JPRN-jRCTs032230425
Recruiting
Phase 2
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 Ryutaro0 sites39 target enrollmentOctober 26, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Akiba Ryutaro
- Enrollment
- 39
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\[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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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