's free will.
6. Eyes without diagnosis of glaucoma or preperimetric glaucoma.

[Glaucoma subject]
Must meet criteria 1-5 of healthy subjects, and have eyes diagnosed as glaucoma.

[Preprimetric glaucoma subject]
Must meet criteria 1-5 of healyh subjects, and have eyesdiagnosed as preperimetric glaucoma.

1. Subject regarded as non-qualified by doctor in chief of the clinical study.
2. Eyes with history of ocular trauma, or intraocular surgery (Except for cataract and glaucoma with no surgical complications.)
3. Eyes with underlying retinal disease, uveitis, and non-glaucomatous optic neuritis.
4. History of optic chiasm disaese or demyelinating disease that affect visual field.
5. History of cognitive disase including Parkinson's diesase, Alzheimer's disease, and cerebral infarction.
6. Eyes with poor fixation upon Humphrey visual field test.

Both

Healthy subjects, Glaucoma, Preperimetric glaucoma

Visual field testing with newly deveoped perimetry.

glaucoma, preperimetric glaucoma

D005901

Correlation analysis between conventional humphrey fielad analyzer and the newly developed perimetry.

Correlation analysis between optical coherence tomography and newly developed perimetry.

+81-43-226-2616

Oct. 16, 2023

No

none